Trial Outcomes & Findings for A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants (NCT NCT03451851)
NCT ID: NCT03451851
Last Updated: 2025-11-13
Results Overview
The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, \>1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
120 participants
Primary outcome timeframe
At Week 16
Results posted on
2025-11-13
Participant Flow
This result is currently reported for primary analysis till clinical cut-off date 29-Mar-2024. In Part 1, the enrollment of participants aged greater than or equal to (\>=) 6 to less than (\<) 12 years started only after all participants aged \>=12 to \<18 years of age had finished Week 16 of the study. Long-term extension (LTE) phase is still ongoing, and results will be posted upon study completion.
Participant milestones
| Measure |
Group 1 (Part 1): Placebo (Week 0-16)
Adolescent participants (aged \>=12 to \<18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 2 (Part 1): Guselkumab (Week 0-16)
Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight \[BW\] \<70 kg, 100 mg for BW \>=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 3 (Part 1): Etanercept (Week 0-16)
Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW \<63 kg and 50 mg for BW \>=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 1 (Part 1): Placebo to Guselkumab (Week 16-52)
Participants who received placebo during PCP were assessed for psoriasis area and severity index (PASI) response at Week 16. Participants who were PASI 90 non-responders at Week 16 received weight-based doses of guselkumab (1.3 mg/kg for BW \<70 kg, 100 mg for BW \>=70 kg) as SC injection at Weeks 16, 20 and then every 8 weeks (q8w) thereafter through Week 52. Participants who were PASI 90 responders at Week 16 stopped treatment until they lost \>= 50 percent (%) of their Week 16 PASI response, at which time they were treated with guselkumab 1.3 mg/kg or 100 mg depending on their body weight followed by a dose 4 weeks later, and then guselkumab q8w thereafter through Week 52. All participants who completed Part 1 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.
|
Group 2 (Part 1): Guselkumab (Week 16-52)
Participants who received guselkumab during PCP were assessed for PASI response at Week 16. Participants who were PASI 90 non-responders at Week 16 received weight-based doses of guselkumab (1.3 mg/kg for BW \<70 kg, 100 mg for BW \>=70 kg) as SC injection at Weeks 16, 20 and then q8w thereafter through Week 52. Participants who were PASI 90 responders at Week 16 stopped treatment until they lost \>= 50 % of their Week 16 PASI response, at which time they were retreated with guselkumab 1.3 mg/kg or 100 mg depending on their body weight followed by a dose 4 weeks later, and then guselkumab every 8 weeks thereafter through Week 52. All participants who completed Part 1 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.
|
Group 3 (Part 1): Etanercept to Guselkumab (Week 16-52)
Participants who received etanercept during the PCP had the option to continue in the study or to discontinue the study. Participants that continued received weight-based doses of guselkumab (1.3 mg/kg for body weight \[BW\] \<70 kg, 100 mg for BW \>=70 kg) as SC injection at Weeks 20 and 24, followed by q8w dosing through Week 48 and remaining participants discontinued from the study. All participants who completed Part 1 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.
|
Part 2: Guselkumab (Week 0-16)
Adolescent participants received weight-based dose of open-label guselkumab (1.3 mg/kg for body weight \[BW\] \<70 kg, 100 mg for BW \>=70 kg) as SC injection at Weeks 0, 4, and 16.
|
Part 2: Guselkumab (Week 16-52)
Participants who completed Week 16 during PCP continued to receive weight-based dose of open-label guselkumab (1.3 mg/kg for body weight \[BW\] \<70 kg, 100 mg for BW \>=70 kg) as SC injection q8w from Weeks 16 through Week 52. All participants who completed Part 2 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.
|
|---|---|---|---|---|---|---|---|---|
|
PCP: Week 0 -16
COMPLETED
|
24
|
41
|
23
|
0
|
0
|
0
|
27
|
0
|
|
PCP: Week 0 -16
STARTED
|
25
|
41
|
26
|
0
|
0
|
0
|
28
|
0
|
|
PCP: Week 0 -16
NOT COMPLETED
|
1
|
0
|
3
|
0
|
0
|
0
|
1
|
0
|
|
Withdrawal and Retreament: Week 16-52
STARTED
|
0
|
0
|
0
|
23
|
41
|
22
|
0
|
27
|
|
Withdrawal and Retreament: Week 16-52
COMPLETED
|
0
|
0
|
0
|
23
|
35
|
21
|
0
|
27
|
|
Withdrawal and Retreament: Week 16-52
NOT COMPLETED
|
0
|
0
|
0
|
0
|
6
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Group 1 (Part 1): Placebo (Week 0-16)
Adolescent participants (aged \>=12 to \<18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 2 (Part 1): Guselkumab (Week 0-16)
Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight \[BW\] \<70 kg, 100 mg for BW \>=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 3 (Part 1): Etanercept (Week 0-16)
Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW \<63 kg and 50 mg for BW \>=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 1 (Part 1): Placebo to Guselkumab (Week 16-52)
Participants who received placebo during PCP were assessed for psoriasis area and severity index (PASI) response at Week 16. Participants who were PASI 90 non-responders at Week 16 received weight-based doses of guselkumab (1.3 mg/kg for BW \<70 kg, 100 mg for BW \>=70 kg) as SC injection at Weeks 16, 20 and then every 8 weeks (q8w) thereafter through Week 52. Participants who were PASI 90 responders at Week 16 stopped treatment until they lost \>= 50 percent (%) of their Week 16 PASI response, at which time they were treated with guselkumab 1.3 mg/kg or 100 mg depending on their body weight followed by a dose 4 weeks later, and then guselkumab q8w thereafter through Week 52. All participants who completed Part 1 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.
|
Group 2 (Part 1): Guselkumab (Week 16-52)
Participants who received guselkumab during PCP were assessed for PASI response at Week 16. Participants who were PASI 90 non-responders at Week 16 received weight-based doses of guselkumab (1.3 mg/kg for BW \<70 kg, 100 mg for BW \>=70 kg) as SC injection at Weeks 16, 20 and then q8w thereafter through Week 52. Participants who were PASI 90 responders at Week 16 stopped treatment until they lost \>= 50 % of their Week 16 PASI response, at which time they were retreated with guselkumab 1.3 mg/kg or 100 mg depending on their body weight followed by a dose 4 weeks later, and then guselkumab every 8 weeks thereafter through Week 52. All participants who completed Part 1 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.
|
Group 3 (Part 1): Etanercept to Guselkumab (Week 16-52)
Participants who received etanercept during the PCP had the option to continue in the study or to discontinue the study. Participants that continued received weight-based doses of guselkumab (1.3 mg/kg for body weight \[BW\] \<70 kg, 100 mg for BW \>=70 kg) as SC injection at Weeks 20 and 24, followed by q8w dosing through Week 48 and remaining participants discontinued from the study. All participants who completed Part 1 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.
|
Part 2: Guselkumab (Week 0-16)
Adolescent participants received weight-based dose of open-label guselkumab (1.3 mg/kg for body weight \[BW\] \<70 kg, 100 mg for BW \>=70 kg) as SC injection at Weeks 0, 4, and 16.
|
Part 2: Guselkumab (Week 16-52)
Participants who completed Week 16 during PCP continued to receive weight-based dose of open-label guselkumab (1.3 mg/kg for body weight \[BW\] \<70 kg, 100 mg for BW \>=70 kg) as SC injection q8w from Weeks 16 through Week 52. All participants who completed Part 2 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.
|
|---|---|---|---|---|---|---|---|---|
|
PCP: Week 0 -16
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
PCP: Week 0 -16
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
PCP: Week 0 -16
Withdrawal by Parent/Guardian
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Withdrawal and Retreament: Week 16-52
Other Withdrawal by Parent/Guardian
|
0
|
0
|
0
|
0
|
3
|
1
|
0
|
0
|
|
Withdrawal and Retreament: Week 16-52
Other Unspecified
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Withdrawal and Retreament: Week 16-52
Other- completed safety follow up
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
Baseline Characteristics
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants
Baseline characteristics by cohort
| Measure |
Group 1 (Part 1): Placebo (Week 0-16)
n=25 Participants
Adolescent participants (aged \>=12 to \<18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 2 (Part 1): Guselkumab (Week 0-16)
n=41 Participants
Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight \[BW\] \<70 kg, 100 mg for BW \>=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 3 (Part 1): Etanercept (Week 0-16)
n=26 Participants
Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW \<63 kg and 50 mg for BW \>=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
Part 2: Guselkumab (Week 0-16)
n=28 Participants
Adolescent participants received weight-based dose of open-label guselkumab (1.3 mg/kg for body weight \[BW\] \<70 kg, 100 mg for BW \>=70 kg) as SC injection at Weeks 0, 4, and 16.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
4 Participants
n=44 Participants
|
|
Age, Customized
>=6 to <12 years
|
10 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
10 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
30 Participants
n=44 Participants
|
|
Age, Customized
>=12 to <18 years
|
15 Participants
n=10 Participants
|
31 Participants
n=10 Participants
|
16 Participants
n=20 Participants
|
28 Participants
n=45 Participants
|
90 Participants
n=44 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=10 Participants
|
17 Participants
n=10 Participants
|
11 Participants
n=20 Participants
|
11 Participants
n=45 Participants
|
52 Participants
n=44 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=10 Participants
|
24 Participants
n=10 Participants
|
15 Participants
n=20 Participants
|
17 Participants
n=45 Participants
|
68 Participants
n=44 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
4 Participants
n=44 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
|
Race/Ethnicity, Customized
White
|
20 Participants
n=10 Participants
|
36 Participants
n=10 Participants
|
22 Participants
n=20 Participants
|
28 Participants
n=45 Participants
|
106 Participants
n=44 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
2 Participants
n=44 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
1 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
1 Participants
n=44 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=10 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
3 Participants
n=44 Participants
|
|
Region of Enrollment
AUSTRALIA
|
0 participants
n=10 Participants
|
1 participants
n=10 Participants
|
0 participants
n=20 Participants
|
0 participants
n=45 Participants
|
1 participants
n=44 Participants
|
|
Region of Enrollment
BELGIUM
|
0 participants
n=10 Participants
|
4 participants
n=10 Participants
|
5 participants
n=20 Participants
|
2 participants
n=45 Participants
|
11 participants
n=44 Participants
|
|
Region of Enrollment
CANADA
|
1 participants
n=10 Participants
|
5 participants
n=10 Participants
|
1 participants
n=20 Participants
|
1 participants
n=45 Participants
|
8 participants
n=44 Participants
|
|
Region of Enrollment
GERMANY
|
4 participants
n=10 Participants
|
4 participants
n=10 Participants
|
5 participants
n=20 Participants
|
9 participants
n=45 Participants
|
22 participants
n=44 Participants
|
|
Region of Enrollment
HUNGARY
|
6 participants
n=10 Participants
|
11 participants
n=10 Participants
|
4 participants
n=20 Participants
|
9 participants
n=45 Participants
|
30 participants
n=44 Participants
|
|
Region of Enrollment
ITALY
|
4 participants
n=10 Participants
|
4 participants
n=10 Participants
|
1 participants
n=20 Participants
|
1 participants
n=45 Participants
|
10 participants
n=44 Participants
|
|
Region of Enrollment
NETHERLANDS
|
1 participants
n=10 Participants
|
2 participants
n=10 Participants
|
0 participants
n=20 Participants
|
0 participants
n=45 Participants
|
3 participants
n=44 Participants
|
|
Region of Enrollment
POLAND
|
5 participants
n=10 Participants
|
7 participants
n=10 Participants
|
6 participants
n=20 Participants
|
6 participants
n=45 Participants
|
24 participants
n=44 Participants
|
|
Region of Enrollment
UNITED STATES
|
4 participants
n=10 Participants
|
3 participants
n=10 Participants
|
4 participants
n=20 Participants
|
0 participants
n=45 Participants
|
11 participants
n=44 Participants
|
|
AgeContinuous
|
12.4 years
STANDARD_DEVIATION 3.63 • n=10 Participants
|
13.4 years
STANDARD_DEVIATION 2.86 • n=10 Participants
|
12.5 years
STANDARD_DEVIATION 3.29 • n=20 Participants
|
15.1 years
STANDARD_DEVIATION 1.59 • n=45 Participants
|
13.4 years
STANDARD_DEVIATION 3.05 • n=44 Participants
|
PRIMARY outcome
Timeframe: At Week 16Population: The efficacy analysis for Part 1 of the study was based upon the full analysis set (FAS) which included all randomized participants in Part 1. In the efficacy analyses, participants were analyzed according to their assigned treatment group regardless of their actual treatment received.
The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, \>1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease.
Outcome measures
| Measure |
Group 1 (Part 1): Placebo (Week 0-16)
n=25 Participants
Adolescent participants (aged \>=12 to \<18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 2 (Part 1): Guselkumab (Week 0-16)
n=41 Participants
Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight \[BW\] \<70 kg, 100 mg for BW \>=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 3 (Part 1): Etanercept (Week 0-16)
n=26 Participants
Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW \<63 kg and 50 mg for BW \>=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
|---|---|---|---|
|
Part 1: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16
|
16.0 Percentages of participants
|
65.9 Percentages of participants
|
69.2 Percentages of participants
|
PRIMARY outcome
Timeframe: At Week 16Population: The efficacy analysis for Part 1 of the study was based upon the FAS which included all randomized participants in Part 1. In the efficacy analyses, participants were analyzed according to their assigned treatment group regardless of their actual treatment received.
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produced a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicated more severe disease. A PASI 75 response represented participants who achieved at least a 75 % improvement from baseline in the PASI score.
Outcome measures
| Measure |
Group 1 (Part 1): Placebo (Week 0-16)
n=25 Participants
Adolescent participants (aged \>=12 to \<18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 2 (Part 1): Guselkumab (Week 0-16)
n=41 Participants
Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight \[BW\] \<70 kg, 100 mg for BW \>=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 3 (Part 1): Etanercept (Week 0-16)
n=26 Participants
Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW \<63 kg and 50 mg for BW \>=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
|---|---|---|---|
|
Part 1: Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 16
|
20.0 Percentage of Participants
|
75.6 Percentage of Participants
|
69.2 Percentage of Participants
|
SECONDARY outcome
Timeframe: At Week 16Population: The efficacy analysis for Part 1 of the study was based upon the FAS which included all randomized participants in Part 1. In the efficacy analyses, participants were analyzed according to their assigned treatment group regardless of their actual treatment received.
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 % to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produced a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicated more severe disease. A PASI 90 response represented participants who achieved at least a 90 % improvement from baseline in the PASI score.
Outcome measures
| Measure |
Group 1 (Part 1): Placebo (Week 0-16)
n=25 Participants
Adolescent participants (aged \>=12 to \<18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 2 (Part 1): Guselkumab (Week 0-16)
n=41 Participants
Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight \[BW\] \<70 kg, 100 mg for BW \>=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 3 (Part 1): Etanercept (Week 0-16)
n=26 Participants
Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW \<63 kg and 50 mg for BW \>=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
|---|---|---|---|
|
Part 1: Percentage of Participants Who Achieve PASI 90 Response at Week 16
|
16.0 Percentage of Participants
|
56.1 Percentage of Participants
|
53.8 Percentage of Participants
|
SECONDARY outcome
Timeframe: At Week 16Population: The efficacy analysis for Part 1 of the study was based upon the FAS which included all randomized participants in Part 1. In the efficacy analyses, participants were analyzed according to their assigned treatment group regardless of their actual treatment received.
The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, \>1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease.
Outcome measures
| Measure |
Group 1 (Part 1): Placebo (Week 0-16)
n=25 Participants
Adolescent participants (aged \>=12 to \<18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 2 (Part 1): Guselkumab (Week 0-16)
n=41 Participants
Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight \[BW\] \<70 kg, 100 mg for BW \>=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 3 (Part 1): Etanercept (Week 0-16)
n=26 Participants
Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW \<63 kg and 50 mg for BW \>=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
|---|---|---|---|
|
Part 1: Percentage of Participants Who Achieved an IGA Score of Cleared (0) at Week 16
|
4.0 Percentages of participants
|
39.0 Percentages of participants
|
26.9 Percentages of participants
|
SECONDARY outcome
Timeframe: At Week 16Population: The efficacy analysis for Part 1 of the study was based upon the FAS which included all randomized participants in Part 1. In the efficacy analyses, participants were analyzed according to their assigned treatment group regardless of their actual treatment received.
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 (none) to 4 (severe). The PASI produced a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicated more severe disease. A PASI 100 response represented participants who achieved a 100 % improvement from baseline in the PASI score.
Outcome measures
| Measure |
Group 1 (Part 1): Placebo (Week 0-16)
n=25 Participants
Adolescent participants (aged \>=12 to \<18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 2 (Part 1): Guselkumab (Week 0-16)
n=41 Participants
Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight \[BW\] \<70 kg, 100 mg for BW \>=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 3 (Part 1): Etanercept (Week 0-16)
n=26 Participants
Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW \<63 kg and 50 mg for BW \>=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
|---|---|---|---|
|
Part 1: Percentage of Participants Who Achieved PASI 100 Response at Week 16
|
0 Percentages of participants
|
34.1 Percentages of participants
|
26.9 Percentages of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: The efficacy analysis for Part 1 of the study was based upon the FAS which included all randomized participants in Part 1. In the efficacy analyses, participants were analyzed according to their assigned treatment group regardless of their actual treatment received.
CDLQI is a 10-item questionnaire that measures the impact of skin disease on children's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of questions 1-10 and ranged from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children. Change from baseline is defined as post baseline score minus baseline score.
Outcome measures
| Measure |
Group 1 (Part 1): Placebo (Week 0-16)
n=25 Participants
Adolescent participants (aged \>=12 to \<18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 2 (Part 1): Guselkumab (Week 0-16)
n=41 Participants
Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight \[BW\] \<70 kg, 100 mg for BW \>=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 3 (Part 1): Etanercept (Week 0-16)
n=26 Participants
Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW \<63 kg and 50 mg for BW \>=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
|---|---|---|---|
|
Part 1: Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score at Week 16
|
-1.68 Score on a scale
Standard Deviation 6.323
|
-7.12 Score on a scale
Standard Deviation 7.633
|
-6.08 Score on a scale
Standard Deviation 5.692
|
SECONDARY outcome
Timeframe: At 4 and 8 weeks post retreatment (retreatment period ranged from Week 16 to Week 52)Population: Analysis population included Guselkumab PASI 90 responders at Week 16 who were retreated with guselkumab prior to Week 52. This outcome measure was planned to be analyzed for "Group 2 (Part 1): Guselkumab (Week 16-52)" arm only. Here, n (Number Analyzed) signifies number of participants evaluable at specified time points.
PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translates to score that ranges from 0 (indicates no involvement) to 6 (90 % to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). PASI produced a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicated more severe disease. A PASI 90 response represented participants who achieved at least a 90 % improvement from baseline in PASI score.
Outcome measures
| Measure |
Group 1 (Part 1): Placebo (Week 0-16)
n=4 Participants
Adolescent participants (aged \>=12 to \<18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 2 (Part 1): Guselkumab (Week 0-16)
Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight \[BW\] \<70 kg, 100 mg for BW \>=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 3 (Part 1): Etanercept (Week 0-16)
Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW \<63 kg and 50 mg for BW \>=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
|---|---|---|---|
|
Part 1: Percentage of Retreated Participants Who Achieved a PASI 90 Response Over Time After Retreatment
4 weeks after retreatment of guselkumab
|
0 Percentages of participants
|
—
|
—
|
|
Part 1: Percentage of Retreated Participants Who Achieved a PASI 90 Response Over Time After Retreatment
8 weeks after retreatment of guselkumab
|
50.0 Percentages of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At 4 and 8 weeks post retreatment (retreatment period ranged from Week 16 to Week 52)Population: Analysis population included guselkumab PASI 90 responders at Week 16 who were retreated with guselkumab prior to Week 52. Here, n (Number Analyzed) signifies number of participants evaluable at specified time points. This outcome measure was planned to be analyzed for "Group 2 (Part 1): Guselkumab (Week 16-52)" arm only.
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produced a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicated more severe disease. PASI 50, 75, 90 and 100 response represented at least 50, 75, 90 and 100% improvement from baseline respectively, in the PASI score.
Outcome measures
| Measure |
Group 1 (Part 1): Placebo (Week 0-16)
n=4 Participants
Adolescent participants (aged \>=12 to \<18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 2 (Part 1): Guselkumab (Week 0-16)
Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight \[BW\] \<70 kg, 100 mg for BW \>=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 3 (Part 1): Etanercept (Week 0-16)
Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW \<63 kg and 50 mg for BW \>=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
|---|---|---|---|
|
Part 1: Percentage of Retreated Participants Who Achieved PASI Responses (PASI 50, 75, 90, and 100) Over Time After Retreatment
4 weeks after retreatment: >=50% improvement
|
50.0 At 4 and 8 weeks post retreatment
|
—
|
—
|
|
Part 1: Percentage of Retreated Participants Who Achieved PASI Responses (PASI 50, 75, 90, and 100) Over Time After Retreatment
4 weeks after retreatment: >=75% improvement
|
0 At 4 and 8 weeks post retreatment
|
—
|
—
|
|
Part 1: Percentage of Retreated Participants Who Achieved PASI Responses (PASI 50, 75, 90, and 100) Over Time After Retreatment
4 weeks after retreatment:>= 90% improvement
|
0 At 4 and 8 weeks post retreatment
|
—
|
—
|
|
Part 1: Percentage of Retreated Participants Who Achieved PASI Responses (PASI 50, 75, 90, and 100) Over Time After Retreatment
4 weeks after retreatment: 100% improvement
|
0 At 4 and 8 weeks post retreatment
|
—
|
—
|
|
Part 1: Percentage of Retreated Participants Who Achieved PASI Responses (PASI 50, 75, 90, and 100) Over Time After Retreatment
8 weeks after retreatment: >=50% improvement
|
50.0 At 4 and 8 weeks post retreatment
|
—
|
—
|
|
Part 1: Percentage of Retreated Participants Who Achieved PASI Responses (PASI 50, 75, 90, and 100) Over Time After Retreatment
8 weeks after retreatment: >=75% improvement
|
50.0 At 4 and 8 weeks post retreatment
|
—
|
—
|
|
Part 1: Percentage of Retreated Participants Who Achieved PASI Responses (PASI 50, 75, 90, and 100) Over Time After Retreatment
8 weeks after retreatment:>= 90% improvement
|
50.0 At 4 and 8 weeks post retreatment
|
—
|
—
|
|
Part 1: Percentage of Retreated Participants Who Achieved PASI Responses (PASI 50, 75, 90, and 100) Over Time After Retreatment
8 weeks after retreatment: 100% improvement
|
50.0 At 4 and 8 weeks post retreatment
|
—
|
—
|
SECONDARY outcome
Timeframe: At 4 and 8 weeks post retreatment (retreatment period ranged from Week 16 to Week 52)Population: Analysis population included Guselkumab PASI 90 responders at Week 16 who were retreated with guselkumab prior to Week 52. Here, n (Number Analyzed) signifies number of participants evaluable at specified time points. This outcome measure was planned to be analyzed for "Group 2 (Part 1): Guselkumab (Week 16-52)" arm only.
The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 points scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, \>1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 points scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease.
Outcome measures
| Measure |
Group 1 (Part 1): Placebo (Week 0-16)
n=4 Participants
Adolescent participants (aged \>=12 to \<18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 2 (Part 1): Guselkumab (Week 0-16)
Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight \[BW\] \<70 kg, 100 mg for BW \>=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 3 (Part 1): Etanercept (Week 0-16)
Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW \<63 kg and 50 mg for BW \>=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
|---|---|---|---|
|
Part 1: Percentage of Retreated Participants Who Achieved IGA Responses (IGA of Cleared [0], Minimal [1], or Mild [2], IGA of Cleared [0] or Minimal [1], and IGA of Cleared [0]) Over Time After Retreatment
4 Weeks after retreatment: IGA-0 or 1
|
25.0 Percentages of participants
|
—
|
—
|
|
Part 1: Percentage of Retreated Participants Who Achieved IGA Responses (IGA of Cleared [0], Minimal [1], or Mild [2], IGA of Cleared [0] or Minimal [1], and IGA of Cleared [0]) Over Time After Retreatment
4 Weeks after retreatment: IGA-2
|
75.0 Percentages of participants
|
—
|
—
|
|
Part 1: Percentage of Retreated Participants Who Achieved IGA Responses (IGA of Cleared [0], Minimal [1], or Mild [2], IGA of Cleared [0] or Minimal [1], and IGA of Cleared [0]) Over Time After Retreatment
8 Weeks after retreatment: IGA-0 or 1
|
50.0 Percentages of participants
|
—
|
—
|
|
Part 1: Percentage of Retreated Participants Who Achieved IGA Responses (IGA of Cleared [0], Minimal [1], or Mild [2], IGA of Cleared [0] or Minimal [1], and IGA of Cleared [0]) Over Time After Retreatment
8 Weeks after retreatment: IGA- 2
|
100.0 Percentages of participants
|
—
|
—
|
|
Part 1: Percentage of Retreated Participants Who Achieved IGA Responses (IGA of Cleared [0], Minimal [1], or Mild [2], IGA of Cleared [0] or Minimal [1], and IGA of Cleared [0]) Over Time After Retreatment
4 Weeks after retreatment: IGA-0
|
0 Percentages of participants
|
—
|
—
|
|
Part 1: Percentage of Retreated Participants Who Achieved IGA Responses (IGA of Cleared [0], Minimal [1], or Mild [2], IGA of Cleared [0] or Minimal [1], and IGA of Cleared [0]) Over Time After Retreatment
8 Weeks after retreatment: IGA-0
|
50.0 Percentages of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: Analysis population included Guselkumab PASI 90 responders at Week 16. This outcome measure was planned to be analyzed for "Group 2 (Part 1): Guselkumab (Week 16-52)" arm only.
Cumulative rate of loss of at least 50% of PASI improvement was defined as percentage of participants with a loss of \>=50% of Week 16 PASI improvement after treatment is withdrawn. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 % to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produced a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicated more severe disease.
Outcome measures
| Measure |
Group 1 (Part 1): Placebo (Week 0-16)
n=23 Participants
Adolescent participants (aged \>=12 to \<18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 2 (Part 1): Guselkumab (Week 0-16)
Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight \[BW\] \<70 kg, 100 mg for BW \>=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 3 (Part 1): Etanercept (Week 0-16)
Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW \<63 kg and 50 mg for BW \>=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
|---|---|---|---|
|
Part 1: Cumulative Rate of Loss of at Least 50% of Week 16 PASI Improvement Through Week 52 Among Guselkumab PASI 90 Responders at Week 16
Week 24
|
0 Percentage of Participants
|
—
|
—
|
|
Part 1: Cumulative Rate of Loss of at Least 50% of Week 16 PASI Improvement Through Week 52 Among Guselkumab PASI 90 Responders at Week 16
Week 28
|
0 Percentage of Participants
|
—
|
—
|
|
Part 1: Cumulative Rate of Loss of at Least 50% of Week 16 PASI Improvement Through Week 52 Among Guselkumab PASI 90 Responders at Week 16
Week 32
|
0 Percentage of Participants
|
—
|
—
|
|
Part 1: Cumulative Rate of Loss of at Least 50% of Week 16 PASI Improvement Through Week 52 Among Guselkumab PASI 90 Responders at Week 16
Week 36
|
0 Percentage of Participants
|
—
|
—
|
|
Part 1: Cumulative Rate of Loss of at Least 50% of Week 16 PASI Improvement Through Week 52 Among Guselkumab PASI 90 Responders at Week 16
Week 40
|
0 Percentage of Participants
|
—
|
—
|
|
Part 1: Cumulative Rate of Loss of at Least 50% of Week 16 PASI Improvement Through Week 52 Among Guselkumab PASI 90 Responders at Week 16
Week 48
|
19.1 Percentage of Participants
|
—
|
—
|
|
Part 1: Cumulative Rate of Loss of at Least 50% of Week 16 PASI Improvement Through Week 52 Among Guselkumab PASI 90 Responders at Week 16
Week 52
|
19.1 Percentage of Participants
|
—
|
—
|
|
Part 1: Cumulative Rate of Loss of at Least 50% of Week 16 PASI Improvement Through Week 52 Among Guselkumab PASI 90 Responders at Week 16
Week 20
|
0 Percentage of Participants
|
—
|
—
|
|
Part 1: Cumulative Rate of Loss of at Least 50% of Week 16 PASI Improvement Through Week 52 Among Guselkumab PASI 90 Responders at Week 16
Week 44
|
9.3 Percentage of Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: Analysis population included Guselkumab PASI 90 responders at Week 16. This outcome measure was planned to be analyzed for "Group 2 (Part 1): Guselkumab (Week 16-52)" arm only.
Cumulative maintenance rate was defined as percentage of participants who maintained their PASI 90 response through Week 52 among guselkumab PASI 90 responders at Week 16. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produced a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicated more severe disease. A PASI 90 response represented participants who achieved at least a 90% improvement from baseline in PASI score.
Outcome measures
| Measure |
Group 1 (Part 1): Placebo (Week 0-16)
n=23 Participants
Adolescent participants (aged \>=12 to \<18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 2 (Part 1): Guselkumab (Week 0-16)
Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight \[BW\] \<70 kg, 100 mg for BW \>=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 3 (Part 1): Etanercept (Week 0-16)
Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW \<63 kg and 50 mg for BW \>=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
|---|---|---|---|
|
Part 1: Cumulative Maintenance Rate of PASI 90 Response Through Week 52 Among Guselkumab PASI 90 Responders at Week 16
Week 24
|
100 Percentage of participants
|
—
|
—
|
|
Part 1: Cumulative Maintenance Rate of PASI 90 Response Through Week 52 Among Guselkumab PASI 90 Responders at Week 16
Week 40
|
50.2 Percentage of participants
|
—
|
—
|
|
Part 1: Cumulative Maintenance Rate of PASI 90 Response Through Week 52 Among Guselkumab PASI 90 Responders at Week 16
Week 44
|
35.8 Percentage of participants
|
—
|
—
|
|
Part 1: Cumulative Maintenance Rate of PASI 90 Response Through Week 52 Among Guselkumab PASI 90 Responders at Week 16
Week 48
|
30.7 Percentage of participants
|
—
|
—
|
|
Part 1: Cumulative Maintenance Rate of PASI 90 Response Through Week 52 Among Guselkumab PASI 90 Responders at Week 16
Week 52
|
25.6 Percentage of participants
|
—
|
—
|
|
Part 1: Cumulative Maintenance Rate of PASI 90 Response Through Week 52 Among Guselkumab PASI 90 Responders at Week 16
Week 20
|
100 Percentage of participants
|
—
|
—
|
|
Part 1: Cumulative Maintenance Rate of PASI 90 Response Through Week 52 Among Guselkumab PASI 90 Responders at Week 16
Week 28
|
86.7 Percentage of participants
|
—
|
—
|
|
Part 1: Cumulative Maintenance Rate of PASI 90 Response Through Week 52 Among Guselkumab PASI 90 Responders at Week 16
Week 32
|
77.5 Percentage of participants
|
—
|
—
|
|
Part 1: Cumulative Maintenance Rate of PASI 90 Response Through Week 52 Among Guselkumab PASI 90 Responders at Week 16
Week 36
|
63.9 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 16Population: The efficacy analysis for Part 1 of the study was based upon the FAS which included all randomized participants in Part 1. In the efficacy analyses, participants were analyzed according to their assigned treatment group regardless of their actual treatment received.
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 % to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produced a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicated more severe disease. A PASI 50 response represented at least a 50% improvement from baseline in the PASI score.
Outcome measures
| Measure |
Group 1 (Part 1): Placebo (Week 0-16)
n=25 Participants
Adolescent participants (aged \>=12 to \<18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 2 (Part 1): Guselkumab (Week 0-16)
n=41 Participants
Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight \[BW\] \<70 kg, 100 mg for BW \>=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 3 (Part 1): Etanercept (Week 0-16)
n=26 Participants
Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW \<63 kg and 50 mg for BW \>=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
|---|---|---|---|
|
Part 1: Percentage of Participants Who Achieved a PASI 50 Response at Week 16
|
28.0 Percentages of participants
|
87.8 Percentages of participants
|
76.9 Percentages of participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, and 16Population: The efficacy analysis for Part 1 of the study was based upon the FAS which included all randomized participants in Part 1. In the efficacy analyses, participants were analyzed according to their assigned treatment group regardless of their actual treatment received. Here, n (number analyzed): number of participants evaluable for each arm at specified time points.
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produced a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicated more severe disease.
Outcome measures
| Measure |
Group 1 (Part 1): Placebo (Week 0-16)
n=25 Participants
Adolescent participants (aged \>=12 to \<18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 2 (Part 1): Guselkumab (Week 0-16)
n=41 Participants
Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight \[BW\] \<70 kg, 100 mg for BW \>=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 3 (Part 1): Etanercept (Week 0-16)
n=26 Participants
Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW \<63 kg and 50 mg for BW \>=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
|---|---|---|---|
|
Part 1: Percent Improvement From Baseline in PASI Through Week 16
Week 8
|
13.61 Percent improvement
Standard Deviation 40.734
|
71.25 Percent improvement
Standard Deviation 28.018
|
64.27 Percent improvement
Standard Deviation 29.314
|
|
Part 1: Percent Improvement From Baseline in PASI Through Week 16
Week 12
|
13.67 Percent improvement
Standard Deviation 52.391
|
79.79 Percent improvement
Standard Deviation 28.570
|
77.30 Percent improvement
Standard Deviation 24.735
|
|
Part 1: Percent Improvement From Baseline in PASI Through Week 16
Week 16
|
16.02 Percent improvement
Standard Deviation 55.538
|
79.83 Percent improvement
Standard Deviation 30.468
|
82.05 Percent improvement
Standard Deviation 23.225
|
|
Part 1: Percent Improvement From Baseline in PASI Through Week 16
Week 4
|
13.37 Percent improvement
Standard Deviation 30.074
|
39.12 Percent improvement
Standard Deviation 27.907
|
42.53 Percent improvement
Standard Deviation 26.013
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20, 28, 36, 44, and 52Population: FAS for Part 2 included all participants enrolled in Part 2. Here, n (number analyzed) signifies number of participants evaluable at specified time points.
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. The PASI produced a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicated more severe disease.
Outcome measures
| Measure |
Group 1 (Part 1): Placebo (Week 0-16)
n=28 Participants
Adolescent participants (aged \>=12 to \<18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 2 (Part 1): Guselkumab (Week 0-16)
Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight \[BW\] \<70 kg, 100 mg for BW \>=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 3 (Part 1): Etanercept (Week 0-16)
Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW \<63 kg and 50 mg for BW \>=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
|---|---|---|---|
|
Part 2: Percent Improvement From Baseline in PASI Through Week 52
Week 4
|
48.33 Percent improvement
Standard Deviation 26.781
|
—
|
—
|
|
Part 2: Percent Improvement From Baseline in PASI Through Week 52
Week 8
|
79.05 Percent improvement
Standard Deviation 21.177
|
—
|
—
|
|
Part 2: Percent Improvement From Baseline in PASI Through Week 52
Week 12
|
86.40 Percent improvement
Standard Deviation 15.541
|
—
|
—
|
|
Part 2: Percent Improvement From Baseline in PASI Through Week 52
Week 16
|
91.96 Percent improvement
Standard Deviation 11.177
|
—
|
—
|
|
Part 2: Percent Improvement From Baseline in PASI Through Week 52
Week 36
|
95.77 Percent improvement
Standard Deviation 7.848
|
—
|
—
|
|
Part 2: Percent Improvement From Baseline in PASI Through Week 52
Week 44
|
95.95 Percent improvement
Standard Deviation 7.430
|
—
|
—
|
|
Part 2: Percent Improvement From Baseline in PASI Through Week 52
Week 52
|
96.32 Percent improvement
Standard Deviation 7.478
|
—
|
—
|
|
Part 2: Percent Improvement From Baseline in PASI Through Week 52
Week 20
|
91.10 Percent improvement
Standard Deviation 14.851
|
—
|
—
|
|
Part 2: Percent Improvement From Baseline in PASI Through Week 52
Week 28
|
93.44 Percent improvement
Standard Deviation 12.948
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, and 16Population: The efficacy analysis for Part 1 of the study was based upon the FAS which included all randomized participants in Part 1. In the efficacy analyses, participants were analyzed according to their assigned treatment group regardless of their actual treatment received.
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. The PASI produced a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicated more severe disease. PASI 50, 75, 90, and 100 responses represented at least 50%, 75%, 90%, and 100% improvement from baseline respectively, in the PASI score.
Outcome measures
| Measure |
Group 1 (Part 1): Placebo (Week 0-16)
n=25 Participants
Adolescent participants (aged \>=12 to \<18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 2 (Part 1): Guselkumab (Week 0-16)
n=41 Participants
Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight \[BW\] \<70 kg, 100 mg for BW \>=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 3 (Part 1): Etanercept (Week 0-16)
n=26 Participants
Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW \<63 kg and 50 mg for BW \>=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
|---|---|---|---|
|
Part 1: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 16
Week 4: >= 50% improvement
|
8.0 Percentages of participants
|
34.1 Percentages of participants
|
38.5 Percentages of participants
|
|
Part 1: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 16
Week 4: >= 75% improvement
|
8.0 Percentages of participants
|
12.2 Percentages of participants
|
15.4 Percentages of participants
|
|
Part 1: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 16
Week 4: >= 90% improvement
|
4.0 Percentages of participants
|
2.4 Percentages of participants
|
3.8 Percentages of participants
|
|
Part 1: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 16
Week 4: 100% improvement
|
0 Percentages of participants
|
0 Percentages of participants
|
0 Percentages of participants
|
|
Part 1: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 16
Week 8: >= 50% improvement
|
20.0 Percentages of participants
|
78.0 Percentages of participants
|
73.1 Percentages of participants
|
|
Part 1: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 16
Week 8: >= 90% improvement
|
4.0 Percentages of participants
|
34.1 Percentages of participants
|
19.2 Percentages of participants
|
|
Part 1: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 16
Week 12: >= 50% improvement
|
24.0 Percentages of participants
|
85.4 Percentages of participants
|
76.9 Percentages of participants
|
|
Part 1: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 16
Week 12: >= 75% improvement
|
12.0 Percentages of participants
|
73.2 Percentages of participants
|
61.5 Percentages of participants
|
|
Part 1: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 16
Week 12: >= 90% improvement
|
8.0 Percentages of participants
|
56.1 Percentages of participants
|
38.5 Percentages of participants
|
|
Part 1: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 16
Week 12: 100% improvement
|
0 Percentages of participants
|
34.1 Percentages of participants
|
26.9 Percentages of participants
|
|
Part 1: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 16
Week 16: >= 50% improvement
|
28.0 Percentages of participants
|
87.8 Percentages of participants
|
76.9 Percentages of participants
|
|
Part 1: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 16
Week 16: >= 75% improvement
|
20.0 Percentages of participants
|
75.6 Percentages of participants
|
69.2 Percentages of participants
|
|
Part 1: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 16
Week 16: >= 90% improvement
|
16.0 Percentages of participants
|
56.1 Percentages of participants
|
53.8 Percentages of participants
|
|
Part 1: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 16
Week 16: 100% improvement
|
0 Percentages of participants
|
34.1 Percentages of participants
|
26.9 Percentages of participants
|
|
Part 1: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 16
Week 8: >= 75% improvement
|
8.0 Percentages of participants
|
51.2 Percentages of participants
|
46.2 Percentages of participants
|
|
Part 1: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 16
Week 8: 100% improvement
|
4.0 Percentages of participants
|
12.2 Percentages of participants
|
11.5 Percentages of participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20, 28, 36, 44, and 52Population: FAS for Part 2 included all participants enrolled in Part 2.
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produced a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicated more severe disease. PASI 50, 75, 90, and 100 responses represented at least 50%, 75%, 90%, and 100% improvement from baseline respectively, in the PASI score.
Outcome measures
| Measure |
Group 1 (Part 1): Placebo (Week 0-16)
n=28 Participants
Adolescent participants (aged \>=12 to \<18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 2 (Part 1): Guselkumab (Week 0-16)
Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight \[BW\] \<70 kg, 100 mg for BW \>=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 3 (Part 1): Etanercept (Week 0-16)
Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW \<63 kg and 50 mg for BW \>=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
|---|---|---|---|
|
Part 2: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 52
Week 44: >= 90% improvement
|
82.1 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 52
Week 44: 100% improvement
|
53.6 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 52
Week 52: >= 50% improvement
|
96.4 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 52
Week 52: >= 75% improvement
|
92.9 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 52
Week 52: >= 90% improvement
|
82.1 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 52
Week 4: >= 50% improvement
|
42.9 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 52
Week 4: >= 75% improvement
|
14.3 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 52
Week 4: >= 90% improvement
|
14.3 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 52
Week 4: 100% improvement
|
3.6 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 52
Week 8: >= 50% improvement
|
89.3 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 52
Week 8: >= 75% improvement
|
67.9 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 52
Week 8: >= 90% improvement
|
39.3 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 52
Week 8: 100% improvement
|
17.9 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 52
Week 12: >= 50% improvement
|
96.4 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 52
Week 12: >= 75% improvement
|
75.0 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 52
Week 12: >= 90% improvement
|
42.9 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 52
Week 12: 100% improvement
|
25.0 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 52
Week 16: >= 50% improvement
|
92.9 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 52
Week 16: >= 75% improvement
|
82.1 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 52
Week 16: >= 90% improvement
|
64.3 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 52
Week 16: 100% improvement
|
35.7 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 52
Week 20: >= 50% improvement
|
92.9 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 52
Week 20: >= 75% improvement
|
82.1 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 52
Week 20: >= 90% improvement
|
75.0 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 52
Week 20: 100% improvement
|
39.3 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 52
Week 28: >= 50% improvement
|
92.9 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 52
Week 28: >= 75% improvement
|
89.3 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 52
Week 28: >= 90% improvement
|
75.0 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 52
Week 28: 100% improvement
|
46.4 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 52
Week 36: >= 50% improvement
|
96.4 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 52
Week 36: >= 75% improvement
|
89.3 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 52
Week 36: >= 90% improvement
|
82.1 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 52
Week 36: 100% improvement
|
53.6 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 52
Week 44: >= 50% improvement
|
96.4 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 52
Week 44: >= 75% improvement
|
89.3 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 52
Week 52: 100% improvement
|
53.6 Percentages of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, and 16Population: The efficacy analysis for Part 1 of the study was based upon the FAS which included all randomized participants in Part 1. In the efficacy analyses, participants were analyzed according to their assigned treatment group regardless of their actual treatment received.
The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 points scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, \>1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 points scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease.
Outcome measures
| Measure |
Group 1 (Part 1): Placebo (Week 0-16)
n=25 Participants
Adolescent participants (aged \>=12 to \<18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 2 (Part 1): Guselkumab (Week 0-16)
n=41 Participants
Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight \[BW\] \<70 kg, 100 mg for BW \>=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 3 (Part 1): Etanercept (Week 0-16)
n=26 Participants
Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW \<63 kg and 50 mg for BW \>=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
|---|---|---|---|
|
Part 1: Percentage of Participants With IGA of Cleared (0), Cleared (0) or Minimal (1), Mild or Better (<=2) Through Week 16
Week 12: IGA of cleared (0)
|
4.0 Percentages of participants
|
43.9 Percentages of participants
|
26.9 Percentages of participants
|
|
Part 1: Percentage of Participants With IGA of Cleared (0), Cleared (0) or Minimal (1), Mild or Better (<=2) Through Week 16
Week 12 : IGA of cleared (0) or minimal (1)
|
8.0 Percentages of participants
|
70.7 Percentages of participants
|
65.4 Percentages of participants
|
|
Part 1: Percentage of Participants With IGA of Cleared (0), Cleared (0) or Minimal (1), Mild or Better (<=2) Through Week 16
Week 12 :IGA of mild or better (<=2)
|
40.0 Percentages of participants
|
87.8 Percentages of participants
|
84.6 Percentages of participants
|
|
Part 1: Percentage of Participants With IGA of Cleared (0), Cleared (0) or Minimal (1), Mild or Better (<=2) Through Week 16
Week 16: IGA of cleared (0)
|
4.0 Percentages of participants
|
39.0 Percentages of participants
|
26.9 Percentages of participants
|
|
Part 1: Percentage of Participants With IGA of Cleared (0), Cleared (0) or Minimal (1), Mild or Better (<=2) Through Week 16
Week 16 : IGA of cleared (0) or minimal (1)
|
16.0 Percentages of participants
|
65.9 Percentages of participants
|
69.2 Percentages of participants
|
|
Part 1: Percentage of Participants With IGA of Cleared (0), Cleared (0) or Minimal (1), Mild or Better (<=2) Through Week 16
Week 16 :IGA of mild or better (<=2)
|
48.0 Percentages of participants
|
92.7 Percentages of participants
|
84.6 Percentages of participants
|
|
Part 1: Percentage of Participants With IGA of Cleared (0), Cleared (0) or Minimal (1), Mild or Better (<=2) Through Week 16
Week 4 : IGA of cleared (0)
|
0 Percentages of participants
|
0 Percentages of participants
|
0 Percentages of participants
|
|
Part 1: Percentage of Participants With IGA of Cleared (0), Cleared (0) or Minimal (1), Mild or Better (<=2) Through Week 16
Week 4 : IGA of cleared (0) or minimal (1)
|
8.0 Percentages of participants
|
19.5 Percentages of participants
|
23.1 Percentages of participants
|
|
Part 1: Percentage of Participants With IGA of Cleared (0), Cleared (0) or Minimal (1), Mild or Better (<=2) Through Week 16
Week 4 :IGA of mild or better (<=2)
|
20.0 Percentages of participants
|
63.4 Percentages of participants
|
73.1 Percentages of participants
|
|
Part 1: Percentage of Participants With IGA of Cleared (0), Cleared (0) or Minimal (1), Mild or Better (<=2) Through Week 16
Week 8: IGA of cleared (0)
|
4.0 Percentages of participants
|
22.0 Percentages of participants
|
11.5 Percentages of participants
|
|
Part 1: Percentage of Participants With IGA of Cleared (0), Cleared (0) or Minimal (1), Mild or Better (<=2) Through Week 16
Week 8 : IGA of cleared (0) or minimal (1)
|
8.0 Percentages of participants
|
58.5 Percentages of participants
|
50.0 Percentages of participants
|
|
Part 1: Percentage of Participants With IGA of Cleared (0), Cleared (0) or Minimal (1), Mild or Better (<=2) Through Week 16
Week 8 :IGA of mild or better (<=2)
|
24.0 Percentages of participants
|
78.0 Percentages of participants
|
88.5 Percentages of participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20, 28, 36, 44, and 52Population: FAS for Part 2 included all participants enrolled in Part 2.
The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 points scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, \>1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 points scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease.
Outcome measures
| Measure |
Group 1 (Part 1): Placebo (Week 0-16)
n=28 Participants
Adolescent participants (aged \>=12 to \<18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 2 (Part 1): Guselkumab (Week 0-16)
Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight \[BW\] \<70 kg, 100 mg for BW \>=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 3 (Part 1): Etanercept (Week 0-16)
Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW \<63 kg and 50 mg for BW \>=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
|---|---|---|---|
|
Part 2: Percentage of Participants With IGA of Cleared (0), Cleared (0) or Minimal (1), Mild or Better (<=2) Through Week 52
Week 4: IGA of cleared (0)
|
3.6 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With IGA of Cleared (0), Cleared (0) or Minimal (1), Mild or Better (<=2) Through Week 52
Week 4: IGA of cleared (0) or minimal (1)
|
25.0 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With IGA of Cleared (0), Cleared (0) or Minimal (1), Mild or Better (<=2) Through Week 52
Week 4:IGA of mild or better (<=2)
|
57.1 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With IGA of Cleared (0), Cleared (0) or Minimal (1), Mild or Better (<=2) Through Week 52
Week 8: IGA of cleared (0)
|
25.0 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With IGA of Cleared (0), Cleared (0) or Minimal (1), Mild or Better (<=2) Through Week 52
Week 8: IGA of cleared (0) or minimal (1)
|
64.3 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With IGA of Cleared (0), Cleared (0) or Minimal (1), Mild or Better (<=2) Through Week 52
Week 8:IGA of mild or better (<=2)
|
92.9 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With IGA of Cleared (0), Cleared (0) or Minimal (1), Mild or Better (<=2) Through Week 52
Week 12: IGA of cleared (0)
|
35.7 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With IGA of Cleared (0), Cleared (0) or Minimal (1), Mild or Better (<=2) Through Week 52
Week 12: IGA of cleared (0) or minimal (1)
|
75.0 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With IGA of Cleared (0), Cleared (0) or Minimal (1), Mild or Better (<=2) Through Week 52
Week 12:IGA of mild or better (<=2)
|
96.4 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With IGA of Cleared (0), Cleared (0) or Minimal (1), Mild or Better (<=2) Through Week 52
Week 16: IGA of cleared (0)
|
46.4 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With IGA of Cleared (0), Cleared (0) or Minimal (1), Mild or Better (<=2) Through Week 52
Week 16: IGA of cleared (0) or minimal (1)
|
89.3 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With IGA of Cleared (0), Cleared (0) or Minimal (1), Mild or Better (<=2) Through Week 52
Week 16:IGA of mild or better (<=2)
|
92.9 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With IGA of Cleared (0), Cleared (0) or Minimal (1), Mild or Better (<=2) Through Week 52
Week 20: IGA of cleared (0)
|
50.0 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With IGA of Cleared (0), Cleared (0) or Minimal (1), Mild or Better (<=2) Through Week 52
Week 20: IGA of cleared (0) or minimal (1)
|
82.1 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With IGA of Cleared (0), Cleared (0) or Minimal (1), Mild or Better (<=2) Through Week 52
Week 20:IGA of mild or better (<=2)
|
96.4 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With IGA of Cleared (0), Cleared (0) or Minimal (1), Mild or Better (<=2) Through Week 52
Week 28: IGA of cleared (0)
|
57.1 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With IGA of Cleared (0), Cleared (0) or Minimal (1), Mild or Better (<=2) Through Week 52
Week 28: IGA of cleared (0) or minimal (1)
|
78.6 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With IGA of Cleared (0), Cleared (0) or Minimal (1), Mild or Better (<=2) Through Week 52
Week 28:IGA of mild or better (<=2)
|
96.4 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With IGA of Cleared (0), Cleared (0) or Minimal (1), Mild or Better (<=2) Through Week 52
Week 36: IGA of cleared (0)
|
64.3 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With IGA of Cleared (0), Cleared (0) or Minimal (1), Mild or Better (<=2) Through Week 52
Week 36: IGA of cleared (0) or minimal (1)
|
89.3 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With IGA of Cleared (0), Cleared (0) or Minimal (1), Mild or Better (<=2) Through Week 52
Week 36:IGA of mild or better (<=2)
|
89.3 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With IGA of Cleared (0), Cleared (0) or Minimal (1), Mild or Better (<=2) Through Week 52
Week 44: IGA of cleared (0)
|
64.3 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With IGA of Cleared (0), Cleared (0) or Minimal (1), Mild or Better (<=2) Through Week 52
Week 44: IGA of cleared (0) or minimal (1)
|
85.7 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With IGA of Cleared (0), Cleared (0) or Minimal (1), Mild or Better (<=2) Through Week 52
Week 44: IGA of mild or better (<=2)
|
89.3 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With IGA of Cleared (0), Cleared (0) or Minimal (1), Mild or Better (<=2) Through Week 52
Week 52: IGA of cleared (0)
|
75.0 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With IGA of Cleared (0), Cleared (0) or Minimal (1), Mild or Better (<=2) Through Week 52
Week 52: IGA of cleared (0) or minimal (1)
|
85.7 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With IGA of Cleared (0), Cleared (0) or Minimal (1), Mild or Better (<=2) Through Week 52
Week 52: IGA of mild or better (<=2)
|
92.9 Percentages of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 8, 16, 28, 36, and 52Population: FAS for Part 2 included all participants enrolled in Part 2. Here, n (number analyzed) signifies number of participants evaluable at specified time points.
Change from baseline in CDLQI score through Week 52 were reported. CDLQI is a 10-item questionnaire that measures the impact of skin disease on children's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of questions 1-10 and ranged from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children.
Outcome measures
| Measure |
Group 1 (Part 1): Placebo (Week 0-16)
n=28 Participants
Adolescent participants (aged \>=12 to \<18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 2 (Part 1): Guselkumab (Week 0-16)
Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight \[BW\] \<70 kg, 100 mg for BW \>=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 3 (Part 1): Etanercept (Week 0-16)
Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW \<63 kg and 50 mg for BW \>=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
|---|---|---|---|
|
Part 2: Change From Baseline in CDLQI Score Through Week 52
Week 8
|
-5.6 Score on a scale
Standard Deviation 6.40
|
—
|
—
|
|
Part 2: Change From Baseline in CDLQI Score Through Week 52
Week 16
|
-6.8 Score on a scale
Standard Deviation 6.32
|
—
|
—
|
|
Part 2: Change From Baseline in CDLQI Score Through Week 52
Week 52
|
-7.3 Score on a scale
Standard Deviation 6.83
|
—
|
—
|
|
Part 2: Change From Baseline in CDLQI Score Through Week 52
Week 28
|
-6.7 Score on a scale
Standard Deviation 6.54
|
—
|
—
|
|
Part 2: Change From Baseline in CDLQI Score Through Week 52
Week 36
|
-7.0 Score on a scale
Standard Deviation 6.88
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 16Population: The efficacy analysis for Part 1 of the study was based upon the FAS which included all randomized participants in Part 1. In the efficacy analyses, participants were analyzed according to their assigned treatment group regardless of their actual treatment received. Here, N (Overall Number of Participants Analyzed) signifies participants evaluable for this outcome measure.
CDLQI is a 10-item questionnaire that measures the impact of skin disease on children's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of question 1-10 and ranges from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children.
Outcome measures
| Measure |
Group 1 (Part 1): Placebo (Week 0-16)
n=23 Participants
Adolescent participants (aged \>=12 to \<18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 2 (Part 1): Guselkumab (Week 0-16)
n=39 Participants
Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight \[BW\] \<70 kg, 100 mg for BW \>=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 3 (Part 1): Etanercept (Week 0-16)
n=26 Participants
Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW \<63 kg and 50 mg for BW \>=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
|---|---|---|---|
|
Part 1: Percentage of Participants With CDLQI Score Equal to 0 or 1 at Week 16 Among Participants With a Baseline CDLQI Score Greater Than (>) 1
|
17.4 Percentages of participants
|
64.1 Percentages of participants
|
38.5 Percentages of participants
|
SECONDARY outcome
Timeframe: Weeks 8, 16, 28, 36, and 52Population: FAS for Part 2 included all participants enrolled in Part 2. Here, N (Overall Number of Participants Analyzed) signifies participants evaluable for this outcome measure.
CDLQI is a 10-item questionnaire that measures the impact of skin disease on children's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of question 1-10 and ranges from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children.
Outcome measures
| Measure |
Group 1 (Part 1): Placebo (Week 0-16)
n=24 Participants
Adolescent participants (aged \>=12 to \<18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 2 (Part 1): Guselkumab (Week 0-16)
Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight \[BW\] \<70 kg, 100 mg for BW \>=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 3 (Part 1): Etanercept (Week 0-16)
Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW \<63 kg and 50 mg for BW \>=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
|---|---|---|---|
|
Part 2: Percentage of Participants With CDLQI Score Equal to of 0 or 1 Through Week 52 Among Participants With a Baseline CDLQI Score > 1
Week 8
|
50.0 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With CDLQI Score Equal to of 0 or 1 Through Week 52 Among Participants With a Baseline CDLQI Score > 1
Week 36
|
62.5 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With CDLQI Score Equal to of 0 or 1 Through Week 52 Among Participants With a Baseline CDLQI Score > 1
Week 16
|
58.3 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With CDLQI Score Equal to of 0 or 1 Through Week 52 Among Participants With a Baseline CDLQI Score > 1
Week 28
|
66.7 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With CDLQI Score Equal to of 0 or 1 Through Week 52 Among Participants With a Baseline CDLQI Score > 1
Week 52
|
66.7 Percentages of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 16Population: The efficacy analysis for Part 1 of the study was based upon the FAS which included all randomized participants in Part 1. In the efficacy analyses, participants were analyzed according to their assigned treatment group regardless of their actual treatment received. Here, N (Overall Number of Participants Analyzed) signifies participants evaluable for this outcome measure.
The FDLQI was a 10-item questionnaire that examined the impact of participant's skin disease on different aspects of their QoL (example: emotional, physical well-being, relationships, social life, leisure activities, burden of care, job/study, housework and expenditure) over the last 1 month, as assessed by a family member/partner. Each item had a four-point response option, where Not at all/Not relevant = 0; A little = 1; Quite a lot = 2; and Very much = 3. The scores of individual items (0-3) were added to give a total scale score that ranged from 0 to 30; a higher score indicated greater impairment of QoL.
Outcome measures
| Measure |
Group 1 (Part 1): Placebo (Week 0-16)
n=23 Participants
Adolescent participants (aged \>=12 to \<18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 2 (Part 1): Guselkumab (Week 0-16)
n=36 Participants
Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight \[BW\] \<70 kg, 100 mg for BW \>=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 3 (Part 1): Etanercept (Week 0-16)
n=26 Participants
Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW \<63 kg and 50 mg for BW \>=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
|---|---|---|---|
|
Part 1: Percentage of Participants With Family Dermatology Life Quality Index (FDLQI) of 0 or 1 at Week 16 Among Participants With a Baseline FDLQI >1
|
13.0 Percentages of participants
|
36.1 Percentages of participants
|
24.0 Percentages of participants
|
SECONDARY outcome
Timeframe: Weeks 8, 16, 28, 36, and 52Population: FAS for Part 2 included all participants enrolled in Part 2. Here, N (Overall Number of Participants Analyzed) signifies participants evaluable for this outcome measure.
The FDLQI was a 10-item questionnaire that examine the impact of participant's skin disease on different aspects of their QoL (example, emotional, physical well-being, relationships, social life, leisure activities, burden of care, job/study, housework and expenditure) over the last 1 month, as assessed by a family member/partner. Each item had a four-point response option, where Not at all/Not relevant = 0; A little = 1; Quite a lot = 2; and Very much = 3. The scores of individual items (0-3) were added to give a total scale score that ranged from 0 to 30; a higher score indicates greater impairment of QoL.
Outcome measures
| Measure |
Group 1 (Part 1): Placebo (Week 0-16)
n=22 Participants
Adolescent participants (aged \>=12 to \<18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 2 (Part 1): Guselkumab (Week 0-16)
Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight \[BW\] \<70 kg, 100 mg for BW \>=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 3 (Part 1): Etanercept (Week 0-16)
Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW \<63 kg and 50 mg for BW \>=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
|---|---|---|---|
|
Part 2: Percentage of Participants With Family Dermatology Life Quality Index (FDLQI) of 0 or 1 Through Week 52 Among Participants With a Baseline FDLQI >1
Week 52
|
50.0 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With Family Dermatology Life Quality Index (FDLQI) of 0 or 1 Through Week 52 Among Participants With a Baseline FDLQI >1
Week 8
|
27.3 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With Family Dermatology Life Quality Index (FDLQI) of 0 or 1 Through Week 52 Among Participants With a Baseline FDLQI >1
Week 16
|
31.8 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With Family Dermatology Life Quality Index (FDLQI) of 0 or 1 Through Week 52 Among Participants With a Baseline FDLQI >1
Week 28
|
59.1 Percentages of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With Family Dermatology Life Quality Index (FDLQI) of 0 or 1 Through Week 52 Among Participants With a Baseline FDLQI >1
Week 36
|
36.4 Percentages of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: The efficacy analysis for Part 1 of the study was based upon the FAS which included all randomized participants in Part 1. In the efficacy analyses, participants were analyzed according to their assigned treatment group regardless of their actual treatment received. Here, N (Overall Number of Participants Analyzed) signifies participants evaluable for this outcome measure.
The FDLQI was a 10-item questionnaire that examined the impact of participant's skin disease on different aspects of their QoL (example, emotional, physical well-being, relationships, social life, leisure activities, burden of care, job/study, housework and expenditure) over the last 1 month, as assessed by a family member/partner. Each item had a four-point response option, where Not at all/Not relevant = 0; A little = 1; Quite a lot = 2; and Very much = 3. The scores of individual items (0-3) are added to give a total scale score that ranged from 0 to 30; a higher score indicates greater impairment of QoL.
Outcome measures
| Measure |
Group 1 (Part 1): Placebo (Week 0-16)
n=24 Participants
Adolescent participants (aged \>=12 to \<18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 2 (Part 1): Guselkumab (Week 0-16)
n=41 Participants
Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight \[BW\] \<70 kg, 100 mg for BW \>=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 3 (Part 1): Etanercept (Week 0-16)
n=23 Participants
Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW \<63 kg and 50 mg for BW \>=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
|---|---|---|---|
|
Part 1: Change From Baseline in FDLQI Score at Week 16
|
-0.50 Score on a scale
Standard Deviation 6.984
|
-6.22 Score on a scale
Standard Deviation 6.299
|
-6.22 Score on a scale
Standard Deviation 4.814
|
SECONDARY outcome
Timeframe: Baseline, Weeks 8, 16, 28, 36, and 52Population: FAS for Part 2 included all participants enrolled in Part 2. Here, N (Overall Number of Participants Analyzed) signifies participants evaluable for this outcome measure and n (number analyzed) signifies number of participants evaluable at specified time points.
The FDLQI was a 10-item questionnaire that examine the impact of participant's skin disease on different aspects of their QoL (example, emotional, physical well-being, relationships, social life, leisure activities, burden of care, job/study, housework and expenditure) over the last 1 month, as assessed by a family member/partner. Each item had a four-point response option, where Not at all/Not relevant = 0; A little = 1; Quite a lot = 2; and Very much = 3. The scores of individual items (0-3) are added to give a total scale score that ranged from 0 to 30; a higher score indicated greater impairment of QoL.
Outcome measures
| Measure |
Group 1 (Part 1): Placebo (Week 0-16)
n=27 Participants
Adolescent participants (aged \>=12 to \<18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 2 (Part 1): Guselkumab (Week 0-16)
Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight \[BW\] \<70 kg, 100 mg for BW \>=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 3 (Part 1): Etanercept (Week 0-16)
Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW \<63 kg and 50 mg for BW \>=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
|---|---|---|---|
|
Part 2: Change From Baseline in FDLQI Score Through Week 52
Week 8
|
-5.4 Score on scale
Standard Deviation 5.58
|
—
|
—
|
|
Part 2: Change From Baseline in FDLQI Score Through Week 52
Week 16
|
-5.5 Score on scale
Standard Deviation 5.90
|
—
|
—
|
|
Part 2: Change From Baseline in FDLQI Score Through Week 52
Week 28
|
-7.5 Score on scale
Standard Deviation 6.15
|
—
|
—
|
|
Part 2: Change From Baseline in FDLQI Score Through Week 52
Week 36
|
-6.7 Score on scale
Standard Deviation 5.00
|
—
|
—
|
|
Part 2: Change From Baseline in FDLQI Score Through Week 52
Week 52
|
-7.8 Score on scale
Standard Deviation 5.68
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: The efficacy analysis for Part 1 of the study was based upon the FAS which included all randomized participants in Part 1. In the efficacy analyses, participants were analyzed according to their assigned treatment group regardless of their actual treatment received.
Change from baseline in percent body surface area with psoriasis skin involvement was reported. BSA as physical measure to define disease severity is to determine how much of the BSA is affected by psoriasis. Involved BSA is calculated by using the palm of the participant's hand as equivalent to 1% of the BSA (rule of palm). Psoriasis affected BSA under 5% suggests mild psoriasis, a BSA of 5% to 10% is considered moderate, and an involved BSA of over 10% indicates severe psoriasis.
Outcome measures
| Measure |
Group 1 (Part 1): Placebo (Week 0-16)
n=25 Participants
Adolescent participants (aged \>=12 to \<18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 2 (Part 1): Guselkumab (Week 0-16)
n=41 Participants
Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight \[BW\] \<70 kg, 100 mg for BW \>=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 3 (Part 1): Etanercept (Week 0-16)
n=24 Participants
Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW \<63 kg and 50 mg for BW \>=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
|---|---|---|---|
|
Part 1: Change From Baseline in Body Surface Area (BSA) With Psoriasis Skin Involvement at Week 16
|
-2.84 Units on a scale
Standard Deviation 13.861
|
-19.59 Units on a scale
Standard Deviation 17.645
|
-17.50 Units on a scale
Standard Deviation 10.628
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 28, 36, 44, and 52Population: FAS for Part 2 included all participants enrolled in Part 2. Here, n (number analyzed) signifies number of participants evaluable at specified time points.
Change from baseline in percent body surface area with psoriasis skin involvement was reported. BSA as physical measure to define disease severity is to determine how much of the BSA is affected by psoriasis. Involved BSA is calculated by using the palm of the participant's hand as equivalent to 1% of the BSA (rule of palm). Psoriasis affected BSA under 5% suggests mild psoriasis, a BSA of 5% to 10% is considered moderate, and an involved BSA of over 10% indicates severe psoriasis.
Outcome measures
| Measure |
Group 1 (Part 1): Placebo (Week 0-16)
n=28 Participants
Adolescent participants (aged \>=12 to \<18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 2 (Part 1): Guselkumab (Week 0-16)
Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight \[BW\] \<70 kg, 100 mg for BW \>=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
Group 3 (Part 1): Etanercept (Week 0-16)
Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW \<63 kg and 50 mg for BW \>=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
|---|---|---|---|
|
Parts 2: Change From Baseline in BSA With Psoriasis Skin Involvement Over Time Through Week 52
Week 4
|
-6.9 Units on a scale
Standard Deviation 7.94
|
—
|
—
|
|
Parts 2: Change From Baseline in BSA With Psoriasis Skin Involvement Over Time Through Week 52
Week 8
|
-16.8 Units on a scale
Standard Deviation 12.00
|
—
|
—
|
|
Parts 2: Change From Baseline in BSA With Psoriasis Skin Involvement Over Time Through Week 52
Week 12
|
-19.6 Units on a scale
Standard Deviation 12.58
|
—
|
—
|
|
Parts 2: Change From Baseline in BSA With Psoriasis Skin Involvement Over Time Through Week 52
Week 16
|
-22.7 Units on a scale
Standard Deviation 13.57
|
—
|
—
|
|
Parts 2: Change From Baseline in BSA With Psoriasis Skin Involvement Over Time Through Week 52
Week 20
|
-24.0 Units on a scale
Standard Deviation 13.46
|
—
|
—
|
|
Parts 2: Change From Baseline in BSA With Psoriasis Skin Involvement Over Time Through Week 52
Week 28
|
-26.0 Units on a scale
Standard Deviation 14.61
|
—
|
—
|
|
Parts 2: Change From Baseline in BSA With Psoriasis Skin Involvement Over Time Through Week 52
Week 36
|
-26.3 Units on a scale
Standard Deviation 14.42
|
—
|
—
|
|
Parts 2: Change From Baseline in BSA With Psoriasis Skin Involvement Over Time Through Week 52
Week 44
|
-26.5 Units on a scale
Standard Deviation 14.05
|
—
|
—
|
|
Parts 2: Change From Baseline in BSA With Psoriasis Skin Involvement Over Time Through Week 52
Week 52
|
-26.4 Units on a scale
Standard Deviation 14.52
|
—
|
—
|
SECONDARY outcome
Timeframe: From Week 52 to End of the study (EOS) (December 2026)Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Week 52 to EOS (December 2026)Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Week 52 to EOS (December 2026)Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Week 52 to EOS (Dec 2026)Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 60 and Week 84Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 60 and Week 84Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 60 and Week 84Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 60 and Week 84Outcome measures
Outcome data not reported
Adverse Events
PCP-Group 1 (Part 1): Placebo (Week 0-16)
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
PCP-Group 2 (Part 1): Guselkumab (Week 0-16)
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
PCP-Group 3 (Part 1): Etanercept (Week 0-16)
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Withdrawal and Re-treatment Period-Group 1 (Part 1): Placebo to Guselkumab (Week 16-52)
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Part 2: Guselkumab (Week 0-52)
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Withdrawal and Re-treatment Period-Group 2 (Part 1): Guselkumab (Week 16-52)
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Withdrawal and Re-treatment Period- Group 3 (Part 1): Etanercept to Guselkumab (Week 16-52)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PCP-Group 1 (Part 1): Placebo (Week 0-16)
n=25 participants at risk
Adolescent participants (aged \>=12 to \<18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.
|
PCP-Group 2 (Part 1): Guselkumab (Week 0-16)
n=41 participants at risk
Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight \[BW\] \<70 kg, 100 mg for BW \>=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
PCP-Group 3 (Part 1): Etanercept (Week 0-16)
n=26 participants at risk
Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW \<63 kg and 50 mg for BW \>=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
Withdrawal and Re-treatment Period-Group 1 (Part 1): Placebo to Guselkumab (Week 16-52)
n=23 participants at risk
Participants who received placebo during PCP were assessed for psoriasis area and severity index (PASI) response at Week 16. Participants who were PASI 90 non-responders at Week 16 received weight-based doses of guselkumab (1.3 mg/kg for BW \<70 kg, 100 mg for BW \>=70 kg) as SC injection at Weeks 16, 20 and then every 8 weeks (q8w) thereafter through Week 52. Participants who were PASI 90 responders at Week 16 stopped treatment until they lost \>= 50 percent (%) of their Week 16 PASI response, at which time they were treated with guselkumab 1.3 mg/kg or 100 mg depending on their body weight followed by a dose 4 weeks later, and then guselkumab q8w thereafter through Week 52. All participants who completed Part 1 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.
|
Part 2: Guselkumab (Week 0-52)
n=28 participants at risk
Adolescent participants received weight-based dose of open-label guselkumab (1.3 mg/kg for body weight \[BW\] \<70 kg, 100 mg for BW \>=70 kg) as SC injection at Weeks 0, 4, and q8w thereafter through Week 52. All participants who completed Part 2 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.
|
Withdrawal and Re-treatment Period-Group 2 (Part 1): Guselkumab (Week 16-52)
n=41 participants at risk
Participants who received guselkumab during PCP were assessed for PASI response at Week 16. Participants who were PASI 90 non-responders at Week 16 received weight-based doses of guselkumab (1.3 mg/kg for BW \<70 kg, 100 mg for BW \>=70 kg) as SC injection at Weeks 16, 20 and then q8w thereafter through Week 52. Participants who were PASI 90 responders at Week 16 stopped treatment until they lost \>= 50 % of their Week 16 PASI response, at which time they were retreated with guselkumab 1.3 mg/kg or 100 mg depending on their body weight followed by a dose 4 weeks later, and then guselkumab every 8 weeks thereafter through Week 52. All participants who completed Part 1 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.
|
Withdrawal and Re-treatment Period- Group 3 (Part 1): Etanercept to Guselkumab (Week 16-52)
n=22 participants at risk
Participants who received etanercept during the PCP had the option to continue in the study or to discontinue the study. Participants that continued received weight-based doses of guselkumab (1.3 mg/kg for body weight \[BW\] \<70 kg, 100 mg for BW \>=70 kg) as SC injection at Weeks 20 and 24, followed by q8w dosing through Week 48 and remaining participants discontinued from the study. All participants who completed Part 1 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Chronic Tonsillitis
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
4.3%
1/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Injury, poisoning and procedural complications
Multiple Injuries
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
3.6%
1/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Injury, poisoning and procedural complications
Radius Fracture
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
2.4%
1/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
Other adverse events
| Measure |
PCP-Group 1 (Part 1): Placebo (Week 0-16)
n=25 participants at risk
Adolescent participants (aged \>=12 to \<18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.
|
PCP-Group 2 (Part 1): Guselkumab (Week 0-16)
n=41 participants at risk
Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight \[BW\] \<70 kg, 100 mg for BW \>=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
PCP-Group 3 (Part 1): Etanercept (Week 0-16)
n=26 participants at risk
Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW \<63 kg and 50 mg for BW \>=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16.
|
Withdrawal and Re-treatment Period-Group 1 (Part 1): Placebo to Guselkumab (Week 16-52)
n=23 participants at risk
Participants who received placebo during PCP were assessed for psoriasis area and severity index (PASI) response at Week 16. Participants who were PASI 90 non-responders at Week 16 received weight-based doses of guselkumab (1.3 mg/kg for BW \<70 kg, 100 mg for BW \>=70 kg) as SC injection at Weeks 16, 20 and then every 8 weeks (q8w) thereafter through Week 52. Participants who were PASI 90 responders at Week 16 stopped treatment until they lost \>= 50 percent (%) of their Week 16 PASI response, at which time they were treated with guselkumab 1.3 mg/kg or 100 mg depending on their body weight followed by a dose 4 weeks later, and then guselkumab q8w thereafter through Week 52. All participants who completed Part 1 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.
|
Part 2: Guselkumab (Week 0-52)
n=28 participants at risk
Adolescent participants received weight-based dose of open-label guselkumab (1.3 mg/kg for body weight \[BW\] \<70 kg, 100 mg for BW \>=70 kg) as SC injection at Weeks 0, 4, and q8w thereafter through Week 52. All participants who completed Part 2 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.
|
Withdrawal and Re-treatment Period-Group 2 (Part 1): Guselkumab (Week 16-52)
n=41 participants at risk
Participants who received guselkumab during PCP were assessed for PASI response at Week 16. Participants who were PASI 90 non-responders at Week 16 received weight-based doses of guselkumab (1.3 mg/kg for BW \<70 kg, 100 mg for BW \>=70 kg) as SC injection at Weeks 16, 20 and then q8w thereafter through Week 52. Participants who were PASI 90 responders at Week 16 stopped treatment until they lost \>= 50 % of their Week 16 PASI response, at which time they were retreated with guselkumab 1.3 mg/kg or 100 mg depending on their body weight followed by a dose 4 weeks later, and then guselkumab every 8 weeks thereafter through Week 52. All participants who completed Part 1 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.
|
Withdrawal and Re-treatment Period- Group 3 (Part 1): Etanercept to Guselkumab (Week 16-52)
n=22 participants at risk
Participants who received etanercept during the PCP had the option to continue in the study or to discontinue the study. Participants that continued received weight-based doses of guselkumab (1.3 mg/kg for body weight \[BW\] \<70 kg, 100 mg for BW \>=70 kg) as SC injection at Weeks 20 and 24, followed by q8w dosing through Week 48 and remaining participants discontinued from the study. All participants who completed Part 1 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
3.6%
1/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
4.0%
1/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
4.3%
1/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
2.4%
1/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
4.5%
1/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
4.0%
1/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
3.6%
1/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Cardiac disorders
Ventricular Extrasystoles
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
2.4%
1/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Eye disorders
Blepharitis
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
4.3%
1/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
4.5%
1/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Eye disorders
Conjunctivitis Allergic
|
4.0%
1/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
4.3%
1/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Eye disorders
Myopia
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
2.4%
1/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
4.9%
2/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
2.4%
1/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
3.8%
1/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
3.6%
1/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
2.4%
1/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Gastrointestinal disorders
Aphthous Ulcer
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
3.8%
1/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
3.6%
1/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Gastrointestinal disorders
Dental Caries
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
3.8%
1/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
2.4%
1/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
4.5%
1/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
2.4%
1/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Gastrointestinal disorders
Food Poisoning
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
3.6%
1/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Gastrointestinal disorders
Mouth Ulceration
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
2.4%
1/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Gastrointestinal disorders
Nausea
|
4.0%
1/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
3.8%
1/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Gastrointestinal disorders
Vomiting
|
4.0%
1/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
2.4%
1/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
General disorders
Application Site Haematoma
|
4.0%
1/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
General disorders
Fatigue
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
7.7%
2/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
3.6%
1/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
2.4%
1/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
General disorders
Influenza Like Illness
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
3.8%
1/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
4.3%
1/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
2.4%
1/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
General disorders
Injection Site Erythema
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
2.4%
1/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
3.6%
1/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
General disorders
Injection Site Haematoma
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
3.6%
1/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
2.4%
1/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
General disorders
Injection Site Induration
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
3.8%
1/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
General disorders
Injection Site Pruritus
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
3.8%
1/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
General disorders
Injection Site Swelling
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
2.4%
1/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
General disorders
Pyrexia
|
4.0%
1/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
4.3%
1/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
3.6%
1/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
2.4%
1/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
4.5%
1/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Immune system disorders
Seasonal Allergy
|
4.0%
1/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Infections and infestations
Abscess
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
3.8%
1/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
2.4%
1/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
3.8%
1/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Infections and infestations
Bacterial Vulvovaginitis
|
4.0%
1/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
4.3%
1/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
7.7%
2/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
4.3%
1/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
2.4%
1/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
4.5%
1/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Infections and infestations
Chronic Tonsillitis
|
4.0%
1/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
4.3%
1/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Infections and infestations
Covid-19
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
2.4%
1/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
21.4%
6/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
2.4%
1/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
4.5%
1/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Infections and infestations
Ear Infection
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
4.5%
1/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Infections and infestations
Enterobiasis
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
2.4%
1/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
2.4%
1/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
9.1%
2/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
4.3%
1/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
2.4%
1/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Infections and infestations
Gastrointestinal Infection
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
3.6%
1/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Infections and infestations
Helminthic Infection
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
4.3%
1/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
3.6%
1/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Infections and infestations
Lice Infestation
|
4.0%
1/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
4.3%
1/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Infections and infestations
Molluscum Contagiosum
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
4.3%
1/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Infections and infestations
Nasopharyngitis
|
28.0%
7/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
12.2%
5/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
11.5%
3/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
34.8%
8/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
25.0%
7/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
22.0%
9/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
18.2%
4/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Infections and infestations
Otitis Externa
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
2.4%
1/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Infections and infestations
Otitis Media
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
4.5%
1/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
2.4%
1/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
3.8%
1/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
4.3%
1/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
3.6%
1/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
4.9%
2/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
4.5%
1/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Infections and infestations
Respiratory Tract Infection
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
7.1%
2/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
2.4%
1/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
4.9%
2/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Infections and infestations
Tinea Capitis
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
4.3%
1/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Infections and infestations
Tinea Versicolour
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
3.6%
1/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Infections and infestations
Tonsillitis
|
4.0%
1/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
2.4%
1/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
8.0%
2/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
9.8%
4/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
7.7%
2/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
7.1%
2/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
14.6%
6/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
13.6%
3/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
3.8%
1/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Infections and infestations
Viral Diarrhoea
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
3.6%
1/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Infections and infestations
Viral Infection
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
2.4%
1/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
2.4%
1/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
4.5%
1/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
2.4%
1/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
2.4%
1/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Infections and infestations
Vulvovaginal Mycotic Infection
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
4.3%
1/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
3.6%
1/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
3.6%
1/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
4.0%
1/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Injury, poisoning and procedural complications
Joint Dislocation
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
2.4%
1/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
4.5%
1/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Injury, poisoning and procedural complications
Ligament Rupture
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
2.4%
1/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
2.4%
1/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
3.8%
1/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
2.4%
1/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
3.6%
1/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
2.4%
1/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Injury, poisoning and procedural complications
Peroneal Nerve Injury
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
3.6%
1/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
4.3%
1/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
3.6%
1/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
3.6%
1/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
2.4%
1/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Investigations
Blood Glucose Increased
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
2.4%
1/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Investigations
Blood Pressure Decreased
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
3.6%
1/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Investigations
Blood Pressure Increased
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
3.6%
1/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Investigations
Cardiac Murmur
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
2.4%
1/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Investigations
Liver Function Test Increased
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
3.8%
1/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Investigations
White Blood Cell Count Increased
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
2.4%
1/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
2.4%
1/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
7.7%
2/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
3.6%
1/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
4.9%
2/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
2.4%
1/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
2.4%
1/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Musculoskeletal and connective tissue disorders
Ligament Laxity
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
2.4%
1/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
3.6%
1/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Nervous system disorders
Headache
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
7.3%
3/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
3.8%
1/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
8.7%
2/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
7.1%
2/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
7.3%
3/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
9.1%
2/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Discomfort
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
4.5%
1/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
3.8%
1/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
2.4%
1/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
2.4%
1/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Nervous system disorders
Migraine
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
3.6%
1/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
2.4%
1/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
3.8%
1/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Psychiatric disorders
Attention Deficit Hyperactivity Disorder
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
4.3%
1/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Psychiatric disorders
Depression
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
3.6%
1/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
3.6%
1/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
7.1%
2/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
2.4%
1/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
4.3%
1/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.0%
1/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
3.6%
1/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
2.4%
1/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
3.6%
1/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
2.4%
1/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
3.6%
1/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
4.3%
1/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
2.4%
1/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
4.3%
1/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
3.6%
1/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
2.4%
1/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
4.5%
1/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar Hypertrophy
|
4.0%
1/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
2.4%
1/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
10.7%
3/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
4.9%
2/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
4.0%
1/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Skin and subcutaneous tissue disorders
Diffuse Alopecia
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
3.6%
1/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Skin and subcutaneous tissue disorders
Lichen Planus
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
2.4%
1/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
4.3%
1/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
2.4%
1/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
4.0%
1/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
2.4%
1/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
4.5%
1/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Skin and subcutaneous tissue disorders
Skin Hypopigmentation
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
3.6%
1/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
4.0%
1/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
3.6%
1/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
|
Vascular disorders
Hypertension
|
0.00%
0/25 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/26 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/23 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
3.6%
1/28 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/41 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
0.00%
0/22 • PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
- Publication restrictions are in place
Restriction type: OTHER