Trial Outcomes & Findings for A Study of Baricitinib (LY3009104) in Adult Participants With Moderate to Severe Atopic Dermatitis (NCT NCT03435081)
NCT ID: NCT03435081
Last Updated: 2022-09-09
Results Overview
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
440 participants
Primary outcome timeframe
Week 16
Results posted on
2022-09-09
Participant Flow
Participants who did not meet IGA 0 or 1 at Week 16 and completed at least 16 Weeks in JAIW were discontinued and if eligible had the option to roll over into the Open-Label Extension study JAIX (NCT03559720).
Participant milestones
| Measure |
Placebo
Placebo administered orally every day.
|
1 Milligram (mg) Baricitinib
1 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
|
2 mg Baricitinib
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
|
|---|---|---|---|
|
Week 0 to Week 16
STARTED
|
147
|
147
|
146
|
|
Week 0 to Week 16
Received at Least One Dose of Study Drug
|
147
|
147
|
146
|
|
Week 0 to Week 16
Completed Week 16 and Entered JAIX Study
|
111
|
112
|
96
|
|
Week 0 to Week 16
COMPLETED
|
126
|
131
|
127
|
|
Week 0 to Week 16
NOT COMPLETED
|
21
|
16
|
19
|
|
Week 16 to Week 104
STARTED
|
8
|
19
|
35
|
|
Week 16 to Week 104
Rolled Over Into the Open-Label Extension Study JAIX.
|
6
|
14
|
19
|
|
Week 16 to Week 104
COMPLETED
|
5
|
6
|
16
|
|
Week 16 to Week 104
NOT COMPLETED
|
3
|
13
|
19
|
Reasons for withdrawal
| Measure |
Placebo
Placebo administered orally every day.
|
1 Milligram (mg) Baricitinib
1 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
|
2 mg Baricitinib
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
|
|---|---|---|---|
|
Week 0 to Week 16
Lack of Efficacy
|
6
|
5
|
0
|
|
Week 0 to Week 16
Adverse Event
|
2
|
2
|
2
|
|
Week 0 to Week 16
Withdrawal by Subject
|
8
|
7
|
10
|
|
Week 0 to Week 16
Lost to Follow-up
|
3
|
1
|
4
|
|
Week 0 to Week 16
Pregnancy
|
1
|
0
|
0
|
|
Week 0 to Week 16
Non-compliance
|
1
|
0
|
2
|
|
Week 0 to Week 16
Inadequate Response
|
0
|
1
|
0
|
|
Week 0 to Week 16
Withdrawal Due to Caregiver Circumstance
|
0
|
0
|
1
|
|
Week 16 to Week 104
Lack of Efficacy
|
2
|
11
|
10
|
|
Week 16 to Week 104
Adverse Event
|
1
|
0
|
2
|
|
Week 16 to Week 104
Withdrawal by Subject
|
0
|
1
|
2
|
|
Week 16 to Week 104
Lost to Follow-up
|
0
|
1
|
4
|
|
Week 16 to Week 104
Non--Compliance
|
0
|
0
|
1
|
Baseline Characteristics
A Study of Baricitinib (LY3009104) in Adult Participants With Moderate to Severe Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
Placebo
n=147 Participants
Placebo administered orally every day.
|
1 mg Baricitinib
n=147 Participants
1 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
|
2 mg Baricitinib
n=146 Participants
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
|
Total
n=440 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
134 Participants
n=5 Participants
|
134 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
405 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
216 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
80 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
224 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
33 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
81 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
24 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
80 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
251 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
42 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
119 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
105 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
321 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: All participants randomized to placebo or 2 mg of study drug. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups.
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.
Outcome measures
| Measure |
Placebo
n=147 Participants
Placebo administered orally every day.
|
2 mg Baricitinib
n=146 Participants
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
|
2 mg Baricitinib
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
|
|---|---|---|---|
|
Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75) (2 mg Baricitinib)
|
8.2 percentage of participants
Interval 4.7 to 13.7
|
29.5 percentage of participants
Interval 22.7 to 37.3
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: All randomized participants. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups.
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
Outcome measures
| Measure |
Placebo
n=147 Participants
Placebo administered orally every day.
|
2 mg Baricitinib
n=147 Participants
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
|
2 mg Baricitinib
n=146 Participants
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
|
|---|---|---|---|
|
Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥ 2 Point Improvement
|
5.4 percentage of participants
Interval 2.8 to 10.4
|
12.9 percentage of participants
Interval 8.4 to 19.3
|
24.0 percentage of participants
Interval 17.8 to 31.5
|
SECONDARY outcome
Timeframe: Week 16Population: All participants randomized to placebo or 1 mg of study drug. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups.
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.
Outcome measures
| Measure |
Placebo
n=147 Participants
Placebo administered orally every day.
|
2 mg Baricitinib
n=147 Participants
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
|
2 mg Baricitinib
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
|
|---|---|---|---|
|
Percentage of Participants Achieving EASI75 (1 mg Baricitinib)
|
8.2 percentage of participants
Interval 4.7 to 13.7
|
12.9 percentage of participants
Interval 8.4 to 19.3
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: All randomized participants. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups.
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI90 is defined as a ≥ 90% improvement from baseline in the EASI score.
Outcome measures
| Measure |
Placebo
n=147 Participants
Placebo administered orally every day.
|
2 mg Baricitinib
n=147 Participants
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
|
2 mg Baricitinib
n=146 Participants
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
|
|---|---|---|---|
|
Percentage of Participants Achieving EASI90
|
3.4 percentage of participants
Interval 1.5 to 7.7
|
7.5 percentage of participants
Interval 4.2 to 12.9
|
20.5 percentage of participants
Interval 14.8 to 27.8
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants with Week 16 EASI data. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups.
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). Least Squares (LS) Means were calculated using a MMRM model with treatment, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Outcome measures
| Measure |
Placebo
n=28 Participants
Placebo administered orally every day.
|
2 mg Baricitinib
n=47 Participants
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
|
2 mg Baricitinib
n=62 Participants
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
|
|---|---|---|---|
|
Percent Change From Baseline in EASI Score
|
-34.07 percent change
Standard Error 5.529
|
-46.66 percent change
Standard Error 4.469
|
-54.37 percent change
Standard Error 4.156
|
SECONDARY outcome
Timeframe: Week 16Population: All randomized participants. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups.
The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3)oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with a visual analogue scales (VAS) where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), \& subjective symptoms (C: 0-20) combine using A/5 + 7\*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. The SCORAD75 responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the SCORAD score.
Outcome measures
| Measure |
Placebo
n=147 Participants
Placebo administered orally every day.
|
2 mg Baricitinib
n=147 Participants
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
|
2 mg Baricitinib
n=146 Participants
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
|
|---|---|---|---|
|
Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD75)
|
2.7 percentage of participants
Interval 1.1 to 6.8
|
3.4 percentage of participants
Interval 1.5 to 7.7
|
14.4 percentage of participants
Interval 9.6 to 21.0
|
SECONDARY outcome
Timeframe: 16 WeeksPopulation: All randomized participants with a Baseline Itch NRS score \>=4.
The Itch NRS is a patient-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours.
Outcome measures
| Measure |
Placebo
n=123 Participants
Placebo administered orally every day.
|
2 mg Baricitinib
n=132 Participants
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
|
2 mg Baricitinib
n=131 Participants
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
|
|---|---|---|---|
|
Percentage of Participants Achieving a 4-Point Improvement on the Itch Numeric Rating Scale (NRS)
|
5.7 percentage of participants
Interval 2.8 to 11.3
|
15.9 percentage of participants
Interval 10.6 to 23.1
|
25.2 percentage of participants
Interval 18.5 to 33.3
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants with Week 16 ADSS Item 2 (frequency of waking) data.
Atopic Dermatitis Sleep Scale (ADSS) is a 3-item, participant-administered questionnaire developed to assess the impact of itch on sleep including difficulty falling asleep, frequency of waking, and difficulty getting back to sleep last night. Item 2, frequency of waking last night is reported by selecting the number of times they woke up each night, ranging from 0 to 29 times, where the higher a number indicates a worse outcome. The ADSS is designed to be completed daily, using a daily diary, with respondents thinking about sleep "last night." Each item is scored individually. LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by- visit-interaction as fixed continuous effects.
Outcome measures
| Measure |
Placebo
n=37 Participants
Placebo administered orally every day.
|
2 mg Baricitinib
n=64 Participants
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
|
2 mg Baricitinib
n=73 Participants
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
|
|---|---|---|---|
|
Change From Baseline in the Score of Item 2 of the Atopic Dermatitis Sleep Scale (ADSS)
|
-0.40 units on a scale
Standard Error 0.207
|
-0.62 units on a scale
Standard Error 0.177
|
-0.99 units on a scale
Standard Error 0.171
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants with Week 16 Skin Pain NRS data.
Skin Pain NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no pain" and 10 representing "worst pain imaginable." Overall severity of a participant's skin pain is indicated by selecting the number, using a daily diary, that best describes the worst level of skin pain in the past 24 hours. LS Means were calculated using a MMRM model with treatment, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Outcome measures
| Measure |
Placebo
n=37 Participants
Placebo administered orally every day.
|
2 mg Baricitinib
n=64 Participants
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
|
2 mg Baricitinib
n=73 Participants
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
|
|---|---|---|---|
|
Change From Baseline in Skin Pain NRS
|
-1.03 units on a scale
Standard Error 0.342
|
-2.16 units on a scale
Standard Error 0.279
|
-2.40 units on a scale
Standard Error 0.266
|
SECONDARY outcome
Timeframe: Week 16Population: All randomized participants.
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100%) and the severity of 4 clinical signs (erythema, edema/papulation, excoriation, and lichenification) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head and neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2 and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI50 is defined as a ≥ 50% improvement from baseline in EASI score.
Outcome measures
| Measure |
Placebo
n=147 Participants
Placebo administered orally every day.
|
2 mg Baricitinib
n=147 Participants
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
|
2 mg Baricitinib
n=146 Participants
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
|
|---|---|---|---|
|
Percentage of of Participants Achieving EASI50
|
12.9 percentage of participants
Interval 8.4 to 19.3
|
19.7 percentage of participants
Interval 14.1 to 26.9
|
34.9 percentage of participants
Interval 27.7 to 43.0
|
SECONDARY outcome
Timeframe: Week 16Population: All randomized participants.
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
Outcome measures
| Measure |
Placebo
n=147 Participants
Placebo administered orally every day.
|
2 mg Baricitinib
n=147 Participants
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
|
2 mg Baricitinib
n=146 Participants
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
|
|---|---|---|---|
|
Percentage of Participants Achieving IGA of 0
|
0.7 percentage of participants
Interval 0.1 to 3.8
|
3.4 percentage of participants
Interval 1.5 to 7.7
|
2.7 percentage of participants
Interval 1.1 to 6.8
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants with Week 16 SCORAD data.
The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), \& subjective symptoms (C: 0-20) combine using A/5 + 7\*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. LS Means were calculated using a MMRM model with treatment, baseline disease severity (IGA), visit and treatment-by-visit interaction as fixed categorial effects and baseline and baseline-by-visit interaction as fixed continuous effects.
Outcome measures
| Measure |
Placebo
n=28 Participants
Placebo administered orally every day.
|
2 mg Baricitinib
n=46 Participants
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
|
2 mg Baricitinib
n=61 Participants
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
|
|---|---|---|---|
|
Change From Baseline in SCORAD
|
-14.37 units on a scale
Standard Error 3.058
|
-18.31 units on a scale
Standard Error 2.445
|
-26.18 units on a scale
Standard Error 2.220
|
SECONDARY outcome
Timeframe: Week 16Population: All randomized participants.
The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), \& subjective symptoms (C: 0-20) combine using A/5 + 7\*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. SCORAD90 is defined as a ≥ 90% improvement from baseline in the SCORAD score.
Outcome measures
| Measure |
Placebo
n=147 Participants
Placebo administered orally every day.
|
2 mg Baricitinib
n=147 Participants
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
|
2 mg Baricitinib
n=146 Participants
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
|
|---|---|---|---|
|
Percentage of Participants Achieving SCORAD90
|
1.4 percentage of participants
Interval 0.4 to 4.8
|
2.0 percentage of participants
Interval 0.7 to 5.8
|
3.4 percentage of participants
Interval 1.5 to 7.8
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants with Week 16 BSA data.
Body surface area affected by AD will be assessed for 4 separate body regions and is collected as part of the EASI assessment: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region will be assessed for disease extent ranging from 0% to 100% involvement. The overall total percentage will be reported based off of all 4 body regions combined, after applying specific multipliers to the different body regions to account for the percent of the total BSA represented by each of the 4 regions. Use the percentage of skin affected for each region (0 to 100%) in EASI as follows: BSA Total = 0.1\*BSAhead and neck + 0.3\*BSAtrunk + 0.2\* BSAupper limbs + 0.4\*BSAlower limbs. LS Means were calculated using a MMRM model with treatment, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interactions as fixed continuous effects.
Outcome measures
| Measure |
Placebo
n=28 Participants
Placebo administered orally every day.
|
2 mg Baricitinib
n=47 Participants
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
|
2 mg Baricitinib
n=62 Participants
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
|
|---|---|---|---|
|
Change From Baseline in Body Surface Area (BSA) Affected
|
-9.67 percentage of BSA
Standard Error 2.352
|
-15.69 percentage of BSA
Standard Error 1.885
|
-17.39 percentage of BSA
Standard Error 1.746
|
SECONDARY outcome
Timeframe: Week 16Population: All randomized participants who received at least 1 dose of study drug and who did not discontinue from study for reason lost to follow-up at the first post-baseline visit.
Percentage of participants developing skin infections requiring antibiotic treatment.
Outcome measures
| Measure |
Placebo
n=146 Participants
Placebo administered orally every day.
|
2 mg Baricitinib
n=147 Participants
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
|
2 mg Baricitinib
n=145 Participants
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
|
|---|---|---|---|
|
Percentage of Participants Developing Skin Infections Requiring Antibiotic Treatment
|
5.5 percentage of participants
|
4.1 percentage of participants
|
4.1 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants with Week 16 Itch NRS data.
The Itch NRS is a participant-administered, 11-point horizontal scale, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. LS Means were calculated using a MMRM model with treatment, baseline disease severity (IGA),and treatment-by-visit-interaction as fixed categorical effects and baseline, and baseline-by-visit-interaction as fixed continuous effects.
Outcome measures
| Measure |
Placebo
n=36 Participants
Placebo administered orally every day.
|
2 mg Baricitinib
n=64 Participants
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
|
2 mg Baricitinib
n=73 Participants
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
|
|---|---|---|---|
|
Percent Change From Baseline in Itch NRS
|
-18.01 percent change
Standard Error 5.133
|
-30.28 percent change
Standard Error 4.104
|
-39.87 percent change
Standard Error 3.904
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants with Week 16 POEM data.
The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) on a scale ranging from 0-4 (0 = no days, 1 = 1-2 days, 2 = 3-4 days, 3 = 5-6 days, 4 = everyday). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). High scores are indicative of more severe disease and poor quality of life. LS Means were calculated using a MMRM model with treatment, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Outcome measures
| Measure |
Placebo
n=28 Participants
Placebo administered orally every day.
|
2 mg Baricitinib
n=47 Participants
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
|
2 mg Baricitinib
n=63 Participants
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
|
|---|---|---|---|
|
Change From Baseline in the Total Score of the Patient Oriented Eczema Measure (POEM)
|
-2.67 units on a scale
Standard Error 1.216
|
-4.57 units on a scale
Standard Error 0.937
|
-7.44 units on a scale
Standard Error 0.848
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants with Week 16 PGI-S-AD data.
The PGI-S-AD is a single-item question asking the participant how they would rate their overall AD symptoms over the past 24 hours, using a daily diary. The 5 categories of responses are "(0) no symptoms", "(1) very mild", "(2) mild" "(3) moderate", and "(4) severe." LS Means were calculated using a MMRM model with treatment, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Outcome measures
| Measure |
Placebo
n=37 Participants
Placebo administered orally every day.
|
2 mg Baricitinib
n=64 Participants
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
|
2 mg Baricitinib
n=73 Participants
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
|
|---|---|---|---|
|
Change From Baseline in the Patient Global Impression of Severity-Atopic Dermatitis (PGI-S-AD) Score
|
-0.46 units on a scale
Standard Error 0.139
|
-0.71 units on a scale
Standard Error 0.111
|
-0.88 units on a scale
Standard Error 0.105
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants with Week 16 HADS data.
The HADS is a participant-rated instrument used to assess both anxiety and depression. This instrument consists of 14 item questionnaire, each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.' LS Means were calculated using a MMRM model with treatment, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Outcome measures
| Measure |
Placebo
n=28 Participants
Placebo administered orally every day.
|
2 mg Baricitinib
n=47 Participants
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
|
2 mg Baricitinib
n=63 Participants
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
|
|---|---|---|---|
|
Change From Baseline on the Hospital Anxiety Depression Scale (HADS)
Depression
|
-1.31 units on a scale
Standard Error 0.362
|
-0.87 units on a scale
Standard Error 0.294
|
-1.73 units on a scale
Standard Error 0.263
|
|
Change From Baseline on the Hospital Anxiety Depression Scale (HADS)
Anxiety
|
-2.03 units on a scale
Standard Error 0.441
|
-1.50 units on a scale
Standard Error 0.356
|
-2.55 units on a scale
Standard Error 0.321
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants with Week 16 DLQI data.
The DLQI is a simple, participant-administered,10 question, validated, quality-of-life questionnaire that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The recall period of this scale is over the last "week." Response categories include "not at all," "a little," "a lot," and "very much," with corresponding scores of 0, 1, 2, and 3, respectively, and unanswered or "not relevant" responses scored as "0." Scores range from 0 to 30 ("no impact on participant's life" to "extremely large effect on participant's life"), and a 4-point change from baseline is considered as the minimal clinically important difference threshold. LS Means were calculated using a MMRM model with treatment, baseline disease severity (IGA),visit, and treatment-by-visit-interaction as fixed categorical and baseline, and baseline-by-visit-interaction as fixed continuous effects.
Outcome measures
| Measure |
Placebo
n=28 Participants
Placebo administered orally every day.
|
2 mg Baricitinib
n=47 Participants
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
|
2 mg Baricitinib
n=63 Participants
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
|
|---|---|---|---|
|
Change From Baseline on the Dermatology Life Quality Index (DLQI)
|
-3.97 units on a scale
Standard Error 0.959
|
-5.47 units on a scale
Standard Error 0.776
|
-7.46 units on a scale
Standard Error 0.695
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants with baseline and at least 1 post-baseline WPAI measure.
The WPAI-AD participant questionnaire was developed to measure the effect of general health and symptom severity on work productivity and regular activities in the 7 days prior to the visit. The WPAI-AD consists of 6 items grouped in 4 domains: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism), and activity impairment, that range from 0% to 100%, with higher values indicating greater impairment. LS Mean were calculated using a MMRM model with treatment, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Outcome measures
| Measure |
Placebo
n=28 Participants
Placebo administered orally every day.
|
2 mg Baricitinib
n=47 Participants
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
|
2 mg Baricitinib
n=62 Participants
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
|
|---|---|---|---|
|
Change From Baseline on the Work Productivity and Activity Impairment - Atopic Dermatitis (WPAI-AD) Questionnaire
Absenteeism
|
3.41 units on a scale
Standard Error 4.741
|
0.05 units on a scale
Standard Error 3.642
|
2.34 units on a scale
Standard Error 3.078
|
|
Change From Baseline on the Work Productivity and Activity Impairment - Atopic Dermatitis (WPAI-AD) Questionnaire
Presenteeism
|
-3.44 units on a scale
Standard Error 4.037
|
-15.18 units on a scale
Standard Error 3.315
|
-19.33 units on a scale
Standard Error 2.990
|
|
Change From Baseline on the Work Productivity and Activity Impairment - Atopic Dermatitis (WPAI-AD) Questionnaire
Overall Work Impairment
|
-0.88 units on a scale
Standard Error 4.848
|
-13.73 units on a scale
Standard Error 3.943
|
-17.15 units on a scale
Standard Error 3.520
|
|
Change From Baseline on the Work Productivity and Activity Impairment - Atopic Dermatitis (WPAI-AD) Questionnaire
Activity Impairment
|
-9.24 units on a scale
Standard Error 3.334
|
-18.87 units on a scale
Standard Error 2.631
|
-22.53 units on a scale
Standard Error 2.401
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants with Week 16 EQ-5D-5L Index Score US and UK Algorithm
The EQ-5D-5L is a 2-part measurement. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the UK algorithm, with scores ranging from -0.594 to 1, and the US algorithm, with scores ranging from -0.109 to 1, with higher score indicating better health state. LS Means were calculated using a MMRM model with treatment, baseline disease activity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interactions as fixed continuous effects.
Outcome measures
| Measure |
Placebo
n=28 Participants
Placebo administered orally every day.
|
2 mg Baricitinib
n=47 Participants
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
|
2 mg Baricitinib
n=62 Participants
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
|
|---|---|---|---|
|
Change From Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Index Score United States (US) and United Kingdom (UK) Algorithm
Health State Index (US Algorithm)
|
0.04 units on a scale
Standard Error 0.021
|
0.06 units on a scale
Standard Error 0.016
|
0.10 units on a scale
Standard Error 0.015
|
|
Change From Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Index Score United States (US) and United Kingdom (UK) Algorithm
Health State Index (UK Algorithm)
|
0.07 units on a scale
Standard Error 0.029
|
0.09 units on a scale
Standard Error 0.023
|
0.14 units on a scale
Standard Error 0.020
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants with Week 16 EQ-5D-5L VAS data.
EQ-5D-5L is a 2-part measurement. The second part is assessed using a visual analog scale (VAS) that ranges from 0 to 100 millimeter (mm), where 0 is the worst health you can imagine and 100 is the best health you can imagine. LS Means were calculated using a MMRM model with treatment, baseline disease activity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interactions as fixed continuous effects.
Outcome measures
| Measure |
Placebo
n=28 Participants
Placebo administered orally every day.
|
2 mg Baricitinib
n=47 Participants
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
|
2 mg Baricitinib
n=62 Participants
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
|
|---|---|---|---|
|
Change From Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Visual Analog Score (VAS)
|
4.67 millimeters
Standard Error 2.022
|
3.34 millimeters
Standard Error 1.631
|
8.14 millimeters
Standard Error 1.497
|
SECONDARY outcome
Timeframe: Week 4Population: All randomized participants.
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
Outcome measures
| Measure |
Placebo
n=147 Participants
Placebo administered orally every day.
|
2 mg Baricitinib
n=147 Participants
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
|
2 mg Baricitinib
n=146 Participants
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
|
|---|---|---|---|
|
Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥ 2 Point Improvement
|
2.7 percentage of participants
Interval 1.1 to 6.8
|
5.4 percentage of participants
Interval 2.8 to 10.4
|
8.2 percentage of participants
Interval 4.8 to 12.8
|
Adverse Events
Placebo (Period 1 WK 0 to 16)
Serious events: 3 serious events
Other events: 34 other events
Deaths: 0 deaths
1 Milligram (mg) Baricitinib (Period 1 WK 0 to 16)
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
2 mg Baricitinib (Period 1 WK 0 to 16)
Serious events: 2 serious events
Other events: 36 other events
Deaths: 0 deaths
Placebo (Period 2 WK 16 to 104)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
1 mg Baricitinib (Period 2 WK 16 to 104)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
2 mg Baricitinib (Period 2 WK 16 to 104)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo (Period 1 WK 0 to 16)
n=146 participants at risk
Placebo administered orally every day (Period 1 WK 0 to 16)
|
1 Milligram (mg) Baricitinib (Period 1 WK 0 to 16)
n=147 participants at risk
1 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind. (Period 1 WK 0 to 16)
|
2 mg Baricitinib (Period 1 WK 0 to 16)
n=145 participants at risk
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind. (Period 1 WK 0 to 16)
|
Placebo (Period 2 WK 16 to 104)
n=8 participants at risk
Placebo administered orally every day (Period 2 WK 16 to 104)
|
1 mg Baricitinib (Period 2 WK 16 to 104)
n=19 participants at risk
1 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind. (Period 2 WK 16 to 104)
|
2 mg Baricitinib (Period 2 WK 16 to 104)
n=35 participants at risk
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind. (Period 2 WK 16 to 104)
|
|---|---|---|---|---|---|---|
|
Congenital, familial and genetic disorders
Hypertrophic cardiomyopathy
|
0.00%
0/146 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/147 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.69%
1/145 • Number of events 1 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/8 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/35 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.68%
1/146 • Number of events 1 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/147 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/145 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/8 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/35 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Infections and infestations
Cellulitis
|
0.68%
1/146 • Number of events 1 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/147 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/145 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/8 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/35 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Infections and infestations
Pneumonia
|
0.00%
0/146 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/147 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.69%
1/145 • Number of events 1 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/8 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/35 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/146 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/147 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.69%
1/145 • Number of events 1 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/8 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/35 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/146 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/147 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.69%
1/145 • Number of events 1 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/8 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/35 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Nervous system disorders
Seizure
|
0.00%
0/146 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.68%
1/147 • Number of events 1 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/145 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/8 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/35 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Psychiatric disorders
Delusion
|
0.68%
1/146 • Number of events 1 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/147 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/145 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/8 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/35 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Psychiatric disorders
Hallucination
|
0.68%
1/146 • Number of events 1 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/147 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/145 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/8 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/35 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/146 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/147 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.69%
1/145 • Number of events 1 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/8 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/35 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
Other adverse events
| Measure |
Placebo (Period 1 WK 0 to 16)
n=146 participants at risk
Placebo administered orally every day (Period 1 WK 0 to 16)
|
1 Milligram (mg) Baricitinib (Period 1 WK 0 to 16)
n=147 participants at risk
1 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind. (Period 1 WK 0 to 16)
|
2 mg Baricitinib (Period 1 WK 0 to 16)
n=145 participants at risk
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind. (Period 1 WK 0 to 16)
|
Placebo (Period 2 WK 16 to 104)
n=8 participants at risk
Placebo administered orally every day (Period 2 WK 16 to 104)
|
1 mg Baricitinib (Period 2 WK 16 to 104)
n=19 participants at risk
1 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind. (Period 2 WK 16 to 104)
|
2 mg Baricitinib (Period 2 WK 16 to 104)
n=35 participants at risk
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind. (Period 2 WK 16 to 104)
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
1.4%
2/146 • Number of events 2 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
2.0%
3/147 • Number of events 3 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
4.1%
6/145 • Number of events 7 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/8 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.7%
2/35 • Number of events 2 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Gastrointestinal disorders
Vomiting
|
0.68%
1/146 • Number of events 1 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/147 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
1.4%
2/145 • Number of events 2 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/8 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/35 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Immune system disorders
Seasonal allergy
|
0.68%
1/146 • Number of events 1 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.68%
1/147 • Number of events 1 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
1.4%
2/145 • Number of events 2 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/8 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/35 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Infections and infestations
Eczema herpeticum
|
0.00%
0/146 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/147 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/145 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/8 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/35 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Infections and infestations
Impetigo
|
2.1%
3/146 • Number of events 3 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/147 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.69%
1/145 • Number of events 1 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
12.5%
1/8 • Number of events 1 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/35 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Infections and infestations
Influenza
|
1.4%
2/146 • Number of events 2 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.68%
1/147 • Number of events 1 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/145 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/8 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
2.9%
1/35 • Number of events 1 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Infections and infestations
Kidney infection
|
0.00%
0/146 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/147 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/145 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/8 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/35 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/146 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/147 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/145 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/8 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/35 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Infections and infestations
Nasopharyngitis
|
7.5%
11/146 • Number of events 12 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
2.0%
3/147 • Number of events 3 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.2%
9/145 • Number of events 9 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/8 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/35 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Infections and infestations
Pneumonia
|
0.00%
0/146 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/147 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.69%
1/145 • Number of events 1 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/8 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/35 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Infections and infestations
Tooth infection
|
0.00%
0/146 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/147 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/145 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/8 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/35 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Infections and infestations
Upper respiratory tract infection
|
6.2%
9/146 • Number of events 11 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.1%
9/147 • Number of events 9 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.9%
10/145 • Number of events 11 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/8 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
10.5%
2/19 • Number of events 2 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
8.6%
3/35 • Number of events 4 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Infections and infestations
Urinary tract infection
|
2.1%
3/146 • Number of events 3 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.68%
1/147 • Number of events 1 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
3.4%
5/145 • Number of events 5 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/8 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
8.6%
3/35 • Number of events 3 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.68%
1/146 • Number of events 1 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/147 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
1.4%
2/145 • Number of events 2 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/8 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/35 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Investigations
Blood creatine phosphokinase increased
|
0.68%
1/146 • Number of events 1 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
2.0%
3/147 • Number of events 3 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
1.4%
2/145 • Number of events 3 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/8 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/35 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.68%
1/146 • Number of events 1 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
2.0%
3/147 • Number of events 3 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/145 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/8 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.7%
2/35 • Number of events 3 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/79 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/75 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/68 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/2 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/4 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
9.1%
1/11 • Number of events 1 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/146 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/147 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/145 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/8 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/35 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.68%
1/146 • Number of events 1 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/147 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.69%
1/145 • Number of events 1 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/8 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/35 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
0.00%
0/67 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/72 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/77 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/6 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 1 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/24 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.4%
2/146 • Number of events 2 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
1.4%
2/147 • Number of events 2 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
1.4%
2/145 • Number of events 2 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/8 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
2.9%
1/35 • Number of events 1 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/146 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/147 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.69%
1/145 • Number of events 1 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/8 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/35 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/146 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/147 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/145 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/8 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/35 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/146 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/147 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/145 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/8 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/35 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Surgical and medical procedures
Sinus operation
|
0.00%
0/146 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/147 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/145 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/8 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/35 • Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60