Trial Outcomes & Findings for Tralokinumab Monotherapy for Moderate to Severe Atopic Dermatitis - ECZTRA 2 (ECZema TRAlokinumab Trial no. 2) (NCT NCT03160885)
NCT ID: NCT03160885
Last Updated: 2025-03-11
Results Overview
The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
794 participants
Primary outcome timeframe
At Week 16
Results posted on
2025-03-11
Participant Flow
The screening period was 2 and 6 weeks and included 1 or 2 visits. The exact duration depended on the wash-out period defined by the exclusion criteria. If no wash-out or only a 2-week wash-out was required, screening Visits 1 and 2 were combined. Eligibility was assessed at the (first) screening visit and on Day 0 prior to randomization.
Participant milestones
| Measure |
Initial Treatment Period - Tralokinumab 300 mg Q2W
Week 0 to Week 16:
Tralokinumab 300 mg Q2W
Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for SC administration
At Day 0, each subject received 4 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab
|
Initial Treatment Period - Placebo Q2W
Week 0 to Week 16:
Placebo Q2W
Placebo: Placebo contains the same excipients, in the same concentration, only lacking tralokinumab
At Day 0, each subject received 4 SC injections (each 1.0 mL) of placebo to receive a total loading dose (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of placebo
|
Maintenance Treatment Period - Tralokinumab 300 mg Q2W
Week 16 to Week 52:
Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to tralokinumab 300 mg Q2W maintenance dosing regimen
At each visit, subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab Q2W to receive a total dose of 300 mg tralokinumab.
|
Maintenance Treatment Period - Tralokinumab 300 mg Q4W
Week 16 to Week 52:
Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to tralokinumab 300 mg Q4W maintenance dosing regimen
At each visit, subject received alternating dose administrations: 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab and 2 SC injections (each 1.0 mL) of placebo.
|
Maintenance Treatment Period - Placebo Q2W
Week 16 to Week 52:
Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to placebo Q2W dosing regimen
At each visit, subject received 2 SC injections (each 1.0 mL) of placebo Q2W to receive a total dose of placebo.
|
Maintenance Treatment Period -Placebo Q2W - Tralokinumab Naive
Week 16 to Week 52:
Subjects achieving a clinical response at Week 16 and initially randomized to placebo re-assigned to placebo Q2W
At each visit, subject received 2 SC injections (each 1.0 mL) of placebo Q2W to receive a total dose of placebo.
|
Open-label Treatment -Tralokinumab 300 mg Q2W + Optional TCS
Week 16 to Week 52:
Subjects receiving initial treatment with tralokinumab/placebo Q2W who did not achieve protocol-defined clinical response assigned to open-label treatment at Week 16 with tralokinumab 300 mg Q2W regimen + optional topical corticosteroids (TCS) OR Subjects receiving maintenance treatment with tralokinumab 300 mg Q2W/Q4W or placebo Q2W assigned to open-label treatment after Week 16 with tralokinumab 300 mg Q2W regimen + optional TCS if
* IGA of at least 2 and not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA=0 at Week 16 OR
* IGA of at least 3 and not achieving EASI75 over at least a 4-week period (i.e. over 3 consecutive visits) for subjects with IGA=1 at Week 16 OR
* Not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA\>1 at Week 16
At each visit, subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab Q2W to receive a total dose of 300 mg
|
|---|---|---|---|---|---|---|---|
|
Initial Treatment Period
STARTED
|
593
|
201
|
0
|
0
|
0
|
0
|
0
|
|
Initial Treatment Period
COMPLETED
|
558
|
179
|
0
|
0
|
0
|
0
|
0
|
|
Initial Treatment Period
NOT COMPLETED
|
35
|
22
|
0
|
0
|
0
|
0
|
0
|
|
Open-label Treatment
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
560
|
|
Open-label Treatment
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
423
|
|
Open-label Treatment
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
137
|
|
Maintenance Treatment Period
STARTED
|
0
|
0
|
91
|
90
|
46
|
31
|
0
|
|
Maintenance Treatment Period
COMPLETED
|
0
|
0
|
52
|
50
|
15
|
16
|
0
|
|
Maintenance Treatment Period
NOT COMPLETED
|
0
|
0
|
39
|
40
|
31
|
15
|
0
|
Reasons for withdrawal
| Measure |
Initial Treatment Period - Tralokinumab 300 mg Q2W
Week 0 to Week 16:
Tralokinumab 300 mg Q2W
Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for SC administration
At Day 0, each subject received 4 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab
|
Initial Treatment Period - Placebo Q2W
Week 0 to Week 16:
Placebo Q2W
Placebo: Placebo contains the same excipients, in the same concentration, only lacking tralokinumab
At Day 0, each subject received 4 SC injections (each 1.0 mL) of placebo to receive a total loading dose (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of placebo
|
Maintenance Treatment Period - Tralokinumab 300 mg Q2W
Week 16 to Week 52:
Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to tralokinumab 300 mg Q2W maintenance dosing regimen
At each visit, subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab Q2W to receive a total dose of 300 mg tralokinumab.
|
Maintenance Treatment Period - Tralokinumab 300 mg Q4W
Week 16 to Week 52:
Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to tralokinumab 300 mg Q4W maintenance dosing regimen
At each visit, subject received alternating dose administrations: 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab and 2 SC injections (each 1.0 mL) of placebo.
|
Maintenance Treatment Period - Placebo Q2W
Week 16 to Week 52:
Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to placebo Q2W dosing regimen
At each visit, subject received 2 SC injections (each 1.0 mL) of placebo Q2W to receive a total dose of placebo.
|
Maintenance Treatment Period -Placebo Q2W - Tralokinumab Naive
Week 16 to Week 52:
Subjects achieving a clinical response at Week 16 and initially randomized to placebo re-assigned to placebo Q2W
At each visit, subject received 2 SC injections (each 1.0 mL) of placebo Q2W to receive a total dose of placebo.
|
Open-label Treatment -Tralokinumab 300 mg Q2W + Optional TCS
Week 16 to Week 52:
Subjects receiving initial treatment with tralokinumab/placebo Q2W who did not achieve protocol-defined clinical response assigned to open-label treatment at Week 16 with tralokinumab 300 mg Q2W regimen + optional topical corticosteroids (TCS) OR Subjects receiving maintenance treatment with tralokinumab 300 mg Q2W/Q4W or placebo Q2W assigned to open-label treatment after Week 16 with tralokinumab 300 mg Q2W regimen + optional TCS if
* IGA of at least 2 and not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA=0 at Week 16 OR
* IGA of at least 3 and not achieving EASI75 over at least a 4-week period (i.e. over 3 consecutive visits) for subjects with IGA=1 at Week 16 OR
* Not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA\>1 at Week 16
At each visit, subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab Q2W to receive a total dose of 300 mg
|
|---|---|---|---|---|---|---|---|
|
Initial Treatment Period
Not dosed
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Initial Treatment Period
Discontinued IMP before Week 16
|
33
|
22
|
0
|
0
|
0
|
0
|
0
|
|
Open-label Treatment
Not dosed
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Open-label Treatment
Discontinued IMP
|
0
|
0
|
0
|
0
|
0
|
0
|
131
|
|
Open-label Treatment
Completed Week 50
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
|
Maintenance Treatment Period
Not dosed - transfer to open-label
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Maintenance Treatment Period
Discontinued IMP
|
0
|
0
|
9
|
13
|
5
|
7
|
0
|
|
Maintenance Treatment Period
Transfer to open-label treatment
|
0
|
0
|
29
|
26
|
26
|
8
|
0
|
|
Maintenance Treatment Period
Completed Week 50
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Number of subjects analysed = subjects with available data for the baseline parameter.
Baseline characteristics by cohort
| Measure |
Initial Treatment Period - Tralokinumab 300 mg Q2W
n=593 Participants
Week 0 to Week 16:
Tralokinumab 300 mg Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab
|
Initial Treatment Period - Placebo Q2W
n=201 Participants
Week 0 to Week 16:
Placebo Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of placebo to receive a total loading dose (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of placebo
|
Total
n=794 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.2 years
STANDARD_DEVIATION 14.7 • n=593 Participants
|
35.1 years
STANDARD_DEVIATION 14.0 • n=201 Participants
|
36.7 years
STANDARD_DEVIATION 14.6 • n=794 Participants
|
|
Age, Customized
18-64 years
|
563 Participants
n=593 Participants
|
194 Participants
n=201 Participants
|
757 Participants
n=794 Participants
|
|
Age, Customized
65-84 years
|
29 Participants
n=593 Participants
|
7 Participants
n=201 Participants
|
36 Participants
n=794 Participants
|
|
Age, Customized
>=85 years
|
1 Participants
n=593 Participants
|
0 Participants
n=201 Participants
|
1 Participants
n=794 Participants
|
|
Sex: Female, Male
Female
|
234 Participants
n=593 Participants
|
87 Participants
n=201 Participants
|
321 Participants
n=794 Participants
|
|
Sex: Female, Male
Male
|
359 Participants
n=593 Participants
|
114 Participants
n=201 Participants
|
473 Participants
n=794 Participants
|
|
Race/Ethnicity, Customized
White
|
374 Participants
n=593 Participants
|
123 Participants
n=201 Participants
|
497 Participants
n=794 Participants
|
|
Race/Ethnicity, Customized
Black or african american
|
43 Participants
n=593 Participants
|
17 Participants
n=201 Participants
|
60 Participants
n=794 Participants
|
|
Race/Ethnicity, Customized
Asian
|
154 Participants
n=593 Participants
|
52 Participants
n=201 Participants
|
206 Participants
n=794 Participants
|
|
Race/Ethnicity, Customized
American indian or alaska native
|
2 Participants
n=593 Participants
|
0 Participants
n=201 Participants
|
2 Participants
n=794 Participants
|
|
Race/Ethnicity, Customized
Native hawaiian or other pacific islander
|
1 Participants
n=593 Participants
|
0 Participants
n=201 Participants
|
1 Participants
n=794 Participants
|
|
Race/Ethnicity, Customized
Other
|
19 Participants
n=593 Participants
|
9 Participants
n=201 Participants
|
28 Participants
n=794 Participants
|
|
Region of Enrollment
Canada
|
146 Participants
n=593 Participants
|
44 Participants
n=201 Participants
|
190 Participants
n=794 Participants
|
|
Region of Enrollment
South Korea
|
58 Participants
n=593 Participants
|
20 Participants
n=201 Participants
|
78 Participants
n=794 Participants
|
|
Region of Enrollment
United States
|
124 Participants
n=593 Participants
|
47 Participants
n=201 Participants
|
171 Participants
n=794 Participants
|
|
Region of Enrollment
Denmark
|
8 Participants
n=593 Participants
|
2 Participants
n=201 Participants
|
10 Participants
n=794 Participants
|
|
Region of Enrollment
Poland
|
67 Participants
n=593 Participants
|
27 Participants
n=201 Participants
|
94 Participants
n=794 Participants
|
|
Region of Enrollment
Italy
|
31 Participants
n=593 Participants
|
10 Participants
n=201 Participants
|
41 Participants
n=794 Participants
|
|
Region of Enrollment
United Kingdom
|
55 Participants
n=593 Participants
|
15 Participants
n=201 Participants
|
70 Participants
n=794 Participants
|
|
Region of Enrollment
Australia
|
90 Participants
n=593 Participants
|
31 Participants
n=201 Participants
|
121 Participants
n=794 Participants
|
|
Region of Enrollment
Russia
|
14 Participants
n=593 Participants
|
5 Participants
n=201 Participants
|
19 Participants
n=794 Participants
|
|
Investigator's Global Assessment
Clear
|
0 Participants
n=593 Participants
|
0 Participants
n=201 Participants
|
0 Participants
n=794 Participants
|
|
Investigator's Global Assessment
Almost clear
|
0 Participants
n=593 Participants
|
0 Participants
n=201 Participants
|
0 Participants
n=794 Participants
|
|
Investigator's Global Assessment
Mild
|
0 Participants
n=593 Participants
|
0 Participants
n=201 Participants
|
0 Participants
n=794 Participants
|
|
Investigator's Global Assessment
Moderate
|
305 Participants
n=593 Participants
|
100 Participants
n=201 Participants
|
405 Participants
n=794 Participants
|
|
Investigator's Global Assessment
Severe
|
286 Participants
n=593 Participants
|
101 Participants
n=201 Participants
|
387 Participants
n=794 Participants
|
|
Investigator's Global Assessment
Missing
|
2 Participants
n=593 Participants
|
0 Participants
n=201 Participants
|
2 Participants
n=794 Participants
|
|
Eczema Area and Severity Index
|
32.1 units on a scale
STANDARD_DEVIATION 14.3 • n=591 Participants • Number of subjects analysed = subjects with available data for the baseline parameter.
|
32.6 units on a scale
STANDARD_DEVIATION 13.9 • n=201 Participants • Number of subjects analysed = subjects with available data for the baseline parameter.
|
32.2 units on a scale
STANDARD_DEVIATION 14.2 • n=792 Participants • Number of subjects analysed = subjects with available data for the baseline parameter.
|
|
Scoring Atopic Dermatitis
|
70.0 units on a scale
STANDARD_DEVIATION 13.4 • n=591 Participants • Number of subjects analysed = subjects with available data for the baseline parameter.
|
70.5 units on a scale
STANDARD_DEVIATION 12.2 • n=201 Participants • Number of subjects analysed = subjects with available data for the baseline parameter.
|
70.1 units on a scale
STANDARD_DEVIATION 13.1 • n=792 Participants • Number of subjects analysed = subjects with available data for the baseline parameter.
|
|
Dermatology Life Quality Index
|
17.7 units on a scale
STANDARD_DEVIATION 7.1 • n=587 Participants • Number of subjects analysed = subjects with available data for the baseline parameter.
|
17.8 units on a scale
STANDARD_DEVIATION 7.3 • n=200 Participants • Number of subjects analysed = subjects with available data for the baseline parameter.
|
17.7 units on a scale
STANDARD_DEVIATION 7.1 • n=787 Participants • Number of subjects analysed = subjects with available data for the baseline parameter.
|
|
Worst Daily Pruritus Numeric rating scale (weekly average)
|
7.9 units on a scale
STANDARD_DEVIATION 1.5 • n=584 Participants • Number of subjects analysed = subjects with available data for the baseline parameter.
|
8.0 units on a scale
STANDARD_DEVIATION 1.4 • n=200 Participants • Number of subjects analysed = subjects with available data for the baseline parameter.
|
7.9 units on a scale
STANDARD_DEVIATION 1.4 • n=784 Participants • Number of subjects analysed = subjects with available data for the baseline parameter.
|
|
Body surface area affected by AD
|
52.6 percent body surface area
STANDARD_DEVIATION 25.6 • n=593 Participants
|
53.0 percent body surface area
STANDARD_DEVIATION 25.0 • n=201 Participants
|
52.7 percent body surface area
STANDARD_DEVIATION 25.4 • n=794 Participants
|
|
Age of onset of atopic dermatitis (AD)
|
2.0 years
n=592 Participants • Number of subjects analysed = subjects with available data for the baseline parameter.
|
2.0 years
n=201 Participants • Number of subjects analysed = subjects with available data for the baseline parameter.
|
2.0 years
n=793 Participants • Number of subjects analysed = subjects with available data for the baseline parameter.
|
|
Duration of atopic dermatitis (AD)
|
28.3 years
STANDARD_DEVIATION 15.9 • n=592 Participants • Number of subjects analysed = subjects with available data for the baseline parameter.
|
27.5 years
STANDARD_DEVIATION 14.7 • n=201 Participants • Number of subjects analysed = subjects with available data for the baseline parameter.
|
28.1 years
STANDARD_DEVIATION 15.6 • n=793 Participants • Number of subjects analysed = subjects with available data for the baseline parameter.
|
PRIMARY outcome
Timeframe: At Week 16Population: The full analysis set (FAS: all subjects randomised to initial treatment who were exposed to IMP) was used for the primary analysis; 794 subjects were randomised to initial treatment and 792 received IMP, thus the FAS comprised 792 subjects.
The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Outcome measures
| Measure |
Tralokinumab 300 mg Q2W
n=591 Participants
Week 0 to Week 16:
Tralokinumab 300 mg Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab
|
Placebo Q2W
n=201 Participants
Week 0 to Week 16:
Placebo Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of placebo to receive a total loading dose (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of placebo
|
Placebo Q2W
Week 16 to Week 52:
Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to placebo Q2W dosing regimen
At each visit, subject received 2 SC injections (each 1.0 mL) of placebo Q2W to receive a total dose of placebo.
|
|---|---|---|---|
|
Subjects With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16.
|
131 Participants
|
22 Participants
|
—
|
PRIMARY outcome
Timeframe: At Week 16Population: Full analysis set
The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Outcome measures
| Measure |
Tralokinumab 300 mg Q2W
n=591 Participants
Week 0 to Week 16:
Tralokinumab 300 mg Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab
|
Placebo Q2W
n=201 Participants
Week 0 to Week 16:
Placebo Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of placebo to receive a total loading dose (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of placebo
|
Placebo Q2W
Week 16 to Week 52:
Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to placebo Q2W dosing regimen
At each visit, subject received 2 SC injections (each 1.0 mL) of placebo Q2W to receive a total dose of placebo.
|
|---|---|---|---|
|
Subjects Achieving at Least 75% Reduction in Eczema Area and Severity Index [EASI].
|
196 Participants
|
23 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 0 to Week 16Population: Full analysis set (FAS). Number of subjects analysed = subjects with baseline pruritus NRS weekly average ≥4.
Subjects will assess their worst itch severity over the past 24 hours using an 11 point NRS ('Worst Daily Pruritus NRS') with 0 indicating 'no itch' and 10 indicating 'worst itch imaginable'.
Outcome measures
| Measure |
Tralokinumab 300 mg Q2W
n=575 Participants
Week 0 to Week 16:
Tralokinumab 300 mg Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab
|
Placebo Q2W
n=200 Participants
Week 0 to Week 16:
Placebo Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of placebo to receive a total loading dose (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of placebo
|
Placebo Q2W
Week 16 to Week 52:
Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to placebo Q2W dosing regimen
At each visit, subject received 2 SC injections (each 1.0 mL) of placebo Q2W to receive a total dose of placebo.
|
|---|---|---|---|
|
Reduction of Worst Daily Pruritus Numeric Rating Scale (Weekly Average) of at Least 4 From Baseline to Week 16.
|
144 Participants
|
19 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 0 to Week 16Population: Full analysis set
The SCORAD is a validated tool to evaluate the extent and severity of AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.
Outcome measures
| Measure |
Tralokinumab 300 mg Q2W
n=591 Participants
Week 0 to Week 16:
Tralokinumab 300 mg Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab
|
Placebo Q2W
n=201 Participants
Week 0 to Week 16:
Placebo Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of placebo to receive a total loading dose (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of placebo
|
Placebo Q2W
Week 16 to Week 52:
Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to placebo Q2W dosing regimen
At each visit, subject received 2 SC injections (each 1.0 mL) of placebo Q2W to receive a total dose of placebo.
|
|---|---|---|---|
|
Change in Scoring Atopic Dermatitis (SCORAD) From Baseline to Week 16.
|
-28.1 units on a scale
Standard Error 0.92
|
-14.0 units on a scale
Standard Error 1.79
|
—
|
SECONDARY outcome
Timeframe: Week 0 to Week 16Population: Full analysis set
The DLQI is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the subject's perception of the impact of their skin disease on different aspects of their quality of life (QoL) over the last week such as dermatology-related symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the treatment. Each item is scored on a 4 point Likert scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; 3 = very much). The total score is the sum of the 10 items (0 to 30); a high score is indicative of a poor QoL.
Outcome measures
| Measure |
Tralokinumab 300 mg Q2W
n=591 Participants
Week 0 to Week 16:
Tralokinumab 300 mg Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab
|
Placebo Q2W
n=201 Participants
Week 0 to Week 16:
Placebo Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of placebo to receive a total loading dose (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of placebo
|
Placebo Q2W
Week 16 to Week 52:
Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to placebo Q2W dosing regimen
At each visit, subject received 2 SC injections (each 1.0 mL) of placebo Q2W to receive a total dose of placebo.
|
|---|---|---|---|
|
Change in Dermatology Life Quality Index (DLQI) Score From Baseline to Week 16.
|
-8.8 units on a scale
Standard Error 0.30
|
-4.9 units on a scale
Standard Error 0.60
|
—
|
SECONDARY outcome
Timeframe: At Week 52Population: Maintenance analysis set - Subjects who achieved IGA 0/1 at Week 16 after initial treatment with tralokinumab without use of rescue medication
The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Outcome measures
| Measure |
Tralokinumab 300 mg Q2W
n=54 Participants
Week 0 to Week 16:
Tralokinumab 300 mg Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab
|
Placebo Q2W
n=49 Participants
Week 0 to Week 16:
Placebo Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of placebo to receive a total loading dose (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of placebo
|
Placebo Q2W
n=28 Participants
Week 16 to Week 52:
Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to placebo Q2W dosing regimen
At each visit, subject received 2 SC injections (each 1.0 mL) of placebo Q2W to receive a total dose of placebo.
|
|---|---|---|---|
|
Subjects With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 52 Among Subjects With IGA of 0/1 at Week 16
|
32 Participants
|
22 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: At Week 52Population: Maintenance analysis set: Subjects who achieved EASI75 at Week 16 after initial treatment with tralokinumab without use of rescue medication
The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Outcome measures
| Measure |
Tralokinumab 300 mg Q2W
n=77 Participants
Week 0 to Week 16:
Tralokinumab 300 mg Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab
|
Placebo Q2W
n=74 Participants
Week 0 to Week 16:
Placebo Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of placebo to receive a total loading dose (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of placebo
|
Placebo Q2W
n=42 Participants
Week 16 to Week 52:
Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to placebo Q2W dosing regimen
At each visit, subject received 2 SC injections (each 1.0 mL) of placebo Q2W to receive a total dose of placebo.
|
|---|---|---|---|
|
Subjects With at Least 75% Reduction in Eczema Area and Severity Index [EASI] at Week 52 Among Subjects With EASI75 at Week 16
|
43 Participants
|
38 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Week 0 to Week 16Population: The analysis was performed on the safety analysis set. The safety analysis set comprised of participants who received at least 1 dose of IMP during the trial.
Overall summary of AEs and SAEs during the Initial treatment period is presented. For list of AEs and SAEs by MedDRA system organ class (SOC) and preferred term (PT) during the entire trial period (including safety follow-up), see Adverse Events Overview section.
Outcome measures
| Measure |
Tralokinumab 300 mg Q2W
n=592 Participants
Week 0 to Week 16:
Tralokinumab 300 mg Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab
|
Placebo Q2W
n=200 Participants
Week 0 to Week 16:
Placebo Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of placebo to receive a total loading dose (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of placebo
|
Placebo Q2W
Week 16 to Week 52:
Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to placebo Q2W dosing regimen
At each visit, subject received 2 SC injections (each 1.0 mL) of placebo Q2W to receive a total dose of placebo.
|
|---|---|---|---|
|
Safety and Tolerability: Adverse Event (AE) /Serious Adverse Event (SAE) Frequency
SAEs
|
10 Participants
|
5 Participants
|
—
|
|
Safety and Tolerability: Adverse Event (AE) /Serious Adverse Event (SAE) Frequency
AEs
|
364 Participants
|
132 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 0 to Week 16Population: All subjects in the safety analysis set are included
Anti-tralokinumab antibody levels were analysed using a validated bioanalytical method
Outcome measures
| Measure |
Tralokinumab 300 mg Q2W
n=592 Participants
Week 0 to Week 16:
Tralokinumab 300 mg Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab
|
Placebo Q2W
n=200 Participants
Week 0 to Week 16:
Placebo Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of placebo to receive a total loading dose (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of placebo
|
Placebo Q2W
Week 16 to Week 52:
Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to placebo Q2W dosing regimen
At each visit, subject received 2 SC injections (each 1.0 mL) of placebo Q2W to receive a total dose of placebo.
|
|---|---|---|---|
|
Frequency of Anti-drug Antibodies
Total positive
|
10 Participants
|
3 Participants
|
—
|
|
Frequency of Anti-drug Antibodies
Pre existing
|
2 Participants
|
1 Participants
|
—
|
|
Frequency of Anti-drug Antibodies
Treatment emergent - Persistent
|
8 Participants
|
2 Participants
|
—
|
|
Frequency of Anti-drug Antibodies
Perishing
|
6 Participants
|
2 Participants
|
—
|
|
Frequency of Anti-drug Antibodies
Negative
|
558 Participants
|
185 Participants
|
—
|
|
Frequency of Anti-drug Antibodies
No post-baseline anti-drug antibody assessment
|
18 Participants
|
10 Participants
|
—
|
SECONDARY outcome
Timeframe: At Week 16Population: Full analysis set
The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Outcome measures
| Measure |
Tralokinumab 300 mg Q2W
n=591 Participants
Week 0 to Week 16:
Tralokinumab 300 mg Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab
|
Placebo Q2W
n=201 Participants
Week 0 to Week 16:
Placebo Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of placebo to receive a total loading dose (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of placebo
|
Placebo Q2W
Week 16 to Week 52:
Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to placebo Q2W dosing regimen
At each visit, subject received 2 SC injections (each 1.0 mL) of placebo Q2W to receive a total dose of placebo.
|
|---|---|---|---|
|
Subjects Achieving at Least 50% Reduction in Eczema Area and Severity Index [EASI] at Week 16
|
295 Participants
|
41 Participants
|
—
|
SECONDARY outcome
Timeframe: At Week 16Population: Full analysis set
The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Outcome measures
| Measure |
Tralokinumab 300 mg Q2W
n=591 Participants
Week 0 to Week 16:
Tralokinumab 300 mg Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab
|
Placebo Q2W
n=201 Participants
Week 0 to Week 16:
Placebo Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of placebo to receive a total loading dose (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of placebo
|
Placebo Q2W
Week 16 to Week 52:
Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to placebo Q2W dosing regimen
At each visit, subject received 2 SC injections (each 1.0 mL) of placebo Q2W to receive a total dose of placebo.
|
|---|---|---|---|
|
Subjects Achieving at Least 90% Reduction in Eczema Area and Severity Index [EASI] at Week 16.
|
108 Participants
|
11 Participants
|
—
|
SECONDARY outcome
Timeframe: At Week 16Population: Full analysis set
The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Outcome measures
| Measure |
Tralokinumab 300 mg Q2W
n=591 Participants
Week 0 to Week 16:
Tralokinumab 300 mg Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab
|
Placebo Q2W
n=201 Participants
Week 0 to Week 16:
Placebo Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of placebo to receive a total loading dose (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of placebo
|
Placebo Q2W
Week 16 to Week 52:
Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to placebo Q2W dosing regimen
At each visit, subject received 2 SC injections (each 1.0 mL) of placebo Q2W to receive a total dose of placebo.
|
|---|---|---|---|
|
Change From Baseline to Week 16 in Eczema Area and Severity Index [EASI] Score
|
-16.9 units on a scale
Interval -18.0 to -15.8
|
-7.0 units on a scale
Interval -9.1 to -5.0
|
—
|
SECONDARY outcome
Timeframe: At Week 16Population: Full analysis set
The SCORAD is a validated tool to evaluate the extent and severity of AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.
Outcome measures
| Measure |
Tralokinumab 300 mg Q2W
n=591 Participants
Week 0 to Week 16:
Tralokinumab 300 mg Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab
|
Placebo Q2W
n=201 Participants
Week 0 to Week 16:
Placebo Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of placebo to receive a total loading dose (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of placebo
|
Placebo Q2W
Week 16 to Week 52:
Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to placebo Q2W dosing regimen
At each visit, subject received 2 SC injections (each 1.0 mL) of placebo Q2W to receive a total dose of placebo.
|
|---|---|---|---|
|
Subjects Achieving at Least 75% Reduction in Scoring Atopic Dermatitis (SCORAD) at Week 16.
|
68 Participants
|
7 Participants
|
—
|
SECONDARY outcome
Timeframe: At Week 16Population: Full analysis set
The SCORAD is a validated tool to evaluate the extent and severity of AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.
Outcome measures
| Measure |
Tralokinumab 300 mg Q2W
n=591 Participants
Week 0 to Week 16:
Tralokinumab 300 mg Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab
|
Placebo Q2W
n=201 Participants
Week 0 to Week 16:
Placebo Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of placebo to receive a total loading dose (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of placebo
|
Placebo Q2W
Week 16 to Week 52:
Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to placebo Q2W dosing regimen
At each visit, subject received 2 SC injections (each 1.0 mL) of placebo Q2W to receive a total dose of placebo.
|
|---|---|---|---|
|
Subjects Achieving at Least 50% Reduction in Scoring Atopic Dermatitis (SCORAD) at Week 16.
|
198 Participants
|
29 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Full analysis set
Subjects will assess their worst itch severity over the past 24 hours using an 11 point NRS ('Worst Daily Pruritus NRS') with 0 indicating 'no itch' and 10 indicating 'worst itch imaginable'
Outcome measures
| Measure |
Tralokinumab 300 mg Q2W
n=584 Participants
Week 0 to Week 16:
Tralokinumab 300 mg Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab
|
Placebo Q2W
n=200 Participants
Week 0 to Week 16:
Placebo Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of placebo to receive a total loading dose (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of placebo
|
Placebo Q2W
Week 16 to Week 52:
Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to placebo Q2W dosing regimen
At each visit, subject received 2 SC injections (each 1.0 mL) of placebo Q2W to receive a total dose of placebo.
|
|---|---|---|---|
|
Change From Baseline to Week 16 in Worst Daily Pruritus NRS (Weekly Average).
|
-2.9 units on a scale
Interval -3.1 to -2.6
|
-1.6 units on a scale
Interval -2.0 to -1.2
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Full analysis set. Number of subjects analysed = subjects with baseline Pruritus NRS weekly average of at least 3
Subjects will assess their worst itch severity over the past 24 hours using an 11 point NRS ('Worst Daily Pruritus NRS') with 0 indicating 'no itch' and 10 indicating 'worst itch imaginable'.
Outcome measures
| Measure |
Tralokinumab 300 mg Q2W
n=583 Participants
Week 0 to Week 16:
Tralokinumab 300 mg Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab
|
Placebo Q2W
n=200 Participants
Week 0 to Week 16:
Placebo Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of placebo to receive a total loading dose (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of placebo
|
Placebo Q2W
Week 16 to Week 52:
Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to placebo Q2W dosing regimen
At each visit, subject received 2 SC injections (each 1.0 mL) of placebo Q2W to receive a total dose of placebo.
|
|---|---|---|---|
|
Reduction of Worst Daily Pruritus NRS (Weekly Average) ≥3 From Baseline to Week 16.
|
199 Participants
|
28 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Full analysis set. Number of subjects analysed = subjects with baseline DLQI ≥4
The DLQI is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the subject's perception of the impact of their skin disease on different aspects of their QoL over the last week such as dermatology related symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the treatment. Each item is scored on a 4 point Likert scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; 3 = very much). The total score is the sum of the 10 items (0 to 30); a high score is indicative of a poor QoL.
Outcome measures
| Measure |
Tralokinumab 300 mg Q2W
n=577 Participants
Week 0 to Week 16:
Tralokinumab 300 mg Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab
|
Placebo Q2W
n=198 Participants
Week 0 to Week 16:
Placebo Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of placebo to receive a total loading dose (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of placebo
|
Placebo Q2W
Week 16 to Week 52:
Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to placebo Q2W dosing regimen
At each visit, subject received 2 SC injections (each 1.0 mL) of placebo Q2W to receive a total dose of placebo.
|
|---|---|---|---|
|
Reduction From Baseline to Week 16 of Dermatology Life Quality Index (DLQI) of ≥4 Points Among Subjects With Baseline DLQI ≥4.
|
325 Participants
|
54 Participants
|
—
|
Adverse Events
Initial Period - Tralokinumab Q2W
Serious events: 10 serious events
Other events: 202 other events
Deaths: 0 deaths
Initial Period - Placebo
Serious events: 5 serious events
Other events: 89 other events
Deaths: 0 deaths
Maintenance Period - Tralokinumab Q2W
Serious events: 0 serious events
Other events: 37 other events
Deaths: 0 deaths
Maintenance Period - Tralokinumab Q4W
Serious events: 3 serious events
Other events: 28 other events
Deaths: 0 deaths
Maintenance Period - Placebo
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Maintenance Period - Placebo - Tralokinumab Naive
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Open-label Period - Tralokinumab Q2W + Optional TCS
Serious events: 16 serious events
Other events: 226 other events
Deaths: 0 deaths
Safety Follow-up
Serious events: 4 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Initial Period - Tralokinumab Q2W
n=592 participants at risk
Initial Period - Tralokinumab Q2W (n=592, patient years of exposure (PYE)=176.90)
|
Initial Period - Placebo
n=200 participants at risk
Initial Period - Placebo (n=200, PYE=57.35)
|
Maintenance Period - Tralokinumab Q2W
n=91 participants at risk
Maintenance Period - Tralokinumab Q2W (n=91, PYE=46.93)
|
Maintenance Period - Tralokinumab Q4W
n=89 participants at risk
Maintenance Period - Tralokinumab Q4W (n=89, PYE=44.65)
|
Maintenance Period - Placebo
n=46 participants at risk
Maintenance Period - Placebo (n=46, PYE=20.07)
|
Maintenance Period - Placebo - Tralokinumab Naive
n=31 participants at risk
Maintenance Period - Placebo - Tralokinumab Naive (n=31, PYE=15.09)
|
Open-label Period - Tralokinumab Q2W + Optional TCS
n=558 participants at risk
Open-label Period - Tralokinumab Q2W + Optional TCS (n=558, PYE=315.48)
|
Safety Follow-up
n=641 participants at risk
Safety Follow-up (n=641, PYE=142.90) includes subjects from Initial, Maintenance and Open-label Periods:
Tralokinumab Q2W (n=83); Tralokinumab Q4W (n=50); Tralokinumab Q2W + optional TCS (n=454); Placebo (n=54)
|
|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.17%
1/592 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/200 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/91 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/89 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/46 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/31 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/558 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/641 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
|
Respiratory, thoracic and mediastinal disorders
Status asthmaticus
|
0.17%
1/592 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/200 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/91 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/89 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/46 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/31 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/558 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.16%
1/641 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.17%
1/592 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/200 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/91 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/89 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/46 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/31 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.18%
1/558 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/641 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/592 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.50%
1/200 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/91 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/89 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/46 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/31 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/558 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/641 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/592 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/200 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/91 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/89 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/46 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/31 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.18%
1/558 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/641 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
|
Surgical and medical procedures
Ovarian cystectomy
|
0.00%
0/592 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/200 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/91 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/89 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/46 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/31 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.18%
1/558 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/641 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
|
Blood and lymphatic system disorders
Benign ethnic neutropenia
|
0.00%
0/592 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/200 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/91 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/89 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/46 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/31 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.18%
1/558 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/641 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/592 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.50%
1/200 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/91 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/89 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/46 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/31 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/558 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/641 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
|
Eye disorders
Cataract subcapsular
|
0.00%
0/592 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.50%
1/200 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/91 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/89 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/46 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/31 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/558 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/641 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
|
Eye disorders
Retinal detachment
|
0.00%
0/592 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/200 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/91 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/89 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/46 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/31 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.18%
1/558 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/641 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/592 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.50%
1/200 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/91 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/89 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/46 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/31 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/558 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/641 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.17%
1/592 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/200 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/91 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/89 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/46 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/31 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/558 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/641 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
|
Gastrointestinal disorders
Gastric perforation
|
0.00%
0/592 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/200 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/91 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/89 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/46 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/31 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/558 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.16%
1/641 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/592 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/200 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/91 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/89 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/46 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/31 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.36%
2/558 • Number of events 2 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/641 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
|
Infections and infestations
Eczema herpeticum
|
0.00%
0/592 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/200 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/91 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/89 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/46 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/31 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/558 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.16%
1/641 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
|
Infections and infestations
Gastroenteritis viral
|
0.17%
1/592 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/200 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/91 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/89 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/46 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/31 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/558 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/641 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
|
Infections and infestations
Keratitis viral
|
0.00%
0/592 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/200 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/91 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/89 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/46 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/31 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.18%
1/558 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/641 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
|
Infections and infestations
Pilonidal cyst
|
0.00%
0/592 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.50%
1/200 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/91 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/89 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/46 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/31 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/558 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/641 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
|
Infections and infestations
Pneumonia
|
0.17%
1/592 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/200 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/91 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/89 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/46 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/31 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.18%
1/558 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/641 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
|
Infections and infestations
Skin infection
|
0.00%
0/592 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.50%
1/200 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/91 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/89 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/46 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/31 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/558 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/641 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
|
Infections and infestations
Staphylococcal abscess
|
0.00%
0/592 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/200 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/91 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/89 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/46 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/31 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/558 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.16%
1/641 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/592 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/200 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/91 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/89 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/46 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/31 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.18%
1/558 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/641 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/592 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/200 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/91 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/89 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/46 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/31 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.18%
1/558 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/641 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/592 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/200 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/91 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/89 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/46 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/31 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.18%
1/558 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/641 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.17%
1/592 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/200 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/91 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/89 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/46 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/31 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/558 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/641 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/592 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/200 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/91 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/89 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/46 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/31 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.18%
1/558 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/641 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/592 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/200 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/91 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/89 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/46 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/31 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.18%
1/558 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/641 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Angiosarcoma
|
0.17%
1/592 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/200 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/91 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/89 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/46 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/31 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/558 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/641 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/592 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/200 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/91 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
1.1%
1/89 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/46 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/31 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/558 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/641 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.17%
1/592 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/200 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/91 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/89 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/46 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/31 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/558 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/641 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
|
Nervous system disorders
Dizziness
|
0.00%
0/592 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/200 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/91 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
1.1%
1/89 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/46 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/31 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/558 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/641 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
|
Nervous system disorders
Neurological symptom
|
0.00%
0/592 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/200 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/91 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/89 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/46 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/31 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.18%
1/558 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/641 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
|
Nervous system disorders
Syncope
|
0.00%
0/592 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/200 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/91 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/89 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/46 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/31 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.18%
1/558 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/641 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
|
Product Issues
Device dislocation
|
0.00%
0/592 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/200 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/91 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/89 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/46 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/31 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.18%
1/558 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/641 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
|
Psychiatric disorders
Depression suicidal
|
0.17%
1/592 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/200 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/91 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/89 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/46 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/31 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/558 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/641 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/592 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/200 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/91 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
1.1%
1/89 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/46 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/31 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/558 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/641 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/592 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/200 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/91 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/89 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/46 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/31 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.18%
1/558 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/641 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
Other adverse events
| Measure |
Initial Period - Tralokinumab Q2W
n=592 participants at risk
Initial Period - Tralokinumab Q2W (n=592, patient years of exposure (PYE)=176.90)
|
Initial Period - Placebo
n=200 participants at risk
Initial Period - Placebo (n=200, PYE=57.35)
|
Maintenance Period - Tralokinumab Q2W
n=91 participants at risk
Maintenance Period - Tralokinumab Q2W (n=91, PYE=46.93)
|
Maintenance Period - Tralokinumab Q4W
n=89 participants at risk
Maintenance Period - Tralokinumab Q4W (n=89, PYE=44.65)
|
Maintenance Period - Placebo
n=46 participants at risk
Maintenance Period - Placebo (n=46, PYE=20.07)
|
Maintenance Period - Placebo - Tralokinumab Naive
n=31 participants at risk
Maintenance Period - Placebo - Tralokinumab Naive (n=31, PYE=15.09)
|
Open-label Period - Tralokinumab Q2W + Optional TCS
n=558 participants at risk
Open-label Period - Tralokinumab Q2W + Optional TCS (n=558, PYE=315.48)
|
Safety Follow-up
n=641 participants at risk
Safety Follow-up (n=641, PYE=142.90) includes subjects from Initial, Maintenance and Open-label Periods:
Tralokinumab Q2W (n=83); Tralokinumab Q4W (n=50); Tralokinumab Q2W + optional TCS (n=454); Placebo (n=54)
|
|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Dry eye
|
0.51%
3/592 • Number of events 3 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.50%
1/200 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
1.1%
1/91 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/89 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
6.5%
3/46 • Number of events 4 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/31 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.90%
5/558 • Number of events 5 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.16%
1/641 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
|
Infections and infestations
Conjunctivitis
|
3.0%
18/592 • Number of events 21 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
1.5%
3/200 • Number of events 3 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
5.5%
5/91 • Number of events 8 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
1.1%
1/89 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
4.3%
2/46 • Number of events 2 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
3.2%
1/31 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
3.9%
22/558 • Number of events 23 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.47%
3/641 • Number of events 3 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
|
Infections and infestations
Oral herpes
|
0.51%
3/592 • Number of events 3 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
2.0%
4/200 • Number of events 4 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
1.1%
1/91 • Number of events 2 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/89 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
2.2%
1/46 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
6.5%
2/31 • Number of events 2 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
1.3%
7/558 • Number of events 7 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.16%
1/641 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
|
Infections and infestations
Skin infection
|
2.0%
12/592 • Number of events 13 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
5.0%
10/200 • Number of events 10 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
2.2%
2/91 • Number of events 2 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/89 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
2.2%
1/46 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/31 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
2.0%
11/558 • Number of events 13 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/641 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
|
Infections and infestations
Upper respiratory tract infection
|
10.0%
59/592 • Number of events 65 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
8.5%
17/200 • Number of events 17 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
15.4%
14/91 • Number of events 18 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
10.1%
9/89 • Number of events 12 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
6.5%
3/46 • Number of events 3 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
6.5%
2/31 • Number of events 2 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
11.6%
65/558 • Number of events 87 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.94%
6/641 • Number of events 7 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
|
Infections and infestations
Viral upper respiratory tract infection
|
8.3%
49/592 • Number of events 52 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
8.5%
17/200 • Number of events 19 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
9.9%
9/91 • Number of events 10 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
6.7%
6/89 • Number of events 6 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
15.2%
7/46 • Number of events 7 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
12.9%
4/31 • Number of events 7 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
10.4%
58/558 • Number of events 83 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.16%
1/641 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.0%
6/592 • Number of events 13 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
2.5%
5/200 • Number of events 5 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
2.2%
2/91 • Number of events 2 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
3.4%
3/89 • Number of events 4 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
6.5%
3/46 • Number of events 4 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/31 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
1.4%
8/558 • Number of events 8 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.16%
1/641 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
16.4%
97/592 • Number of events 131 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
33.5%
67/200 • Number of events 97 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
14.3%
13/91 • Number of events 25 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
15.7%
14/89 • Number of events 19 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
19.6%
9/46 • Number of events 16 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
6.5%
2/31 • Number of events 2 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
20.4%
114/558 • Number of events 174 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
2.3%
15/641 • Number of events 15 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
|
Vascular disorders
Hypertension
|
1.4%
8/592 • Number of events 8 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.50%
1/200 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
1.1%
1/91 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
1.1%
1/89 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
6.5%
3/46 • Number of events 3 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/31 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
1.1%
6/558 • Number of events 6 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
0.00%
0/641 • Initial Treatment Period: Week 0 to Week 16; Maintenance Treatment Period: Week 16 to Week 52; Open-label Treatment: Week 16 to Week 52; Safety follow-up Period (All treatment arms): Week 52 to Week 66
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee LEO Pharma seeks publication of all Phase 3 clinical trials in peer-reviewed journals within 18 months of trial completion, regardless of whether the findings are positive or negative. If there is no multi-centre publication within 18 months after the clinical trial has been completed or terminated at all trial sites, the investigator has the right to publish the results from the clinical trial generated by the investigator.
- Publication restrictions are in place
Restriction type: OTHER