Trial Outcomes & Findings for A Study of Lebrikizumab in Combination With Topical Corticosteroids in Patients With Atopic Dermatitis (AD) That Are Not Adequately Controlled With or Are Non-eligible for Cyclosporine (NCT NCT05149313)
NCT ID: NCT05149313
Last Updated: 2025-05-20
Results Overview
The EASI score is used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. The severity of the clinical signs of AD for each of 4 body regions was scored on a 4-point scale: 0=absent, 1=mild, 2=moderate and 3=severe. The area of AD involvement on each of the 4 anatomic regions was assessed as a percentage by body area: 0=no eruption, 1=1% to 9%, 2=10% to 29%, 3=30% to 49%, 4=50% to 60%, 5=70% to 80% and 6=90% to 100%. The composite index with total score ranged from 0 to 72, where higher scores indicates more severe and or extensive disease.
COMPLETED
PHASE3
331 participants
At Week 16
2025-05-20
Participant Flow
Study was conducted at 54 sites in Austria, Belgium, France, Germany, Italy, Netherlands, Poland, Spain, and United Kingdom. Randomization was stratified by previous use of dupilumab, age (adolescent participants aged \>=12 to \< 18 years comprises 11.8% of the overall population compared to adults aged \>=18 years) and baseline disease severity (IGA 3 vs 4).
A total of 368 participants were screened, of which 331 participants were randomized into 2 treatment arms (Lebrikizumab and Placebo). The study has 2 treatment periods: a 16-week double-blind Induction Period and 36-week open-label Maintenance Period.
Participant milestones
| Measure |
Double-blind Induction Period: Lebrikizumab +TCS
Participants received loading dose of lebrikizumab 500 milligrams (mg) subcutaneous (SC) injection at Day 1 (Baseline) and Week 2 followed by lebrikizumab 250 mg SC injection once every two weeks (Q2W) for up to 16 weeks concomitantly with topical corticosteroids (TCS) in the double-blind induction period.
|
Double-blind Induction Period: Placebo +TCS
Participants received lebrikizumab-matched placebo SC injection, Q2W for up to 16 weeks concomitantly with TCS in the double-blind induction period.
|
Open-label Maintenance Period: Lebrikizumab to Lebrikizumab
Participants who received lebrikizumab 250 mg Q2W during the Double-blind Induction Period continued to receive lebrikizumab 250 mg, Q2W during the 36-week Maintenance Period.
|
Open-label Maintenance Period: Placebo to Lebrikizumab
During Maintenance Period, participants who received placebo Q2W during the Induction Period received loading doses of lebrikizumab (500 mg) at Weeks 16 and 18. From Week 20 onward, the participants received 1 injection of lebrikizumab 250mg Q2W.
|
|---|---|---|---|---|
|
Double-blind Induction Period (16-weeks)
STARTED
|
220
|
111
|
0
|
0
|
|
Double-blind Induction Period (16-weeks)
COMPLETED
|
212
|
100
|
0
|
0
|
|
Double-blind Induction Period (16-weeks)
NOT COMPLETED
|
8
|
11
|
0
|
0
|
|
Open-label Maintenance Period (36 Weeks)
STARTED
|
0
|
0
|
212
|
100
|
|
Open-label Maintenance Period (36 Weeks)
COMPLETED
|
0
|
0
|
180
|
87
|
|
Open-label Maintenance Period (36 Weeks)
NOT COMPLETED
|
0
|
0
|
32
|
13
|
Reasons for withdrawal
| Measure |
Double-blind Induction Period: Lebrikizumab +TCS
Participants received loading dose of lebrikizumab 500 milligrams (mg) subcutaneous (SC) injection at Day 1 (Baseline) and Week 2 followed by lebrikizumab 250 mg SC injection once every two weeks (Q2W) for up to 16 weeks concomitantly with topical corticosteroids (TCS) in the double-blind induction period.
|
Double-blind Induction Period: Placebo +TCS
Participants received lebrikizumab-matched placebo SC injection, Q2W for up to 16 weeks concomitantly with TCS in the double-blind induction period.
|
Open-label Maintenance Period: Lebrikizumab to Lebrikizumab
Participants who received lebrikizumab 250 mg Q2W during the Double-blind Induction Period continued to receive lebrikizumab 250 mg, Q2W during the 36-week Maintenance Period.
|
Open-label Maintenance Period: Placebo to Lebrikizumab
During Maintenance Period, participants who received placebo Q2W during the Induction Period received loading doses of lebrikizumab (500 mg) at Weeks 16 and 18. From Week 20 onward, the participants received 1 injection of lebrikizumab 250mg Q2W.
|
|---|---|---|---|---|
|
Double-blind Induction Period (16-weeks)
Adverse Event
|
2
|
2
|
0
|
0
|
|
Double-blind Induction Period (16-weeks)
Lost to Follow-up
|
2
|
3
|
0
|
0
|
|
Double-blind Induction Period (16-weeks)
Pregnancy
|
1
|
0
|
0
|
0
|
|
Double-blind Induction Period (16-weeks)
Withdrawal by Subject
|
2
|
5
|
0
|
0
|
|
Double-blind Induction Period (16-weeks)
Physician Decision
|
1
|
0
|
0
|
0
|
|
Double-blind Induction Period (16-weeks)
Other
|
0
|
1
|
0
|
0
|
|
Open-label Maintenance Period (36 Weeks)
Adverse Event
|
0
|
0
|
7
|
1
|
|
Open-label Maintenance Period (36 Weeks)
Withdrawal by Subject
|
0
|
0
|
14
|
7
|
|
Open-label Maintenance Period (36 Weeks)
Lack of Efficacy
|
0
|
0
|
6
|
5
|
|
Open-label Maintenance Period (36 Weeks)
Lost to Follow-up
|
0
|
0
|
4
|
0
|
|
Open-label Maintenance Period (36 Weeks)
Protocol Deviation
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study of Lebrikizumab in Combination With Topical Corticosteroids in Patients With Atopic Dermatitis (AD) That Are Not Adequately Controlled With or Are Non-eligible for Cyclosporine
Baseline characteristics by cohort
| Measure |
Double-blind Induction Period: Lebrikizumab +TCS
n=220 Participants
Participants received loading dose of lebrikizumab 500 mg SC injection at Day 1 (Baseline) and Week 2 followed by lebrikizumab 250 mg SC injection Q2W for up to 16 weeks concomitantly with TCS in the double-blind induction period.
|
Double-blind Induction Period: Placebo +TCS
n=111 Participants
Participants received lebrikizumab-matched placebo SC injection, Q2W for up to 16 weeks concomitantly with TCS in the double-blind induction period.
|
Total
n=331 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.7 Years
STANDARD_DEVIATION 14.85 • n=5 Participants
|
34.1 Years
STANDARD_DEVIATION 15.24 • n=7 Participants
|
33.8 Years
STANDARD_DEVIATION 14.96 • n=5 Participants
|
|
Sex: Female, Male
Female
|
100 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
120 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
175 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
197 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
290 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
206 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
310 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Week 16Population: FAS included all randomized participants and were analyzed under the treatment group as randomized.
The EASI score is used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. The severity of the clinical signs of AD for each of 4 body regions was scored on a 4-point scale: 0=absent, 1=mild, 2=moderate and 3=severe. The area of AD involvement on each of the 4 anatomic regions was assessed as a percentage by body area: 0=no eruption, 1=1% to 9%, 2=10% to 29%, 3=30% to 49%, 4=50% to 60%, 5=70% to 80% and 6=90% to 100%. The composite index with total score ranged from 0 to 72, where higher scores indicates more severe and or extensive disease.
Outcome measures
| Measure |
Double-blind Induction Period: Lebrikizumab +TCS
n=220 Participants
Participants received loading dose of lebrikizumab 500 mg SC injection at Day 1 (Baseline) and Week 2 followed by lebrikizumab 250 mg SC injection once Q2W for up to 16 weeks concomitantly with TCS in the double-blind induction period.
|
Double-blind Induction Period: Placebo +TCS
n=111 Participants
Participants received lebrikizumab-matched placebo SC injection, Q2W for up to 16 weeks concomitantly with TCS in the double-blind induction period.
|
|---|---|---|
|
Double-blind Induction Period: Percentage of Participants Who Achieved Eczema Area and Severity Index (EASI) 75 (>=75% Reduction From Baseline in EASI Score) at Week 16
|
68.4 Percentage of participants
|
40.8 Percentage of participants
|
SECONDARY outcome
Timeframe: At Week 16Population: FAS included all randomized participants and were analyzed under the treatment group as randomized.
The IGA is an instrument used to globally rate the severity of the participants AD. It is based on a 5-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate) and 4 (severe), and a score is selected using descriptors that best describe the overall appearance of the lesions at a given time point. The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting (minimal, palpable induration and significant induration). Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear).
Outcome measures
| Measure |
Double-blind Induction Period: Lebrikizumab +TCS
n=220 Participants
Participants received loading dose of lebrikizumab 500 mg SC injection at Day 1 (Baseline) and Week 2 followed by lebrikizumab 250 mg SC injection once Q2W for up to 16 weeks concomitantly with TCS in the double-blind induction period.
|
Double-blind Induction Period: Placebo +TCS
n=111 Participants
Participants received lebrikizumab-matched placebo SC injection, Q2W for up to 16 weeks concomitantly with TCS in the double-blind induction period.
|
|---|---|---|
|
Double-blind Induction Period: Percentage of Participants Who Achieved Investigator Global Assessment (IGA) Score of 0 or 1 and 2-point Improvement at Week 16
|
42.0 Percentage of participants
|
24.5 Percentage of participants
|
SECONDARY outcome
Timeframe: At Week 16Population: FAS included all randomized participants with the Baseline score \>=4. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
The Pruritus NRS is an 11-point scale used by participants to rate their worst pruritus (itch) severity over the past 24 hours, with 0 indicating "No itch," and 10 indicating "Worst itch imaginable. Higher score indicates more severity.
Outcome measures
| Measure |
Double-blind Induction Period: Lebrikizumab +TCS
n=199 Participants
Participants received loading dose of lebrikizumab 500 mg SC injection at Day 1 (Baseline) and Week 2 followed by lebrikizumab 250 mg SC injection once Q2W for up to 16 weeks concomitantly with TCS in the double-blind induction period.
|
Double-blind Induction Period: Placebo +TCS
n=102 Participants
Participants received lebrikizumab-matched placebo SC injection, Q2W for up to 16 weeks concomitantly with TCS in the double-blind induction period.
|
|---|---|---|
|
Double-blind Induction Period: Percentage of Participants Who Achieved a 4-point Improvement in Pruritus Numeric Rating Score (NRS) at Week 16
|
49.9 Percentage of participants
|
29.7 Percentage of participants
|
SECONDARY outcome
Timeframe: At Weeks 2, 4, 8, and12Population: FAS included all randomized participants and were analyzed under the treatment group as randomized.
The EASI score is used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. The severity of the clinical signs of AD for each of 4 body regions was scored on a 4-point scale: 0=absent, 1=mild, 2=moderate and 3=severe. The area of AD involvement on each of the 4 anatomic regions was assessed as a percentage by body area: 0=no eruption, 1=1% to 9%, 2=10% to 29%, 3=30% to 49%, 4=50% to 60%, 5=70% to 80% and 6=90% to 100%. The composite index with total score ranged from 0 to 72, where higher scores indicates more severe and or extensive disease. Percentage of participants who achieved EASI 75 (\>=75% reduction from baseline in EASI score) at Weeks 2, 4, 8, and 12 were reported
Outcome measures
| Measure |
Double-blind Induction Period: Lebrikizumab +TCS
n=220 Participants
Participants received loading dose of lebrikizumab 500 mg SC injection at Day 1 (Baseline) and Week 2 followed by lebrikizumab 250 mg SC injection once Q2W for up to 16 weeks concomitantly with TCS in the double-blind induction period.
|
Double-blind Induction Period: Placebo +TCS
n=111 Participants
Participants received lebrikizumab-matched placebo SC injection, Q2W for up to 16 weeks concomitantly with TCS in the double-blind induction period.
|
|---|---|---|
|
Double-blind Induction Period: Percentage of Participants Who Achieved EASI 75 (>=75% Reduction From Baseline in EASI Score) at Weeks 2, 4, 8, and 12
At Week 2
|
9.7 Percentage of participants
|
6.3 Percentage of participants
|
|
Double-blind Induction Period: Percentage of Participants Who Achieved EASI 75 (>=75% Reduction From Baseline in EASI Score) at Weeks 2, 4, 8, and 12
At Week 4
|
28.3 Percentage of participants
|
19.2 Percentage of participants
|
|
Double-blind Induction Period: Percentage of Participants Who Achieved EASI 75 (>=75% Reduction From Baseline in EASI Score) at Weeks 2, 4, 8, and 12
At Week 8
|
54.9 Percentage of participants
|
31.5 Percentage of participants
|
|
Double-blind Induction Period: Percentage of Participants Who Achieved EASI 75 (>=75% Reduction From Baseline in EASI Score) at Weeks 2, 4, 8, and 12
At Week 12
|
64.9 Percentage of participants
|
41.1 Percentage of participants
|
SECONDARY outcome
Timeframe: At Weeks 2, 4, 8, 12 and 16Population: FAS included all randomized participants and were analyzed under the treatment group as randomized.
The EASI score is used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. The severity of the clinical signs of AD for each of 4 body regions was scored on a 4-point scale: 0=absent, 1=mild, 2=moderate and 3=severe. The area of AD involvement on each of the 4 anatomic regions was assessed as a percentage by body area: 0=no eruption, 1=1% to 9%, 2=10% to 29%, 3=30% to 49%, 4=50% to 60%, 5=70% to 80% and 6=90% to 100%. The composite index with total score ranged from 0 to 72, where higher scores indicates more severe and or extensive disease.
Outcome measures
| Measure |
Double-blind Induction Period: Lebrikizumab +TCS
n=220 Participants
Participants received loading dose of lebrikizumab 500 mg SC injection at Day 1 (Baseline) and Week 2 followed by lebrikizumab 250 mg SC injection once Q2W for up to 16 weeks concomitantly with TCS in the double-blind induction period.
|
Double-blind Induction Period: Placebo +TCS
n=111 Participants
Participants received lebrikizumab-matched placebo SC injection, Q2W for up to 16 weeks concomitantly with TCS in the double-blind induction period.
|
|---|---|---|
|
Double-blind Induction Period: Percentage of Participants Who Achieved EASI 90 (>=90% Reduction From Baseline in EASI Score) at Weeks 2, 4, 8, 12 and 16
At Week 2
|
1.5 Percentage of participants
|
0.9 Percentage of participants
|
|
Double-blind Induction Period: Percentage of Participants Who Achieved EASI 90 (>=90% Reduction From Baseline in EASI Score) at Weeks 2, 4, 8, 12 and 16
At Week 4
|
15.8 Percentage of participants
|
6.4 Percentage of participants
|
|
Double-blind Induction Period: Percentage of Participants Who Achieved EASI 90 (>=90% Reduction From Baseline in EASI Score) at Weeks 2, 4, 8, 12 and 16
At Week 8
|
28.9 Percentage of participants
|
10.6 Percentage of participants
|
|
Double-blind Induction Period: Percentage of Participants Who Achieved EASI 90 (>=90% Reduction From Baseline in EASI Score) at Weeks 2, 4, 8, 12 and 16
At Week 12
|
42.1 Percentage of participants
|
21.0 Percentage of participants
|
|
Double-blind Induction Period: Percentage of Participants Who Achieved EASI 90 (>=90% Reduction From Baseline in EASI Score) at Weeks 2, 4, 8, 12 and 16
At Week 16
|
42.9 Percentage of participants
|
20.8 Percentage of participants
|
SECONDARY outcome
Timeframe: At Weeks 2, 4, 8, 12 and 16Population: FAS included all randomized participants and were analyzed under the treatment group as randomized.
The EASI score is used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. The severity of the clinical signs of AD for each of 4 body regions was scored on a 4-point scale: 0=absent, 1=mild, 2=moderate and 3=severe. The area of AD involvement on each of the 4 anatomic regions was assessed as a percentage by body area: 0=no eruption, 1=1% to 9%, 2=10% to 29%, 3=30% to 49%, 4=50% to 60%, 5=70% to 80% and 6=90% to 100%. The composite index with total score ranged from 0 to 72, where higher scores indicates more severe and or extensive disease.
Outcome measures
| Measure |
Double-blind Induction Period: Lebrikizumab +TCS
n=220 Participants
Participants received loading dose of lebrikizumab 500 mg SC injection at Day 1 (Baseline) and Week 2 followed by lebrikizumab 250 mg SC injection once Q2W for up to 16 weeks concomitantly with TCS in the double-blind induction period.
|
Double-blind Induction Period: Placebo +TCS
n=111 Participants
Participants received lebrikizumab-matched placebo SC injection, Q2W for up to 16 weeks concomitantly with TCS in the double-blind induction period.
|
|---|---|---|
|
Double-blind Induction Period: Percentage of Participants Who Achieved EASI 50 (>=50% Reduction From Baseline in EASI Score) at Weeks 2, 4, 8, 12 and 16
At Week 2
|
30.8 Percentage of participants
|
23.4 Percentage of participants
|
|
Double-blind Induction Period: Percentage of Participants Who Achieved EASI 50 (>=50% Reduction From Baseline in EASI Score) at Weeks 2, 4, 8, 12 and 16
At Week 4
|
58.9 Percentage of participants
|
46.0 Percentage of participants
|
|
Double-blind Induction Period: Percentage of Participants Who Achieved EASI 50 (>=50% Reduction From Baseline in EASI Score) at Weeks 2, 4, 8, 12 and 16
At Week 8
|
75.2 Percentage of participants
|
59.3 Percentage of participants
|
|
Double-blind Induction Period: Percentage of Participants Who Achieved EASI 50 (>=50% Reduction From Baseline in EASI Score) at Weeks 2, 4, 8, 12 and 16
At Week 12
|
80.3 Percentage of participants
|
68.0 Percentage of participants
|
|
Double-blind Induction Period: Percentage of Participants Who Achieved EASI 50 (>=50% Reduction From Baseline in EASI Score) at Weeks 2, 4, 8, 12 and 16
At Week 16
|
82.6 Percentage of participants
|
65.3 Percentage of participants
|
SECONDARY outcome
Timeframe: At Weeks 2, 4, 8, 12 and 16Population: FAS included all randomized participants with Baseline DLQI score of \>=4. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
The DLQI is a 10-item validated questionnaire completed by the participant or caregiver used to assess the impact of skin disease on the participant's quality of life (QoL during the previous week. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment. Each question was scored on a 4-point scale (ranged from 0 to 3) where, 0 = not at all, 1= a little, 2= a lot, 3= very much, giving a total score ranging from 0 (not at all) to 30 (very much). A high score is indicative of a poor QoL.
Outcome measures
| Measure |
Double-blind Induction Period: Lebrikizumab +TCS
n=180 Participants
Participants received loading dose of lebrikizumab 500 mg SC injection at Day 1 (Baseline) and Week 2 followed by lebrikizumab 250 mg SC injection once Q2W for up to 16 weeks concomitantly with TCS in the double-blind induction period.
|
Double-blind Induction Period: Placebo +TCS
n=90 Participants
Participants received lebrikizumab-matched placebo SC injection, Q2W for up to 16 weeks concomitantly with TCS in the double-blind induction period.
|
|---|---|---|
|
Double-blind Induction Period: Percentage of Participants Who Achieved a 4-point Improvement in Dermatology Life Quality Index (DLQI) at Weeks 2, 4, 8, 12 and 16
At Week 2
|
52.8 Percentage of participants
|
57.1 Percentage of participants
|
|
Double-blind Induction Period: Percentage of Participants Who Achieved a 4-point Improvement in Dermatology Life Quality Index (DLQI) at Weeks 2, 4, 8, 12 and 16
At Week 4
|
66.1 Percentage of participants
|
61.9 Percentage of participants
|
|
Double-blind Induction Period: Percentage of Participants Who Achieved a 4-point Improvement in Dermatology Life Quality Index (DLQI) at Weeks 2, 4, 8, 12 and 16
At Week 8
|
70.5 Percentage of participants
|
56.1 Percentage of participants
|
|
Double-blind Induction Period: Percentage of Participants Who Achieved a 4-point Improvement in Dermatology Life Quality Index (DLQI) at Weeks 2, 4, 8, 12 and 16
At Week 12
|
73.1 Percentage of participants
|
59.6 Percentage of participants
|
|
Double-blind Induction Period: Percentage of Participants Who Achieved a 4-point Improvement in Dermatology Life Quality Index (DLQI) at Weeks 2, 4, 8, 12 and 16
At Week 16
|
78.0 Percentage of participants
|
69.6 Percentage of participants
|
SECONDARY outcome
Timeframe: At Weeks 2, 4, 8, 12 and 16Population: FAS included all randomized participants with Baseline Score \>= 4. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
The CDLQI is validated from adolescents younger than age of 16 years, which is based on a set of 10 questions different from those of the DLQI to measure the impact of AD disease on QoL in children during the previous week. Each question is scored as follows: 0=not at all or unanswered, 1 = only a little, 2 = quite a lot and 3 = very much. Question 7 has an added possible response, which was scored as 3. CDLQI equals the sum of the score of each question, ranged from 0 (no impact of skin disease on QoL) to 30 (maximum impact on QoL). Higher scores indicate higher impact on QoL.
Outcome measures
| Measure |
Double-blind Induction Period: Lebrikizumab +TCS
n=22 Participants
Participants received loading dose of lebrikizumab 500 mg SC injection at Day 1 (Baseline) and Week 2 followed by lebrikizumab 250 mg SC injection once Q2W for up to 16 weeks concomitantly with TCS in the double-blind induction period.
|
Double-blind Induction Period: Placebo +TCS
n=8 Participants
Participants received lebrikizumab-matched placebo SC injection, Q2W for up to 16 weeks concomitantly with TCS in the double-blind induction period.
|
|---|---|---|
|
Double-blind Induction Period: Percentage of Participants Who Achieved a 4-point Improvement in Children's Dermatology Life Quality Index (CDLQI) at Weeks 2, 4, 8, 12 and 16
At Week 2
|
90.9 Percentage of participants
|
100 Percentage of participants
|
|
Double-blind Induction Period: Percentage of Participants Who Achieved a 4-point Improvement in Children's Dermatology Life Quality Index (CDLQI) at Weeks 2, 4, 8, 12 and 16
At Week 4
|
68.2 Percentage of participants
|
62.5 Percentage of participants
|
|
Double-blind Induction Period: Percentage of Participants Who Achieved a 4-point Improvement in Children's Dermatology Life Quality Index (CDLQI) at Weeks 2, 4, 8, 12 and 16
At Week 8
|
90.9 Percentage of participants
|
100 Percentage of participants
|
|
Double-blind Induction Period: Percentage of Participants Who Achieved a 4-point Improvement in Children's Dermatology Life Quality Index (CDLQI) at Weeks 2, 4, 8, 12 and 16
At Week 12
|
95.5 Percentage of participants
|
100 Percentage of participants
|
|
Double-blind Induction Period: Percentage of Participants Who Achieved a 4-point Improvement in Children's Dermatology Life Quality Index (CDLQI) at Weeks 2, 4, 8, 12 and 16
At Week 16
|
93.1 Percentage of participants
|
100 Percentage of participants
|
SECONDARY outcome
Timeframe: At Week 16Population: FAS included all randomized participants with Baseline Score \>= 4. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
The Skin Pain NRS is an 11-point scale completed by participants to rate their worst skin pain (example, discomfort or soreness) severity over the past 24 hours, with 0 (indicating "No pain") and 10 (indicating "Worst pain imaginable). Higher scores indicated worse pain.
Outcome measures
| Measure |
Double-blind Induction Period: Lebrikizumab +TCS
n=173 Participants
Participants received loading dose of lebrikizumab 500 mg SC injection at Day 1 (Baseline) and Week 2 followed by lebrikizumab 250 mg SC injection once Q2W for up to 16 weeks concomitantly with TCS in the double-blind induction period.
|
Double-blind Induction Period: Placebo +TCS
n=88 Participants
Participants received lebrikizumab-matched placebo SC injection, Q2W for up to 16 weeks concomitantly with TCS in the double-blind induction period.
|
|---|---|---|
|
Double-blind Induction Period: Percentage of Participants Who Achieved a 4- Point Improvement in Skin Pain NRS at Week 16
|
51.6 Percentage of participants
|
27.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12 and 16Population: FAS included all randomized participants and were analyzed under the treatment group as randomized. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable for specified timepoints.
The BSA assessment estimates the extent of disease or skin involvement with respect to AD and is expressed as a percentage of total body surface. BSA was determined by the Investigator or designee using the participant palm = 1% BSA rule. The participant's palm is measured from the wrist to the proximal interphalangeal and thumb. This higher the BSA %, the more active atopic dermatitis is present. Percent of BSA for a body region = total number of palms in a body region \* % surface area equivalent to 1 palm. Overall percent BSA for an individual is arithmetic mean of % BSA of all 4 body regions and ranges from 0% to 100% with higher values representing greater severity of AD and negative change from baseline indicate no severity.
Outcome measures
| Measure |
Double-blind Induction Period: Lebrikizumab +TCS
n=217 Participants
Participants received loading dose of lebrikizumab 500 mg SC injection at Day 1 (Baseline) and Week 2 followed by lebrikizumab 250 mg SC injection once Q2W for up to 16 weeks concomitantly with TCS in the double-blind induction period.
|
Double-blind Induction Period: Placebo +TCS
n=111 Participants
Participants received lebrikizumab-matched placebo SC injection, Q2W for up to 16 weeks concomitantly with TCS in the double-blind induction period.
|
|---|---|---|
|
Double-blind Induction Period: Change From Baseline in Body Surface Area (BSA) at Weeks 2, 4, 8, 12 and 16
Change at Week 2
|
-11.4 Percentage of body surface area
Standard Deviation 15.33
|
-10.6 Percentage of body surface area
Standard Deviation 12.04
|
|
Double-blind Induction Period: Change From Baseline in Body Surface Area (BSA) at Weeks 2, 4, 8, 12 and 16
Change at Week 4
|
-19.5 Percentage of body surface area
Standard Deviation 19.22
|
-15.3 Percentage of body surface area
Standard Deviation 13.77
|
|
Double-blind Induction Period: Change From Baseline in Body Surface Area (BSA) at Weeks 2, 4, 8, 12 and 16
Change at Week 8
|
-27.3 Percentage of body surface area
Standard Deviation 20.60
|
-19.2 Percentage of body surface area
Standard Deviation 17.12
|
|
Double-blind Induction Period: Change From Baseline in Body Surface Area (BSA) at Weeks 2, 4, 8, 12 and 16
Change at Week 12
|
-30.6 Percentage of body surface area
Standard Deviation 21.25
|
-22.5 Percentage of body surface area
Standard Deviation 17.06
|
|
Double-blind Induction Period: Change From Baseline in Body Surface Area (BSA) at Weeks 2, 4, 8, 12 and 16
Change at Week 16
|
-32.5 Percentage of body surface area
Standard Deviation 21.44
|
-22.1 Percentage of body surface area
Standard Deviation 18.57
|
SECONDARY outcome
Timeframe: Baseline, Weeks 8 and 16Population: FAS included all randomized participants and were analyzed under the treatment group as randomized. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable for specified time points.
SCORAD is a validated clinical tool for assessing the extent and intensity of AD. There are 3 components: A) Surface involvement is assessed as proportion of involved surface area segment by segment by applying the rule of 9s and reported as the sum of all areas, with a score ranging from 0-100. B) Intensity part of the SCORAD consists of 6 items: erythema, oedema, oozing/crusting, excoriation, lichenification, and dryness. Each item graded as: none (0), mild (1), moderate (2), or severe (3). C) Subjective assessment of itch and of sleeplessness is recorded for each symptom using a visual analogue scale (VAS), where 0=no itch (or no sleeplessness) and 10= worst imaginable itch (or sleeplessness), with maximum score of 20. Formula is: A/5+7B/2+C, A: extent (0-100), B: intensity (0-18), C: subjective symptoms (0-20). SCORAD total score ranged from 0 (no disease) to 103 (severe disease). Higher values represent worse outcome and negative change from baseline indicate improvement.
Outcome measures
| Measure |
Double-blind Induction Period: Lebrikizumab +TCS
n=199 Participants
Participants received loading dose of lebrikizumab 500 mg SC injection at Day 1 (Baseline) and Week 2 followed by lebrikizumab 250 mg SC injection once Q2W for up to 16 weeks concomitantly with TCS in the double-blind induction period.
|
Double-blind Induction Period: Placebo +TCS
n=94 Participants
Participants received lebrikizumab-matched placebo SC injection, Q2W for up to 16 weeks concomitantly with TCS in the double-blind induction period.
|
|---|---|---|
|
Double-blind Induction Period: Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at Weeks 8 and 16
Change at Week 8
|
-32.1 Score on a Scale
Standard Deviation 17.90
|
-20.0 Score on a Scale
Standard Deviation 18.04
|
|
Double-blind Induction Period: Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at Weeks 8 and 16
Change at Week 16
|
-36.8 Score on a Scale
Standard Deviation 20.40
|
-23.7 Score on a Scale
Standard Deviation 21.25
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and 16Population: FAS included all randomized participants and were analyzed under the treatment group as randomized. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable for specified timepoints.
The Pruritus NRS is an 11-point scale used by participants to rate their worst pruritus (itch) severity over the past 24 hours, with 0 indicating "No itch," and 10 indicating "Worst itch imaginable." Higher scores indicated greater severity and negative change from baseline indicate no severity.
Outcome measures
| Measure |
Double-blind Induction Period: Lebrikizumab +TCS
n=214 Participants
Participants received loading dose of lebrikizumab 500 mg SC injection at Day 1 (Baseline) and Week 2 followed by lebrikizumab 250 mg SC injection once Q2W for up to 16 weeks concomitantly with TCS in the double-blind induction period.
|
Double-blind Induction Period: Placebo +TCS
n=108 Participants
Participants received lebrikizumab-matched placebo SC injection, Q2W for up to 16 weeks concomitantly with TCS in the double-blind induction period.
|
|---|---|---|
|
Double-blind Induction Period: Change From Baseline in Pruritus NRS by Week up to Week 16
Change at Week 2
|
-1.543 Score on a Scale
Standard Deviation 1.6304
|
-1.113 Score on a Scale
Standard Deviation 1.7468
|
|
Double-blind Induction Period: Change From Baseline in Pruritus NRS by Week up to Week 16
Change at Week 3
|
-2.199 Score on a Scale
Standard Deviation 2.0960
|
-1.420 Score on a Scale
Standard Deviation 2.1401
|
|
Double-blind Induction Period: Change From Baseline in Pruritus NRS by Week up to Week 16
Change at Week 4
|
-2.351 Score on a Scale
Standard Deviation 2.2558
|
-1.450 Score on a Scale
Standard Deviation 2.3924
|
|
Double-blind Induction Period: Change From Baseline in Pruritus NRS by Week up to Week 16
Change at Week 5
|
-2.771 Score on a Scale
Standard Deviation 2.4152
|
-1.485 Score on a Scale
Standard Deviation 2.4553
|
|
Double-blind Induction Period: Change From Baseline in Pruritus NRS by Week up to Week 16
Change at Week 6
|
-3.053 Score on a Scale
Standard Deviation 2.3975
|
-1.711 Score on a Scale
Standard Deviation 2.5330
|
|
Double-blind Induction Period: Change From Baseline in Pruritus NRS by Week up to Week 16
Change at Week 7
|
-3.204 Score on a Scale
Standard Deviation 2.4643
|
-1.823 Score on a Scale
Standard Deviation 2.5263
|
|
Double-blind Induction Period: Change From Baseline in Pruritus NRS by Week up to Week 16
Change at Week 8
|
-3.080 Score on a Scale
Standard Deviation 2.4552
|
-1.856 Score on a Scale
Standard Deviation 2.5670
|
|
Double-blind Induction Period: Change From Baseline in Pruritus NRS by Week up to Week 16
Change at Week 9
|
-3.283 Score on a Scale
Standard Deviation 2.5105
|
-1.861 Score on a Scale
Standard Deviation 2.5872
|
|
Double-blind Induction Period: Change From Baseline in Pruritus NRS by Week up to Week 16
Change at Week 10
|
-3.245 Score on a Scale
Standard Deviation 2.6101
|
-1.529 Score on a Scale
Standard Deviation 2.7489
|
|
Double-blind Induction Period: Change From Baseline in Pruritus NRS by Week up to Week 16
Change at Week 11
|
-3.285 Score on a Scale
Standard Deviation 2.5484
|
-1.776 Score on a Scale
Standard Deviation 2.7302
|
|
Double-blind Induction Period: Change From Baseline in Pruritus NRS by Week up to Week 16
Change at Week 12
|
-3.388 Score on a Scale
Standard Deviation 2.6195
|
-1.853 Score on a Scale
Standard Deviation 2.3583
|
|
Double-blind Induction Period: Change From Baseline in Pruritus NRS by Week up to Week 16
Change at Week 13
|
-3.326 Score on a Scale
Standard Deviation 2.6697
|
-2.053 Score on a Scale
Standard Deviation 2.5284
|
|
Double-blind Induction Period: Change From Baseline in Pruritus NRS by Week up to Week 16
Change at Week 14
|
-3.313 Score on a Scale
Standard Deviation 2.6843
|
-1.948 Score on a Scale
Standard Deviation 2.4181
|
|
Double-blind Induction Period: Change From Baseline in Pruritus NRS by Week up to Week 16
Change at Week 15
|
-3.366 Score on a Scale
Standard Deviation 2.5291
|
-1.938 Score on a Scale
Standard Deviation 2.5245
|
|
Double-blind Induction Period: Change From Baseline in Pruritus NRS by Week up to Week 16
Change at Week 16
|
-3.476 Score on a Scale
Standard Deviation 2.5453
|
-2.183 Score on a Scale
Standard Deviation 2.4246
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and 16Population: FAS included all randomized participants and were analyzed under the treatment group as randomized. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable for specified timepoints.
Sleep loss was assessed by all participants using a PRO instrument. Participants (and if applicable, with help of parents/caregiver if required) rate their sleep on a 5-point Likert scale (with scores ranging from 0 \[not at all\] to 4 \[unable to sleep at all\]). Higher scores indicated a greater impact and worse outcome; therefore, negative change from baseline indicate less impact.
Outcome measures
| Measure |
Double-blind Induction Period: Lebrikizumab +TCS
n=214 Participants
Participants received loading dose of lebrikizumab 500 mg SC injection at Day 1 (Baseline) and Week 2 followed by lebrikizumab 250 mg SC injection once Q2W for up to 16 weeks concomitantly with TCS in the double-blind induction period.
|
Double-blind Induction Period: Placebo +TCS
n=108 Participants
Participants received lebrikizumab-matched placebo SC injection, Q2W for up to 16 weeks concomitantly with TCS in the double-blind induction period.
|
|---|---|---|
|
Double-blind Induction Period: Change From Baseline in the Sleep Loss at Week 16 Using Patient-related Outcome (PRO) by Week up to Week 16
Change at Week 2
|
-0.603 Score on a Scale
Standard Deviation 0.6985
|
-0.493 Score on a Scale
Standard Deviation 0.8407
|
|
Double-blind Induction Period: Change From Baseline in the Sleep Loss at Week 16 Using Patient-related Outcome (PRO) by Week up to Week 16
Change at Week 3
|
-0.816 Score on a Scale
Standard Deviation 0.8809
|
-0.673 Score on a Scale
Standard Deviation 1.0262
|
|
Double-blind Induction Period: Change From Baseline in the Sleep Loss at Week 16 Using Patient-related Outcome (PRO) by Week up to Week 16
Change at Week 4
|
-0.875 Score on a Scale
Standard Deviation 0.9387
|
-0.577 Score on a Scale
Standard Deviation 1.0885
|
|
Double-blind Induction Period: Change From Baseline in the Sleep Loss at Week 16 Using Patient-related Outcome (PRO) by Week up to Week 16
Change at Week 5
|
-0.942 Score on a Scale
Standard Deviation 0.9646
|
-0.607 Score on a Scale
Standard Deviation 1.1342
|
|
Double-blind Induction Period: Change From Baseline in the Sleep Loss at Week 16 Using Patient-related Outcome (PRO) by Week up to Week 16
Change at Week 6
|
-0.998 Score on a Scale
Standard Deviation 0.9088
|
-0.613 Score on a Scale
Standard Deviation 1.0641
|
|
Double-blind Induction Period: Change From Baseline in the Sleep Loss at Week 16 Using Patient-related Outcome (PRO) by Week up to Week 16
Change at Week 7
|
-1.038 Score on a Scale
Standard Deviation 0.9388
|
-0.661 Score on a Scale
Standard Deviation 1.1119
|
|
Double-blind Induction Period: Change From Baseline in the Sleep Loss at Week 16 Using Patient-related Outcome (PRO) by Week up to Week 16
Change at Week 8
|
-0.974 Score on a Scale
Standard Deviation 0.9941
|
-0.708 Score on a Scale
Standard Deviation 1.1500
|
|
Double-blind Induction Period: Change From Baseline in the Sleep Loss at Week 16 Using Patient-related Outcome (PRO) by Week up to Week 16
Change at Week 9
|
-1.052 Score on a Scale
Standard Deviation 0.9352
|
-0.668 Score on a Scale
Standard Deviation 1.0604
|
|
Double-blind Induction Period: Change From Baseline in the Sleep Loss at Week 16 Using Patient-related Outcome (PRO) by Week up to Week 16
Change at Week 10
|
-1.091 Score on a Scale
Standard Deviation 0.9624
|
-0.560 Score on a Scale
Standard Deviation 1.1349
|
|
Double-blind Induction Period: Change From Baseline in the Sleep Loss at Week 16 Using Patient-related Outcome (PRO) by Week up to Week 16
Change at Week 11
|
-1.040 Score on a Scale
Standard Deviation 0.9966
|
-0.676 Score on a Scale
Standard Deviation 1.0938
|
|
Double-blind Induction Period: Change From Baseline in the Sleep Loss at Week 16 Using Patient-related Outcome (PRO) by Week up to Week 16
Change at Week 12
|
-1.123 Score on a Scale
Standard Deviation 1.0281
|
-0.721 Score on a Scale
Standard Deviation 1.0768
|
|
Double-blind Induction Period: Change From Baseline in the Sleep Loss at Week 16 Using Patient-related Outcome (PRO) by Week up to Week 16
Change at Week 13
|
-1.069 Score on a Scale
Standard Deviation 0.9776
|
-0.797 Score on a Scale
Standard Deviation 1.1037
|
|
Double-blind Induction Period: Change From Baseline in the Sleep Loss at Week 16 Using Patient-related Outcome (PRO) by Week up to Week 16
Change at Week 14
|
-1.072 Score on a Scale
Standard Deviation 1.0446
|
-0.809 Score on a Scale
Standard Deviation 1.0751
|
|
Double-blind Induction Period: Change From Baseline in the Sleep Loss at Week 16 Using Patient-related Outcome (PRO) by Week up to Week 16
Change at Week 15
|
-1.096 Score on a Scale
Standard Deviation 0.9819
|
-0.756 Score on a Scale
Standard Deviation 1.0891
|
|
Double-blind Induction Period: Change From Baseline in the Sleep Loss at Week 16 Using Patient-related Outcome (PRO) by Week up to Week 16
Change at Week 16
|
-1.201 Score on a Scale
Standard Deviation 0.9775
|
-0.857 Score on a Scale
Standard Deviation 1.0615
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12 and 16Population: FAS included all randomized participants and were analyzed under the treatment group as randomized. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable for specified timepoints.
The POEM is a 7-item, validated questionnaire completed by the participant (and, if applicable, with help of parents/caregiver if required) to assess disease symptoms. Participants are asked to respond to questions on skin dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping. All answers carry equal weight, with a total possible score ranging from 0 to 28 (answers scored as: No days = 0; 1 to 2 days = 1; 3 to 4 days = 2; 5 to 6 days = 3; every day = 4. Higher scores indicated more severe disease and poor quality of life (QoL); therefore, negative change from baseline indicate improvement in QoL.
Outcome measures
| Measure |
Double-blind Induction Period: Lebrikizumab +TCS
n=201 Participants
Participants received loading dose of lebrikizumab 500 mg SC injection at Day 1 (Baseline) and Week 2 followed by lebrikizumab 250 mg SC injection once Q2W for up to 16 weeks concomitantly with TCS in the double-blind induction period.
|
Double-blind Induction Period: Placebo +TCS
n=98 Participants
Participants received lebrikizumab-matched placebo SC injection, Q2W for up to 16 weeks concomitantly with TCS in the double-blind induction period.
|
|---|---|---|
|
Double-blind Induction Period: Change From Baseline in Patient-Oriented Eczema Measure (POEM) Total Score at Weeks 4, 8, 12 and 16
Change at Week 4
|
-8.4 Score on a Scale
Standard Deviation 6.82
|
-4.7 Score on a Scale
Standard Deviation 6.42
|
|
Double-blind Induction Period: Change From Baseline in Patient-Oriented Eczema Measure (POEM) Total Score at Weeks 4, 8, 12 and 16
Change at Week 8
|
-10.9 Score on a Scale
Standard Deviation 7.45
|
-5.2 Score on a Scale
Standard Deviation 6.65
|
|
Double-blind Induction Period: Change From Baseline in Patient-Oriented Eczema Measure (POEM) Total Score at Weeks 4, 8, 12 and 16
Change at Week 12
|
-11.3 Score on a Scale
Standard Deviation 8.08
|
-5.1 Score on a Scale
Standard Deviation 7.25
|
|
Double-blind Induction Period: Change From Baseline in Patient-Oriented Eczema Measure (POEM) Total Score at Weeks 4, 8, 12 and 16
Change at Week 16
|
-11.9 Score on a Scale
Standard Deviation 8.01
|
-5.8 Score on a Scale
Standard Deviation 7.18
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12 and 16Population: FAS included all randomized participants and were analyzed under the treatment group as randomized. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable for specified timepoints.
The DLQI is a 10-item validated questionnaire completed by the participant or caregiver used to assess the impact of skin disease on the participant's QoL during the previous week. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment. Each question was scored on a 4-point scale (ranged from 0 to 3) where, 0 = not at all, 1= a little, 2= a lot, 3= very much, giving a total score ranging from 0 (not at all) to 30 (very much). A high score is indicative of a poor QoL and negative change from baseline indicate improvement in QoL.
Outcome measures
| Measure |
Double-blind Induction Period: Lebrikizumab +TCS
n=185 Participants
Participants received loading dose of lebrikizumab 500 mg SC injection at Day 1 (Baseline) and Week 2 followed by lebrikizumab 250 mg SC injection once Q2W for up to 16 weeks concomitantly with TCS in the double-blind induction period.
|
Double-blind Induction Period: Placebo +TCS
n=91 Participants
Participants received lebrikizumab-matched placebo SC injection, Q2W for up to 16 weeks concomitantly with TCS in the double-blind induction period.
|
|---|---|---|
|
Double-blind Induction Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Weeks 2. 4, 8, 12 and 16
Change at Week 2
|
-4.6 Score on a Scale
Standard Deviation 5.54
|
-4.5 Score on a Scale
Standard Deviation 6.00
|
|
Double-blind Induction Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Weeks 2. 4, 8, 12 and 16
Change at Week 4
|
-7.1 Score on a Scale
Standard Deviation 6.54
|
-5.4 Score on a Scale
Standard Deviation 6.86
|
|
Double-blind Induction Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Weeks 2. 4, 8, 12 and 16
Change at Week 8
|
-8.3 Score on a Scale
Standard Deviation 7.03
|
-5.7 Score on a Scale
Standard Deviation 7.89
|
|
Double-blind Induction Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Weeks 2. 4, 8, 12 and 16
Change at Week 12
|
-8.7 Score on a Scale
Standard Deviation 7.38
|
-5.9 Score on a Scale
Standard Deviation 7.90
|
|
Double-blind Induction Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Weeks 2. 4, 8, 12 and 16
Change at Week 16
|
-9.5 Score on a Scale
Standard Deviation 7.40
|
-8.1 Score on a Scale
Standard Deviation 7.62
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12 and 16Population: FAS included all randomized participants and were analyzed under the treatment group as randomized. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable for specified timepoints.
The CDLQI is validated from adolescents younger than age of 16 years, which is based on a set of 10 questions different from those of the DLQI to measure the impact of AD disease on QoL in children during the previous week. Each question is scored as follows: 0=not at all or unanswered, 1 = only a little, 2 = quite a lot and 3 = very much. Question 7 has an added possible response, which was scored as 3. CDLQI equals the sum of the score of each question, ranged from 0 (no impact of skin disease on QoL) to 30 (maximum impact on QoL). Higher scores indicate higher impact on QoL and negative change from baseline indicate low impact on QoL.
Outcome measures
| Measure |
Double-blind Induction Period: Lebrikizumab +TCS
n=23 Participants
Participants received loading dose of lebrikizumab 500 mg SC injection at Day 1 (Baseline) and Week 2 followed by lebrikizumab 250 mg SC injection once Q2W for up to 16 weeks concomitantly with TCS in the double-blind induction period.
|
Double-blind Induction Period: Placebo +TCS
n=8 Participants
Participants received lebrikizumab-matched placebo SC injection, Q2W for up to 16 weeks concomitantly with TCS in the double-blind induction period.
|
|---|---|---|
|
Double-blind Induction Period: Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 2. 4, 8, 12 and 16
Change at Week 2
|
-2.9 Score on a Scale
Standard Deviation 3.41
|
-3.6 Score on a Scale
Standard Deviation 3.25
|
|
Double-blind Induction Period: Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 2. 4, 8, 12 and 16
Change at Week 4
|
-5.1 Score on a Scale
Standard Deviation 4.76
|
-4.3 Score on a Scale
Standard Deviation 4.65
|
|
Double-blind Induction Period: Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 2. 4, 8, 12 and 16
Change at Week 8
|
-6.6 Score on a Scale
Standard Deviation 6.69
|
-6.9 Score on a Scale
Standard Deviation 4.82
|
|
Double-blind Induction Period: Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 2. 4, 8, 12 and 16
Change at Week 12
|
-7.7 Score on a Scale
Standard Deviation 7.60
|
-7.4 Score on a Scale
Standard Deviation 6.30
|
|
Double-blind Induction Period: Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 2. 4, 8, 12 and 16
Change at Week 16
|
-7.7 Score on a Scale
Standard Deviation 6.91
|
-6.8 Score on a Scale
Standard Deviation 5.73
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and 16Population: FAS included all randomized participants and were analyzed under the treatment group as randomized. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable for specified categories.
The Skin Pain NRS is an 11-point scale completed by participants to rate their worst skin pain (example, discomfort or soreness) severity over the past 24 hours, with 0 (indicating "No pain") to 10 (indicating "Worst pain imaginable). Higher scores indicated worse pain and negative change from baseline indicate no pain.
Outcome measures
| Measure |
Double-blind Induction Period: Lebrikizumab +TCS
n=214 Participants
Participants received loading dose of lebrikizumab 500 mg SC injection at Day 1 (Baseline) and Week 2 followed by lebrikizumab 250 mg SC injection once Q2W for up to 16 weeks concomitantly with TCS in the double-blind induction period.
|
Double-blind Induction Period: Placebo +TCS
n=108 Participants
Participants received lebrikizumab-matched placebo SC injection, Q2W for up to 16 weeks concomitantly with TCS in the double-blind induction period.
|
|---|---|---|
|
Double-blind Induction Period: Change From Baseline in Skin Pain NRS by Week up to Week 16
Change at Week 2
|
-1.546 Score on a Scale
Standard Deviation 1.7978
|
-0.905 Score on a Scale
Standard Deviation 1.9170
|
|
Double-blind Induction Period: Change From Baseline in Skin Pain NRS by Week up to Week 16
Change at Week 3
|
-2.152 Score on a Scale
Standard Deviation 2.1719
|
-1.316 Score on a Scale
Standard Deviation 2.2680
|
|
Double-blind Induction Period: Change From Baseline in Skin Pain NRS by Week up to Week 16
Change at Week 4
|
-2.308 Score on a Scale
Standard Deviation 2.2457
|
-1.271 Score on a Scale
Standard Deviation 2.4880
|
|
Double-blind Induction Period: Change From Baseline in Skin Pain NRS by Week up to Week 16
Change at Week 5
|
-2.589 Score on a Scale
Standard Deviation 2.3577
|
-1.333 Score on a Scale
Standard Deviation 2.4462
|
|
Double-blind Induction Period: Change From Baseline in Skin Pain NRS by Week up to Week 16
Change at Week 6
|
-2.862 Score on a Scale
Standard Deviation 2.4428
|
-1.309 Score on a Scale
Standard Deviation 2.5079
|
|
Double-blind Induction Period: Change From Baseline in Skin Pain NRS by Week up to Week 16
Change at Week 7
|
-2.886 Score on a Scale
Standard Deviation 2.4473
|
-1.656 Score on a Scale
Standard Deviation 2.4816
|
|
Double-blind Induction Period: Change From Baseline in Skin Pain NRS by Week up to Week 16
Change at Week 8
|
-2.872 Score on a Scale
Standard Deviation 2.4975
|
-1.711 Score on a Scale
Standard Deviation 2.7208
|
|
Double-blind Induction Period: Change From Baseline in Skin Pain NRS by Week up to Week 16
Change at Week 9
|
-3.017 Score on a Scale
Standard Deviation 2.4897
|
-1.598 Score on a Scale
Standard Deviation 2.5693
|
|
Double-blind Induction Period: Change From Baseline in Skin Pain NRS by Week up to Week 16
Change at Week 10
|
-3.017 Score on a Scale
Standard Deviation 2.6017
|
-1.382 Score on a Scale
Standard Deviation 2.7463
|
|
Double-blind Induction Period: Change From Baseline in Skin Pain NRS by Week up to Week 16
Change at Week 11
|
-3.116 Score on a Scale
Standard Deviation 2.6230
|
-1.572 Score on a Scale
Standard Deviation 2.6465
|
|
Double-blind Induction Period: Change From Baseline in Skin Pain NRS by Week up to Week 16
Change at Week 12
|
-3.115 Score on a Scale
Standard Deviation 2.6181
|
-1.520 Score on a Scale
Standard Deviation 2.5976
|
|
Double-blind Induction Period: Change From Baseline in Skin Pain NRS by Week up to Week 16
Change at Week 13
|
-3.140 Score on a Scale
Standard Deviation 2.5568
|
-1.788 Score on a Scale
Standard Deviation 2.4726
|
|
Double-blind Induction Period: Change From Baseline in Skin Pain NRS by Week up to Week 16
Change at Week 14
|
-3.035 Score on a Scale
Standard Deviation 2.6733
|
-1.683 Score on a Scale
Standard Deviation 2.4462
|
|
Double-blind Induction Period: Change From Baseline in Skin Pain NRS by Week up to Week 16
Change at Week 15
|
-3.138 Score on a Scale
Standard Deviation 2.6062
|
-1.781 Score on a Scale
Standard Deviation 2.6443
|
|
Double-blind Induction Period: Change From Baseline in Skin Pain NRS by Week up to Week 16
Change at Week 16
|
-3.302 Score on a Scale
Standard Deviation 2.5844
|
-1.831 Score on a Scale
Standard Deviation 2.5766
|
SECONDARY outcome
Timeframe: Baseline up to Week 16Population: FAS included all randomized participants and were analyzed under the treatment group as randomized.
TCS free days proportion = Number of days participant did not take TCS medication / Number of days from Baseline to Week 16 Date or early discontinuation
Outcome measures
| Measure |
Double-blind Induction Period: Lebrikizumab +TCS
n=220 Participants
Participants received loading dose of lebrikizumab 500 mg SC injection at Day 1 (Baseline) and Week 2 followed by lebrikizumab 250 mg SC injection once Q2W for up to 16 weeks concomitantly with TCS in the double-blind induction period.
|
Double-blind Induction Period: Placebo +TCS
n=111 Participants
Participants received lebrikizumab-matched placebo SC injection, Q2W for up to 16 weeks concomitantly with TCS in the double-blind induction period.
|
|---|---|---|
|
Double-blind Induction Period: Proportion of Topical Corticosteroids (TCS) Medication Free Days
|
0.224 Proportion of Days
Standard Deviation 0.3491
|
0.151 Proportion of Days
Standard Deviation 0.3032
|
SECONDARY outcome
Timeframe: Baseline up to Week 16Population: FAS included all randomized participants and were analyzed under the treatment group as randomized.
Days from first study drug injection to the day participant stopped using all TCS.
Outcome measures
| Measure |
Double-blind Induction Period: Lebrikizumab +TCS
n=220 Participants
Participants received loading dose of lebrikizumab 500 mg SC injection at Day 1 (Baseline) and Week 2 followed by lebrikizumab 250 mg SC injection once Q2W for up to 16 weeks concomitantly with TCS in the double-blind induction period.
|
Double-blind Induction Period: Placebo +TCS
n=111 Participants
Participants received lebrikizumab-matched placebo SC injection, Q2W for up to 16 weeks concomitantly with TCS in the double-blind induction period.
|
|---|---|---|
|
Double-blind Induction Period: Median Time (Days) to TCS-Free Use
|
NA Days
Median and full range was not estimated due to insufficient number of events.
|
NA Days
Median and full range was not estimated due to insufficient number of events.
|
Adverse Events
Double-blind Induction Period: Lebrikizumab +TCS
Double-blind Induction Period: Placebo +TCS
Open-label Maintenance Period: Lebrikizumab to Lebrikizumab
Open-label Maintenance Period: Placebo to Lebrikizumab
Serious adverse events
| Measure |
Double-blind Induction Period: Lebrikizumab +TCS
n=220 participants at risk
Participants received loading dose of lebrikizumab 500 mg SC injection at Day 1 (Baseline) and Week 2 followed by lebrikizumab 250 mg SC injection once Q2W for up to 16 weeks concomitantly with TCS in the double-blind induction period.
|
Double-blind Induction Period: Placebo +TCS
n=111 participants at risk
Participants received lebrikizumab-matched placebo SC injection, Q2W for up to 16 weeks concomitantly with TCS in the double-blind induction period.
|
Open-label Maintenance Period: Lebrikizumab to Lebrikizumab
n=212 participants at risk
Participants who received lebrikizumab 250 mg Q2W during the Double-blind Induction Period continued to receive lebrikizumab 250 mg, Q2W during the 36-week Maintenance Period.
|
Open-label Maintenance Period: Placebo to Lebrikizumab
n=100 participants at risk
During Maintenance Period, participants who received placebo Q2W during the Induction Period received loading doses of lebrikizumab (500 mg) at Weeks 16 and 18. From Week 20 onward, the participants received 1 injection of lebrikizumab 250mg Q2W.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/220 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.00%
0/111 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.47%
1/212 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.00%
0/100 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
|
Musculoskeletal and connective tissue disorders
Fracture pain
|
0.00%
0/220 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.00%
0/111 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.47%
1/212 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.00%
0/100 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
|
Infections and infestations
Infection
|
0.45%
1/220 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.00%
0/111 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.00%
0/212 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.00%
0/100 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
|
Infections and infestations
Influenza
|
0.45%
1/220 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.00%
0/111 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.00%
0/212 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.00%
0/100 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
|
Nervous system disorders
Multiple sclerosis
|
0.45%
1/220 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.00%
0/111 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.00%
0/212 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.00%
0/100 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/220 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.90%
1/111 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.47%
1/212 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.00%
0/100 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
|
Infections and infestations
Bronchitis
|
0.00%
0/220 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.00%
0/111 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.47%
1/212 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.00%
0/100 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/220 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.00%
0/111 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.47%
1/212 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.00%
0/100 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/220 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.00%
0/111 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.47%
1/212 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.00%
0/100 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/220 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.00%
0/111 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.47%
1/212 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.00%
0/100 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/220 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.00%
0/111 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.47%
1/212 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.00%
0/100 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/220 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.00%
0/111 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.47%
1/212 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.00%
0/100 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/220 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.00%
0/111 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.94%
2/212 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.00%
0/100 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/220 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.00%
0/111 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.47%
1/212 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.00%
0/100 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
|
Psychiatric disorders
Delirium
|
0.00%
0/220 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.00%
0/111 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.47%
1/212 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.00%
0/100 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/220 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.00%
0/111 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.94%
2/212 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.00%
0/100 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/220 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.00%
0/111 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.47%
1/212 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.00%
0/100 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma of breast
|
0.00%
0/220 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.00%
0/111 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.47%
1/212 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.00%
0/100 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cutaneous T-cell lymphoma
|
0.00%
0/220 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.00%
0/111 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.00%
0/212 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
1.0%
1/100 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/220 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.00%
0/111 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.47%
1/212 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.00%
0/100 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.00%
0/220 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.00%
0/111 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.00%
0/212 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
1.0%
1/100 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/220 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.00%
0/111 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.00%
0/212 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
1.0%
1/100 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/220 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.00%
0/111 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.00%
0/212 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
1.0%
1/100 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
Other adverse events
| Measure |
Double-blind Induction Period: Lebrikizumab +TCS
n=220 participants at risk
Participants received loading dose of lebrikizumab 500 mg SC injection at Day 1 (Baseline) and Week 2 followed by lebrikizumab 250 mg SC injection once Q2W for up to 16 weeks concomitantly with TCS in the double-blind induction period.
|
Double-blind Induction Period: Placebo +TCS
n=111 participants at risk
Participants received lebrikizumab-matched placebo SC injection, Q2W for up to 16 weeks concomitantly with TCS in the double-blind induction period.
|
Open-label Maintenance Period: Lebrikizumab to Lebrikizumab
n=212 participants at risk
Participants who received lebrikizumab 250 mg Q2W during the Double-blind Induction Period continued to receive lebrikizumab 250 mg, Q2W during the 36-week Maintenance Period.
|
Open-label Maintenance Period: Placebo to Lebrikizumab
n=100 participants at risk
During Maintenance Period, participants who received placebo Q2W during the Induction Period received loading doses of lebrikizumab (500 mg) at Weeks 16 and 18. From Week 20 onward, the participants received 1 injection of lebrikizumab 250mg Q2W.
|
|---|---|---|---|---|
|
Eye disorders
Conjunctivitis allergic
|
8.2%
18/220 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
2.7%
3/111 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
8.5%
18/212 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
11.0%
11/100 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
|
Infections and infestations
COVID-19
|
3.6%
8/220 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
6.3%
7/111 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
6.1%
13/212 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
4.0%
4/100 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
|
Infections and infestations
Conjunctivitis
|
11.4%
25/220 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
1.8%
2/111 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
11.8%
25/212 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
11.0%
11/100 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
|
Infections and infestations
Nasopharyngitis
|
12.7%
28/220 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
12.6%
14/111 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
24.5%
52/212 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
16.0%
16/100 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
|
Infections and infestations
Oral herpes
|
5.0%
11/220 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
2.7%
3/111 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.00%
0/212 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.00%
0/100 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
|
Infections and infestations
Upper respiratory tract infection
|
3.6%
8/220 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
6.3%
7/111 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
8.0%
17/212 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
6.0%
6/100 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
|
Nervous system disorders
Headache
|
2.7%
6/220 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
5.4%
6/111 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.00%
0/212 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.00%
0/100 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/220 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
0.00%
0/111 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
5.7%
12/212 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
2.0%
2/100 • Double-blind Induction Period: Day 1 to Week 16; Open-label Maintenance Period: Week 16 to Week 52
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER