The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in combination with a topical corticosteroids in Japanese participants with atopic dermatitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
286
Percentage of Participants With an Investigators Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 16
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
Time frame: Baseline to Week 16
Percentage of Participants Achieving Eczema Area Severity Index-75 (EASI-75) (≥75% Reduction in EASI Score) at Week 16
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent, i.e., percentage of skin affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI-75 score was obtained by weight-averaging these 4 scores and will range from 0 (none) to 72 (severe). The EASI-75 responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the EASI score.
Time frame: Week 16
Percent Change in Eczema Area Severity Index (EASI) Score From Baseline to Week 16
The EASI assesses objective physician estimates of 2 dimensions of AD - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). Least Square (LS) Mean was calculated using ANCOVA model with treatment, stratification factors of geographic region, age group, baseline IGA score (IGA 3 versus 4) as fixed factors baseline value as covariate.
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Yanagihara dermatology clinic
Ainokawa, Ichikawa-shi, Chiba, Japan
Kawashima Dermatology Clinic
Ichikawa-shi, Chiba, Japan
Charme Clinique
Matsudo, Chiba, Japan
Yasumoto Dermatology Clinic
Chikushino-shi, Fukuoka, Japan
Hino Dermatology Clinic
Fukutsu, Fukuoka, Japan
Hiroshima University Hospital
Hiroshima, Hiroshima, Japan
Takagi Dermatology
Obihiro, Hokkaido, Japan
Sapporo Skin Clinic
Sapporo, Hokkaido, Japan
Kobayashi Skin Clinic
Sapporo, Hokkaido, Japan
Dermatology Shimizu Clinic
Kobe, Hyōgo, Japan
...and 27 more locations
Time frame: Baseline to Week 16
Percentage of Participants Achieving EASI-90 at Week 16
The EASI assesses objective physician estimates of 2 dimensions of AD - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI-90 responder is defined as a participant who achieves a ≥ 90% reduction from baseline in the EASI score.
Time frame: Week 16
Percentage of Participants With an Itch Numeric Rating Scale (NRS) Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction From Baseline to Week 1
The Itch Numeric Rating Scale (NRS) is a an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."
Time frame: Baseline to Week 1
Percentage of Participants With an Itch NRS Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction From Baseline to Week 2
The Itch Numeric Rating Scale (NRS) is a an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."
Time frame: Baseline to Week 2
Percentage of Participants With an Itch NRS Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction From Baseline to Week 4
The Itch Numeric Rating Scale (NRS) is a an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."
Time frame: Baseline to Week 4
Percentage of Participants With an Itch NRS Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction From Baseline to Week 16
The Itch Numeric Rating Scale (NRS) is a an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."
Time frame: Baseline to Week 16