A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, 3-arm, Multinational, Multicenter Study to Evaluate the Efficacy and Safety of Amlitelimab Monotherapy by Subcutaneous Injection in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, 3-arm, Multinational, Multicenter Study to Evaluate the Efficacy and Safety of Amlitelimab Monotherapy by Subcutaneous Injection in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis
This is a parallel group, Phase 3, multinational, multicenter, randomized, double blind, placebo-controlled, 3-arm monotherapy study for treatment of participants diagnosed with moderate to severe atopic dermatitis (AD), whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
The purpose of this study is to measure the efficacy and safety of treatment with amlitelimab solution for SC injection compared with placebo in participants with moderate to severe AD aged 12 years and older.
Study details include:
At the end of the treatment period, participants will have an option to enter a separate study: the blinded extension study EFC17600 (ESTUARY).
For participants not entering the blinded extension Study EFC17600 (ESTUARY), the study duration will be up to 44 weeks including a 2 to 4-week screening, a 24-week randomized double-blind period, and a 16-week safety follow-up.
For participants entering the blinded extension Study EFC17600 (ESTUARY), the study duration will be up to 28 weeks including a 2 to 4-week screening and a 24-week randomized double-blind period.
The total treatment duration will be up to 24 weeks. The total number of visits will be up to 10 visits (or 9 visits for those entering the blinded extension study EFC17600] (ESTUARY).
Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial
Fremont, California 94538, United States
North Hollywood, California 91606, United States
Northridge, California 91325, United States
Fort Myers, Florida 33919, United States
Orlando, Florida 32806, United States
Ridgeland, Mississippi 39157, United States
New York, New York 10075, United States
Charlotte, North Carolina 28277, United States
Camp Hill, Pennsylvania 17011, United States
Philadelphia, Pennsylvania 19114, United States
Greenville, South Carolina 29607, United States
San Antonio, Texas 78218, United States
Norfolk, Virginia 23502, United States
SAN Miguel de Tucumã¡n, Tucumán Province T4000, Argentina
Salvador, Estado de Bahia 41820-020, Brazil
Curitiba, Paraná 80060-900, Brazil
Curitiba, Paraná 80230-130, Brazil
Porto Alegre, Rio Grande do Sul 90020-090, Brazil
Rio de Janeiro, 22241-180, Brazil
São Paulo, 04020-060, Brazil
São Paulo, 05403-000, Brazil
Bupyeong-gu, Incheon-gwangyeoksi 21431, South Korea