A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallelgroup, 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, Parallelgroup, 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:
Participants are excluded from the study if any of the following criteria apply:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Scottsdale, Arizona 85260, United States
Los Angeles, California 90045, United States
Mission Viejo, California 92691, United States
Farmington, Connecticut 06032, United States
Marriottsville, Maryland 21104, United States
Jackson, Mississippi 39216, United States
Albuquerque, New Mexico 87102, United States
The Bronx, New York 10467, United States
Plymouth Meeting, Pennsylvania 19462, United States
Columbia, South Carolina 29212, United States
Houston, Texas 77004, United States
San Antonio, Texas 78229, United States
Miyagi-gun, Miyagi 981-0112, Japan