A Phase 3, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group 52-week Extension Study to Evaluate the Treatment Response and Safety of Two Amlitelimab Dose Regimens Administered by Subcutaneous Injection in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis
A Phase 3, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group 52-week Extension Study to Evaluate the Treatment Response and Safety of Two Amlitelimab Dose Regimens Administered by Subcutaneous Injection in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis
This is a multinational, multicenter, randomized, double-blind, placebo-controlled, parallel, Phase 3 study for treatment of participants aged 12 years and older diagnosed with moderate-to-severe atopic dermatitis (AD).
The primary objective of ESTUARY is to assess the maintenance of treatment response on continued Q12W dosing compared to treatment withdrawal.
Study details include:
The study duration will be up to 68 weeks including a 52-week randomized double-blind period, and a 16-week safety follow-up for participants not entering the LTS17367 (RIVER-AD).
The study duration will be up to 52 weeks for participants entering the LTS17367 [RIVER-AD] study at the Week 52 visit of 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.
Birmingham, Alabama 35244, United States
Scottsdale, Arizona 85260, United States
Fremont, California 94538, United States
Lomita, California 90717, United States
Los Angeles, California 90045, United States
Northridge, California 91325, United States
Fort Myers, Florida 33919, United States
Miami, Florida 33173, United States
St. Petersburg, Florida 33705, United States
Skokie, Illinois 60077, United States
Lafayette, Louisiana 70508, United States
Brighton, Massachusetts 02135, United States
Ypsilanti, Michigan 48197, United States
Ridgeland, Mississippi 39157, United States
New York, New York 10029, United States
New York, New York 10075, United States
Philadelphia, Pennsylvania 19114, United States
Plymouth Meeting, Pennsylvania 19462, United States
Columbia, South Carolina 29212, United States
Greenville, South Carolina 29607, United States
Missouri City, Texas 77459, United States
San Antonio, Texas 78218, United States
Norfolk, Virginia 23502, United States
Vitória, Espírito Santo 29055-450, Brazil
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
Porto Alegre, Rio Grande do Sul 90610-000, Brazil
Ribeirão Preto, São Paulo 14049-900, Brazil
Rio de Janeiro, 22241-180, Brazil
São Paulo, 04020-060, Brazil
São Paulo, 05403-000, Brazil
Miyagi-gun, Miyagi 981-0112, Japan
Bupyeong-gu, Incheon-gwangyeoksi 21431, South Korea
Burjassot - Valencia, Valenciana, Comunidad 46100, Spain