A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis (COAST 2)

Description

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).

Conditions

Dermatitis Atopic

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Study Overview

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Study Details

Study overview

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).

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 Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis (COAST 2)

Condition
Dermatitis Atopic
Intervention / Treatment

-

Contacts and Locations

Scottsdale

Center for Dermatology and Plastic Surgery- Site Number : 8401119, Scottsdale, Arizona, United States, 85260

Tucson

Eclipse Clinical Research- Site Number : 8401158, Tucson, Arizona, United States, 85745

Lomita

Torrance Clinical Research- Site Number : 8401027, Lomita, California, United States, 90717

Los Angeles

Dermatology Research Associates - Los Angeles- Site Number : 8401092, Los Angeles, California, United States, 90045

Mission Viejo

Allergy & Asthma Associates of Southern California - Mission Viejo- Site Number : 8401079, Mission Viejo, California, United States, 92691

Oxnard

Cura Clinical Research- Site Number : 8401142, Oxnard, California, United States, 93030

Santa Monica

Clinical Science Institute- Site Number : 8401028, Santa Monica, California, United States, 90404

Farmington

University of Connecticut Health Center- Site Number : 8401115, Farmington, Connecticut, United States, 06032

Coral Gables

Pediatric Skin Research- Site Number : 8401198, Coral Gables, Florida, United States, 33146

Hollywood

Skin Care Research - Hollywood- Site Number : 8401071, Hollywood, Florida, United States, 33021

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Participants must be 12 years of age (when signing informed consent form)
  • * Diagnosis of AD for at least 1 year (defined by the American Academy of Dermatology Consensus Criteria)
  • * Documented history (within 6 months before screening) of either inadequate response or inadvisability to topical treatments, and/or inadequate response to systemic therapies (within 12 months before screening)
  • * v-IGA-AD of 3 or 4 at baseline visit
  • * EASI score of 16 or higher at baseline
  • * AD involvement of 10% or more of BSA at baseline
  • * Weekly average of daily PP-NRS of ≥ 4 at baseline visit.
  • * Able and willing to comply with requested study visits and procedures
  • * Body weight ≥ 25 kg
  • * Skin co-morbidity that would adversely affect the ability to undertake AD assessments
  • * Known history of or suspected significant current immunosuppression
  • * Any malignancies or history of malignancies prior to baseline (with the exception of non-melanoma skin cancer excised and cured \>5 years prior to baseline)
  • * History of solid organ or stem cell transplant
  • * Any active or chronic infection including helminthic infection requiring systemic treatment within 4 weeks prior to baseline
  • * Positive for human immunodeficiency virus (HIV), Hepatitis B or hepatitis C at screening visit
  • * Having active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, or who are at high risk of contracting TB
  • * Having received any of the specified therapy within the specified timeframe(s) prior to the baseline visit
  • * In the Investigator's opinion, any clinically significant laboratory results or protocol specified laboratory abnormalities at screening
  • * History of hypersensitivity or allergy to any of the excipients or investigational medicinal product (IMP)

Ages Eligible for Study

12 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Sanofi,

Study Record Dates

2026-02-03