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NCT06181435

PHASE3

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)

Sponsor: Sanofi

View on ClinicalTrials.gov

Summary

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).

Official title: 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

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

589

Start Date

2023-12-21

Completion Date

2026-03-12

Last Updated

2026-08-13

Healthy Volunteers

Conditions

Dermatitis Atopic

Interventions

DRUG

Amlitelimab

Pharmaceutical form: Injection solution Route of administration: SC injection

DRUG

Placebo

Pharmaceutical form: Injection solution Route of administration: SC injection

Inclusion 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 Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * 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) The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Locations (142)

Center for Dermatology and Plastic Surgery- Site Number : 8401119

Scottsdale, Arizona, United States

Eclipse Clinical Research- Site Number : 8401158

Tucson, Arizona, United States

Torrance Clinical Research- Site Number : 8401027

Lomita, California, United States

Dermatology Research Associates - Los Angeles- Site Number : 8401092

Los Angeles, California, United States

Allergy & Asthma Associates of Southern California - Mission Viejo- Site Number : 8401079

Mission Viejo, California, United States

Cura Clinical Research - Oxnard- Site Number : 8401142

Oxnard, California, United States

Clinical Science Institute- Site Number : 8401028

Santa Monica, California, United States

University of Connecticut Health Center- Site Number : 8401115

Farmington, Connecticut, United States

Pediatric Skin Research- Site Number : 8401198

Coral Gables, Florida, United States

Skin Care Research - Hollywood- Site Number : 8401071

Hollywood, Florida, United States

Savin Medical Group - Miami- Site Number : 8401085

Miami, Florida, United States

Anchor Medical Research- Site Number : 8401300

Miami, Florida, United States

Accel Research - Nona Pediatric Center- Site Number : 8401081

Orlando, Florida, United States

Nuline Clinical Trial Center- Site Number : 8401161

Pompano Beach, Florida, United States

Clinical Research Trials of Florida- Site Number : 8401023

Tampa, Florida, United States

AllerVie Clinical Research - Columbus- Site Number : 8401104

Columbus, Georgia, United States

First Georgia Physician Group- Site Number : 8401190

Fayetteville, Georgia, United States

Access Dermatology- Site Number : 8401296

Bowling Green, Kentucky, United States

MedPharmics - Covington- Site Number : 8401137

Covington, Louisiana, United States

Care Access Research - Marriottsville- Site Number : 8401126

Marriottsville, Maryland, United States

Tufts Medical Center Site Number : 8401201

Boston, Massachusetts, United States

University Of Mississippi Medical Center- Site Number : 8401184

Jackson, Mississippi, United States

Care Access - Hoboken- Site Number : 8401132

Hoboken, New Jersey, United States

University of New Mexico Comprehensive Cancer Center- Site Number : 8401263

Albuquerque, New Mexico, United States

OmeraNY- Site Number : 8401156

Brooklyn, New York, United States

Equity Medical- Site Number : 8401239

New York, New York, United States

Montefiore Medical Center - Moses Campus- Site Number : 8401150

The Bronx, New York, United States

Red River Research Partners- Site Number : 8401196

Fargo, North Dakota, United States

Bexley Dermatology Research- Site Number : 8401051

Bexley, Ohio, United States

Velocity Clinical Research - Springdale- Site Number : 8401153

Cincinnati, Ohio, United States

Dermatology Associates of Plymouth Meeting- Site Number : 8401147

Plymouth Meeting, Pennsylvania, United States

PEAK Research- Site Number : 8401083

Upper Saint Clair, Pennsylvania, United States

Columbia Dermatology & Aesthetics- Site Number : 8401166

Columbia, South Carolina, United States

Health Concepts- Site Number : 8401059

Rapid City, South Dakota, United States

Arlington Research Center- Site Number : 8401248

Arlington, Texas, United States

Derm Texas- Site Number : 8401217

Dallas, Texas, United States

Center for Clinical Studies - Houston - Binz Street- Site Number : 8401063

Houston, Texas, United States

Prolato Clinical Research Center- Site Number : 8401209

Houston, Texas, United States

Sienna Dermatology- Site Number : 8401148

Missouri City, Texas, United States

Progressive Clinical Research - San Antonio- Site Number : 8401016

San Antonio, Texas, United States

Advanced Research Institute - Odgen- Site Number : 8401057

Ogden, Utah, United States

Care Access - Arlington- Site Number : 8401134

Arlington, Virginia, United States

Velocity Clinical Research - Hampton- Site Number : 8401154

Hampton, Virginia, United States

Investigational Site Number : 0320021

Berazategui, Buenos Aires, Argentina

Investigational Site Number : 0320017

Pilar, Buenos Aires, Argentina

Investigational Site Number : 0320006

Rosario, Santa Fe Province, Argentina

Investigational Site Number : 0320007

Rosario, Santa Fe Province, Argentina

Investigational Site Number : 0320015

Rosario, Santa Fe Province, Argentina

Investigational Site Number : 0320016

Buenos Aires, Argentina

Investigational Site Number : 0320001

Buenos Aires, Argentina

Investigational Site Number : 0320002

Buenos Aires, Argentina

Investigational Site Number : 0320009

Buenos Aires, Argentina

Investigational Site Number : 1002008

Gabrovo, Bulgaria

Investigational Site Number : 1002004

Pleven, Bulgaria

Investigational Site Number : 1002005

Sofia, Bulgaria

Investigational Site Number : 1520004

Valdivia, Los Ríos Region, Chile

Investigational Site Number : 1520013

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1520003

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1520014

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1520015

Quillota, Valparaiso, Chile

Investigational Site Number : 1560004

Beijing, China

Investigational Site Number : 1560030

Beijing, China

Investigational Site Number : 1560022

Chengdu, China

Investigational Site Number : 1560021

Guangzhou, China

Investigational Site Number : 1560025

Guangzhou, China

Investigational Site Number : 1560002

Hangzhou, China

Investigational Site Number : 1560006

Hangzhou, China

Investigational Site Number : 1560029

Hangzhou, China

Investigational Site Number : 1560007

Jinan, China

Investigational Site Number : 1560024

Ningbo, China

Investigational Site Number : 1560001

Shanghai, China

Investigational Site Number : 1560005

Shanghai, China

Investigational Site Number : 1560026

Shenyang, China

Investigational Site Number : 1560023

Wenzhou, China

Investigational Site Number : 1560003

Wuxi, China

Investigational Site Number : 1560028

Zhenjiang, China

Investigational Site Number : 2032106

Kutná Hora, Czechia

Investigational Site Number : 2030010

Olomouc, Czechia

Investigational Site Number : 2032104

Ostrava, Czechia

Investigational Site Number : 2030011

Prague, Czechia

Investigational Site Number : 2030006

Prague, Czechia

Investigational Site Number : 2080002

Aalborg, Denmark

Investigational Site Number : 2080001

Aarhus, Denmark

Investigational Site Number : 2080003

Herlev, Denmark

Investigational Site Number : 3800018

Rozzano, Milano, Italy

Investigational Site Number : 3800013

Rome, Roma, Italy

Investigational Site Number : 3800009

Catania, Italy

Investigational Site Number : 3800008

Pisa, Italy

Investigational Site Number : 3800022

Vicenza, Italy

Investigational Site Number : 3920009

Chitose, Hokkaido, Japan

Investigational Site Number : 3923114

Obihiro, Hokkaido, Japan

Investigational Site Number : 3920008

Sapporo, Hokkaido, Japan

Investigational Site Number : 3920006

Kobe, Hyōgo, Japan

Investigational Site Number : 3920005

Sagamihara, Kanagawa, Japan

Investigational Site Number : 3923113

Yokohama, Kanagawa, Japan

Investigational Site Number : 3920010

Miyagi-gun, Miyagi, Japan

Investigational Site Number : 3920011

Sendai, Miyagi, Japan

Investigational Site Number : 3923109

Habikino, Osaka, Japan

Investigational Site Number : 3923110

Sakai, Osaka, Japan

Investigational Site Number : 3920002

Iruma, Saitama, Japan

And 42 more locations on ClinicalTrials.gov

Clinical Research Directory

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)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (142)