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A Study to Evaluate the Treatment Response and Safety of Two Dose Regimens of Subcutaneous Amlitelimab Compared With Treatment Withdrawal in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis
Sponsor: Sanofi
Summary
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).
Official title: 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
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1541
Start Date
2024-05-08
Completion Date
2027-03-17
Last Updated
2026-07-10
Healthy Volunteers
No
Conditions
Interventions
Amlitelimab
Pharmaceutical form: Injection solution Route of administration: Subcutaneous (SC) injection
Placebo
Pharmaceutical form: Injection solution Route of administration: SC injection
Locations (324)
Cahaba Dermatology & Skin Health Center- Site Number : 8401066
Birmingham, Alabama, United States
Center for Dermatology and Plastic Surgery- Site Number : 8401119
Scottsdale, Arizona, United States
Scottsdale Clinical Trials- Site Number : 8401149
Scottsdale, Arizona, United States
Eclipse Clinical Research- Site Number : 8401158
Tucson, Arizona, United States
Johnson Dermatology- Site Number : 8401076
Fort Smith, Arkansas, United States
Encino Research Center- Site Number : 8401042
Encino, California, United States
First OC Dermatology- Site Number : 8401025
Fountain Valley, California, United States
Center for Dermatology Clinical Research- Site Number : 8401018
Fremont, California, United States
Marvel Clinical Research- Site Number : 8401102
Huntington Beach, California, United States
Sunwise Clinical Research- Site Number : 8401022
Lafayette, California, United States
Torrance Clinical Research - Narbonne Avenue- Site Number : 8401027
Lomita, California, United States
Dermatology Research Associates - Los Angeles- Site Number : 8401092
Los Angeles, California, United States
LA Universal Research Center- Site Number : 8401064
Los Angeles, California, United States
Northridge Clinical Trials - Northridge- Site Number : 8401080
Northridge, California, United States
Cura Clinical Research - Oxnard- Site Number : 8401142
Oxnard, California, United States
Southern California Dermatology- Site Number : 8401043
Santa Ana, California, United States
Clinical Science Institute- Site Number : 8401028
Santa Monica, California, United States
UConn Health - Farmington- Site Number : 8401115
Farmington, Connecticut, United States
Pediatric Skin Research- Site Number : 8401198
Coral Gables, Florida, United States
St. Jude Clinical Research- Site Number : 8401287
Doral, Florida, United States
Beth Israel Deaconess Medical Center - Fort Myers- Site Number : 8401286
Fort Myers, Florida, United States
Direct Helpers Research Center- Site Number : 8401056
Hialeah, Florida, United States
Encore Medical Research - Hollywood- Site Number : 8401030
Hollywood, Florida, United States
Clever Medical Research- Site Number : 8401160
Miami, Florida, United States
Acevedo Clinical Research Associates- Site Number : 8401088
Miami, Florida, United States
Florida International Research Center- Site Number : 8401091
Miami, Florida, United States
Miami Dermatology and Laser Research - Miami - Southwest 87th Avenue- Site Number : 8401086
Miami, Florida, United States
Anchor Medical Research- Site Number : 8401300
Miami, Florida, United States
Savin Medical Group - Miami Lakes- Site Number : 8401085
Miami Lakes, Florida, United States
Nuline Clinical Trial Center- Site Number : 8401161
Pompano Beach, Florida, United States
Global Clinical Professionals (GCP)- Site Number : 8401045
St. Petersburg, 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
Cleaver Medical Group- Site Number : 8401138
Dawsonville, Georgia, United States
First Georgia Physician Group- Site Number : 8401190
Fayetteville, Georgia, United States
Skin Care Physicians of Georgia - Macon- Site Number : 8401034
Macon, Georgia, United States
Javara Research - Thomasville- Site Number : 8401189
Thomasville, Georgia, United States
Rophe Adult & Pediatric Medicine- Site Number : 8401289
Union City, Georgia, United States
NorthShore University Health System - Endeavor Health Medical Group - Skokie - Woods Drive- Site Number : 8401038
Skokie, Illinois, United States
Dawes Fretzin Clinical Research- Site Number : 8401015
Indianapolis, Indiana, United States
Equity Medical - Bowling Green- Site Number : 8401296
Bowling Green, Kentucky, United States
Skin Sciences- Site Number : 8401039
Louisville, Kentucky, United States
MedPharmics - Covington- Site Number : 8401137
Covington, Louisiana, United States
BRCR Global Gretna- Site Number : 8401243
Gretna, Louisiana, United States
Velocity Clinical Research - Lafayette- Site Number : 8401152
Lafayette, Louisiana, United States
MetroBoston Clinical Partners - Brighton- Site Number : 8401128
Brighton, Massachusetts, United States
Henry Ford Hospital- Site Number : 8401044
Detroit, Michigan, United States
Revival Research Institute - Troy- Site Number : 8401012
Troy, Michigan, United States
Oakland Medical Center- Site Number : 8401116
Troy, Michigan, United States
Allergy & Immunology Associates of Ann Arbor- Site Number : 8401078
Ypsilanti, Michigan, United States
SKY Integrative Medical Center/SKYCRNG - Ridgeland- Site Number : 8401058
Ridgeland, Mississippi, United States
Skin Specialists- Site Number : 8401068
Omaha, Nebraska, United States
Jubilee Clinical Research- Site Number : 8401054
Las Vegas, Nevada, United States
Care Access - Hoboken- Site Number : 8401132
Hoboken, New Jersey, United States
The University of New Mexico- Site Number : 8401263
Albuquerque, New Mexico, United States
Equity Medical- Site Number : 8401239
New York, New York, United States
Icahn School of Medicine at Mount Sinai- Site Number : 8401129
New York, New York, United States
Sadick Research Group - New York - Park Avenue- Site Number : 8401050
New York, New York, United States
OptiSkin- Site Number : 8401163
New York, New York, United States
AXIS Clinicals - Fargo- Site Number : 8401196
Fargo, North Dakota, United States
Bexley Dermatology Research- Site Number : 8401051
Bexley, Ohio, United States
Apex Clinical Research Center- Site Number : 8401237
Mayfield Heights, Ohio, United States
Oregon Medical Research Center- Site Number : 8401017
Portland, Oregon, United States
Best Skin Research - Camp Hill- Site Number : 8401031
Camp Hill, Pennsylvania, United States
Paddington Testing Company- Site Number : 8401041
Philadelphia, Pennsylvania, United States
Clinical Research of Philadelphia- Site Number : 8401193
Philadelphia, Pennsylvania, United States
Dermatology Associates of Plymouth Meeting- Site Number : 8401147
Plymouth Meeting, Pennsylvania, United States
Columbia Dermatology & Aesthetics- Site Number : 8401166
Columbia, South Carolina, United States
Tribe Clinical Research - Greenville - Verdae Boulevard- Site Number : 8401225
Greenville, 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
Dermatology Treatment and Research Center- Site Number : 8401164
Dallas, Texas, United States
Derm Texas- Site Number : 8401217
Dallas, Texas, United States
Prolato Clinical Research Center- Site Number : 8401209
Houston, Texas, United States
SMS Clinical Research- Site Number : 8401182
Mesquite, Texas, United States
Synapse Clinical Research - Missouri City- Site Number : 8401148
Missouri City, Texas, United States
Texas Dermatology and Laser Specialists - San Antonio - Oakwell Court- Site Number : 8401131
San Antonio, Texas, United States
Stryde Research - Epiphany Dermatology- Site Number : 8401185
Southlake, Texas, United States
Complete Dermatology - Sugar Land- Site Number : 8401061
Sugar Land, Texas, United States
Tanner Clinic - Layton Antelope A- Site Number : 8401151
Layton, Utah, United States
Care Access - Arlington- Site Number : 8401134
Arlington, Virginia, United States
Virginia Dermatology & Skin Cancer Center- Site Number : 8401047
Norfolk, 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 : 0320024
San Miguel de Tucumán, Tucumán Province, Argentina
Investigational Site Number : 0320020
San Miguel de Tucumán, Tucumán Province, Argentina
Investigational Site Number : 0320022
Buenos Aires, Argentina
Investigational Site Number : 0320023
Buenos Aires, Argentina
Investigational Site Number : 0320011
Buenos Aires, Argentina
Investigational Site Number : 0320016
Buenos Aires, Argentina
Investigational Site Number : 0320008
Buenos Aires, Argentina
Investigational Site Number : 0320001
Buenos Aires, Argentina
Investigational Site Number : 0320018
Buenos Aires, Argentina
Investigational Site Number : 0320010
Buenos Aires, Argentina
Investigational Site Number : 0320002
Buenos Aires, Argentina
Investigational Site Number : 0320004
Buenos Aires, Argentina
Investigational Site Number : 0320009
Buenos Aires, Argentina