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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

Active, not recruiting · Phase 3 · NCT06407934

Conditions: Dermatitis Atopic

At a glance

Research payments reported, 2025
$13.9M
U.S. investigators named
89
Sites paid
80
Planned or actual enrollment
1,541

About the trial

Sponsor
Sanofi
Tested
Amlitelimab (drug), Placebo (drug)
Dates
Started 2024-05-08; completion 2027-03-17
Results posted
Not yet

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 EFC1760…

From ClinicalTrials.gov, last updated 2026-07-10. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Sanofi US Services Inc. reported $13.9M in research payments for this study in 2025 (901 payments).

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.

U.S. investigators named on this study

Clinicians the company named as principal investigators in its Open Payments reports.

Sites paid to run it

  • Elias Research Associates LLC $1.5M
  • Equity Medical Llc $631,660
  • St Jude Clinical Research Llc $578,330
  • Javara Inc $468,110
  • Stryde Consulting Llc $451,500
  • Interspond LLC $406,379
  • Cahaba Dermatology and Skin Health Center Llc $404,279
  • Direct Helpers Medical Center Inc Direct Helpers Research Center $333,954
  • Clinical Research Trials of Florida $323,005
  • T Joseph Raoof MD Inc $311,969
  • La Universal Research Center Inc $311,460
  • Velocity Clinical Research Inc $277,395
  • Mount Sinai School of Medicine Psychiatry $264,521
  • Sky Clinical Research Network Group Integrative Skin Care of Ms Skycrng $263,933
  • Arlington Research Center Inc $250,216
  • Dermatology Research Associates $246,831
  • Elite Clinical Network Llc $242,682
  • First Oc Dermatology Research Inc $238,398
  • Florida International Research Center Inc $237,683
  • Oregon Medical Research Center $235,202
  • Respiratory Medicine Research Institute of Michigan Plc $231,233
  • Sms Clinical Research Llc $228,875
  • Cura Clinical Research Llc $224,023
  • Stride Clinical Research Llc $223,822
  • Dermatology Associates of Plymouth Meeting $213,726
  • Texas Dermatology and Laser Special $209,218
  • Sunwise Clinical Research Llc $204,675
  • Rlb MD PC $200,345
  • Encore Medical Research Llc $191,947
  • Red River Research PArtners Llc $190,004
  • Paddington Testing Company $184,858
  • Care Access Research Llc $177,466
  • Miami Dermatology and Laser Research Miami Southwest 87th Avenue $163,057
  • Pediatric Skin Research Llc $162,377
  • J Robert West M D Inc $157,663
  • Complete Dermatology PLLC $152,152
  • Revival Research Institute, Inc $137,623
  • Torrance Clinical Research $135,559
  • Henry Ford Health Hospital, MI $133,455
  • Prolato Research Llc $117,620
  • Johnson Dermatology $104,568
  • Vaishali PAtel Summit Clinical Research Llc $102,599
  • Cleaver Medical Group Dermatology I Cleaver Medical Group Dermatology $100,419
  • Leon Kircik MD Skin Sciences PLLC $88,054
  • Orit Markowitz Markowitz Medical PLLC $87,456
  • Skin Care Physicians of Georgia $86,610
  • Eclipse Clinical Research $83,264
  • Qcare Site Services Inc $79,119
  • Institute of Clinical Research and Consulting Inc $78,667
  • Best Skin Research Llc $76,760
  • Tanner Memorial Clinic Tanner Clinic $73,116
  • Skin Specialists PC Schlessinger MD Joel Schlessinger MD $72,910
  • Center for Dermatology Clinical Research Inc $72,770
  • Apex Clinical Research Center Llc $68,704
  • Dawes Fretzin Clinical Research Gro LLC $66,052
  • Physicians Research Group II Llc $64,479
  • Derm Texas PLLC $62,321
  • Beth Israel Deaconess Medical Center, MA $61,811
  • Clinical Research Philadelphia Llc $59,672
  • Uconn Health Carole and Ray Neag Comprehensive Cancer Center $58,307
  • Dermatology Treatment and Research Center $52,559
  • Columbia Dermatology $50,164
  • Jubilee Clinical Research $49,909
  • Phoenix Clinical Trials Scottsdale Clinical Trials $49,190
  • Tribe Clinical Research Llc Mountain View Clinical Research $42,696
  • Gcp Global Clinical Professionals L $42,353
  • Sadick Research Group LLC $41,028
  • Marvel Clinical Research, Llc $40,188
  • Northshore University Healthsystem - Evanston Hospital, IL $39,710
  • Northridge Clinical Trials Llc $38,894
  • Brcr Medical Center Inc $35,302
  • Anchor Medical Research Llc $33,424
  • Probity Medical Research Corp $28,185
  • Acevedo Clinical Research Associates Co $27,904
  • Clinical Research Center of Alabama LLC $27,295
  • University of New Mexico $22,753
  • Omerany Llc $18,521
  • Skin Care Research Llc $16,900
  • Progressive Clinical Research $12,600
  • Dermatology Trial Associates $1,980

Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.