A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis on Background Topical Corticosteroids
Completed · Phase 3 · NCT06224348
Conditions: Dermatitis Atopic
At a glance
- Research payments reported, 2025
- $2.6M
- U.S. investigators named
- 41
- Sites paid
- 39
- Planned or actual enrollment
- 643
About the trial
- Sponsor
- Sanofi
- Tested
- Amlitelimab (drug), Placebo (drug), Topical corticosteroids (drug), Topical calcineurin inhibitors (drug)
- Dates
- Started 2024-01-18; completion 2025-11-01
- Results posted
- Not yet
This is a parallel group, Phase 3, multinational, multicenter, randomized, double-blind, placebo controlled, 3-arm study for treatment of participants diagnosed with moderate-to-severe atopic dermatitis (AD) with a history of inadequate response of topical treatment, on background topical corticosteroid (TCS) and/or topical calcineurin inhibitor (TCI). The purpose of this study is to measure the efficacy and safety of treatment with amlitelimab solution for subcutaneous (SC) injection compared with placebo in participants with moderate to severe AD aged 12 years and older on background TCS and/or TCI. Study details include: At the end of the treatment period, participants will have an opt…
From ClinicalTrials.gov, last updated 2026-08-13. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Sanofi US Services Inc. reported $2.6M in research payments for this study in 2025 (290 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
- Vlada Groysman, MD Dermatology · Hoover, AL
- Sandra M. Johnson, MD Dermatology · Fort Smith, AR
- Sam S. Ahn, M.D. Allergy & Immunology · Napa, CA
- Aram H. Kechichian, D.O. Dermatology · Santa Clarita, CA
- Jennifer Ornelas Dermatology · Sacramento, CA
- Tooraj J. Raoof, MD Internal Medicine · Encino, CA
- David J. Rayhan, MD Dermatology · Huntington Beach, CA
- Jennifer Soung, M.D. Dermatology · Santa Ana, CA
- Bruce Torkan, M.D. General Practice · Los Angeles, CA
- James D. Jensen, MD Dermatology · Castle Rock, CO
- Armando E. Acevedo, M.D. General Practice · Miami, FL
- Jose C. Cabrera Saavedra, MD General Practice · South Miami, FL
- Thomas B. Casale, M.D. Allergy & Immunology · Tampa, FL
- Mojgan Hosseinipour, DO Dermatology · Miami, FL
- Roxana M. Stoici, MD Family Medicine · St Petersburg, FL
- Thomas M. Taylor, MD Dermatology · Tampa, FL
- Eduardo T. Weiss, MD Dermatology · Hollywood, FL
- Nathan J. Cleaver, DO Dermatology · Cumming, GA
- Yvonne L. Smith, MD Pediatrics · Union City, GA
- Joel C. Joyce, MD Dermatology · Skokie, IL
- Scott A. Fretzin, M.D. Dermatology · Indianapolis, IN
- Hai N. Nguyen, M.D. Internal Medicine · Gretna, LA
- Scott P. Striplin, M.D. OB-GYN (Obstetrics & Gynecology) · Covington, LA
- Jeffrey G. Leflein, MD Allergy & Immunology · Ypsilanti, MI
- Jay H. Sandberg, D.O Internal Medicine · Troy, MI
- Joel Schlessinger, M.D Dermatology · Omaha, NE
- Abel D. Jarell, MD Dermatology · Portsmouth, NH
- Elliot Shin, MD Family Medicine · Las Vegas, NV
- Michael C. Cameron Dermatology · New York, NY
- Orit Markowitz Dermatology · New York, NY
- Benjamin Ungar, MD Dermatology · New York, NY
- Jorge A. Garcia-zuazaga, M.D. Mohs Surgery · Concord Township, OH
- Jeffrey E. Chasteen, DO Family Medicine · Tulsa, OK
- Stephen M. Schleicher, M.D. Dermatology · Sugarloaf, PA
- Todd E. Schlesinger, M.D. Dermatology · Charleston, SC
- John C. Browning, MD Dermatology · San Antonio, TX
- Bartley J. Gill, M.D., PH.D. Internal Medicine · Sugar Land, TX
- Brian K. Macgillivray, MD Family Medicine · San Antonio, TX
- Salma Saiger, M.D. Internal Medicine · Mesquite, TX
- Scott R. Checketts, MD Dermatology · Layton, UT
- Jason C. Hadley, MD Dermatology · Bountiful, UT
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Elias Research Associates LLC $394,232
- Sms Clinical Research Llc $272,810
- Cahaba Dermatology and Skin Health Center Llc $153,979
- T Joseph Raoof MD Inc $130,816
- J Robert West M D Inc $127,790
- Equity Medical Llc $103,684
- Respiratory Medicine Research Institute of Michigan Plc $103,171
- Integrative Skin Science and Resear $89,024
- Sky Clinical Research Network Group Integrative Skin Care of Ms Skycrng $84,713
- La Universal Research Center Inc $83,006
- Apex Clinical Research Center Llc $71,136
- Orit Markowitz Markowitz Medical PLLC $69,015
- Allcutis Research Llc $63,952
- Dawes Fretzin Clinical Research Gro LLC $63,871
- Tanner Memorial Clinic Tanner Clinic $62,030
- Acevedo Clinical Research Associates Co $57,684
- Brcr Medical Center Inc $57,022
- Gcp Global Clinical Professionals L $56,037
- Complete Dermatology PLLC $55,393
- Best Skin Research Llc $54,908
- Texas Dermatology and Laser Special $53,558
- Marvel Clinical Research, Llc $46,759
- Jubilee Clinical Research $44,760
- Velocity Clinical Research Inc $35,634
- Mount Sinai School of Medicine Psychiatry $35,075
- Northshore University Healthsystem - Evanston Hospital, IL $33,575
- One of A Kind Clinical Research $26,432
- Essential Medical Research LLC $23,572
- Qcare Site Services Inc $22,714
- Johnson Dermatology $21,420
- Interspond LLC $19,887
- Skin Specialists PC Schlessinger MD Joel Schlessinger MD $17,473
- Cura Clinical Research Llc $14,870
- Skin Care Research Llc $11,504
- Clinical Research Center of the Carolinas $9,600
- Cleaver Medical Group Dermatology I Cleaver Medical Group Dermatology $9,391
- University of South Florida $5,750
- Dct Stoneoak Llc Dba Discovery Clinical Trials $3,500
- Physicians Research Group II Llc $1,000
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.