A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor
Active, not recruiting · Phase 3 · NCT06241118
Conditions: Dermatitis Atopic
At a glance
- Research payments reported, 2025
- $3.9M
- U.S. investigators named
- 35
- Sites paid
- 33
- Planned or actual enrollment
- 464
About the trial
- Sponsor
- Sanofi
- Tested
- Amlitelimab (drug), Placebo (drug), Topical corticosteroids (drug), Topical tacrolimus or pimecrolimus (drug)
- Dates
- Started 2024-02-29; completion 2028-09-29
- 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 AD on background TCS who have had inadequate response to prior biologic or oral JAKi therapy. 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 have had an inadequate response to prior biologic or an oral JAKi therapy. Study details include: At the end of the treatment period, participants will have the option to e…
From ClinicalTrials.gov, last updated 2026-10-13. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Sanofi US Services Inc. reported $3.9M in research payments for this study in 2025 (250 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
- Kenneth Steil, D.O. Dermatology · Scottsdale, AZ
- Neal D. Bhatia, MD Dermatology · San Diego, CA
- Sunil S. Dhawan, MD Dermatology · Fremont, CA
- Suzanne L. Fussell, MD Family Medicine · Oxnard, CA
- Mia Gatti Physician Assistants · Newport Beach, CA
- Tooraj J. Raoof, MD Internal Medicine · Encino, CA
- David O. Schairer, M.D. Dermatology · San Diego, CA
- Howard L. Sofen, M.D. Dermatology · Los Angeles, CA
- Bruce Torkan, M.D. General Practice · Los Angeles, CA
- Kimberly M. Neyman, M.D. Dermatology · Wheat Ridge, CO
- Jeffrey S. Rumbyrt, M. D. Allergy & Immunology · Lakewood, CO
- Brian J. Feinstein, D.O. Dermatology · Delray Beach, FL
- Pearl C. Kwong, MD PHD Dermatology · Jacksonville, FL
- Thomas M. Taylor, MD Dermatology · Tampa, FL
- Gustavo A. Torres, MD General Practice · Hialeah, FL
- Joel C. Joyce, MD Dermatology · Skokie, IL
- Walter Liszewski, MD Dermatology · Chicago, IL
- James Allred, MD Dermatology · Franklin, KY
- David L. Schneider, MD Allergy & Immunology · Metairie, LA
- Rajan Ravikumar, M.D. Allergy & Immunology · Brighton, MI
- Joel Schlessinger, M.D Dermatology · Omaha, NE
- Alexa M. Hetzel, PA-C Physician Assistants · East Windsor, NJ
- John R. Durkin, MD Dermatology · Albuquerque, NM
- Michael C. Cameron Dermatology · New York, NY
- Kalyani S. Marathe, MD, MPH Dermatology · Cincinnati, OH
- Eric L. Simpson, MD Dermatology · Portland, OR
- Jason M. Schoenfeld, M.D. Mohs Surgery · Philadelphia, PA
- Lara Wine Lee, M.D. Dermatology · Charleston, SC
- Aaron Farberg, M.D. Mohs Surgery · Rockwall, TX
- Adelaide A. Hebert, M.D. Dermatology · Bellaire, TX
- Tiffany Mayo Dermatology · Dallas, TX
- Matthew P. Elliott, MD Neurology · Charlottesville, VA
- Brian L. Johnson, MD Mohs Surgery · Norfolk, VA
- Kristen E. Holland, MD Dermatology · Milwaukee, WI
- Krystal J. Massey, M.D. Dermatology · Cheyenne, WY
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- St Jude Clinical Research Llc $938,141
- Equity Medical Llc $769,610
- Interspond LLC $324,850
- The Clinical Trials Network Llc $179,526
- Northshore University Healthsystem - Evanston Hospital, IL $136,879
- Suncoast Holdings Target Llc $133,321
- Encore Medical Research of Boynton Beach Llc $133,205
- Dermatology Research Associates $130,518
- Qcare Site Services Inc $117,661
- Oregon Health Science Univ Phs $92,792
- T Joseph Raoof MD Inc $87,003
- Clinical Research Philadelphia Llc $83,779
- Cincinnati Children's Hospital Medical Center, OH $80,214
- Northwestern University $72,133
- Paradigm Clinical Research Centers, Inc $70,933
- University of New Mexico $70,503
- Sdg Dermatology PC $64,435
- The Regents of the University of Michigan $43,981
- University of Alabama Hospital, AL $41,800
- Reveal Research Institute PLLC $40,976
- Medical University of South Carolin $34,753
- Medical University of South Carolina $26,051
- Medical College of Wisconsin Inc Attn Donald Basel $25,438
- Western States Clinical Research in $24,900
- The University of Texas Health Scie Center at Houston $24,095
- University of California San Diegodispersements $18,088
- Center for Dermatology Clinical Research Inc $17,800
- $17,100
- Vaishali PAtel Summit Clinical Research Llc $14,609
- University of Virginia $13,133
- Tcr Medical Corporation $12,718
- University Dermatology Trials Inc $12,500
- La Universal Research Center Inc $10,206
- Skin Specialists PC Schlessinger MD Joel Schlessinger MD $7,000
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.