A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Adult Participants With Severe Alopecia Areata
Terminated · Phase 2 · NCT06444451
Conditions: Alopecia Areata
At a glance
- Research payments reported, 2025
- $999,763
- U.S. investigators named
- 18
- Sites paid
- 18
- Planned or actual enrollment
- 166
About the trial
- Sponsor
- Sanofi
- Tested
- Amlitelimab (drug), Placebo (drug)
- Dates
- Started 2024-06-06; completion 2026-05-21
- Results posted
- Not yet
This is a parallel, Phase 2 multinational, multicenter, randomized, double-blind, placebo-controlled, 3-arm study to investigate the efficacy and safety of subcutaneous (SC) injections of amlitelimab treatment as monotherapy in participants aged 18 years and older with severe alopecia areata (AA). At the end of the double-blind treatment period, all participants will have the option to enter the open-label extension (OLE) period. The study duration will be up to 160 weeks for participants entering the OLE period including a 2-to-4-week screening, a 36-week randomized double-blind period, an optional OLE period (104 weeks) and a 16-week safety follow-up. The open-label extension period is …
From ClinicalTrials.gov, last updated 2026-08-10. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Sanofi US Services Inc. reported $999,763 in research payments for this study in 2025 (183 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
- James Krell Dermatology · Birmingham, AL
- Sunil S. Dhawan, MD Dermatology · Fremont, CA
- Justin M. Ko, MD Dermatology · Stanford, CA
- Vivian Laquer, M.D. Dermatology · Irvine, CA
- Natasha Mesinkovska, M.D. PH.D. Dermatology · Mission Viejo, CA
- Howard L. Sofen, M.D. Dermatology · Los Angeles, CA
- Lazaro D. Nunez, MD Pediatrics · Coral Gables, FL
- Kenneth W. Dawes, M.D. Dermatology · Indianapolis, IN
- Joel Schlessinger, M.D Dermatology · Omaha, NE
- Benjamin Ungar, MD Dermatology · New York, NY
- Wilma F. Bergfeld, M.D. Dermatology · Cleveland, OH
- Jorge A. Garcia-zuazaga, M.D. Mohs Surgery · Concord Township, OH
- Melissa P. Piliang, MD Dermatopathology · Cleveland, OH
- Iftikhar Hussain, MD Allergy & Immunology · Tulsa, OK
- Benjamin D. Ehst, M.D., PH.D. Dermatology · Portland, OR
- Jason M. Schoenfeld, M.D. Mohs Surgery · Philadelphia, PA
- Richard L. Beasley, MD Internal Medicine · Rapid City, SD
- Mark S. Lee, M.D. Dermatology · San Antonio, TX
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Mount Sinai School of Medicine Psychiatry $310,088
- Oregon Medical Research Center $92,036
- Apex Clinical Research Center Llc $88,228
- Vital Prospects Clinical Research I Institute PC $86,995
- New Horizon Research Center $81,399
- Rlb MD PC $57,480
- Cleveland Clinic Educational Found Attn Christian Nasr, MD $47,348
- First Oc Dermatology Research Inc $45,344
- Board of Trustees of the Leland $35,699
- Dermatology Research Associates $30,487
- Center for Dermatology Clinical Research Inc $27,537
- Uci Health-Orange, CA $20,752
- Progressive Clinical Research $20,313
- Clinical Research Philadelphia Llc $18,023
- Dawes Fretzin Clinical Research Gro LLC $13,300
- New Horizon Research Group Inc $12,555
- Skin Specialists PC Schlessinger MD Joel Schlessinger MD $7,825
- Total Skin Beauty Dermatology Center PC Total Dermatology $4,355
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.