A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis (COAST 2)
Completed · Phase 3 · NCT06181435
Conditions: Dermatitis Atopic
At a glance
- Research payments reported, 2025
- $4.0M
- U.S. investigators named
- 47
- Sites paid
- 43
- Planned or actual enrollment
- 589
About the trial
- Sponsor
- Sanofi
- Tested
- Amlitelimab (drug), Placebo (drug)
- Dates
- Started 2023-12-21; completion 2026-03-12
- Results posted
- Not yet
This is a parallel group, Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, 3-arm monotherapy study for treatment of participants diagnosed with moderate to severe atopic dermatitis (AD), whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The purpose of this study is to measure the efficacy and safety of treatment with amlitelimab solution for SC injection compared with placebo in participants with moderate to severe AD aged 12 years and older. Study details include: At the end of the treatment period, participants will have an option to enter a separate study: the blinded extension stu…
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 $4.0M in research payments for this study in 2025 (363 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
- Eve C. Shapiro, MD Pediatrics · Tucson, AZ
- Kenneth Steil, D.O. Dermatology · Scottsdale, AZ
- Warner W. Carr, MD Allergy & Immunology · Laguna Niguel, CA
- Marvi Iqbal, M.D. , MPH Dermatology · La Palma, CA
- Michael T. Lin, MD Dermatology · Sherman Oaks, CA
- Marina Raikhel, MD Family Medicine · Lomita, CA
- Howard L. Sofen, M.D. Dermatology · Los Angeles, CA
- Paul S. Yamauchi, M.D., PHD Dermatology · Santa Monica, CA
- Jun Lu, MD Dermatology · Farmington, CT
- Sady A. Alpizar, MD Internal Medicine · Tampa, FL
- Jessica Bernstein, DO Dermatology · Delray Beach, FL
- Salma H. Elfaki, MD Pediatrics · Orlando, FL
- Mercedes E. Gonzalez, M.D. Dermatology · Miami, FL
- Jason Green, DO Dermatology · Fort Lauderdale, FL
- Juvenal E. Martinez, MD Family Medicine · Miami, FL
- David A. Rodriguez, M D Specialist · Miami, FL
- Eduardo T. Weiss, MD Dermatology · Hollywood, FL
- Robert C. Cartwright, MD Allergy & Immunology · Columbus, GA
- G A. Slagel, MD Dermatology · Fayetteville, GA
- James Allred, MD Dermatology · Franklin, KY
- Andrea T. Murina, M.D. Dermatology · New Orleans, LA
- Kathryn Quarls, M.D. Pediatrics · Covington, LA
- David L. Schneider, MD Allergy & Immunology · Metairie, LA
- Chesahna Kindred, MD Dermatology · Marriottsville, MD
- Kaharu Sumino, MD Pulmonology · Saint Louis, MO
- Thy Huynh Dermatology · Jackson, MS
- Alexander E. Osowa, MD Family Medicine · Jackson, MS
- Michael Blankinship Dermatology · Fargo, ND
- Adolfo C. Fernandez-obregon, M.D. Specialist · Hoboken, NJ
- John R. Durkin, MD Dermatology · Albuquerque, NM
- Michael C. Cameron Dermatology · New York, NY
- Holly E. Kanavy, D.O. Dermatology · Bronx, NY
- Douglas K. Logan, M.D. Internal Medicine · Cincinnati, OH
- Matthew J. Zirwas, MD Dermatology · Bexley, OH
- James M. Moretti, M.D. Family Medicine · Pittsburgh, PA
- Jonathan T. Wolfe, MD Dermatology · Plymouth Meeting, PA
- Jessica R. Burgy, MD Dermatology · Columbia, SC
- Richard L. Beasley, MD Internal Medicine · Rapid City, SD
- Mark S. Lee, M.D. Dermatology · San Antonio, TX
- Sreedhar A. Mandayam, M.D. Nephrology (Kidney) · Houston, TX
- Angela Y. Moore, MD, PA Dermatopathology · Arlington, TX
- Mary M. Moore, M.D. Dermatology · Missouri City, TX
- Stephen K. Tyring, MD PHD Dermatology · Webster, TX
- Kelly J. Warren, MD Dermatology · Dallas, TX
- John E. Lowe, MD Gastroenterology · Ogden, UT
- David W. Bray, M.D. Dermatology · Alexandria, VA
- Brian C. Mccormick, M.D. Family Medicine · Hampton, VA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Equity Medical Llc $535,401
- Elias Research Associates LLC $288,134
- Javara Inc $273,977
- Interspond LLC $239,760
- Care Access Research Llc $228,320
- Prolato Research Llc $192,544
- Pediatric Skin Research Llc $192,141
- Derm Texas PLLC $177,148
- Arlington Research Center Inc $161,323
- Cura Clinical Research Llc $119,918
- University of New Mexico $117,408
- Velocity Clinical Research Inc $117,082
- Red River Research PArtners Llc $105,995
- Dermatology Associates of Plymouth Meeting $93,177
- Anchor Medical Research Llc $84,626
- Eclipse Clinical Research $72,043
- Torrance Clinical Research $70,819
- Peak Research Llc $70,707
- Omerany Llc $70,525
- Dermatology Research Associates $69,875
- Clinical Research Center of Alabama LLC $68,330
- University of Connecticut Health Center $66,863
- Qcare Site Services Inc $65,571
- Rlb MD PC $65,386
- Axis Clinicals Llc $53,903
- Institute of Clinical Research and Consulting Inc $47,223
- Uconn Health Carole and Ray Neag Comprehensive Cancer Center $44,240
- Center for Clinical Studies Ltd LLP $43,661
- Clinical Research Trials of Florida $39,237
- Stride Clinical Research Llc $31,715
- Probity Medical Research Corp $26,044
- University Clinical Research Deland Accel Research Sites $24,356
- Advanced Research Inc $20,120
- Imax Clinical Trials Llc 1 $19,025
- Columbia Dermatology $17,634
- Cognitive Clinical Trials LLC $17,022
- Allergy Asthma Association of Southern California,a Medical Group Inc $15,474
- Administrators of the Tulane Educational Fund $15,250
- Progressive Clinical Research $9,763
- Biomedical Research Alliance of New York LLC $8,765
- Skin Care Research Llc $8,427
- University of Mississippi Med Center, MS $5,315
- Tufts Medical Center, MA $3,750
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.