A Phase 2a/b Study of the Efficacy and Safety of Subcutaneous Amlitelimab in Adults With Nonresponsive Celiac Disease
Active, not recruiting · Phase 2 · NCT06557772
Conditions: Coeliac Disease, Celiac Disease
At a glance
- Research payments reported, 2025
- $4.6M
- U.S. investigators named
- 39
- Sites paid
- 36
- Planned or actual enrollment
- 229
About the trial
- Sponsor
- Sanofi
- Tested
- Amlitelimab (drug), Placebo (drug), SIGE (dietary_supplement), Gluten-free product (GFP) (dietary_supplement)
- Dates
- Started 2024-08-29; completion 2029-04-10
- Results posted
- Not yet
This is a Phase 2a/b, randomized, double-blind, placebo-controlled, parallel-group, 6-arm study to evaluate the efficacy and safety of amlitelimab in adult participants with non-responsive celiac disease (NRCD) who are on a gluten free diet (GFD) with and without simulated inadvertent gluten exposure (SIGE). The primary purpose of this study is to demonstrate the efficacy of subcutaneous (SC) amlitelimab in male and female participants (aged 18 to 75 years, inclusive) with NRCD. The study will assess the effect of amlitelimab when compared to placebo on gluten induced changes in the intestinal mucosa as measured by the villous height to crypt depth (Vh:Cd) ratio. The effect of amlitelimab…
From ClinicalTrials.gov, last updated 2026-08-31. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Sanofi US Services Inc. reported $4.6M in research payments for this study in 2025 (376 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
- Florin Gaidici, M.D. Gastroenterology · Phoenix, AZ
- Seyedehsan Navabi, M.D. Gastroenterology · Murrieta, CA
- Jatinder S. Pruthi, M.D. Gastroenterology · Lancaster, CA
- Karen Simon, M.D. Gastroenterology · Oxnard, CA
- Elias A. Tarakji, M.D. Gastroenterology · Arcadia, CA
- Wesley Prichard, D.O. Gastroenterology · Lakewood, CO
- Paul Feuerstadt, M.D. Gastroenterology · Hamden, CT
- Lucky Flores, M.D. Family Medicine · Miami Lakes, FL
- Henry Levine, MD Gastroenterology · Orlando, FL
- Raymond W. Phillips, M.D. Specialist · Naples, FL
- Alan M. Weintraub, MD Gastroenterology · Tampa, FL
- David B. Rausher, M.D. Specialist · Decatur, GA
- Shadi Hamdeh, MD Gastroenterology · Kansas City, KS
- James Ruhlmann, MD Internal Medicine · Hutchinson, KS
- Jason M. Bratcher, M.D. Gastroenterology · Pittsfield, MA
- John Leung, M.D. Gastroenterology · Boston, MA
- Allan G. Coates, DO Gastroenterology · Wyoming, MI
- Neetu Talreja, MD Hospitalist · Detroit, MI
- Adam C. Bledsoe, M.D. Gastroenterology · Rochester, MN
- Osama Altayar, MD Gastroenterology · Saint Louis, MO
- Mitchell A. Mah'moud, MD Gastroenterology · Smithfield, NC
- Adekunle Adeoti, MD Specialist · Irvington, NJ
- Colin C. Brown, M.D. Gastroenterology · Freehold, NJ
- Deon Miller Emergency Medicine · Perth Amboy, NJ
- George Vagujhelyi, M.D. Gastroenterology · Reno, NV
- Stephanie M. Moleski, MD Gastroenterology · Philadelphia, PA
- Jonathan M. Spergel, M.D. Pediatrics · Philadelphia, PA
- David Fried, MD Internal Medicine · East Greenwich, RI
- Natasha E. Ballard, M.D. Family Medicine · Chattanooga, TN
- Stephanie D. Pointer Gastroenterology · Nashville, TN
- Alan P. Glombicki, M.D. Obesity Medicine · Houston, TX
- Muhammad Irfan, M.D. Internal Medicine · Tomball, TX
- Lilah S. Mansour, MD Gastroenterology · Cedar Park, TX
- Jignesh P. Shah, MD Gastroenterology · Houston, TX
- Robert K. Barnett, M.D. Gastroenterology · Sandy, UT
- Umaprasanna S. Karnam, MD Gastroenterology · Riverton, UT
- John E. Lowe, MD Gastroenterology · Ogden, UT
- Robert S. Call, M.D. Allergy & Immunology · Richmond, VA
- William H. Holderman, M.D. Gastroenterology · Tacoma, WA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Clinical Research PArtners LLC $851,282
- Advanced Research Inc $759,103
- Gcp Clinical Research Llc $593,280
- Gcp Global Clinical Professionals L $260,138
- Om Research Llc $205,614
- Treasure Valley Medical Research Neetu Talreja $201,721
- Quality Medical Research Plcc $145,130
- Medcare Pharma Llc $144,061
- Sanmora Bespoke Clinical Research Solution Llc $127,301
- Fomat Medical Research Inc $121,084
- Endoscopic Research Inc $118,382
- Wellness Clinical Research (wcr) $95,259
- Linq Research Llc $91,577
- Tandeem Allied Clinical Research Llc $87,255
- Gastroenterology Associates of West Michigan Plc West Michigan Clinical Research Center $86,656
- Boston Specialists $82,603
- Texas Digestive Disease Consultants PLLC Gi Alliance $79,481
- Velocity Clinical Research Inc $72,696
- United Medical Doctors United Gastroenterologists $56,831
- Berkshire Medical Center $55,166
- Advanced Research Institute New Port Richey $49,200
- Mayo Clinic Cont Nursing Education $37,860
- Dynamed Clinical Research LP $37,398
- M3 Wake Research Inc $36,736
- Washington University $34,051
- University of Kansas Hospital $26,183
- One of A Kind Clinical Research $23,500
- Jefferson Health Nephrology $23,245
- Elligo Health Research Inc $20,741
- Medical Research Center of Connecti $20,200
- Innovo Research Inc $19,911
- Mayo Clinic $15,880
- Emvenio Research Inc $15,200
- $14,571
- Gi Pros Inc $13,975
- Children's Hospital of Philadelphia, PA $5,400
- University of Kansas Medical Center Research Inst Inc $668
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.