A Phase 2a/b Study of the Efficacy and Safety of Subcutaneous Amlitelimab in Adults With Nonresponsive Celiac Disease
Public ClinicalTrials.gov record NCT06557772. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2a/b, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of Subcutaneous Amlitelimab in Adult Patients With Nonresponsive Celiac Disease as an Adjunct to a Gluten-free Diet
Study identification
- NCT ID
- NCT06557772
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- Sanofi
- Industry
- Enrollment
- 229 participants
Conditions and interventions
Conditions
Interventions
- Amlitelimab Drug
- Placebo Drug
- SIGE Dietary Supplement
- Gluten-free product (GFP) Dietary Supplement
Drug · Dietary Supplement
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 28, 2024
- Primary completion
- Aug 4, 2026
- Completion
- Apr 9, 2029
- Last update posted
- Feb 24, 2026
2024 – 2029
United States locations
- U.S. sites
- 35
- U.S. states
- 20
- U.S. cities
- 35
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| One of a Kind Clinical Research Center - Scottsdale- Site Number : 8400055 | Scottsdale | Arizona | 85253 | — |
| FOMAT Medical Research - inSite Digestive Health Care - Arcadia- Site Number : 8400052 | Arcadia | California | 91006 | — |
| Om Research- Site Number : 8400001 | Lancaster | California | 93534 | — |
| United Medical Doctors - Los Alamitos- Site Number : 8400014 | Los Alamitos | California | 90720 | — |
| Om Research- Site Number : 8400010 | Oxnard | California | 93030 | — |
| Advanced Research Institute - Denver- Site Number : 8400048 | Denver | Colorado | 80218 | — |
| Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8400040 | Miami Lakes | Florida | 33016 | — |
| Center for Digestive Health- Site Number : 8400013 | Orlando | Florida | 32803 | — |
| GCP Clinical Research- Site Number : 8400007 | Tampa | Florida | 33609 | — |
| Treasure Valley Medical Research- Site Number : 8400006 | Boise | Idaho | 83706 | — |
| Hutchinson Clinic- Site Number : 8400020 | Hutchinson | Kansas | 67502 | — |
| University of Kansas Medical Center- Site Number : 8400041 | Kansas City | Kansas | 66160 | — |
| Boston Specialists- Site Number : 8400051 | Boston | Massachusetts | 02111 | — |
| Berkshire Medical Center- Site Number : 8400017 | Pittsfield | Massachusetts | 01201 | — |
| Gastroenterology Associates of Western Michigan - Wyoming- Site Number : 8400004 | Wyoming | Michigan | 49519 | — |
| Mayo Clinic in Rochester - Minnesota- Site Number : 8400049 | Rochester | Minnesota | 55905 | — |
| Washington University- Site Number : 8400025 | St Louis | Missouri | 63110 | — |
| Advanced Research Institute - Reno- Site Number : 8400036 | Reno | Nevada | 89511 | — |
| Sanmora Bespoke Clinical Research Solutions- Site Number : 8400015 | East Orange | New Jersey | 07018 | — |
| Allied Digestive Health - Middlesex Monmouth Gastroenterology- Site Number : 8400053 | Freehold | New Jersey | 07728 | — |
| M3 Wake Research- Site Number : 8400008 | Raleigh | North Carolina | 27612 | — |
| Thomas Jefferson University Hospital- Site Number : 8400056 | Philadelphia | Pennsylvania | 19107 | — |
| Velocity Clinical Research - Providence- Site Number : 8400002 | East Greenwich | Rhode Island | 02818 | — |
| M3 Wake Research - Chattanooga- Site Number : 8400012 | Chattanooga | Tennessee | 37421 | — |
| Quality Medical Research- Site Number : 8400018 | Nashville | Tennessee | 37211 | — |
| Texas Digestive Disease Consultants - Cedar Park- Site Number : 8400030 | Cedar Park | Texas | 78613 | — |
| MedCare Pharma - Houston - Cypress Creek Parkway- Site Number : 8400016 | Houston | Texas | 77090 | — |
| LinQ Research - Smith Ranch Road- Site Number : 8400028 | Pearland | Texas | 77584 | — |
| DM Clinical Research - Tomball- Site Number : 8400042 | Tomball | Texas | 77375 | — |
| Advanced Research Institute - Odgen- Site Number : 8400044 | Ogden | Utah | 84405 | — |
| Advanced Research Institute - Sandy - South 1300 East- Site Number : 8400046 | Sandy City | Utah | 84094 | — |
| Velocity Clinical Research - Salt Lake City- Site Number : 8400023 | West Jordan | Utah | 84088 | — |
| Gastroenterology Associates of Central Virginia- Site Number : 8400057 | Lynchburg | Virginia | 24502 | — |
| Clinical Research Partners - Richmond - Forest Avenue- Site Number : 8400011 | Richmond | Virginia | 23220 | — |
| GI Alliance - Tacoma- Site Number : 8400033 | Tacoma | Washington | 98405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 83 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06557772, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 24, 2026 · Synced Jul 23, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06557772 live on ClinicalTrials.gov.