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A Phase 2a/b Study of the Efficacy and Safety of Subcutaneous Amlitelimab in Adults With Nonresponsive Celiac Disease
NCT06557772 · View on ClinicalTrials.gov ↗
Study Summary
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 on participant-reported celiac signs and symptoms along with the safety, tolerability, and pharmacokinetics of amlitelimab will also be studied. Study details include: The study duration will be up to 48 weeks (including a 16-week safety follow-up period) with 10 visits for participants who opt not to enter the optional long-term extension. The study duration will be up to 172 weeks (including an 8-week safety follow-up period) with 22 visits for participants who enter the optional long-term extension. The double-blind placebo-controlled treatment duration will be up to 28 weeks.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Amlitelimab
- DIETARY_SUPPLEMENT SIGE
- DIETARY_SUPPLEMENT Gluten-free product (GFP)
Study Locations (20)
California
- FOMAT Medical Research - inSite Digestive Health Care - Arcadia- Site Number : 8400052 — Arcadia
- Om Research- Site Number : 8400001 — Lancaster
- United Medical Doctors - Los Alamitos- Site Number : 8400014 — Los Alamitos
- Om Research- Site Number : 8400010 — Oxnard
Florida
- Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8400040 — Miami Lakes
- Center for Digestive Health- Site Number : 8400013 — Orlando
- GCP Clinical Research- Site Number : 8400007 — Tampa
Kansas
- Hutchinson Clinic- Site Number : 8400020 — Hutchinson
- University of Kansas Medical Center- Site Number : 8400041 — Kansas City
Massachusetts
- Boston Specialists- Site Number : 8400051 — Boston
- Berkshire Medical Center- Site Number : 8400017 — Pittsfield
New Jersey
- Sanmora Bespoke Clinical Research Solutions- Site Number : 8400015 — East Orange
- Allied Digestive Health - Middlesex Monmouth Gastroenterology- Site Number : 8400053 — Freehold
Arizona
- One of a Kind Clinical Research Center - Scottsdale- Site Number : 8400055 — Scottsdale
Colorado
- Advanced Research Institute - Denver- Site Number : 8400048 — Denver
Idaho
- Treasure Valley Medical Research- Site Number : 8400006 — Boise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 229 participants |
| Start Date | 2024-08-29 |
| Est. Completion | 2029-04-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06557772
The ClinicalTrials.gov registry entry for NCT06557772 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 229 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 275 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Celiac Disease appearing as the primary indexed condition, and to 4 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06557772 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Florida, Kansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06557772 about?
NCT06557772 is a clinical study titled "A Phase 2a/b Study of the Efficacy and Safety of Subcutaneous Amlitelimab in Adults With Nonresponsive Celiac Disease". 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 exposur...
What is the current status of trial NCT06557772?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 229 participants. The study started on 2024-08-29. Estimated completion is 2029-04-10.
What conditions does trial NCT06557772 study?
This clinical trial studies the following conditions: Celiac Disease, Coeliac Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06557772?
The interventions under investigation include: Placebo (DRUG), Amlitelimab (DRUG), SIGE (DIETARY_SUPPLEMENT), Gluten-free product (GFP) (DIETARY_SUPPLEMENT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06557772?
This trial is sponsored by Sanofi, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06557772 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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