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NCT06557772 · ClinicalTrials.gov registry record · Phase 2
A Phase 2a/b Study of the Efficacy and Safety of Subcutaneous Amlitelimab in Adults With Nonresponsive Celiac Disease
A Phase 2 study of Celiac Disease and Coeliac Disease, sponsored by Sanofi.
- Active
- Registry status
- Phase 2
- Development phase
- 229
- Enrollment target
- 20
- Study locations
NCT06557772: Active Phase 2 study of Celiac Disease and Coeliac Disease, sponsored by Sanofi.
NCT06557772 is a Phase 2 study of Celiac Disease and Coeliac Disease that is active but no longer recruiting, run by Sanofi. The registered enrollment target is 229 participants, below the 1,971-participant average among 24 other Celiac Disease trials with a reported enrollment target (88% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06557772, a Phase 2 study of Celiac Disease and Coeliac Disease, is active but no longer recruiting, sponsored by Sanofi.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 229 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Change in Vh:Cd ratio.
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 |
What the registry record for NCT06557772 still lists
NCT06557772 is an interventional study that assigns participants to a tested intervention. The registered 229 participants enrollment target is mid-sized for trials with a published cap, below the 1,971-participant average among 24 other Celiac Disease trials with a reported enrollment target (88% lower).
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.
NCT06557772 names 20 study sites across 12 states, led by California, Florida, Kansas.
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.
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).
Who is sponsoring clinical trial NCT06557772?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT06557772's enrollment target sits among peer trials
229 8th of 24 higher than 17 of 24 other Celiac Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Celiac Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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