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Clinical Trial Active — Not Recruiting Phase II NCT06557772

A Phase 2a/b Study of the Efficacy and Safety of Subcutaneous Amlitelimab in Adults With Nonresponsive Celiac Disease

A Phase 2a/b Study of the Efficacy and Safety of Subcutaneous Amlitelimab in Adults With Nonresponsive Celiac Disease — Active Not Recruiting • Phase II • Gastroenterology •…

📅 31 Aug 2026 ⏱ 2 min read
Active — Not Recruiting
Check the registry for current status and eligibility criteria.
Status
Active — Not Recruiting
Phase
Phase II
NCT ID
NCT06557772
Start
2024-08-29
Completion
2026-08-05
ClinicaliQ Trial Snapshot
  • A Phase 2a/b Study of the Efficacy and Safety of Subcutaneous Amlitelimab in Adults With Nonresponsive Celiac Disease — Active Not Recruiting • Phase II • Gastroenterology • NCT06557772.
  • A trial testing whether amlitelimab injection reduces intestinal damage in adults with celiac disease unresponsive to gluten-free diet alone.

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What This Trial Is Studying

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…

Full Trial Details
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Eligibility criteria, protocol, and results when available
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