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

> **NCT06557772** · PHASE2 · ACTIVE_NOT_RECRUITING · sponsor: **Sanofi** · enrollment: 229 (actual)

## Conditions studied

- Coeliac Disease
- Celiac Disease

## Interventions

- **DRUG:** Amlitelimab
- **DRUG:** Placebo
- **DIETARY_SUPPLEMENT:** SIGE
- **DIETARY_SUPPLEMENT:** Gluten-free product (GFP)

## Key facts

- **NCT ID:** NCT06557772
- **Lead sponsor:** Sanofi
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2024-08-29
- **Primary completion:** 2026-08-05
- **Final completion:** 2029-04-10
- **Target enrollment:** 229 (ACTUAL)
- **Last updated:** 2026-02-25


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT06557772

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT06557772, "A Phase 2a/b Study of the Efficacy and Safety of Subcutaneous Amlitelimab in Adults With Nonresponsive Celiac Disease". Retrieved via AI Analytics 2026-05-29 from https://api.ai-analytics.org/clinical/NCT06557772. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*