Trial · NCT06557772
A Phase 2a/b Study of the Efficacy and Safety of Subcutaneous Amlitelimab in Adults With Nonresponsive Celiac Disease
NCT06557772, Phase 2, Active not recruiting, Sanofi
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Phase 2a/b Study of the Efficacy and Safety of Subcutaneous Amlitelimab in Adults With Nonresponsive Celiac Disease. Trials, record NCT06557772. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06557772
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 2a/b Study of the Efficacy and Safety of Subcutaneous Amlitelimab in Adults With Nonresponsive Celiac Disease
- NCT number
- NCT06557772
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 229 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Coeliac Disease, Celiac Disease
- Interventions
- Amlitelimab, Placebo, SIGE, Gluten-free product (GFP)
- First posted
- 2024-08-16
- Last updated
- 2026-08-31
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Villus Height to Crypt Depth Ratio (Vh:Cd) from baseline to Week 28 | Baseline to Week 28 | Change in Vh:Cd ratio. |
| Secondary | Change in Celiac Disease Symptom Diary (CDSD) Gastrointestinal (GI) symptom severity score | Baseline to Week 28 | The CDSD is a patient report outcome instrument that assesses common celiac symptoms (abdominal pain, bloating, tiredness, nausea, and diarrhea). GI symptom severity score ranges from 0-20 with higher score indicating more severe disease. |
| Secondary | Percentage of participants who experienced treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs) and adverse events of special interest (AESI) during the placebo-controlled treatment period and the long-term extension | Baseline to Week 168 | |
| Secondary | Percentage of participants with potentially clinically significant abnormalities (PCSA) for vital signs and clinical laboratory assessments during the placebo-controlled treatment period and the long-term extension | Baseline to Week 168 | |
| Secondary | Percentage of participants discontinued from study treatment due to TEAEs during the placebo-controlled treatment period and the long-term extension | Baseline to Week 168 | |
| Secondary | Serum amlitelimab concentrations measured at prespecified timepoints | Baseline to Week 168 | |
| Secondary | Incidence of antidrug antibodies (ADAs) of amlitelimab | Baseline to Week 168 |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06557772
GET https://conductscience.org/api/trials/v1/NCT06557772/registered