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

Conditions

• Celiac Disease
• Coeliac Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Amlitelimab — DRUG
  Pharmaceutical form: Injection solution Route of administration: SC injection
• Placebo — DRUG
  Pharmaceutical form: Injection solution Route of administration: SC injection
• SIGE — DIETARY_SUPPLEMENT
  Pharmaceutical form: Capsule Route of administration: Oral
• Gluten-free product (GFP) — DIETARY_SUPPLEMENT
  Pharmaceutical form: Capsule Route of administration: Oral

Study Details

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.

Key Dates

Start date

Aug 29, 2024

Status verified

Feb 2026

Primary completion

Aug 5, 2026

Completion

Apr 10, 2029

Study Design

Enrollment

229 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Amlitelimab dose 1 + Gluten-free product (GFP)
  Amlitelimab SC as per protocol + GFP
• Experimental: Amlitelimab dose 2 + GFP
  Amlitelimab SC as per protocol + GFP
• Experimental: Amlitelimab dose 3 + GFP
  Amlitelimab SC as per protocol + GFP
• Experimental: Amlitelimab dose 1 + SIGE
  Amlitelimab SC as per protocol + SIGE
• Placebo Comparator: Placebo + GFP
  Placebo SC as per protocol + GFP
• Placebo Comparator: Placebo + SIGE
  Placebo SC as per protocol + SIGE

Primary Outcome Measure

Change in Villus Height to Crypt Depth Ratio (Vh:Cd) from baseline to Week 28 [ Time Frame: Baseline to Week 28 ]

Locations (35)

Find similar trials in Scottsdale, AZ

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