Clinical Research Partners, LLC | Forest Avenue, Richmond, VA
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About
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 to improve or attenuate 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 for participants not entering the long-term extension study (including a 16-week safety follow-up period).
The study duration will be up to 32 weeks for participants who enter the long-term extension study.
The treatment duration will be up to 28 weeks. The number of visits will be up to 10 visits.
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Exclusion criteria
Participants are excluded from the study if any of the following criteria apply:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Primary purpose
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Interventional model
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204 participants in 6 patient groups, including a placebo group
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Trial Transparency email recommended (Toll free for US & Canada)
Data sourced from clinicaltrials.gov
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