NCT04424927

PRV-015 in Gluten-free Diet Non-responsive Celiac Disease

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of PRV-015 in Adult Patients With Non-Responsive Celiac Disease as an Adjunct to a Gluten-free Diet

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 388 (actual)
• Sponsor: Provention Bio, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy and safety of PRV-015 in adult patients with non-responsive celiac disease (NRCD) who are on a gluten-free diet (GFD).

Detailed description

PRV-015-002b is a Phase 2b, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 3 dose regimens of PRV-015 in adult patients with NRCD who are on a GFD. Eligible subjects include male or female adults, 18 to 70 years of age, with a diagnosis of celiac disease and have followed a GFD for at least 12 consecutive months, yet continue to experience symptoms. Study drug (1 of the 3 doses of PRV-015 or placebo) will be administered in a double-blind fashion, followed by a safety follow-up period.

Conditions

• Celiac Disease

Interventions

Type	Name	Description
BIOLOGICAL	PRV-015	Fully human monoclonal antibody against interleukin 15 (IL-15)
OTHER	Placebo	Placebo

Timeline

• Start date: 2020-08-24
• Primary completion: 2024-07-30
• Completion: 2024-07-30
• First posted: 2020-06-11
• Last updated: 2025-10-20
• Results posted: 2025-10-20

Locations

38 sites across 4 countries: United States, Canada, Netherlands, Spain

Regulatory

• FDA-regulated drug study