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

NCT04424927 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 388

Last updated 2025-10-20

Study results available
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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).

Conditions

Interventions

BIOLOGICAL

PRV-015

Fully human monoclonal antibody against interleukin 15 (IL-15)

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • Provention Bio, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-24
Primary Completion
2024-07-30
Completion
2024-07-30
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Netherlands
  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04424927 on ClinicalTrials.gov