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

Completed · Phase 2 · Has a placebo group

Conditions studied: Celiac Disease

In brief

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).

Key facts

Study ID

NCT04424927

Run by

Provention Bio, a Sanofi Company

People needed

388

Starts

2020-08-24

Expected to finish

2024-07-30

Last updated by the study team

2025-10-20

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A diagnosis of celiac disease by intestinal biopsy
• Following a GFD for at least 12 consecutive months
• Must have detectable (above the lower limit of detection) serum celiac-related antibodies
• Must have human leukocyte antigen DQ (HLA-DQ) typing consistent with celiac disease (DQ2 and/or DQ8)
• Subjects must have had at least one of the following symptoms at least once per week during the month before screening: diarrhea, loose stools, abdominal pain, abdominal cramping, bloating, or gas.
• Body weight between 35 and 120 kg

You may not qualify if…

• Current diagnosis of any severe complication of celiac disease, such as refractory celiac disease type 1 (RCD-I) or RCD-II, enteropathy-associated T-cell lymphoma (EATL), ulcerative jejunitis, or gastrointestinal (GI) perforation
• Diagnosis of any chronic, active GI disease other than celiac disease
• Presence of any active infection
• Selective immunoglobulin A (IgA) deficiency, defined as having undetectable levels of IgA
• Known or suspected exposure to coronavirus disease 2019 (COVID-19) infection in the 4 weeks before screening
• Administration of a live vaccine within 14 days prior to randomization and the first administration of study drug
• History or presence of any clinically significant disease that, in the opinion of the Investigator, may confound the subject's participation and follow-up in the clinical trial or put the subject at unnecessary risk
• Females who are pregnant or planning to become pregnant during the study period, or who are currently breastfeeding

Where it is running

• Clinical Site — Los Angeles, California, United States
• Clinical Site — Ventura, California, United States
• Clinical Site — Denver, Colorado, United States
• Clinical Site — Leesburg, Florida, United States
• Clinical Site — Tampa, Florida, United States
• Clinical Site — Winter Park, Florida, United States
• Clinical Site — Chicago, Illinois, United States
• Clinical Trial Site — Northbrook, Illinois, United States
• Clinical Trial Site — Chevy Chase, Maryland, United States
• Clinical Site — Boston, Massachusetts, United States
• Clinical Site — Chesterfield, Michigan, United States
• Clinical Site — Rochester, Minnesota, United States
• Clinical Site — Morristown, New Jersey, United States
• Clinical Trial Site — Brooklyn, New York, United States
• Clinical Site — New Windsor, New York, United States
• Clinical Trial Site — New York, New York, United States
• Clinical Site — Raleigh, North Carolina, United States
• Clinical Trial Site — Dublin, Ohio, United States
• Clinical Site — Philadelphia, Pennsylvania, United States
• Clinical Site — Uniontown, Pennsylvania, United States
• Clinical Site — Warwick, Rhode Island, United States
• Clinical Trial Site — North Charleston, South Carolina, United States
• Clinical Site — Nashville, Tennessee, United States
• Clinical Trial Site — Cedar Park, Texas, United States
• Clinical Site — Garland, Texas, United States

Full record on ClinicalTrials.gov

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