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New hope for celiac sufferers: drug targets stubborn symptoms

NCT ID NCT04424927

Symptom relief Sponsor: Provention Bio, a Sanofi Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a drug called PRV-015 in 388 adults with celiac disease who still had symptoms like belly pain and bloating even after following a strict gluten-free diet. The goal was to see if the drug could reduce these symptoms better than a placebo. Participants took the drug or a placebo for 24 weeks while continuing their gluten-free diet.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

388 people

The number who actually took part.

Started

Aug 2020

Finished

Jul 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

celiac disease refractory celiac disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Celiac disease

Contacts and locations

Locations

  • Clinical Site

    Los Angeles, California, 90036, United States

  • Clinical Site

    Ventura, California, 93003, United States

  • Clinical Site

    Denver, Colorado, 80209, United States

  • Clinical Site

    Leesburg, Florida, 34748, United States

  • Clinical Site

    Tampa, Florida, 33613, United States

  • Clinical Site

    Winter Park, Florida, 32789, United States

  • Clinical Site

    Chicago, Illinois, 60637, United States

  • Clinical Site

    Boston, Massachusetts, 02111, United States

  • Clinical Site

    Chesterfield, Michigan, 48047, United States

  • Clinical Site

    Rochester, Minnesota, 55905, United States

  • Clinical Site

    Morristown, New Jersey, 07960, United States

  • Clinical Site

    New Windsor, New York, 12553, United States

  • Clinical Site

    Raleigh, North Carolina, 27607, United States

  • Clinical Site

    Philadelphia, Pennsylvania, 19104, United States

  • Clinical Site

    Uniontown, Pennsylvania, 14401, United States

  • Clinical Site

    Warwick, Rhode Island, 02886, United States

  • Clinical Site

    Nashville, Tennessee, 37212, United States

  • Clinical Site

    Garland, Texas, 75044, United States

  • Clinical Site

    West Jordan, Utah, 84088, United States

  • Clinical Site

    Bellevue, Washington, 98004, United States

  • Clinical Site

    Tacoma, Washington, 98405, United States

  • Clinical Site

    Hamilton, Ontario, L8S4K1, Canada

  • Clinical Site

    Amsterdam, 1105 AZ, Netherlands

  • Clinical Site

    Seville, Andalusia, 41013, Spain

  • Clinical Site

    León, Castille and León, 24071, Spain

  • Clinical Site

    Madrid, 28034, Spain

  • Clinical Site

    Madrid, 28041, Spain

  • Clinical Site

    Madrid, 28222, Spain

  • Clinical Trial Site

    Northbrook, Illinois, 60062, United States

  • Clinical Trial Site

    Chevy Chase, Maryland, 20815, United States

  • Clinical Trial Site

    Brooklyn, New York, 11235, United States

  • Clinical Trial Site

    New York, New York, 10032, United States

  • Clinical Trial Site

    Dublin, Ohio, 43016, United States

  • Clinical Trial Site

    North Charleston, South Carolina, 29405, United States

  • Clinical Trial Site

    Cedar Park, Texas, 78613, United States

  • Clinical Trial Site

    Terrassa, Catalonia, 082211, Spain

  • Clinical Trial Site

    Girona, 17007, Spain

  • Clinical Trial Site

    Lleida, 25196, Spain

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