For Healthcare Professionals

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

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About the study

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).
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. A diagnosis of celiac disease by intestinal biopsy
  2. Following a GFD for at least 12 consecutive months
  3. Must have detectable (above the lower limit of detection) serum celiac-related antibodies
  4. Must have human leukocyte antigen DQ (HLA-DQ) typing consistent with celiac disease (DQ2 and/or DQ8)
  5. 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.
  6. Body weight between 35 and 120 kg

EXCLUSION CRITERIA

  1. 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
  2. Diagnosis of any chronic, active GI disease other than celiac disease
  3. Presence of any active infection
  4. Selective immunoglobulin A (IgA) deficiency, defined as having undetectable levels of IgA
  5. Known or suspected exposure to coronavirus disease 2019 (COVID-19) infection in the 4 weeks before screening
  6. Administration of a live vaccine within 14 days prior to randomization and the first administration of study drug
  7. 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
  8. Females who are pregnant or planning to become pregnant during the study period, or who are currently breastfeeding
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall (908) 941-0784Email iconEmail Study Center

Study’s details


Contition

Celiac Disease

Age (in years)

18 - 70

Phase

Phase 2

Participants needed

220

Est. Completion Date

Dec 2023

Treatment type

Interventional


Sponsor

Provention Bio, Inc.

ClinicalTrials.gov identifier

NCT04424927

Study number

PRV-015-002b

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