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

NCT04424927

CompletedPhase 2

Sponsor: Provention Bio, a Sanofi Company

Conditions: Celiac Disease

Interventions: PRV-015, Placebo

Countries: United States, Canada, Netherlands, Spain

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).

Eligibility overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (38)
  • Los Angeles, California, United States
  • Ventura, California, United States
  • Denver, Colorado, United States
  • Leesburg, Florida, United States
  • Tampa, Florida, United States
  • Winter Park, Florida, United States
  • Chicago, Illinois, United States
  • Northbrook, Illinois, United States
  • Chevy Chase, Maryland, United States
  • Boston, Massachusetts, United States
  • Chesterfield, Michigan, United States
  • Rochester, Minnesota, United States
  • Morristown, New Jersey, United States
  • Brooklyn, New York, United States
  • New Windsor, New York, United States
  • New York, New York, United States
  • Raleigh, North Carolina, United States
  • Dublin, Ohio, United States
  • Philadelphia, Pennsylvania, United States
  • Uniontown, Pennsylvania, United States
  • Warwick, Rhode Island, United States
  • North Charleston, South Carolina, United States
  • Nashville, Tennessee, United States
  • Cedar Park, Texas, United States
  • Garland, Texas, United States
  • West Jordan, Utah, United States
  • Bellevue, Washington, United States
  • Tacoma, Washington, United States
  • Hamilton, Ontario, Canada
  • Amsterdam, Netherlands
  • + 8 more on CT.gov