Status:
COMPLETED
PRV-015 in Gluten-free Diet Non-responsive Celiac Disease
Lead Sponsor:
Provention Bio, a Sanofi Company
Conditions:
Celiac Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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).
Detailed Description
PRV-015-002b is a Phase 2b, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 3 dose regimens of PRV-015 in adult patients with NRCD who are on ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2024
Estimated Enrollment :
388 Patients enrolled
Trial Details
Trial ID
NCT04424927
Start Date
August 24 2020
End Date
July 30 2024
Last Update
October 20 2025
Active Locations (38)
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1
Clinical Site
Los Angeles, California, United States, 90036
2
Clinical Site
Ventura, California, United States, 93003
3
Clinical Site
Denver, Colorado, United States, 80209
4
Clinical Site
Leesburg, Florida, United States, 34748