A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of PRV-015 in Adult Patients With Non-Responsive Celiac Disease as an Adjunct to a Gluten-free Diet

PRV-015-002b

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).

2020-08-24

2024-08-31

2024-08-31

Active (not recruiting)

Early phase I

226

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 226, 'type': 'ACTUAL'}}

2024-04-16