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

Launched by PROVENTION BIO, A SANOFI COMPANY · Jun 5, 2020

Keywords

ClinConnect Summary

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 a GFD.

Eligible subjects include male or female adults, 18 to 70 years of age, with a diagnosis of celiac disease and have followed a GFD for at least 12 consecutive months, yet continue to experience symptoms.

Study drug (1 of the 3 doses of PRV-015 or placebo) will be administered in a double-blind fashion, followed by a safety follow-up period.

Gender

ALL

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