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

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