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

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-relatedantibodies

• 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 weekduring the month before screening: diarrhea, loose stools, abdominal pain, abdominalcramping, bloating, or gas.

• Body weight between 35 and 120 kg

Exclusion Criteria:

• Current diagnosis of any severe complication of celiac disease, such as refractoryceliac 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 levelsof 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 firstadministration of study drug

• History or presence of any clinically significant disease that, in the opinion ofthe Investigator, may confound the subject's participation and follow-up in theclinical trial or put the subject at unnecessary risk

• Females who are pregnant or planning to become pregnant during the study period, orwho are currently breastfeeding