celiac disease
Conditions
Interventions
After the single-blind placebo run-in phase, subjects will be randomized to one 
of the 4 treatment
groups in a ratio of 1:1:1:1 as follows:
• PRV-015 100 mg q2w
• PRV-015 300 mg q2w
• PRV-015 600 mg q2w
• Placebo q2w
At each visit, each subject will receive 4 injections for a to
Sponsors
Provention Bio, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Adult male or females, 18-70 years of age • 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 known celiac disease alleles (typically 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
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 • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Endpoint: • Absolute change from baseline through Week 24 in abdominal symptoms as measured by the Abdominal Symptoms domain of the CeD PRO questionnaire Estimand: • The primary estimand is the difference in the overall mean values (averaged across 24 weeks) of each of the 3 PRV-015 treatment groups compared with placebo of the change from baseline in the Abdominal Symptoms domain of the CeD PRO questionnaire in the target population, regardless of compliance to study treatment or the occurrence of intercurrent events. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary efficacy endpoints: • Absolute change from baseline through Week 24 in the Diarrhea and Loose Stool domain of the CeD PRO • Absolute change from baseline through Week 24 in gastrointestinal (GI) symptoms as assessed by the Total GI score (comprising the Abdominal Symptoms domain, the Diarrhea and Loose Stool domain, and the Nausea item) of the CeD PRO • Absolute change from baseline to Week 24 in small intestinal mucosal inflammation, as measured by intraepithelial lymphocyte (IEL) density using immunohistochemistry (IHC) Safety endpoints: • Adverse events (AEs): treatmentemergent adverse events (TEAEs), TEAEs leading to treatment discontinuation, and treatment-emergent serious adverse events (SAEs) • Treatment-emergent adverse events of special interest (AESIs) • Potentially clinically important (PCI) changes in clinical laboratory values (hematology, chemistry, and urinalysis), vital signs (blood pressure [BP], heart rate, temperature, respiratory rate), and weight • Immunogenicity, as assessed by the presence of anti-PRV-015 antibodies PK endpoint: • Serum PRV-015 trough concentrations (Cmin) | — |
Countries
Netherlands
Outcome results
None listed