PRV-015 in Gluten-free Diet Non-responsive Celiac Disease
- Conditions
- Celiac Disease
- Interventions
- Biological: PRV-015Other: Placebo
- Registration Number
- NCT04424927
- Lead Sponsor
- Provention Bio, a Sanofi Company
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 226
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PRV-015 Low Dose PRV-015 PRV-015 Low Dose, sterile solution for subcutaneous administration PRV-015 High Dose PRV-015 PRV-015 High Dose, sterile solution for subcutaneous administration Placebo Placebo Placebo, sterile solution for subcutaneous administration PRV-015 Medium Dose PRV-015 PRV-015 Medium Dose, sterile solution for subcutaneous administration
- Primary Outcome Measures
Name Time Method Efficacy of PRV-015 in attenuating the symptoms of celiac disease in adult patients with NRCD as measured by the Celiac Disease Patient-Reported Outcome (CeD PRO) questionnaire 24 weeks Celiac Disease Patient-Reported Outcome (CeD PRO)
- Secondary Outcome Measures
Name Time Method Incidence of anti-PRV-015 antibodies 28 weeks Immunogenicity endpoint
Effect of treatment with PRV-015 on other measures of disease activity 24 weeks Intraepithelial lymphocyte (IEL) density
Incidence of treatment-emergent adverse events (TEAEs) 28 weeks Safety endpoint
Serum trough concentrations of PRV-015 at scheduled visits 28 weeks Characterize the pharmacokinetics (PK) of PRV-015
Trial Locations
- Locations (2)
Clinical Trial Site
🇪🇸Lleida, Spain
Clinical Site
🇪🇸Madrid, Spain