Phase 2b Study of PRV-015 in Gluten-free Diet Non-responsive Celiac Disease
- Conditions
- Celiac DiseaseMedDRA version: 20.0Level: LLTClassification code 10007864Term: Celiac diseaseSystem Organ Class: 100000004856Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2020-000649-16-ES
- Lead Sponsor
- Provention Bio, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 220
• 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 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
• 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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): 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;Timepoint(s) of evaluation of this end point: Week 24;Main Objective: To assess the efficacy of PRV-015 in attenuating the symptoms of celiac disease in adult patients with non-responsive celiac disease (NRCD) as measured by the Abdominal Symptoms domain of the Celiac Disease Patient Reported Outcome (CeD PRO) questionnaire.;Secondary Objective: • To assess the effect of treatment with PRV-015 on other measures of disease activity<br>• To assess the safety, tolerability, and pharmacokinetics (PK) of PRV-015 when administered to adult patients with non-responsive celiac disease (NRCD).
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Effect of treatment with PRV-015 on other measures of disease activity - Intraepithelial lymphocyte (IEL) density<br>2. Incidence of treatment-emergent adverse events (TEAEs) - Safety endpoint<br>3. Serum trough concentrations of PRV-015 at scheduled visits - Characterize the pharmacokinetics (PK) of PRV-015<br>4. Incidence of anti-PRV-015 antibodies - Immunogenicity endpoint;Timepoint(s) of evaluation of this end point: Week 24 to Week 28