PRV-015 in Gluten-free Diet Non-responsive Celiac Disease (PROACTIVE)

Provention Bio, a Sanofi Company

Status and phase: Completed; Phase 2

Conditions: Celiac Disease

Treatments: Biological: PRV-015; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04424927

PRV-015-002b

Details and patient eligibility

About

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).

Full 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.

Enrollment: 226 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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-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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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226 participants in 4 patient groups, including a placebo group

PRV-015 Low Dose

Experimental group

Description:

PRV-015 Low Dose, sterile solution for subcutaneous administration

Treatment:

Biological: PRV-015

PRV-015 Medium Dose

Experimental group

Description:

PRV-015 Medium Dose, sterile solution for subcutaneous administration

Treatment:

Biological: PRV-015

PRV-015 High Dose

Experimental group

Description:

PRV-015 High Dose, sterile solution for subcutaneous administration

Treatment:

Biological: PRV-015

Placebo

Placebo Comparator group

Description:

Placebo, sterile solution for subcutaneous administration

Treatment:

Other: Placebo