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

Celiac Disease Clinical Trial

— PROACTIVE  

Official title:

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of PRV-015 in Adult Patients With Non-Responsive Celiac Disease as an Adjunct to a Gluten-free Diet

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04424927
• Other study ID #: PRV-015-002b
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: August 24, 2020
• Est. completion date: August 31, 2024

Study information

• Verified date: April 2024
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 226
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Celiac Disease

Intervention

Biological:
• PRV-015
Fully human monoclonal antibody against interleukin 15 (IL-15)

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
Canada	Clinical Site	Hamilton	Ontario
Netherlands	Clinical Site	Amsterdam
Spain	Clinical Trial Site	Girona
Spain	Clinical Site	Leon	Castilla Y Leon
Spain	Clinical Trial Site	Lleida
Spain	Clinical Site	Madrid
Spain	Clinical Site	Madrid
Spain	Clinical Site	Madrid
Spain	Clinical Site	Seville	Andalusia
Spain	Clinical Trial Site	Terrassa	Catalunya
United States	Clinical Site	Bellevue	Washington
United States	Clinical Site	Boston	Massachusetts
United States	Clinical Trial Site	Brooklyn	New York
United States	Clinical Trial Site	Cedar Park	Texas
United States	Clinical Site	Chesterfield	Michigan
United States	Clinical Trial Site	Chevy Chase	Maryland
United States	Clinical Site	Chicago	Illinois
United States	Clinical Site	Denver	Colorado
United States	Clinical Trial Site	Dublin	Ohio
United States	Clinical Site	Garland	Texas
United States	Clinical Site	Leesburg	Florida
United States	Clinical Site	Los Angeles	California
United States	Clinical Site	Morristown	New Jersey
United States	Clinical Site	Nashville	Tennessee
United States	Clinical Site	New Windsor	New York
United States	Clinical Trial Site	New York	New York
United States	Clinical Trial Site	North Charleston	South Carolina
United States	Clinical Trial Site	Northbrook	Illinois
United States	Clinical Site	Philadelphia	Pennsylvania
United States	Clinical Site	Raleigh	North Carolina
United States	Clinical Site	Rochester	Minnesota
United States	Clinical Site	Tacoma	Washington
United States	Clinical Site	Tampa	Florida
United States	Clinical Site	Uniontown	Pennsylvania
United States	Clinical Site	Ventura	California
United States	Clinical Site	Warwick	Rhode Island
United States	Clinical Site	West Jordan	Utah
United States	Clinical Site	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Provention Bio, a Sanofi Company

Countries where clinical trial is conducted

United States,  Canada,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Celiac Disease Patient-Reported Outcome (CeD PRO)	24 weeks
Secondary	Effect of treatment with PRV-015 on other measures of disease activity	Intraepithelial lymphocyte (IEL) density	24 weeks
Secondary	Incidence of treatment-emergent adverse events (TEAEs)	Safety endpoint	28 weeks
Secondary	Serum trough concentrations of PRV-015 at scheduled visits	Characterize the pharmacokinetics (PK) of PRV-015	28 weeks
Secondary	Incidence of anti-PRV-015 antibodies	Immunogenicity endpoint	28 weeks