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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04424927
Other study ID # PRV-015-002b
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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