PRV-015 in Gluten-free Diet Non-responsive Celiac Disease
NCT ID: NCT04424927
Last Updated: 2025-10-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
388 participants
INTERVENTIONAL
2020-08-24
2024-07-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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PRV-015 Low Dose
PRV-015 Low Dose, sterile solution for subcutaneous administration
PRV-015
Fully human monoclonal antibody against interleukin 15 (IL-15)
PRV-015 Medium Dose
PRV-015 Medium Dose, sterile solution for subcutaneous administration
PRV-015
Fully human monoclonal antibody against interleukin 15 (IL-15)
PRV-015 High Dose
PRV-015 High Dose, sterile solution for subcutaneous administration
PRV-015
Fully human monoclonal antibody against interleukin 15 (IL-15)
Placebo
Placebo, sterile solution for subcutaneous administration
Placebo
Placebo
Interventions
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PRV-015
Fully human monoclonal antibody against interleukin 15 (IL-15)
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Provention Bio, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Clinical Site
Los Angeles, California, United States
Clinical Site
Ventura, California, United States
Clinical Site
Denver, Colorado, United States
Clinical Site
Leesburg, Florida, United States
Clinical Site
Tampa, Florida, United States
Clinical Site
Winter Park, Florida, United States
Clinical Site
Chicago, Illinois, United States
Clinical Trial Site
Northbrook, Illinois, United States
Clinical Trial Site
Chevy Chase, Maryland, United States
Clinical Site
Boston, Massachusetts, United States
Clinical Site
Chesterfield, Michigan, United States
Clinical Site
Rochester, Minnesota, United States
Clinical Site
Morristown, New Jersey, United States
Clinical Trial Site
Brooklyn, New York, United States
Clinical Site
New Windsor, New York, United States
Clinical Trial Site
New York, New York, United States
Clinical Site
Raleigh, North Carolina, United States
Clinical Trial Site
Dublin, Ohio, United States
Clinical Site
Philadelphia, Pennsylvania, United States
Clinical Site
Uniontown, Pennsylvania, United States
Clinical Site
Warwick, Rhode Island, United States
Clinical Trial Site
North Charleston, South Carolina, United States
Clinical Site
Nashville, Tennessee, United States
Clinical Trial Site
Cedar Park, Texas, United States
Clinical Site
Garland, Texas, United States
Clinical Site
West Jordan, Utah, United States
Clinical Site
Bellevue, Washington, United States
Clinical Site
Tacoma, Washington, United States
Clinical Site
Hamilton, Ontario, Canada
Clinical Site
Amsterdam, , Netherlands
Clinical Site
Seville, Andalusia, Spain
Clinical Site
León, Castille and León, Spain
Clinical Trial Site
Terrassa, Catalonia, Spain
Clinical Trial Site
Girona, , Spain
Clinical Trial Site
Lleida, , Spain
Clinical Site
Madrid, , Spain
Clinical Site
Madrid, , Spain
Clinical Site
Madrid, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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DRI18114
Identifier Type: OTHER
Identifier Source: secondary_id
2020-000649-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PRV-015-002b
Identifier Type: -
Identifier Source: org_study_id
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