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

ClinicalTrials.gov processed this data on April 12, 2024. Link to the current ClinicalTrials.gov record.

Recruitment Status

ACTIVE, NOT RECRUITING (See Contacts and Locations)
Verified April 2024 by Provention Bio, a Sanofi Company

Sponsor

Provention Bio, a Sanofi Company

Information Provided by (Responsible Party)

Provention Bio, a Sanofi Company

Clinicaltrials.gov Identifier

NCT04424927
Other Study ID Numbers: PRV-015-002b
First Submitted: May 28, 2020
First Posted: June 11, 2020
Last Update Posted: April 16, 2024
Last Verified: April 2024
History of Changes

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Study 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.
Condition or Disease Intervention/Treatment
  • Celiac Disease
  • Biological: PRV-015
  • Other: Placebo

Study Design

Study TypeInterventional
Actual Enrollment226 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleA 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
Study Start DateAugust 24, 2020
Anticipated Primary Completion DateAugust 31, 2024
Anticipated Study Completion DateAugust 31, 2024

Groups and Cohorts

Group/ CohortIntervention/ Treatment
  • PRV-015 Low Dose
    • PRV-015 Low Dose, sterile solution for subcutaneous administration
  • Biological: PRV-015
    • Fully human monoclonal antibody against interleukin 15 (IL-15)
  • PRV-015 Medium Dose
    • PRV-015 Medium Dose, sterile solution for subcutaneous administration
  • Biological: PRV-015
    • Fully human monoclonal antibody against interleukin 15 (IL-15)
  • PRV-015 High Dose
    • PRV-015 High Dose, sterile solution for subcutaneous administration
  • Biological: PRV-015
    • Fully human monoclonal antibody against interleukin 15 (IL-15)
  • Placebo
    • Placebo, sterile solution for subcutaneous administration
  • Other: Placebo

    Outcome Measures

    Primary Outcome Measures

    1. 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 [24 weeks]
      Celiac Disease Patient-Reported Outcome (CeD PRO)

    Secondary Outcome Measures

    1. Effect of treatment with PRV-015 on other measures of disease activity [24 weeks]
      Intraepithelial lymphocyte (IEL) density
    2. Incidence of treatment-emergent adverse events (TEAEs) [28 weeks]
      Safety endpoint
    3. Serum trough concentrations of PRV-015 at scheduled visits [28 weeks]
      Characterize the pharmacokinetics (PK) of PRV-015
    4. Incidence of anti-PRV-015 antibodies [28 weeks]
      Immunogenicity endpoint

    Eligibility Criteria

    Ages Eligible for Study 18 Years to 70 Years (Adult, Older Adult)
    Sexes Eligible for Study All
    Accepts Healthy Volunteers No
    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

    Contacts and Locations

    Sponsors and Collaborators Provention Bio, a Sanofi Company
    Locations
    • Clinical Site | Los Angeles, California, United States, 90036
    • Clinical Site | Ventura, California, United States, 93003
    • Clinical Site | Denver, Colorado, United States, 80209
    • Clinical Site | Leesburg, Florida, United States, 34748
    • Clinical Site | Tampa, Florida, United States, 33613
    • Clinical Site | Winter Park, Florida, United States, 32789
    • Clinical Site | Chicago, Illinois, United States, 60637
    • Clinical Trial Site | Northbrook, Illinois, United States, 60062
    • Clinical Trial Site | Chevy Chase, Maryland, United States, 20815
    • Clinical Site | Boston, Massachusetts, United States, 02111
    • Clinical Site | Chesterfield, Michigan, United States, 48047
    • Clinical Site | Rochester, Minnesota, United States, 55905
    • Clinical Site | Morristown, New Jersey, United States, 07960
    • Clinical Trial Site | Brooklyn, New York, United States, 11235
    • Clinical Site | New Windsor, New York, United States, 12553
    • Clinical Trial Site | New York, New York, United States, 10032
    • Clinical Site | Raleigh, North Carolina, United States, 27607
    • Clinical Trial Site | Dublin, Ohio, United States, 43016
    • Clinical Site | Philadelphia, Pennsylvania, United States, 19104
    • Clinical Site | Uniontown, Pennsylvania, United States, 14401
    • Clinical Site | Warwick, Rhode Island, United States, 02886
    • Clinical Trial Site | North Charleston, South Carolina, United States, 29405
    • Clinical Site | Nashville, Tennessee, United States, 37212
    • Clinical Trial Site | Cedar Park, Texas, United States, 78613
    • Clinical Site | Garland, Texas, United States, 75044
    • Clinical Site | West Jordan, Utah, United States, 84088
    • Clinical Site | Bellevue, Washington, United States, 98004
    • Clinical Site | Tacoma, Washington, United States, 98405
    • Clinical Site | Hamilton, Ontario, Canada, L8S4K1
    • Clinical Site | Amsterdam, Netherlands, 1105 AZ
    • Clinical Site | Seville, Andalusia, Spain, 41013
    • Clinical Site | Leon, Castilla Y Leon, Spain, 24071
    • Clinical Trial Site | Terrassa, Catalunya, Spain, 082211
    • Clinical Trial Site | Girona, Spain, 17007
    • Clinical Trial Site | Lleida, Spain, 25196
    • Clinical Site | Madrid, Spain, 28034
    • Clinical Site | Madrid, Spain, 28041
    • Clinical Site | Madrid, Spain, 28222
    Investigators

      More Information

      Additional Relevant MeSH Terms

      • Celiac Disease
      • Malabsorption Syndromes
      • Intestinal Diseases
      • Gastrointestinal Diseases
      • Digestive System Diseases
      • Metabolic Diseases