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

• ClinicalTrials.gov Identifier: NCT04424927
• Recruitment Status: Active, not recruiting
• First Posted: June 11, 2020
• Last Update Posted: April 16, 2024
• Sponsor: Provention Bio, a Sanofi Company
• Information provided by (Responsible Party): Sanofi ( Provention Bio, a Sanofi Company )

Tracking Information

• First Submitted Date: May 28, 2020
• First Posted Date: June 11, 2020
• Last Update Posted Date: April 16, 2024
• Actual Study Start Date: August 24, 2020
• Estimated Primary Completion Date: August 31, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 5, 2020)

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 [ Time Frame: 24 weeks ]

Celiac Disease Patient-Reported Outcome (CeD PRO)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 5, 2020)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: PRV-015 in Gluten-free Diet Non-responsive Celiac Disease
• 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
• Brief 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).

Detailed 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.

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Celiac Disease

Intervention

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

Study Arms

• Experimental: PRV-015 Low Dose
  PRV-015 Low Dose, sterile solution for subcutaneous administration
  Intervention: Biological: PRV-015
• Experimental: PRV-015 Medium Dose
  PRV-015 Medium Dose, sterile solution for subcutaneous administration
  Intervention: Biological: PRV-015
• Experimental: PRV-015 High Dose
  PRV-015 High Dose, sterile solution for subcutaneous administration
  Intervention: Biological: PRV-015
• Placebo Comparator: Placebo
  Placebo, sterile solution for subcutaneous administration
  Intervention: Other: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: February 20, 2024): 226
• Original Estimated Enrollment (submitted: June 5, 2020): 220
• Estimated Study Completion Date: August 31, 2024
• Estimated Primary Completion Date: August 31, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, Netherlands, Spain, United States

Administrative Information

• NCT Number: NCT04424927
• Other Study ID Numbers: PRV-015-002b
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

• Current Responsible Party: Sanofi ( Provention Bio, a Sanofi Company )
• Original Responsible Party: Provention Bio, Inc.
• Current Study Sponsor: Provention Bio, a Sanofi Company
• Original Study Sponsor: Provention Bio, Inc.
• Collaborators: Not Provided

Investigators

• Study Director: Clinical Sciences & Operations; Sanofi

• PRS Account: Sanofi
• Verification Date: April 2024