PRV-015 in Gluten-free Diet Non-responsive Celiac Disease
PROACTIVE
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
3 other identifiers
interventional
388
4 countries
38
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2020
Typical duration for phase_2
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2020
CompletedFirst Posted
Study publicly available on registry
June 11, 2020
CompletedStudy Start
First participant enrolled
August 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2024
CompletedResults Posted
Study results publicly available
October 20, 2025
CompletedOctober 20, 2025
October 1, 2025
3.9 years
May 28, 2020
July 24, 2025
October 2, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Absolute Change From Baseline in Celiac Disease Patient-Reported Outcome Abdominal Symptoms Domain Score Through Week 24
The CeD PRO questionnaire was captured daily in the eDiary. The questionnaire included 9 items: abdominal cramping, abdominal pain, bloating, gas, diarrhea, loose stool, nausea, headache and tiredness. Participants were asked to rate their symptom severity on an 11-point scale and scores range from 0 (not experiencing the symptom) to 10 (the worst possible symptom experience). Abdominal Symptoms domain included abdominal cramping, abdominal pain, bloating and gas. Total score for abdominal symptoms domain range from 0 to 40. Higher scores indicated worse outcome. Baseline abdominal symptoms domain score was defined as the average of the daily scores for the last week of the placebo run-in period.
Baseline (average of Day -7 to Day -1) up to Week 24
Secondary Outcomes (10)
Absolute Change From Baseline in Celiac Disease Patient-Reported Outcome Diarrhea and Loose Stool Domain Score Through Week 24
Baseline (average of Day -7 to Day -1) up to Week 24
Absolute Change From Baseline in Celiac Disease Patient-Reported Outcome Total Gastrointestinal (GI) Score Through Week 24
Baseline (average of Day -7 to Day -1) up to Week 24
Absolute Change From Baseline in Intraepithelial Lymphocyte (IEL) Density at Week 24
Baseline to Week 24
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs) and Treatment-Emergent Adverse Events of Special Interest (AESIs)
From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days
Number of Participants With Potentially Clinically Important Changes in Hematology
From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days
- +5 more secondary outcomes
Study Arms (4)
PRV-015 Low Dose
EXPERIMENTALPRV-015 Low Dose, sterile solution for subcutaneous administration
PRV-015 Medium Dose
EXPERIMENTALPRV-015 Medium Dose, sterile solution for subcutaneous administration
PRV-015 High Dose
EXPERIMENTALPRV-015 High Dose, sterile solution for subcutaneous administration
Placebo
PLACEBO COMPARATORPlacebo, sterile solution for subcutaneous administration
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (38)
Clinical Site
Los Angeles, California, 90036, United States
Clinical Site
Ventura, California, 93003, United States
Clinical Site
Denver, Colorado, 80209, United States
Clinical Site
Leesburg, Florida, 34748, United States
Clinical Site
Tampa, Florida, 33613, United States
Clinical Site
Winter Park, Florida, 32789, United States
Clinical Site
Chicago, Illinois, 60637, United States
Clinical Trial Site
Northbrook, Illinois, 60062, United States
Clinical Trial Site
Chevy Chase, Maryland, 20815, United States
Clinical Site
Boston, Massachusetts, 02111, United States
Clinical Site
Chesterfield, Michigan, 48047, United States
Clinical Site
Rochester, Minnesota, 55905, United States
Clinical Site
Morristown, New Jersey, 07960, United States
Clinical Trial Site
Brooklyn, New York, 11235, United States
Clinical Site
New Windsor, New York, 12553, United States
Clinical Trial Site
New York, New York, 10032, United States
Clinical Site
Raleigh, North Carolina, 27607, United States
Clinical Trial Site
Dublin, Ohio, 43016, United States
Clinical Site
Philadelphia, Pennsylvania, 19104, United States
Clinical Site
Uniontown, Pennsylvania, 14401, United States
Clinical Site
Warwick, Rhode Island, 02886, United States
Clinical Trial Site
North Charleston, South Carolina, 29405, United States
Clinical Site
Nashville, Tennessee, 37212, United States
Clinical Trial Site
Cedar Park, Texas, 78613, United States
Clinical Site
Garland, Texas, 75044, United States
Clinical Site
West Jordan, Utah, 84088, United States
Clinical Site
Bellevue, Washington, 98004, United States
Clinical Site
Tacoma, Washington, 98405, United States
Clinical Site
Hamilton, Ontario, L8S4K1, Canada
Clinical Site
Amsterdam, 1105 AZ, Netherlands
Clinical Site
Seville, Andalusia, 41013, Spain
Clinical Site
León, Castille and León, 24071, Spain
Clinical Trial Site
Terrassa, Catalonia, 082211, Spain
Clinical Trial Site
Girona, 17007, Spain
Clinical Trial Site
Lleida, 25196, Spain
Clinical Site
Madrid, 28034, Spain
Clinical Site
Madrid, 28041, Spain
Clinical Site
Madrid, 28222, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Trial Transparency Team
- Organization
- Sanofi aventis recherche & développement
Study Officials
- STUDY DIRECTOR
Clinical Sciences & Operations
Sanofi
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2020
First Posted
June 11, 2020
Study Start
August 24, 2020
Primary Completion
July 30, 2024
Study Completion
July 30, 2024
Last Updated
October 20, 2025
Results First Posted
October 20, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
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