Completed

PROACTIVEA 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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

PRV-015

+ Placebo

BiologicalOther
Who is being recruted

Celiac Disease+4

+ Digestive System Diseases

+ Gastrointestinal Diseases

From 18 to 70 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: August 2020
See protocol details

Summary

Principal SponsorProvention Bio, a Sanofi Company
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 24, 2020

Actual date on which the first participant was enrolled.

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.

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
NCT04424927
Principal SponsorProvention Bio, a Sanofi Company
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

388 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Celiac DiseaseDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesMalabsorption SyndromesMetabolic DiseasesNutritional and Metabolic Diseases

Criteria

6 inclusion criteria required to participate
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)
Show More Criteria
8 exclusion criteria prevent from participating
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

25% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
PRV-015 High Dose, sterile solution for subcutaneous administration

Group II

Experimental
PRV-015 Low Dose, sterile solution for subcutaneous administration

Group III

Experimental
PRV-015 Medium Dose, sterile solution for subcutaneous administration

Group IV

Placebo
Placebo, sterile solution for subcutaneous administration

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 38 locations

Suspended

Clinical Site

Los Angeles, United StatesOpen Clinical Site in Google Maps
Suspended

Clinical Site

Ventura, United States
Suspended

Clinical Site

Denver, United States
Suspended

Clinical Site

Leesburg, United States
Completed38 Study Centers
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 | PatLynk