Phase 2
N=388
PRV-015 in Gluten-free Diet Non-responsive Celiac Disease
Celiac Disease
Bottom Line
View on ClinicalTrials.gov: NCT04424927 ↗Enrolled (actual)
388
Serious AEs
0.7%
Results posted
Oct 2025
Primary outcome: Primary: Absolute Change From Baseline in Celiac Disease Patient-Reported Outcome Abdominal Symptoms Domain Score Through Week 24 — -1.32; -1.28; -1.21; -1.28 score on a scale — p=0.8543
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- PRV-015 (Biological); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Provention Bio, a Sanofi Company
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Change From Baseline in Celiac Disease Patient-Reported Outcome Abdominal Symptoms Domain Score Through Week 24 |
-1.32; -1.28; -1.21; -1.28 | 0.8543 |
| SECONDARY Absolute Change From Baseline in Celiac Disease Patient-Reported Outcome Diarrhea and Loose Stool Domain Score Through Week 24 |
-0.77; -0.66; -1.02; -1.07 | 0.6757 |
| SECONDARY Absolute Change From Baseline in Celiac Disease Patient-Reported Outcome Total Gastrointestinal (GI) Score Through Week 24 |
-0.89; -0.84; -0.88; -1.05 | 0.7829 |
| SECONDARY Absolute Change From Baseline in Intraepithelial Lymphocyte (IEL) Density at Week 24 |
-0.39; 1.54; -4.11; -4.53 | 0.4397 |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs) and Treatment-Emergent Adverse Events of Special Interest (AESIs) |
34; 34; 36; 29; 1; 1 | — |
| SECONDARY Number of Participants With Potentially Clinically Important Changes in Hematology |
0; 0; 1; 2; 2; 1 | — |
| SECONDARY Number of Participants With Potentially Clinically Important Changes in Clinical Chemistry |
1; 4; 1; 2; 1; 2 | — |
| SECONDARY Number of Participants With Potentially Clinically Important Changes in Urinalysis |
54; 51; 55; 47; 3; 4 | — |
| SECONDARY Number of Participants With Potentially Clinically Important Changes in Vital Signs and Body Weight |
5; 2; 6; 1; 2; 1 | — |
| SECONDARY Number of Participants With Anti-PRV-015 Antibodies |
3; 8; 7; 8; 9; 9 | — |
| SECONDARY Minimum Serum Concentrations (Cmin) of PRV-015 |
8778; 27820; 66400; 15140; 51190; 98420 | — |
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).
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
Data sourced from ClinicalTrials.gov (NCT04424927). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.