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NCT04424927 · ClinicalTrials.gov registry record · Phase 2
PRV-015 in Gluten-free Diet Non-responsive Celiac Disease
A Phase 2 study, sponsored by Provention Bio, a Sanofi Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 388
- Enrollment target
NCT04424927: Completed Phase 2 study, sponsored by Provention Bio, a Sanofi Company.
NCT04424927 is a Phase 2 study that has completed, run by Provention Bio, a Sanofi Company. The registered enrollment target is 388 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (192% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04424927, a Phase 2 study, has completed, sponsored by Provention Bio, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 388 participants
- Enrollment target
Study 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).
Primary Outcome
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 sympt
Interventions
- OTHER Placebo
- BIOLOGICAL PRV-015
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 388 participants |
| Start Date | 2020-08-24 |
| Est. Completion | 2024-07-30 |
| Phase | Phase 2 |
What the finished NCT04424927 record still lists
NCT04424927 is an interventional study that assigns participants to a tested intervention. The registered 388 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (192% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04424927 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04424927 about?
NCT04424927 is a clinical study titled "PRV-015 in Gluten-free Diet Non-responsive Celiac Disease". 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).
What is the current status of trial NCT04424927?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 388 participants. The study started on 2020-08-24. Estimated completion is 2024-07-30.
What interventions are being tested in trial NCT04424927?
The interventions under investigation include: Placebo (OTHER), PRV-015 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04424927?
This trial is sponsored by Provention Bio, a Sanofi Company, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04424927's enrollment target sits among peer trials
388 109th of 2000 higher than 1,892 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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