The PROACTIVE Celiac Study is currently enrolling individuals diagnosed with biopsy-confirmed celiac disease who have been on a gluten-free diet for at least the last 12 months. This is a Phase 2 clinical trial testing the safety and effects of the investigational medication PRV-015. In combination with a gluten-free diet, PRV-015 aims to reduce symptoms and intestinal inflammation caused by accidental gluten exposure. You will not be asked to ingest gluten for this study.
Qualifying Participant Requirements:
- Be male or female, 18 to 70 years of age with biopsy-confirmed celiac disease
- Have been on a gluten-free diet for at least the last 12 months
- Still experiencing celiac disease symptoms
- Are willing and able to complete the scheduled study assessments, throughout a nine-month period during which you will continue to follow your usual gluten-free diet
Study Design Timing (Approximately 9 months):
- 28 days – Screening
- 7 months – Receive the study drug or placebo while the study doctor monitors your health. You will have one endoscopy with a biopsy at the beginning of the study and one at the end. Participants are given an electronic diary, similar to a smartphone, to track symptoms throughout the study.
- 1 month – Follow-up