OPUS-Pouch Study
Overview
This Phase 2 clinical trial is designed to evaluate the safety and effectiveness of CLF065 in the treatment of chronic pouchitis. The OPUS-Pouch Study is randomized and placebo-controlled, meaning some participants receive CLF065 while others receive a placebo.
This J-pouch surgery clinical trial is enrolling individuals who continue to experience pouchitis symptoms despite prior treatments and may benefit from a new investigational product.
Participants May Qualify If They Are:
- 18 to 80 years old
- Had ileal pouch-anal anastomosis (IPAA), also known as J-pouch surgery at least 1 year ago
- Had 3+ pouchitis episodes in the past year, or are taking long-term antibiotics
- Able to stop antibiotics on Day 1 of the clinical trial
- Willing to taper off steroids under supervision
What to Expect in the OPUS-Pouch Study
- Weekly injections (CLF065 or placebo*) for 13 weeks
- Two follow-up visits: Week 14 and Week 24
- Lab tests, a bowel symptom diary, and regular safety monitoring
- Dedicated support from the clinical trial team
*A placebo looks like the investigational product but doesn’t contain any active ingredients.
Benefits of Participation
- May have access to an investigational product
- Study-related care provided at no cost
- Opportunity to support future chronic pouchitis research
- Opportunity to help future patients with pouchitis