CLF065 for Pouchitis
(OPUS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment called CLF065 for individuals with chronic pouchitis, a condition affecting the pouch created during ulcerative colitis surgery. Researchers aim to determine if weekly doses of CLF065 are safe and effective compared to a placebo. Participants who have experienced multiple pouchitis flare-ups treated with antibiotics or require ongoing antibiotic therapy may be suitable candidates. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group.
Do I have to stop taking my current medications for the trial?
Yes, you will need to stop taking antibiotics on Day 1 of the study and taper off any corticosteroids or budesonide starting by Week 4. The protocol does not specify other medications, so it's best to discuss with the study team.
Is there any evidence suggesting that CLF065 is likely to be safe for humans?
Research shows that CLF065, a medication under study for chronic pouchitis, targets specific areas in the body. Earlier studies tested its safety, and most participants tolerated CLF065 well. Some experienced side effects, but these were usually mild and manageable. The drug is currently in a mid-stage clinical trial, having already passed initial safety tests in humans. Researchers are now examining it further to ensure its safety and effectiveness. While more research is needed, current data suggests that CLF065 is relatively safe at the tested doses.12345
Why do researchers think this study treatment might be promising for pouchitis?
Most treatments for pouchitis involve antibiotics or biologics designed to reduce inflammation. But CLF065 stands out because it's administered subcutaneously, offering a potentially more convenient option for patients. Additionally, CLF065 may have a unique mechanism that targets specific pathways involved in pouchitis, which could result in better symptom control and fewer side effects. Researchers are particularly excited because this fresh approach might offer relief to those who haven't responded well to existing therapies.
What evidence suggests that CLF065 might be an effective treatment for pouchitis?
Research has shown that CLF065, which participants in this trial may receive, might help treat chronic pouchitis. Early results suggest this treatment aids in healing the gut and reducing swelling. Initial studies with patients who have similar conditions showed encouraging outcomes. These studies indicate that new treatments can lead to symptom improvement or remission. Evidence suggests that CLF065 could help patients with pouchitis manage their condition more effectively.12567
Are You a Good Fit for This Trial?
Adults aged 18-80 with chronic pouchitis, who've had at least three episodes in the past year or need ongoing antibiotics, can join this trial. They must understand the study and agree to stop current antibiotics on Day 1. Participants should have had an IPAA surgery for ulcerative colitis over a year ago and be willing to taper off steroids. Men and women must use contraception.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive CLF065 or placebo as a subcutaneous injection once a week for 13 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- CLF065
Trial Overview
The trial is testing CLF065 against a placebo in adults with chronic pouchitis. It aims to check if weekly doses of CLF065 are safe, doable, and effective compared to no active treatment (placebo).
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
CLF065 subcutaneous weekly
Matching placebo subcutaneous weekly
Find a Clinic Near You
Who Is Running the Clinical Trial?
Calibr, a division of Scripps Research
Lead Sponsor
Citations
Study Details | NCT07226050 | CLF065 for Chronic Pouchitis
This clinical trial is to evaluate investigational compound CLF065 as a treatment for adult patients with chronic pouchitis. The goals are to ...
2.
bachrachfamilyfoundation.org
bachrachfamilyfoundation.org/our-grants/testing-the-effectiveness-of-a-new-therapy-for-chronic-pouchitis/Testing the Effectiveness of a New Regenerative, Anti ...
This randomized, placebo-controlled Phase 2 trial investigates whether CLF065 can safely and effectively treat chronic pouchitis using clinical, ...
CLF-065 - Drug Targets, Indications, Patents
A Randomized, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of CLF065 in the Treatment of Chronic Pouchitis. 100 Clinical Results ...
Pouchitis unveiled: exploring clinical features, diagnosis, and ...
Nevertheless, remission rates among patients with UC treated with new therapeutic agents remain modest, typically ranging from 20% to 30%, ...
Incidence and Long-Term Outcomes of Pouchitis in ...
Results: Among 233 patients, 118 (50.6%) experienced 519 pouchitis events. 437 (84.2%) had intermittent pouchitis, 60 (11.6%) had chronic antibiotic-dependent ...
CLF 065 - AdisInsight
CLF 065 is a long-acting, glucagon-like peptide-2 receptor (GLP2R) agonist being developed by California Institute for Biomedical Research ...
What's next for IBD care: Insights from a surgeon-scientist
Episode topics: Inflammatory bowel disease; Crohn's disease; ulcerative colitis; colon cancer; pouchitis; IBD phase 2 clinical trial; CLF065; colorectal surgery.
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