A Randomized, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of CLF065 in the Treatment of Chronic Pouchitis (OPUS Trial)
General Information:
This research study is being done to learn more about CLF065 as a potential treatment for chronic pouchitis. The purpose is to learn about the safety of CLF065, and how well a weekly dose of CLF065 treats chronic pouchitis.
Eligibility:
You may be eligible to participate if:
- You are between 18 and 80 years old.
- You are willing to sign a consent form before any study procedures begin.
About your condition:
- You have pouchitis (inflammation of the pouch created during surgery for ulcerative colitis) that has come back multiple times or has been ongoing.
- This includes:
- Having more than 3 episodes in the past year that required antibiotics or other prescription treatment for at least 2 weeks, or needing to take antibiotics continuously for more than 4 weeks.
- Having more than 3 episodes in the past year that required antibiotics or other prescription treatment for at least 2 weeks, or needing to take antibiotics continuously for more than 4 weeks.
- This includes:
Your medical history:
- You had surgery for ulcerative colitis (removal of the colon and creation of a pouch, called IPAA) at least 1 year ago.
Medication requirements:
- You are willing to stop antibiotics before starting the study (with guidance from the study team).
- If you are taking steroids (such as prednisone or budesonide), you are willing to gradually reduce the dose.
- Willing to maintain effective contraception
You can’t be in the study if:
- You are unable to understand the study or give consent.
- You have recently taken part in another clinical trial or are taking certain advanced medications (such as biologics).
Related to your condition:
- You have a different diagnosis (such as Crohn’s disease affecting areas outside the pouch).
- Your symptoms are due to another condition (such as irritable pouch syndrome or cuffitis).
- You have structural or surgical issues with your pouch, or surgery is planned.
- You currently have a stoma (an opening on the abdomen for waste).
Medications and treatments:
- You have recently taken certain immune-suppressing medications.
- You are currently taking NSAIDs (like ibuprofen).
- You have had a fecal transplant in the past 12 weeks.
Medical history:
- You have had certain cancers within the past 2 years (with some exceptions for early-stage or localized cancers).
- You have certain liver conditions (such as primary sclerosing cholangitis).
- You have active infections or complications in the pelvic area.
- You are pregnant or breastfeeding or not using effective birth control (if applicable).
- You have a medical condition or lab abnormality that, in the study doctor’s opinion, would make participation unsafe.
Study Details:
Study description/explanation of participation:
If you join this study, you will have visits regularly for about 6 months (up to 16 visits) and they will be a mix of clinic (monthly) and at home visits for administering the study drug (weekly). Clinic visits will include physical exams, questions about your health, medications and how you feel. There will also be sample collection of blood and stool about every 4 weeks. You will have endoscopy procedures at the beginning and again later in the study. You will also be asked to complete surveys about how your disease affects your health and quality of life and to complete a daily bowel diary card.
Description of treatment or intervention (mechanism of action):
You will be randomized to receive either the study drug (CLF065) or a placebo (inactive drug). CLF065 is a long-acting investigational product based on a natural hormone, GLP-2. In people with pouchitis, inflammation and damage to the lining of the ileal pouch impair healing and contribute to chronic symptoms such as increased stool frequency, urgency, and abdominal discomfort. By improving intestinal healing, CLF065 may reduce inflammation and improve symptoms associated with pouchitis.
Patient Participation Requirements:
If you join this study, your responsibilities as a study participant include the following:
- Since some of your visits are conducted at home, you must be able to store the study drug in a freezer and be able to prepare and administer the study drug yourself.
- You must have access to a video device (phone, tablet, or computer) and be able to connect to the site staff.
- Some medications are allowed during the study; some may need to have the dose reduced or stopped before you start taking the study drug.
- You must provide truthful and informative responses for assessments and questionnaires.
Possible risks and side effects:
You may experience side effects from the study drug (such as headache, dizziness, constipation / bloating, nausea, vomiting, injection site reactions or back pain, and rare but serious allergic reactions).
Study procedures (like pouchoscopy, blood draws, and injections) may cause discomfort, bleeding, or infection, and there are small risks related to privacy with video calls.