PouchitisPhase 2OPUSNCT07226050
CLF065 for Chronic Pouchitis
A Phase 2 study testing CLF065 in people with Pouchitis, run by Calibr, a division of Scripps Research at 3 sites in United States.
Trial summary
This clinical trial is to evaluate investigational compound CLF065 as a treatment for adult patients with chronic pouchitis. The goals are to establish the safety, feasibility and efficacy of weekly dosing of long acting CLF065 versus placebo. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pouchitis
- What is being tested?
- CLF065
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jun 2026to Jun 2027
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult subjects aged 18-80 years, inclusive.
- In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements.
- The subject signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
- Diagnosis of pouchitis that is recurrent, defined by mPDAI score of ≥ 5 assessed as the average from 3 days immediately prior to Baseline endoscopy, and a minimum endoscopic subscore of 2 (outside the staple or suture line) with either:
- ≥ 3 episodes of pouchitis within 1 year of Screening visit, each treated with antibiotic or other prescription therapy for at least 2 weeks OR Requiring maintenance antibiotic therapy taken continuously for ≥ 4 weeks immediately prior to the Baseline endoscopic visit
- The patient has a history of proctocolectomy and construction of an IPAA for ulcerative colitis at least one year before the Screening Visit.
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- The patient agrees that antibiotic therapy will be managed per investigator discretion in accordance with standard of care.
- Patient agrees to taper any corticosteroid or budesonide starting by Week 4 of the study per guidelines below.
- A male subject who is nonsterilized and sexually activity with a female partner of childbearing potential agrees to use a barrier method of contraception (e.g., condom with spermicide) from signing informed consent throughout the duration of the study.
- Women of childbearing potential must not have a positive pregnancy test at the Screening Visit and must have a negative pregnancy test at the baseline visit prior to study drug dosing. Note: subjects with borderline serum pregnancy test at Screening must have an absence of clinical suspicion of pregnancy or other pathological cause of a borderline result and a serum pregnancy test ≥ 3 days later to document continued lack of a positive result.
- If female, the patient must be either postmenopausal, OR permanently surgically sterile or for women of childbearing potential practicing at least one protocol specified method of birth control, that is effective from baseline visit through at least 30 days after the last dose of study drug.
- Patient is judged to be in good health as determined by the principal investigator based upon the results of medical history, laboratory profile, physical examination
Who cannot join
- Inability to give informed consent.
- The patient has received any investigational product or approved biologic or biosimilar agent within 60 days or 5 half-lives of randomization (whichever is longer)
- No prior exposure to CLF065
- Chronic pouchitis specific:
- The patient has received 6-MP, Azathioprine or methotrexate within 4 weeks of the Randomization Visit
- Crohn's disease with disease proximal to the pouch inlet confirmed on prior imaging or endoscopy
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- Irritable pouch syndrome
- Predominate or isolated cuffitis
- Mechanical complications of the pouch
- Diverting stoma
- Planned surgical intervention of the pouch
- History of malignancy including melanoma (with the exception of localized skin cancers, carcinoma in situ of the cervix and localized prostate cancer) within 2 years of study enrollment
- Pregnant or breast feeding.
- Lack of effective contraception in women of childbearing potential.
- Ongoing treatment with NSAID (nonsteroidal anti-inflammatory drug).
- Anastomotic or anal canal stricture which precludes endoscopic evaluation.
- The patient has evidence of pelvic sepsis and pelvic penetrating fistulizing disease on clinical exam.
- Known diagnosis of primary sclerosing cholangitis.
- Fecal transplantation within 12 weeks prior to study enrollment.
- History of clinically significant medical conditions or any other reason that in the opinion of the investigator would interfere with the subject's participation in this study or would make the subject an unsuitable candidate to receive study drug or would put the subject at risk by participating in the study.
- The patient has any of the following laboratory abnormalities during the Screening Period:
- Hemoglobin level <8 g/dL
- White blood cell (WBC) count <3 x 109/L
- Platelet count <100 x 109/L or >1200 x 109/L
- Serum creatinine >2 x ULN
- Alanine aminotransferase (ALT) or aspartate aminiotransferase (AST) >2x ULN
- Alkaline phosphatase >2 x ULN
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Scripps Health
La Jolla, California, 92037
Phillip Fleshner, M.D. Inc
Los Angeles, California, 90048
Lenox Hill Hospital
New York, New York, 10075
About this study
Official title: A Randomized, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of CLF065 in the Treatment of Chronic Pouchitis
This clinical trial is to evaluate investigational compound CLF065 as a treatment for adult patients with chronic pouchitis. The goals are to establish the safety, feasibility and efficacy of weekly dosing of long acting CLF065 versus placebo.
Read the detailed description
CLF065 is a long acting Glucagon-like peptide-2 (GLP-2). Participants will receive CLF065 or a placebo as a subcutaneous injection (just under the skin) once a week for the first 13 weeks of a 24-week total study period. Some weeks the subcutaneous injection will be given at the study site and some weeks it will be self-administered. Participants will be asked to complete a daily bowel diary card in addition to questionnaires about living with chronic pouchitis.
- Conditions
- Pouchitis
- Being tested
- CLF065, Placebo
- Keywords
- chronic pouchitis
- Medical subject headings
- Pouchitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLF065Drug
will receive investigational product every week for 13 weeks as a sub-cutaneous injection
PlaceboDrug
CLF065 matching placebo
| Study group | Role | What they receive |
|---|---|---|
| CLF065 | Experimental | CLF065 subcutaneous weekly Receives: Drug: CLF065 |
| Placebo | Placebo comparator | Matching placebo subcutaneous weekly Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Pouchitis Disease Activity Index (PDAI) and Modified PDAI
The PDAI contains three separate 6-point domain scales based on clinical symptoms, endoscopic inflammation, and acute histologic inflammation. On the scale, 0 = normal and 6 = severe inflammation with an overall possible score of 18 points. Higher scores indicate more severe disease. Patients with a total PDAI score >7 points are classed as having pouchitis. The clinical symptom scale assesses stool frequency, rectal bleeding, fecal urgency, and fever. The endoscopic inflammation scale evaluates edema, granularity, friability, loss of vascular pattern, mucus exudates, and ulceration. The modified PDAI is without the histologic findings.
Measured: Baseline, Week 14, Week 24
Secondary outcomes (2)
Change from baseline in Simple Endoscopic Score for Crohn's disease (SES-CD)
The Simple Endoscopic Score for Crohn's Disease (SES-CD) is a validated tool used to evaluate endoscopic disease activity in Crohn's disease. It assesses four key parameters: (1) the size of ulcers, (2) the ulcerated surface, (3) the affected surface, and (4) the presence of stenosis across five bowel segments (ileum, right colon, transverse colon, left colon, and rectum). Each parameter is scored from 0 to 3 for a total score range of 0-56. Higher scores indicate more severe endoscopic disease activity.
Measured: Baseline and Week 14 and Week 24
Robarts Histopathology Index (RHI)
For histologic assessment, biopsies will be collected and sent for independent central review. Histologic inflammation will be assessed using the Robarts Histopathology Index (RHI) for chronic pouchitis. Each component is scored 0 - 3 and the total possible score is 33, with higher scores reflecting greater histologic disease activity.
Measured: Baseline and Week 14 and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2025
- Study start1 Jun 2026
- Primary completionMar 2027 (estimated)
- Study completionJun 2027 (estimated)
Why it stopped: Clinical Hold
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PouchitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Calibr, a division of Scripps Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07226050
- Sponsor's protocol ID
- CBR-CLF065-4001
- Acronym
- OPUS
- Status last verified
- Jul 2026
- First submitted
- 6 Nov 2025
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of CLF065 in the Treatment of Chronic Pouchitis
- ClinicalTrials.gov ID
- NCT07226050
- Acronym / sponsor ID
- OPUS / CBR-CLF065-4001
- Conditions
- Pouchitis
- Keywords
- chronic pouchitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Clinical Hold
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Calibr, a division of Scripps ResearchUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 10 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial is to evaluate investigational compound CLF065 as a treatment for adult patients with chronic pouchitis. The goals are to establish the safety, feasibility and efficacy of weekly dosing of long acting CLF065 versus placebo.
Detailed description
CLF065 is a long acting Glucagon-like peptide-2 (GLP-2). Participants will receive CLF065 or a placebo as a subcutaneous injection (just under the skin) once a week for the first 13 weeks of a 24-week total study period. Some weeks the subcutaneous injection will be given at the study site and some weeks it will be self-administered. Participants will be asked to complete a daily bowel diary card in addition to questionnaires about living with chronic pouchitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CLF065 | Experimental | Drug: CLF065CLF065 subcutaneous weekly |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo subcutaneous weekly |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Adult subjects aged 18-80 years, inclusive.
- In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements.
- The subject signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
- Diagnosis of pouchitis that is recurrent, defined by mPDAI score of ≥ 5 assessed as the average from 3 days immediately prior to Baseline endoscopy, and a minimum endoscopic subscore of 2 (outside the staple or suture line) with either:
- ≥ 3 episodes of pouchitis within 1 year of Screening visit, each treated with antibiotic or other prescription therapy for at least 2 weeks OR Requiring maintenance antibiotic therapy taken continuously for ≥ 4 weeks immediately prior to the Baseline endoscopic visit
Key exclusion criteria (27 listed)
- Inability to give informed consent.
- The patient has received any investigational product or approved biologic or biosimilar agent within 60 days or 5 half-lives of randomization (whichever is longer)
- No prior exposure to CLF065
- Chronic pouchitis specific:
- History of malignancy including melanoma (with the exception of localized skin cancers, carcinoma in situ of the cervix and localized prostate cancer) within 2 years of study enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CLF065will receive investigational product every week for 13 weeks as a sub-cutaneous injection | Drug | CLF065 |
| PlaceboCLF065 matching placebo | Drug | Placebo |
Primary outcome
Change from baseline in Pouchitis Disease Activity Index (PDAI) and Modified PDAI
Time frame: Baseline, Week 14, Week 24
The PDAI contains three separate 6-point domain scales based on clinical symptoms, endoscopic inflammation, and acute histologic inflammation. On the scale, 0 = normal and 6 = severe inflammation with an overall possible score of 18 points. Higher scores indicate more severe disease. Patients with a total PDAI score >7 points are classed as having pouchitis. The clinical symptom scale assesses stool frequency, rectal bleeding, fecal urgency, and fever. The endoscopic inflammation scale evaluates edema, granularity, friability, loss of vascular pattern, mucus exudates, and ulceration. The modified PDAI is without the histologic findings.
2 secondary outcomes
Change from baseline in Simple Endoscopic Score for Crohn's disease (SES-CD)
Time frame: Baseline and Week 14 and Week 24
Robarts Histopathology Index (RHI)
Time frame: Baseline and Week 14 and Week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CLF065 in people with Pouchitis, run by Calibr, a division of Scripps Research at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Pouchitis Disease Activity Index (PDAI) and Modified PDAI (time frame: Baseline, Week 14, Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.