GUSELKUMAB for Pouchitis|Chronic pouchitis|Relapsing or refractory pouchitis

Inclusion criteria

• {"criterion_text":"- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures"}
• {"criterion_text":"- Fluent in reading and speaking Dutch"}
• {"criterion_text":"- Participants must be at least 18 years of age and younger than 80 years of age at the time of signing the Informed Consent Form (ICF)"}
• {"criterion_text":"- Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner"}
• {"criterion_text":"- The subject agrees to take ciprofloxacin (500 mg twice daily) on Day 1 and through Week 4, regardless of the previous treatment and to stop any previous antibiotic therapy on Day 1 of the study. For patients who did previously not tolerate quinolone therapy, an alternative antibiotic therapy between Day 1 and Week 4 with metronidazole (500 mg three times a day) will be allowed. (Additional courses of antibiotics will be allowed, as needed, for flares after Week 16.)"}
• {"criterion_text":"- Participant with a proctocolectomy and IPAA for UC who developed chronic or recurrent pouchitis, defined as mPDAI score ≥5 and a minimum endoscopic subscore of 2 (outside the staple or suture line) with either: (a) ≥2 recurrent episodes within 1 year prior to the screening visit, each treated with ≥2 weeks of antibiotic or other prescription therapy, or (b) patients treated with maintenance antibiotic therapy taken continuously for four consecutive weeks before the screening visit and who are refractory to this antibiotic therapy, or (c) previously failure of another biologic therapy to treat chronic pouchitis."}

Exclusion criteria

• {"criterion_text":"- Crohn’s disease (CD), CD-related complications of the pouch (pouch fistula, pouch strictures, ulcerations in the pre-pouch ileum without pouchitis), irritable pouch syndrome (IPS), isolated or predominant cuffitis, infectious pouchitis, diverting ostomy or mechanical complications of the pouch"}
• {"criterion_text":"- Chronic hepatitis B virus (HBV)* infection, chronic hepatitis C virus (HCV)** infection, a known history of human immunodeficiency virus (HIV) infection (or is found to be seropositive at screening) or subject is immunodeficient (e.g., due to organtransplantation, history of common variable immunodeficiency, etc). * Subjects who are positive for hepatitis B virus surface antigen (HBsAg) will be excluded. For subjects who are negative for HBsAg but are positive for either surface antibodiesand/or core antibodies, HBV DNA polymerase chain reaction will be performed and if anytest result meets or exceeds detection sensitivity, the subject will be excluded.** If subject is HCV antibody positive, then a viral load test will be performed. If the viralload test is positive then the subject will be excluded."}
• {"criterion_text":"- Active severe infection (eg sepsis, cytomegalovirus, listeriosis or C. difficile)"}
• {"criterion_text":"- The subject has allergies to and/or contraindications for ciprofloxacin and metronidazole"}
• {"criterion_text":"- Participant has a history of malignancy or current malignancy, except for the following: adequately treated non-metastatic basal cell skin cancer, squamous cell skin cancer and cervical carcinoma in situ. Subjects with a remote history of malignancy (e.g., >10 years since completion of curative therapy without recurrence) will be considered based on the nature of the malignancy and the therapy"}
• {"criterion_text":"- Participant has serious hypersensitivity to guselkumab or to any of its excipients."}
• {"criterion_text":"- Any disorder or laboratory abnormalities which in the Investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol"}
• {"criterion_text":"- Any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial"}
• {"criterion_text":"- Female who is pregnant, breast-feeding or intends to become pregnant before, during, or within 12 weeks after the last dose of study drug; or intending to donate ova during such time period or is of child-bearing potential and not using an adequate, highly effective contraceptive or males who want to make their partner pregnant or intend to donate sperm during the course of this study or for 12 weeks after the last dose of study drug"}
• {"criterion_text":"- Participation in another interventional Trial with an investigational medicinal product (IMP) or device"}
• {"criterion_text":"- Previous treatment with an anti-IL12/23 or an anti-IL23 antibody"}
• {"criterion_text":"- Any investigational or approved biologic agent within 30 days of screening"}
• {"criterion_text":"- Nonbiologic investigational therapy or JAK inhibitors within 30 days prior to screening"}
• {"criterion_text":"- Active or untreated latent tuberculosis (TB). In case of a newly identified positive diagnostic TB test result (defined as a positive tuberculin skin test) , active TB has to be ruled out and appropriate treatment for latent TB has to be initiated for a minimum of 4 weeks prior to the first administration of study medication"}

Primary endpoints

• {"endpoint_text":"- the percentage of subjects with chronic or recurrent pouchitis achieving clinical remission (mPDAI score <5 and a reduction of overall score by ≥2 points from Baseline) after 16 weeks of treatment with guselkumab compared to 16 weeks of guselkumab and a dietary intervention","definition_or_measurement_approach":"Clinical remission defined as mPDAI score <5 and a reduction of overall score by ≥2 points from Baseline; measured as the percentage of subjects meeting this definition at Week 16 in each group."}

Secondary endpoints

• {"endpoint_text":"- The percentage of subjects achieving clinical remission (mPDAI score <5 and a reduction of overall score by ≥2 points from Baseline) after 48 weeks in both groups","definition_or_measurement_approach":"Clinical remission per mPDAI definition, measured as percentage at Week 48 in each group."}
• {"endpoint_text":"- The percentage of subjects achieving antibiotic free clinical remission by week 16 and 48","definition_or_measurement_approach":"Proportion of subjects in clinical remission without antibiotic use at Weeks 16 and 48."}
• {"endpoint_text":"- The percentage of subjects achieving partial response (reduction of mPDAI score by ≥2 points from Baseline) after 16 and 48 weeks in both groups","definition_or_measurement_approach":"Partial response defined as reduction in mPDAI score by ≥2 points from Baseline; measured as percentage at Weeks 16 and 48."}
• {"endpoint_text":"- Time to clinically relevant remission in both groups","definition_or_measurement_approach":"Time (e.g., days/weeks) from baseline to achieving clinical remission per mPDAI definition."}
• {"endpoint_text":"- Change in mPDAI endoscopic subscore at Week 16 and 48 compared to Baseline in both groups","definition_or_measurement_approach":"Change from Baseline in the mPDAI endoscopic subscore at Weeks 16 and 48."}
• {"endpoint_text":"- Change in mPDAI histologic subscore at Week 16 and 48 compared to Baseline in both groups","definition_or_measurement_approach":"Change from Baseline in the mPDAI histologic subscore at Weeks 16 and 48."}
• {"endpoint_text":"- Change in total mPDAI score at Week 16 and 48 compared to Baseline in both groups","definition_or_measurement_approach":"Change from Baseline in total mPDAI score at Weeks 16 and 48."}
• {"endpoint_text":"- The percentage of subjects achieving a (endoscopic proven) flare after initial response in both groups","definition_or_measurement_approach":"Proportion of subjects with endoscopically proven flare following an initial response during study follow-up."}
• {"endpoint_text":"- Changes in intestinal microbiota (metagenomic microbiota profiling) at Week 8, 16, 24, 32, 40 and 48 compared to Baseline in both groups","definition_or_measurement_approach":"Metagenomic microbiota profiling changes at specified timepoints compared to Baseline."}
• {"endpoint_text":"- Changes in IL-23p19 expression in the tissue at Week 16 and 48 compared to Baseline in both groups","definition_or_measurement_approach":"Tissue IL-23p19 expression measured at Weeks 16 and 48 vs Baseline."}
• {"endpoint_text":"- Association between IL-23p19 expression and response to therapy in both groups","definition_or_measurement_approach":"Correlation/association analyses between tissue IL-23p19 levels and clinical/endoscopic response."}
• {"endpoint_text":"- Compliance to the prescribed diet with food record and food frequency questionnaire in the group with the dietary intervention","definition_or_measurement_approach":"Dietary adherence assessed by food records and food frequency questionnaires in the diet intervention group."}
• {"endpoint_text":"- Safety of the prescribed diet in the group with the dietary intervention","definition_or_measurement_approach":"Assessment of adverse events and safety parameters related to the dietary intervention."}
• {"endpoint_text":"- Tolerability of the prescribed diet with questionnaire in the group with the dietary intervention","definition_or_measurement_approach":"Participant-reported tolerability via questionnaire in the diet group."}
• {"endpoint_text":"- Time to relapse of pouchitis symptoms and number of relapses in both groups","definition_or_measurement_approach":"Time from remission to relapse and count of relapse events during follow-up."}
• {"endpoint_text":"- Change in CRP at Week 8, 16, 24, 32, 40 and 48 compared to Baseline in both groups","definition_or_measurement_approach":"Change from Baseline in serum CRP at specified timepoints."}
• {"endpoint_text":"- Change in faecal calprotectin at Week 8, 16, 24, 32, 40 and 48 compared to Baseline in both groups","definition_or_measurement_approach":"Change from Baseline in faecal calprotectin at specified timepoints."}
• {"endpoint_text":"- Evolution of guselkumab serum levels and anti-guselkumab antibodies between Baseline and Week 8, 16, 24, 32, 40 and 48 in both groups","definition_or_measurement_approach":"Measurement of guselkumab trough/serum levels and anti-drug antibodies at listed timepoints."}
• {"endpoint_text":"- Correlation of guselkumab serum levels and anti-guselkumab antibodies with clinical, endoscopic and histological outcomes between Baseline and Week 8, 16, 24, 32, 40 and 48 in both groups","definition_or_measurement_approach":"Correlation analyses between PK/ADA measures and clinical/endoscopic/histological outcomes at specified timepoints."}

Belgium

Earliest CTIS Part Ii Submission Date

27-02-2026

Latest Decision Or Authorization Date

19-03-2026

Processing Time Days

20

Number Of Sites

1

Number Of Participants

20

Primary sponsor

Full Name

UZ Leuven

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Belgium

Third parties

• {"country":"United Kingdom","full_name":"Clinigen Healthcare Limited","duties_or_roles":"sponsorDuties codes: 14; 15 (labeling and shipping of the IMP)","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"Vlaams Instituut Voor Biotechnologie Flanders Institute For Biotechnology","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Laboratory/Research/Testing facility"}