Guselkumab intervention and diet evaluation for pouchitis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

UZ Leuven

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18], Diseases [C] - Digestive System Diseases [C06], Diseases [C] - Immune System Diseases [C20]

Trial duration

21 Apr 2026 → ongoing

Decision date (initial)

2026-03-19

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

J&J Innovative Medicine

External identifiers

EU CT number

2025-521683-35-00

ClinicalTrials.gov

NCT06916390

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Safety

To describe the efficacy of guselkumab and the efficacy of the combination of guselkumab and a dietary intervention in improving the symptoms of patients with relapsing or refractory pouchitis.

Secondary objectives 3

1. To describe the efficacy of guselkumab and the efficacy of the combination of guselkumab and a dietary intervention in improving the endoscopic activity of patients with relapsing or refractory pouchitis
2. To describe the safety of guselkumab or and the safety of the combination of guselkumab and a dietary intervention in patients with relapsing or refractory pouchitis
3. To describe compliance to and tolerability of the prescribed dietary intervention.

Conditions and MedDRA coding

Pouchitis

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
2. Fluent in reading and speaking Dutch
3. 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)
4. 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
5. 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.)
6. 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 14

1. 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
2. Any disorder or laboratory abnormalities which in the Investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol
3. Any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial
4. 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
5. Participation in another interventional Trial with an investigational medicinal product (IMP) or device
6. Previous treatment with an anti-IL12/23 or an anti-IL23 antibody
7. Any investigational or approved biologic agent within 30 days of screening
8. Nonbiologic investigational therapy or JAK inhibitors within 30 days prior to screening
9. 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
10. 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.
11. Active severe infection (eg sepsis, cytomegalovirus, listeriosis or C. difficile)
12. The subject has allergies to and/or contraindications for ciprofloxacin and metronidazole
13. 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
14. Participant has serious hypersensitivity to guselkumab or to any of its excipients.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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

Secondary endpoints 19

1. 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
2. The percentage of subjects achieving antibiotic free clinical remission by week 16 and 48
3. The percentage of subjects achieving partial response (reduction of mPDAI score by ≥2 points from Baseline) after 16 and 48 weeks in both groups
4. Time to clinically relevant remission in both groups
5. Change in mPDAI endoscopic subscore at Week 16 and 48 compared to Baseline in both groups
6. Change in mPDAI histologic subscore at Week 16 and 48 compared to Baseline in both groups
7. Change in total mPDAI score at Week 16 and 48 compared to Baseline in both groups
8. The percentage of subjects achieving a (endoscopic proven) flare after initial response in both groups
9. Changes in intestinal microbiota (metagenomic microbiota profiling) at Week 8, 16, 24, 32, 40 and 48 compared to Baseline in both groups
10. Changes in IL-23p19 expression in the tissue at Week 16 and 48 compared to Baseline in both groups
11. Association between IL-23p19 expression and response to therapy in both groups
12. Compliance to the prescribed diet with food record and food frequency questionnaire in the group with the dietary intervention
13. Safety of the prescribed diet in the group with the dietary intervention
14. Tolerability of the prescribed diet with questionnaire in the group with the dietary intervention
15. Time to relapse of pouchitis symptoms and number of relapses in both groups
16. Change in CRP at Week 8, 16, 24, 32, 40 and 48 compared to Baseline in both groups
17. Change in faecal calprotectin at Week 8, 16, 24, 32 and 48 compared to Baseline in both groups
18. Evolution of guselkumab serum levels and anti-guselkumab antibodies between Baseline and Week 8, 16, 24, 32, 40 and 48 in both groups
19. 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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

UZ Leuven

Sponsor organisation

UZ Leuven

Address

Herestraat 49

City

Leuven

Postcode

3000

Country

Belgium

Scientific contact point

Organisation

UZ Leuven

Contact name

joao Sabino

Public contact point

Organisation

UZ Leuven

Contact name

joao Sabino

Third parties 2

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications