Stelara fOr ChRonic AntibioTic rEfractory pouchitiS

• Status: Recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy and safety of ustekinumab in the treatment of chronic antibiotic refractory and relapsing pouchitis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universitaire Ziekenhuizen Leuven
• Collaborator: Janssen, LP
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Ustekinumab

Criteria

Inclusion Criteria:

• The subject has a history of ileal pouch-anal anastomosis (IPAA) for ulcerative colitis (UC)

• The subject has pouchitis that is (a) relapsing or (b) chronic antibiotic refractory, defined by an mPDAI score ≥5 assessed as the average from 3 days immediately prior to the baseline endoscopy visit and a minimum endoscopic subscore of 2 (outside the staple or suture line) with either (a) ≥3 recurrent episodes within the last year, each treated with ≥2 weeks of antibiotic or other prescription therapy, or (b) requiring maintenance antibiotic therapy taken continuously for ≥4 weeks immediately prior to the baseline endoscopy visit

Exclusion Criteria:

• 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, infectiouw pouchitis, diverting ostomy or mechanical complications of the pouch

• Previous treatment with an anti-IL12/23 or an anti-IL23 antibody

• Any investigational or approved biologic agent within 30 days of baseline

• Nonbiologic investigational therapy or tofacitinib within 30 days prior to baseline

• Active or untreated latent tuberculosis (TB)

• 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

• Active severe infection (e.g. sepsis, cytomegalovirus, listeriosis or C. difficile)

• History of malignancy or current malignancy