Overview

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