Status:
COMPLETED
Stelara fOr ChRonic AntibioTic rEfractory pouchitiS
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsors:
Janssen Pharmaceuticals
Conditions:
Pouchitis
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
To evaluate the efficacy and safety of ustekinumab in the treatment of chronic antibiotic refractory and relapsing pouchitis.
Detailed Description
This study is a Belgian prospective open label multicenter study to evaluate the efficacy and safety of ustekinumab in the treatment of relapsing or chronic antibiotic refractory pouchitis during a 48...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04089345
Start Date
June 15 2020
End Date
May 1 2023
Last Update
December 11 2024
Active Locations (3)
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1
UZ Leuven
Leuven, Flanders, Belgium, 3000
2
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
3
CHU de Liège, Sart Tilman
Liège, Belgium, 4000