Stelara for Chronic AntibioTic refractory inflammation of the pouch: A Belgian multicenter study

Phase 1

• Conditions: Chronic antibiotic refractory and relapsing pouchitis; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2019-003151-11-BE
• Lead Sponsor: Z Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-23
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

•The subject is male or female and aged 18 to 80 years inclusive
•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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified