Stelara fOr ChRonic AntibioTic rEfractory pouchitiS

  • STATUS
    Recruiting
  • End date
    May 6, 2023
  • participants needed
    20
  • sponsor
    Universitaire Ziekenhuizen Leuven
Updated on 6 May 2021

Summary

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

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-week treatment period. Twenty subjects with a RPC and IPAA for UC who have developed relapsing or chronic antibiotic refractory pouchitis will be enrolled.

All patients will receive intravenously (IV) ustekinumab ~6mg/kg at baseline and subcutaneously (SC) ustekinumab 90mg every 8 weeks thereafter until Week 48. All subjects will receive concomitant antibiotic treatment with ciprofloxacin or metronidazole from baseline through Week 4. Intravenous induction doses will be 260mg for patients <55kg, 390mg for patients between 55 and 85kg, and 520mg for patients with a body weight >85 kg.

Clinical and biochemical evaluation will be planned every 8 weeks. Efficacy will be assessed at Week 16 and Week 48 using mPDAI and PDAI scores, therefor a pouchoscopy with biopsy sampling will be performed. Patients who do not achieve partial response (reduction of mPDAI score by 2 points from baseline) at Week 16 will be discontinued.

Details
Condition Pouchitis
Treatment ustekinumab
Clinical Study IdentifierNCT04089345
SponsorUniversitaire Ziekenhuizen Leuven
Last Modified on6 May 2021

Eligibility

Yes No Not Sure

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
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