A Phase 3 interventional study of Ustekinumab in Pouchitis, sponsored by Universitaire Ziekenhuizen KU Leuven. Completed at 3 sites in Belgium. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-12-11.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Phase 3, Interventional, and Treatment
To evaluate the efficacy and safety of ustekinumab in the treatment of chronic antibiotic refractory and relapsing pouchitis.
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.
50 studies on the registry are indexed under Pouchitis; 13 are open to participants now.
This study's enrollment of 20 is close to the median of 20 across 42 interventional studies indexed under Pouchitis.
Browse Pouchitis studies →Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 958 studies on the registry; 263 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
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.
Drug: Ustekinumab
All patients will receive intravenously (IV) ustekinumab \~6mg/kg at baseline and subcutaneously (SC) ustekinumab 90mg every 8 weeks thereafter until Week 48.
Also known as: Stelara
The percentage of subjects achieving clinically relevant steroid-free remission
mPDAI score \<5 and a reduction by ≥2 points from baseline
Time frame: 16 weeks after baseline
The percentage of subjects achieving clinically relevant steroid-free remission
mPDAI score \<5 and a reduction by ≥2 points from baseline, without need for steroids
Time frame: 48 weeks after baseline
The percentage of subjects achieving partial response
reduction of mPDAI score by ≥2 points from baseline
Time frame: 16 weeks after baseline
The percentage of subjects achieving partial response
reduction of mPDAI score by ≥2 points from baseline
Time frame: 48 weeks after baseline
Time to clinically relevant remission
Time to mPDAI score \<5 and a reduction by ≥2 points from baseline
Time frame: Within 48 weeks after baseline
Change in mPDAI endoscopic subscore
Change in mPDAI endoscopic subscore from baseline
Time frame: At Week 16 and 48 compared to baseline
Change in mPDAI symptomatic subscore
Change in mPDAI symptomatic subscore from baseline
Time frame: At Week 16 and 48 compared to baseline
Change in total mPDAI score
Change in total mPDAI score from baseline
Time frame: At Week 16 and 48 compared to baseline
Change in European Quality of Life 5 Dimensions (EQ-5D)
Change in European Quality of Life 5 Dimensions (EQ-5D) from baseline
Time frame: At Week 16, 32 and 48 compared to baseline
Plan to share: Yes — All IPD that underlie results in a publication
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ustekinumab
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