Stelara fOr ChRonic AntibioTic rEfractory pouchitiS

Sponsor
Universitaire Ziekenhuizen KU Leuven
Study ID
NCT04089345
Phase
PHASE3
Status
Completed

Conditions

  • Pouchitis

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Ustekinumab — DRUG
    All patients will receive intravenously (IV) ustekinumab \~6mg/kg at baseline and subcutaneously (SC) ustekinumab 90mg every 8 weeks thereafter until Week 48.

Study Details

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

Key Dates

Start date
Jun 15, 2020
Status verified
Apr 2021
Primary completion
Dec 1, 2022
Completion
May 1, 2023

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Open label ustekinumab
    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.

Primary Outcome Measure

The percentage of subjects achieving clinically relevant steroid-free remission [ Time Frame: 16 weeks after baseline ]

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