A Study of Ustekinumab in Participants With Takayasu Arteritis (TAK) (NCT04882072) | Clinical Trial Compass
TerminatedPhase 3
A Study of Ustekinumab in Participants With Takayasu Arteritis (TAK)
Stopped: Due to difficulties in enrollment and ongoing feasibility issues
Japan14 participantsStarted 2021-09-15
Plain-language summary
The purpose of this study is to evaluate the efficacy of ustekinumab compared to placebo, in combination with oral glucocorticoid (GC) taper regimen, in participants with relapsing Takayasu Arteritis (TAK).
Who can participate
Age range15 Years – 75 Years
SexALL
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Inclusion Criteria:
* Must have developed a relapse of Takayasu Arteritis (TAK) within 12 weeks prior to administration of study intervention and the relapse must have occurred at a dose of at least 7.5 milligrams (mg)/day (prednisolone or equivalent)
* Must be receiving oral glucorticoid (GC) treatment of greater than or equal to (\>=)15 mg/day (prednisolone or equivalent), inclusive for the treatment of relapsing TAK and be on a stable dose for at least 2 weeks prior to the first administration of study intervention
* If receiving an oral anti-platelet therapy (including but not limited to aspirin, clopidogrel, ticlopidine) or anti-coagulation therapy (including but not limited to warfarin) for treatment of TAK, the dose must have been stable for at least 2 weeks prior to first administration of the study intervention. In terms of warfarin, the dose should be controlled 1-5mg/day to maintain Prothrombin Time and International Normalized Ratio (PT-INR) target range between 2.0-3.0 (if participants are over 70 years old, PT-INR target range should be between 1.6-2.6)
* Have no history of latent or active Tuberculosis (TB) prior to screening. An exception is made for participants who have a history of latent TB and are currently receiving treatment for latent TB, will initiate treatment for latent TB at least 3 weeks prior to the first administration of the study intervention, or have documentation of having completed appropriate treatment for latent TB within 3 years prior t…
What they're measuring
1
Time to Relapse (ToR) of Takayasu Arteritis (TAK) According to Protocol-defined Criteria Through the End of Double-blind Period
Timeframe: From double-blind Week 0 up to end of double-blind period (up to 71.1 weeks)