A Study of Ustekinumab in Participants With Takayasu Arteritis (TAK)

NCT04882072 ↗

Phase 3 Terminated 14 enrolled Janssen Pharmaceutical K.K.

RandomizedParallel-groupDouble-blindTreatment

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).

Timeline

Start: 2021-09-15
Primary completion: 2023-05-25
Completion: 2023-05-25

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

Stopped (Enrollment): “Due to difficulties in enrollment and ongoing feasibility issues”

paper The efficacy of UST in patients with TAK cannot be adequately assessed as the pre-determined sample size was not reached PMID 40104212 ↗

Publications

Yoshifuji H, Ishii T, Ohashi H, Yoshizawa K, Mihoya M, Nishikawa K, Nakaoka Y. Phase 3, multicentre, randomized, double-blind, placebo-controlled, parallel-group study of ustekinumab in patients with Takayasu arteritis. Rheumatol Adv Pract. 2025 Feb 3;9(2):rkaf013. doi: 10.1093/rap/rkaf013. eCollection 2025.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ustekinumab	Monoclonal antibody	90 mg	Intravenous