Clinical Trials Directory

Trials / Terminated

TerminatedNCT04882072

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

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Participants With Takayasu Arteritis

Status
Terminated
Phase
Phase 3
Study type
Interventional
Enrollment
14 (actual)
Sponsor
Janssen Pharmaceutical K.K. · Industry
Sex
All
Age
15 Years – 75 Years
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
DRUGUstekinumabParticipants will receive IV infusion and SC injection of ustekinumab.
OTHERPlaceboParticipants will receive IV infusion and SC injection of matching placebo.
DRUGGlucorticoid Taper RegimenGlucocorticoid will be administered orally.

Timeline

Start date
2021-09-15
Primary completion
2023-05-25
Completion
2023-05-25
First posted
2021-05-11
Last updated
2025-04-29
Results posted
2024-12-02

Locations

27 sites across 1 country: Japan

Source: ClinicalTrials.gov record NCT04882072. Inclusion in this directory is not an endorsement.