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

NCT04882072 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2025-04-29

Study results available
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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

  • Takayasu Arteritis

Interventions

DRUG

Ustekinumab

Participants will receive IV infusion and SC injection of ustekinumab.

OTHER

Placebo

Participants will receive IV infusion and SC injection of matching placebo.

DRUG

Glucorticoid Taper Regimen

Glucocorticoid will be administered orally.

Sponsors & Collaborators

  • Janssen Pharmaceutical K.K.

    lead INDUSTRY

Principal Investigators

  • Janssen Pharmaceutical K.K., Japan Clinical Trial · Janssen Pharmaceutical K.K.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04882072 on ClinicalTrials.gov