A Study to Evaluate the Efficacy and Safety of Upadacitinib in Participants With Takayasu Arteritis (TAK)

Sponsor
AbbVie
Study ID
NCT04161898
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Takayasu Arteritis (TAK)

Eligibility Criteria

Sex
ALL
Age
15 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Upadacitinib — DRUG
    Upadacitinib will be administered as oral tablet
  • Placebo for Upadacitinib — DRUG
    Placebo for upadacitinib will be administered as oral tablet
  • Prednisolone — DRUG
    Prednisolone will be administered as oral tablet

Study Details

The main objective of this study is to evaluate the efficacy of upadacitinib in combination with a corticosteroid taper regimen compared to placebo in combination with a corticosteroid taper regimen.

Key Dates

Start date
Feb 4, 2020
Status verified
Feb 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
56 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 2: Placebo for Upadacitinib
    Participants will be administered placebo once daily (QD) along with prednisolone.
  • Experimental: Arm 1: Upadacitinib
    Participants will be administered updadacitinib once daily (QD) along with prednisolone.

Primary Outcome Measure

Time to First Relapse of Takayasu Arteritis (TAK) From Baseline through End of the Double-Blind (DB) Period [ Time Frame: Up to occurrence of 40 events (approximately 52 months) ]

Related Studies