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

Sponsor
Janssen Pharmaceutical K.K.
Study ID
NCT04882072
Phase
PHASE3
Status
Terminated

Conditions

  • Takayasu Arteritis

Eligibility Criteria

Sex
ALL
Age
15 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Ustekinumab — DRUG
    Participants will receive IV infusion and SC injection of ustekinumab.
  • Placebo — OTHER
    Participants will receive IV infusion and SC injection of matching placebo.
  • Glucorticoid Taper Regimen — DRUG
    Glucocorticoid will be administered orally.

Study Details

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).

Key Dates

Start date
Sep 15, 2021
Status verified
Apr 2025
Primary completion
May 25, 2023
Completion
May 25, 2023

Study Design

Enrollment
14 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ustekinumab
    Double-blind (DB) Period: Participants will receive weight-ranged based ustekinumab (6 milligrams/kilogram\[mg/kg\]) as IV infusion at Week 0 followed by ustekinumab 90mg injection SC 8 weeks after initial IV dose, then every 8 weeks (q8w) thereafter until the end of the DB period with starting the protocol defined oral GC taper regimen from Week 2 visit. Open Label Extension (OLE) period: Participants will receive ustekinumab SC injection at Week OL-0, followed by ustekinumab 90mg SC injection with oral GC taper at investigator's discretion for 52 weeks (Week OL-52) or until 32 weeks from first SC administration after end of DB period whichever is later. Long-term Extension (LTE) Period: Participants who completed OLE period may be eligible to enter LTE and continue to receive ustekinumab 90mg SC injection q8w.
  • Placebo Comparator: Placebo
    DB period: Participants will receive placebo intravenous (IV) infusion at Week 0 followed by placebo subcutaneous (SC) injection administration, 8 weeks after the initial IV dose, then q8w thereafter until the end of DB period with starting the protocol defined oral GC taper regimen from Week 2 visit. OLE period: Participants will receive ustekinumab SC at Week OL-0, followed by SC administration of ustekinumab with oral GC taper at investigator's discretion for 52 weeks (Week OL-52) or until 32 weeks from the first SC administration after the end of DB period, whichever is later. LTE Period: Participants who complete their participation in OLE period may be eligible to enter the LTE and continue to receive 90 mg SC ustekinumab q8w.

Primary Outcome Measure

Time to Relapse (ToR) of Takayasu Arteritis (TAK) According to Protocol-defined Criteria Through the End of Double-blind Period [ Time Frame: From double-blind Week 0 up to end of double-blind period (up to 71.1 weeks) ]

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