A Study of Ustekinumab in Chinese Participants With Active Systemic Lupus Erythematosus

Sponsor
Janssen Research & Development, LLC
Study ID
NCT04060888
Phase
PHASE3
Status
Withdrawn

Conditions

  • Lupus Erythematosus, Systemic

Eligibility Criteria

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

Interventions

  • Ustekinumab (approximately 6 mg/kg) — DRUG
    Participants will receive ustekinumab approximately 6 milligram per kilogram via IV route based on body weight-range.
  • Ustekinumab 90 milligram (mg) — DRUG
    Participants will receive 90 mg ustekinumab via SC route.
  • Placebo — DRUG
    Participants will receive placebo matching to ustekinumab IV or SC.

Study Details

The purpose of this study is to evaluate the efficacy of ustekinumab in Chinese participants with active systemic lupus erythematosus (SLE) who have not adequately responded to one or more standard-of-care treatments.

Key Dates

Start date
Jul 14, 2020
Status verified
Jan 2025
Primary completion
Jan 31, 2022
Completion
Mar 31, 2026

Study Design

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

Arms

  • Experimental: Ustekinumab
    Participants will receive ustekinumab approximately 6 milligram per kilogram (mg/kg) intravenously (IV) based on body weight-range at Week 0 followed by 90 mg ustekinumab subcutaneously (SC) at Week 8 and every 8 weeks (q8w) thereafter through Week 48 during double-blind period. Eligible participants who will enter the extension period will continue to receive 90 mg ustekinumab SC q8w through Week 160.
  • Placebo Comparator: Placebo
    Participants will receive matching placebo to ustekinumab IV at Week 0, followed by matching placebo to ustekinumab SC at Week 8 and q8w thereafter through Week 48 during double-blind period. Eligible participants who will enter the extension period will cross-over to receive 90 mg ustekinumab SC q8w through Week 160.

Primary Outcome Measure

Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index-4 (SRI-4) Composite Response at Week 52 [ Time Frame: Week 52 ]

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