A Study of Ustekinumab in Participants With Active Systemic Lupus Erythematosus

Conditions

• Lupus Erythematosus, Systemic

Eligibility Criteria

Sex

ALL

Age

16 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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

Key Dates

Start date

Apr 16, 2018

Status verified

Apr 2025

Primary completion

Nov 5, 2020

Completion

Nov 5, 2020

Study Design

Enrollment

516 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.
• Experimental: 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 ]

Locations (69)

Find similar trials in Anniston, AL

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