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

• Status: Withdrawn
• Trial end date: 2026-03-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Ustekinumab

Criteria

Inclusion Criteria:

• Had a documented medical history (that is, met at least 1 of the two criteria below) that participant met the Systemic Lupus International Collaborating Clinics (SLICC) classification criteria for systemic lupus erythematosus (SLE) at least 3 months prior to first dose of study agent:

1. Met a total of at least 4 SLICC criteria, including at least 1 clinical and at least 1 immunologic;

2. Has a diagnosis of lupus nephritis, confirmed by renal biopsy and at least 1 of the following autoantibodies: antinuclear antibodies (ANA) or anti-double-stranded deoxyribonucleic acid (anti-dsDNA)

• Have a positive test in the medical history and confirmed at screening for at least 1 of the following autoantibodies: antinuclear antibodies, anti-double-stranded deoxyribonucleic acid, and/or anti-Smith

• Have at least 1 British Isles Lupus Assessment Group (BILAG) A and/or 2 BILAG B scores observed during screening

• Have a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score at least 4 (excluding diffuse non-inflammatory alopecia) or at least 4 joints with pain and signs of inflammation at screening, Week 0, or both

• Have a Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score greater than or equal to [>=] 6 at screening. Must also have SLEDAI-2K >= 4 for clinical features (excluding headache and laboratory abnormalities) at Week 0

Exclusion Criteria:

• Has any unstable or progressive SLE manifestation (example: central nervous system lupus, systemic vasculitis, end-stage renal disease, severe or rapidly progressive glomerulonephritis, pulmonary hemorrhage, myocarditis) that may warrant escalation in therapy beyond permitted background medications. Participants requiring renal hemodialysis or peritoneal dialysis are also excluded

• Has other inflammatory diseases that might confound the evaluations of efficacy (including but not limited to rheumatoid arthritis, psoriasis, psoriatic arthritis, Crohn's disease)

• Has urinary protein level of greater than (>) 4 gram per day (g/day) or protein/creatinine ratio estimating >4g/day equivalent proteinuria

• Has known allergies, hypersensitivity, or intolerance to ustekinumab or its excipients

• Has a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location, clinically significant splenomegaly, or history of monoclonal gammopathy of undetermined significance