A Study of Ustekinumab in Participants With Active Systemic Lupus Erythematosus

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Lupus Erythematosus, Systemic

In brief

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 facts

Study ID

NCT03517722

Run by

Janssen Research & Development, LLC

People needed

516

Starts

2018-04-16

Expected to finish

2020-11-05

Last updated by the study team

2025-04-29

Who can join

Age: 16 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Be male or female
• Has 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:
• Met a total of at least 4 SLICC criteria, including at least 1 clinical and at least 1 immunologic;
• 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)
• Has 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
• Has greater than or equal to (>=) 1 British Isles Lupus Assessment Group (BILAG) A and/or >= 2 BILAG B scores observed during screening
• Has a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score >=4 (excluding diffuse non-inflammatory alopecia) or >= 4 joints with pain and signs of inflammation at screening, Week 0, or both
• Has a Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score >=6 at screening. Must also have SLEDAI-2K >= 4 for clinical features (excluding headache and laboratory abnormalities) at Week 0
• Cannot be pregnant, nursing, intending to become pregnant, or unwilling to follow contraception or egg/sperm donation guidelines
• Must be receiving stable doses of >=1 protocol-permitted standard of care SLE treatment: oral glucocorticoids, anti-malarials, immunomodulators (methotrexate, azathioprine, 6-mercaptopurine, mycophenolate mofetil, mycophenolic acid)

You may not qualify if…

• 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 co-existent inflammatory diseases (example: rheumatoid arthritis, psoriasis, psoriatic arthritis, Crohn's disease)
• Has a urinary protein to creatinine ratio of greater than (>)4 gram per gram (g/g) per day
• Has an acute or chronic infectious illness (example: human immunodeficiency virus, hepatitis B or C virus, tuberculosis, opportunistic infections)
• Has a history of cancer or lymphoproliferative disease within the last 5 years except for treated and non-recurrent cutaneous basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma
• Has any condition requiring multiple courses of systemic glucocorticoids (example: uncontrolled asthma, chronic obstructive pulmonary disease)
• Has a history of major surgery within the last month
• Has received live virus or bacterial vaccines within 16 weeks prior to first dose of study agent or Bacille Calmette-Guerin (BCG) vaccination within 12 months of screening
• Has previously received ustekinumab
• Has received cyclophosphamide orally within 90 days or intravenously within 180 days of screening
• Has received a single B-cell targeted therapy (e.g. belimumab) within 3 months, >1 previous B-cell targeted therapy within 6 months, or B-cell depleting therapy (example: rituximab) within 12 months of first dose of study agent
• Has received protocol-prohibited oral or biologic immunomodulatory therapy in the last 3 months or less than (<)5 half-lives (whichever is longer) prior to first dose of study agent
• Has received adrenocorticotropic hormone (ACTH) within 1 month prior to first dose of study agent
• Has received epidural, intravenous, intramuscular, intraarticular, intrabursal, intralesional glucocorticoids within 6 weeks of first dose of study agent
• Locally-delivered therapies except for ophthalmic use of cyclosporine A or topical use of nonsteroidal anti inflammatory drugs (NSAIDs), analgesics, or high-potency glucocorticoids (World Health Organization criteria) are prohibited

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Achieve Clinical Research, LLC — Vestavia Hills, Alabama, United States
• Medvin Clinical Research — Covina, California, United States
• Lugene Eye Institute — Glendale, California, United States
• C.V. Mehta, MD Medical Corp. — Hemet, California, United States
• University of California at San Diego — La Jolla, California, United States
• Advanced Medical Research - Lakewood — Lakewood, California, United States
• Loma Linda University — Loma Linda, California, United States
• Loma Linda University Health Care — Loma Linda, California, United States
• Valerius Medical Group & Research Center — Los Alamitos, California, United States
• Keck School of Medicine of USC — Los Angeles, California, United States
• Wallace Rheumatic Study Center — Los Angeles, California, United States
• East Bay Rheumatology Medical Group — San Leandro, California, United States
• Westlake Medical Research Clinical Trials — Thousand Oaks, California, United States
• University Clinical Investigators, Inc — Tustin, California, United States
• Inland Rheumatology Clinical Trials Inc. — Upland, California, United States
• University of Colorado — Aurora, Colorado, United States
• Denver Arthritis Clinic — Denver, Colorado, United States
• UPMC Lupus Center of Excellence — New Haven, Connecticut, United States
• Stamford Therapeutics Consortium — Stamford, Connecticut, United States
• Arthritis and Rheumatic Disease Specialties — Aventura, Florida, United States
• Bay Area Arthritis and Osteoporosis — Brandon, Florida, United States
• Centre for Rheumatology, Immunology and Arthritis — Fort Lauderdale, Florida, United States
• University of Florida Health Jacksonville — Jacksonville, Florida, United States
• Pinnacle Research Group, LLC — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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