Overview

A Study of Ustekinumab in Participants With Active Systemic Lupus Erythematosus

Status:
Terminated

Trial end date:
2020-11-05

Target enrollment:
0

Participant gender:
All

Summary

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Janssen Research & Development, LLC

Treatments:

Ustekinumab

Criteria

Inclusion Criteria:

- 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:

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)

- 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)

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 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