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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03517722




Registration number
NCT03517722
Ethics application status
Date submitted
13/04/2018
Date registered
4/05/2018
Date last updated
16/05/2018

Titles & IDs
Public title
A Study of Ustekinumab in Participants With Active Systemic Lupus Erythematosus
Scientific title
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus
Secondary ID [1] 0 0
2017-001489-53
Secondary ID [2] 0 0
CR108440
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lupus Erythematosus, Systemic 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Ustekinumab (approximately 6 mg/kg)
Treatment: Drugs - Ustekinumab 90 mg

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.


Treatment: Drugs: Placebo
Participants will receive placebo matching to ustekinumab IV or SC.

Treatment: Drugs: Ustekinumab (approximately 6 mg/kg)
Participants will receive ustekinumab approximately 6 mg/kg via IV route based on body weight-range.

Treatment: Drugs: Ustekinumab 90 mg
Participants will receive 90 mg ustekinumab via SC route.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving an Systemic Lupus Erythematosus Responder Index-4 (SRI-4) Composite Response at Week 52 - SRI-4 is a composite of at least 4 point improvement in Systemic Lupus Erythematosus Disease Activity Index 2000(SLEDAI-2K), no worsening in British Isles Lupus Assessment Group (BILAG) and no worsening in Physician's Global Assessment of Disease Activity score (PGA).
Timepoint [1] 0 0
Week 52
Secondary outcome [1] 0 0
Time to Flare - Time to flare will be calculated with flare defined as either 1 or more new BILAG A or 2 or more new BILAG B domain scores relative to baseline.
Timepoint [1] 0 0
Baseline to Week 52
Secondary outcome [2] 0 0
Percentage of Participants with an SRI-4 Composite Response at Week 24 - SRI-4 is a composite of at least 4 point improvement in SLEDAI-2K, no worsening in BILAG and no worsening in PGA.
Timepoint [2] 0 0
Week 24
Secondary outcome [3] 0 0
Percentage of Participants Achieving at Least a 50% Improvement in the Number of Joints with Pain and Signs of Inflammation at Week 52 - The percentage of participants achieving at least a 50 percent (%) improvement in the number of joints with pain and signs of inflammation at week 52 will be reported in participants with at least 4 affected joints at baseline.
Timepoint [3] 0 0
Week 52
Secondary outcome [4] 0 0
Percentage of Participants Receiving Glucocorticoids at Baseline who Achieve Reduction in Glucocorticoid Dose by Week 40 and Sustain That Reduction Through Week 52 - Reduction of glucocorticoid dose is defined as a reduction in average daily oral glucocorticoid dose by at least 50% (relative to the baseline dose) or reduction of average daily oral glucocorticoid dose by at least 25% (relative to the baseline dose) so that the average daily dose is reduced to less than or equal to (<=) 7.5 milligram (mg) (prednisone or equivalent). Sustained reduction of glucocorticoid dose is defined as achieving an average daily oral glucocorticoid dose reduction (as described above) between Weeks 24 and 40, and sustaining that reduction through Week 52, in those participants who, at baseline, were receiving oral glucocorticoids.
Timepoint [4] 0 0
Baseline to Week 52
Secondary outcome [5] 0 0
Percentage of Participants Achieving at Least a 50% Improvement in the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score at Week 52 - Percentage of participants achieving at least 50% improvement in CLASI Activity Score at Week 52 will be reported in participants with a CLASI Activity Score of 4 or greater at baseline.
Timepoint [5] 0 0
Week 52
Secondary outcome [6] 0 0
Percentage of Participants Receiving Glucocorticoids at Baseline who Achieve Reduction in Glucocorticoid Dose by Week 40, Sustain That Reduction Through Week 52, and Achieve an SRI-4 Composite Response at Week 52 - Percentage of participants receiving glucocorticoids at baseline who achieve reduction in glucocorticoidits dose (as described above) by Week 40, sustain that reduction through Week 52 (as described above), and achieve an SRI-4 composite response (as described above) at Week 52 will be reported.
Timepoint [6] 0 0
Baseline to Week 52

Eligibility
Key inclusion criteria
- Be male or female

- Provide documented history of systemic lupus erythematosus (SLE) diagnosis including
evidence that the Systemic Lupus International Collaborating Clinics (SLICC)
classification criteria for SLE were met at least 3 months prior to dosing of study
agent

- 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)
Minimum age
16 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

- 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 low or moderate
potency (World Health Organization criteria) corticosteroids are prohibited

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Rheumatology Research Unit - Maroochydore
Recruitment postcode(s) [1] 0 0
4558 - Maroochydore
Recruitment outside Australia
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Kharkiv
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Poltava
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Vinnytsia
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Ukraine
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Zhytomyr

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/show/NCT03517722
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Contact
Address 0 0
Country 0 0
Phone 0 0
844-434-4210
Fax 0 0
Email 0 0
JNJ.CT@sylogent.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03517722