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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02349061




Registration number
NCT02349061
Ethics application status
Date submitted
23/01/2015
Date registered
28/01/2015
Date last updated
24/03/2020

Titles & IDs
Public title
A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus Erythematosus
Scientific title
A Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus
Secondary ID [1] 0 0
CNTO1275SLE2001
Secondary ID [2] 0 0
CR106661
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 - Ustekinumab IV
Treatment: Drugs - Placebo Infusion
Treatment: Drugs - Placebo SC
Treatment: Drugs - Ustekinumab SC
Other interventions - Concomitant Medication

Experimental: Ustekinumab plus Concomitant Medication - Participants will receive weight-range based dosing of approximately 6 mg/kg of ustekinumab intravenously at Week 0 followed by ustekinumab 90 mg subcutaneously (SC) every 8 weeks (q8w) up to Week 40. Participants who meet the study extension inclusion criteria will continue to receive ustekinumab 90 mg SC q8w starting at Week 48 or 56 through Week 104. Participants will continue stable concomitant treatment through Week 48, as well as through the study extension although tapering of corticosteroids is encouraged beyond Week 48. Participants who complete or discontinue study treatment will be evaluated for 16 additional Weeks of safety follow-up.

Experimental: Placebo followed by Ustekinumab plus Concomitant Medication - Participants will receive placebo intravenously at Week 0 followed by placebo subcutaneously at Weeks 8 and 16. At week 24 participants will receive ustekinumab SC q8w up to Week 40. Participants who meet the study extension inclusion criteria will continue to receive ustekinumab 90 mg SC q8w starting at Week 48 or 56 through Week 104. Participants will continue stable concomitant treatment through Week 48, as well as through the study extension although tapering of corticosteroids is encouraged beyond Week 48. Participants who complete or discontinue study treatment will be evaluated for 16 additional Weeks of safety follow-up.


Treatment: Drugs: Ustekinumab IV
Weight-range based dosing of approximately 6 mg/kg of ustekinumab intravenously at Week 0.

Treatment: Drugs: Placebo Infusion
Placebo intravenously at Week 0.

Treatment: Drugs: Placebo SC
Placebo subcutaneously at Weeks 8 and 16.

Treatment: Drugs: Ustekinumab SC
Ustekinumab 90 mg subcutaneously every 8 weeks up to Week 40 and up to Week 104 in study extension (for eligible participants)

Other interventions: Concomitant Medication
Concomitant treatment (mycophenolate, azathioprine/6-mercaptopurine, methotrexate, hydroxychloroquine and/or chloroquine, oral corticosteroids, NSAIDs, antihypertensive medications, and topical medications) through Week 48, as well as through the study extension although tapering of corticosteroids is encouraged beyond Week 48.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With a Systemic Lupus Erythematosus Responder Index (SRI-4) Composite Response (CR) at Week 24
Timepoint [1] 0 0
Week 24
Secondary outcome [1] 0 0
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI 2K) Score at Week 24
Timepoint [1] 0 0
Baseline, Week 24
Secondary outcome [2] 0 0
Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Score at Week 24
Timepoint [2] 0 0
Baseline, Week 24
Secondary outcome [3] 0 0
Number of Participants With BILAG-based Combined Lupus Assessment (BICLA) Response at Week 24
Timepoint [3] 0 0
Week 24
Secondary outcome [4] 0 0
Change From Baseline in Number of Joints With Pain and Signs of Inflammation at Week 24
Timepoint [4] 0 0
Baseline, Week 24

Eligibility
Key inclusion criteria
- Subjects must have documented medical history to meet SLICC classification criteria
for SLE for a minimum of 3 months prior to first dose

- At least 1 well-documented (subject file, referring physician letter, or laboratory
result), unequivocally positive, documented test for autoantibodies in medical history
including either of the following: ANA, and/or anti-dsDNA antibodies, and/or
anti-Smith antibodies

- At least 1 unequivocally positive autoantibody test including ANA and/or anti-dsDNA
antibodies and/or anti-Smith antibodies detected during screening

- At least 1 BILAG A and/or 2 BILAG B domain scores observed during screening prior to
first administration of study agent

- Demonstrate active disease based on SLEDAI-2K score greater than or equal to (>=) 6
observed during screening and assessed approximately 2 to 6 weeks prior to
randomization. Must also have SLEDAI-2K score >= 4 for clinical features (ie, SLEDAI
excluding laboratory results) at Week 0 prior to the first administration of study
agent
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Have other inflammatory diseases that might confound the evaluations of efficacy,
including but not limited to rheumatoid arthritis (RA), psoriatic arthritis (PsA),
RA/lupus overlap, psoriasis or active Lyme disease

- Are pregnant, nursing, or planning a pregnancy or fathering a child while enrolled in
the study or within 4 months after receiving the last administration of study agent

- Have received systemic or topical cream/ointment preparations of cyclosporine A or
other systemic immunomodulatory agents other than those described in inclusion
criteria within the past 3 months prior to first administration of study agent

- Have received a single B cell targeting agent within 3 months prior to first study
agent administration; or received more than 1 previous B cell targeting therapy
including belimumab or epratuzamab within 6 months prior to first administration of
the study agent; or received B cell depleting therapy (eg, rituximab) within 12 months
prior to first administration of the study agent or have evidence of continued B-cell
depletion following such therapy

- Have ever received ustekinumab

- Participant has a history of malignancy within 5 years before screening (exceptions
are squamous and basal cell carcinomas of the skin that has been treated with no
evidence of recurrence for at least 3 months before the first study agent
administration and carcinoma in situ of the cervix that has been surgically cured)

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
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/10/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/03/2019
Sample size
Target
Accrual to date
Final
102
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Camberwell
Recruitment hospital [3] 0 0
- Heidelberg
Recruitment hospital [4] 0 0
- Liverpool
Recruitment hospital [5] 0 0
- Nedlands
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Camberwell
Recruitment postcode(s) [3] 0 0
- Heidelberg
Recruitment postcode(s) [4] 0 0
- Liverpool
Recruitment postcode(s) [5] 0 0
- Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Oklahoma
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
South Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee
Country [10] 0 0
Argentina
State/province [10] 0 0
Buenos Aires
Country [11] 0 0
Argentina
State/province [11] 0 0
Ciudad De San Miguel De Tucuman
Country [12] 0 0
Argentina
State/province [12] 0 0
San Juan
Country [13] 0 0
Germany
State/province [13] 0 0
Berlin
Country [14] 0 0
Germany
State/province [14] 0 0
Frankfurt
Country [15] 0 0
Germany
State/province [15] 0 0
Koeln
Country [16] 0 0
Hungary
State/province [16] 0 0
Budapest
Country [17] 0 0
Hungary
State/province [17] 0 0
Debrecen
Country [18] 0 0
Hungary
State/province [18] 0 0
Szeged
Country [19] 0 0
Hungary
State/province [19] 0 0
Zalaegerszeg
Country [20] 0 0
Mexico
State/province [20] 0 0
Chihuahua
Country [21] 0 0
Mexico
State/province [21] 0 0
Guadalajara
Country [22] 0 0
Mexico
State/province [22] 0 0
Leon
Country [23] 0 0
Mexico
State/province [23] 0 0
Mexico
Country [24] 0 0
Poland
State/province [24] 0 0
Bydgoszcz
Country [25] 0 0
Poland
State/province [25] 0 0
Poznan
Country [26] 0 0
Poland
State/province [26] 0 0
Szczecin
Country [27] 0 0
Poland
State/province [27] 0 0
Wroclaw
Country [28] 0 0
Spain
State/province [28] 0 0
Barcelona
Country [29] 0 0
Spain
State/province [29] 0 0
Madrid
Country [30] 0 0
Spain
State/province [30] 0 0
Málaga
Country [31] 0 0
Spain
State/province [31] 0 0
Santiago de Compostela
Country [32] 0 0
Spain
State/province [32] 0 0
Sevilla
Country [33] 0 0
Taiwan
State/province [33] 0 0
Kaohsiung
Country [34] 0 0
Taiwan
State/province [34] 0 0
Taichung City
Country [35] 0 0
Taiwan
State/province [35] 0 0
Taichung
Country [36] 0 0
Taiwan
State/province [36] 0 0
Taoyuan

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 as measured by a
reduction in disease activity for subjects with active Active Systemic Lupus Erythematosus
(SLE - chronic disorder of connective tissue in which there can be skin rash, arthritis,
kidney problems, and anemia, among other problems).
Trial website
https://clinicaltrials.gov/ct2/show/NCT02349061
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02349061