A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus Erythematosus

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02349061
• Date of registration: 23/01/2015
• Prospective Registration: Yes
• Primary sponsor: Janssen Research & Development, LLC
• 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
• Date of first enrolment: October 15, 2015
• Target sample size: 102
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02349061
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Argentina, Australia, Germany, Hungary, Mexico, Poland, Spain, Taiwan, United Kingdom, United States

Contacts

• Name: Janssen Research & Development, LLC Clinical Trial
• Affiliation: Janssen Research & Development, LLC

Key inclusion & exclusion criteria

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

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)



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Lupus Erythematosus, Systemic

Intervention(s)

Drug: Placebo Infusion

Drug: Ustekinumab SC

Other: Concomitant Medication

Drug: Ustekinumab IV

Drug: Placebo SC

Primary Outcome(s)

Percentage of Participants With a Systemic Lupus Erythematosus Responder Index (SRI-4) Composite Response (CR) at Week 24 [Time Frame: Week 24]

Secondary Outcome(s)

Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Score at Week 24 [Time Frame: Baseline, Week 24]

Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI 2K) Score at Week 24 [Time Frame: Baseline, Week 24]

Number of Participants With BILAG-based Combined Lupus Assessment (BICLA) Response at Week 24 [Time Frame: Week 24]

Change From Baseline in Number of Joints With Pain and Signs of Inflammation at Week 24 [Time Frame: Baseline, Week 24]

Secondary ID(s)

2014-005000-19

CR106661

CNTO1275SLE2001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 12/06/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02349061