A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus Erythematosus
- Conditions
- Systemic Lupus ErythematosusMedDRA version: 18.1 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2014-005000-19-HU
- Lead Sponsor
- Janssen-Cilag International N.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 134
- 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 welldocumented (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 antidsDNA antibodies, and/or antiSmith
antibodies
- At least 1 unequivocally positive autoantibody test including ANA and/or antidsDNA
antibodies and/or antiSmith 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 SLEDAI2K score greater than or
equal to (>=) 6 observed during screening and assessed approximately 2 to 6 weeks prior to randomization. Must also have SLEDAI2K score >= 4 for clinical features (ie, SLEDAI excluding laboratory results) at Week 0 prior to the first administration of study agent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 14
- 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 Bcell 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
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of ustekinumab as measured by a reduction in disease activity for subjects with active SLE;<br> Secondary Objective: To evaluate:<br> • The safety and tolerability of ustekinumab in subjects with SLE.<br> • The effect of ustekinumab administration on health-related quality of life in subjects with SLE.<br> • The effects of ustekinumab on cutaneous manifestations of SLE.<br> • Pharmacokinetics and immunogenicity of ustekinumab in subjects with SLE<br> ;Primary end point(s): Percentage of Participants With a Composite SRI-4 Response at Week 24;Timepoint(s) of evaluation of this end point: Week 24
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): - Change From Baseline in SLEDAI-2K Score at Week 24.<br> - Change From Baseline in Physician Global Assessment of Disease Activity (PGA) at Week 24<br> - Percentage of Participants With BICLA Response at Week 24<br> ;Timepoint(s) of evaluation of this end point: Week 24