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

Phase 1

• Conditions: Systemic Lupus Erythematosus; MedDRA version: 18.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2014-005000-19-DE
• Lead Sponsor: Janssen-Cilag International N.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-12
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 134

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 welldocumented (subject file, referring physician letter, or laboratory result), unequivocally positive, documented test for auto antibodies 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

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 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