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

Completed · Phase 2 · Has a placebo group

Conditions studied: Lupus Erythematosus, Systemic

In brief

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).

Key facts

Study ID

NCT02349061

Run by

Janssen Research & Development, LLC

People needed

102

Starts

2015-10-15

Expected to finish

2019-03-13

Last updated by the study team

2020-03-24

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Study site — Huntsville, Alabama, United States
• Study site — Beverly Hills, California, United States
• Study site — Tampa, Florida, United States
• Study site — Lansing, Michigan, United States
• Study site — Manhasset, New York, United States
• Study site — New York, New York, United States
• Study site — Syracuse, New York, United States
• Study site — Tulsa, Oklahoma, United States
• Study site — Duncansville, Pennsylvania, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Charleston, South Carolina, United States
• Study site — Jackson, Tennessee, United States
• Study site — Buenos Aires, Argentina
• Study site — Ciudad de San Miguel de Tucuman, Argentina
• Study site — San Juan, Argentina
• Study site — Adelaide, Australia
• Study site — Camberwell, Australia
• Study site — Heidelberg, Australia
• Study site — Liverpool, Australia
• Study site — Nedlands, Australia
• Study site — Berlin, Germany
• Study site — Cologne, Germany
• Study site — Frankfurt, Germany
• Study site — Budapest, Hungary
• Study site — Debrecen, Hungary

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.