NCT02349061

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

A Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Detailed description

A multicenter (more than one medical research center involved in study), randomized (study drug assigned by chance), double-blind (neither the Investigator nor the participant know about the study drug), placebo-controlled, proof-of-concept study of ustekinumab in participants with active systemic lupus erythematosus. Participants will be screened to achieve all inclusion criteria and none exclusion criteria and will then receive either ustekinumab or placebo along with concomitant background medicine. Participants will be primarily assessed for response using the Systemic Lupus Erythematosus Response Index 2000 (SRI-4). Participants' safety will be assessed throughout the study.

Conditions

• Lupus Erythematosus, Systemic

Interventions

Type	Name	Description
DRUG	Ustekinumab IV	Weight-range based dosing of approximately 6 mg/kg of ustekinumab intravenously at Week 0.
DRUG	Placebo Infusion	Placebo intravenously at Week 0.
DRUG	Placebo SC	Placebo subcutaneously at Weeks 8 and 16.
DRUG	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	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.

Timeline

• Start date: 2015-10-15
• Primary completion: 2017-05-15
• Completion: 2019-03-13
• First posted: 2015-01-28
• Last updated: 2020-03-24
• Results posted: 2018-06-12

Locations

43 sites across 9 countries: United States, Argentina, Australia, Germany, Hungary, Mexico, Poland, Spain, Taiwan