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

PHASE2CompletedINTERVENTIONAL
Enrollment

102

Participants

Timeline

Start Date

October 15, 2015

Primary Completion Date

May 15, 2017

Study Completion Date

March 13, 2019

Conditions
Lupus Erythematosus, Systemic
Interventions
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.

Trial Locations (43)

Unknown

Huntsville

Beverly Hills

Tampa

Lansing

Manhasset

New York

Syracuse

Tulsa

Duncansville

Philadelphia

Charleston

Jackson

Buenos Aires

Ciudad de San Miguel de Tucuman

San Juan

Adelaide

Camberwell

Heidelberg

Liverpool

Nedlands

Berlin

Cologne

Frankfurt

Budapest

Debrecen

Szeged

Zalaegerszeg

Chihuahua City

Guadalajara

León

México

Bydgoszcz

Poznan

Szczecin

Wroclaw

Barcelona

Madrid

Málaga

Santiago de Compostela

Seville

Kaohsiung City

Taichung

Taoyuan District

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT02349061 - A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus Erythematosus | Biotech Hunter | Biotech Hunter