This study is open to adults with systemic lupus erythematosus (SLE). The purpose of this study is to find out whether a medicine called BI 3000202 helps people with SLE. The study tests different doses of BI 3000202 and aims to find the best dose for people with this condition. Participants are put into 5 groups randomly, which means by chance. 4 groups get different doses of BI 3000202, and 1 group gets a placebo. Placebo tablets look like BI 3000202 tablets but do not contain any medicine. Participants take the tablets for 1 year. All participants also continue their regular treatment for SLE. Participants are in the study for a bit longer than 1 year. During this time, they visit the study site regularly. Doctors check the participants' health and take note of any unwanted effects. They also compare the results between the groups to see if the treatment works.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
405
BI 3000202 at different doses
Placebo matching BI 3000202
Wallace & Lee Center
Beverly Hills, California, United States
NOT_YET_RECRUITINGArthritis & Osteoporosis Medical Center, Inc - La Palma
La Palma, California, United States
RECRUITINGUniversity of California San Diego
San Diego, California, United States
NOT_YET_RECRUITINGUniversity of California Los Angeles
Torrance, California, United States
Achievement of a Systemic Lupus Erythematosus Responder Index (SRI)-4 response
Time frame: At Week 32
Achievement of SRI-4 response
Time frame: At Week 52
Achievement of SRI-4 response and oral corticosteroid reduction to ≤5 mg/day prednisone or equivalent
Time frame: At Week 32
Achievement of Lupus Low Disease Activity State (LLDAS)
Time frame: At Week 32
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Inland Rheumatology Clinical Trials, Inc
Upland, California, United States
RECRUITINGFocus Clinical Research
West Hills, California, United States
RECRUITINGDenver Arthritis Clinic - Lowry
Denver, Colorado, United States
NOT_YET_RECRUITINGAARDS Research, Inc.
Aventura, Florida, United States
RECRUITINGMeris Clinical Research-Brandon-69466
Brandon, Florida, United States
NOT_YET_RECRUITINGClinical Research of West Florida, Inc.
Clearwater, Florida, United States
NOT_YET_RECRUITING...and 130 more locations