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NCT07409181
A Study to Test Whether Different Doses of BI 3000202 Help People With Systemic Lupus Erythematosus (SLE)
Conditions: Systemic Lupus Erythematosus
Sex: All
Ages: 18 Years – 74 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 405
Sponsor: Boehringer Ingelheim
Location: Wallace & Lee Center Beverly Hills California
Summary
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.
Eligibility Criteria
Inclusion Criteria:
1. Male and female adult patients from ≥18 years (or alternative age for adults based on local regulations) to \2 × Upper Limit of Normal (ULN) and/or Urine Protein Creatinine Ratio (UPCR) that is unstable or \> 3mg/mg (339 mg/mmol)
5. Oral corticosteroids (prednisone or equivalent) \>30 mg/day at screening Further exclusion criteria apply.
Source: ClinicalTrials.gov (NCT07409181). StuddyBuddy aggregates publicly available trial information.