A study to test whether different doses of BI 3000202 help people with systemic lupus erythematosus (SLE)

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2026
INTERVENTION: Intervention1: Interventional agent: BI 3000202 : Dose: 25 mg or 50 mg per tablet Route: oral Frequency: daily Duration: 52 weeks Control Intervention1: Comparator: Placebo : Dose: matching placebo Route: oral Frequency: daily Duration: 52 weeks CONDITION: Health Condition 1: M32‐ Systemic lupus erythematosus (SLE) PRIMARY OUTCOME: To demonstrate a non‐flat dose response curve based on the primary endpoint of achievement of SRI‐4 response at Week 32 ; To evaluate the treatment effect of different dose regimens of BI 3000202 vs. placebo based on the primary endpoint of achievement of SRI‐4 response at Week 32Timepoint: Week 32 SECONDARY OUTCOME: To evaluate the size of the treatment effect based on the secondary endpoints of achievement of SRI‐4 response at Week 52, achievement of SRI‐4 response and oral corticosteroid reduction to less than equals to 5 mg/day prednisone or equivalent at Week 32, and achievement of LLDAS at Week 32Timepoint: Week 52 INCLUSION CRITERIA: To be eligible to participate in this trial an individual must meet all the following criteria at screening. The participant must continue to meet all eligibility criteria for randomisation on Day 1 based on investigators clinical assessment 1. Male and female adult patients from more than equals to 18 years or alternative age for adults based on local regulations to less than 75 years on the date of signing the informed consent. 2. Confirmed SLE diagnosis meeting the EULAR or ACR classification criteria, example a total score of at least 10 see Section 3.3.1 and 10.4 at least 24 weeks prior to screening Visit 1. 3. At least one of the following at screening Positive ANA more than equals to 1 ration 80 or Positive anti dsDNA antibody or Positive anti Smith antibody 4. Total SLEDAI 2K score more than equals to 6 points at screening and clinical SLEDAI 2K score more than equals to 4 points at screen
Epistemonikos ID: 0442406679fb102ad8913c098c41c0dd84a7c913
First added on: Oct 08, 2026