Phase II Randomized Placebo-Controlled Trial of Oral BI 3000202 in Patients With Moderate-to-Severe Systemic Lupus Erythematosus

The primary objective of this study is to demonstrate a non-flat dose response curve and to evaluate the treatment effect of various dose regimens of BI 3000202 compared to placebo in patients with moderate to severe systemic lupus erythematosus. This is assessed based on the achievement of SRI-4 response at Week 32.

The secondary objectives are to evaluate the magnitude of the treatment effect through the following endpoints:

• Achievement of SRI-4 response at Week 52.
• Achievement of SRI-4 response with oral corticosteroid use of ≤5 mg/day prednisone or equivalent at Week 32.
• Achievement of LLDAS at Week 32.

This clinical trial involves a total of 110 participants diagnosed with systemic lupus erythematosus. The study population consists of adult male and female patients aged between 18 and 74 years. Participants must have a confirmed diagnosis meeting the EULAR/ACR classification criteria for at least 24 weeks prior to screening. Required serological markers include positive antinuclear antibodies, anti-dsDNA antibody, or anti-Smith antibody. To ensure sufficient disease activity, subjects must meet specific thresholds for the SLEDAI-2K score and BILAG grades. Additionally, participants are required to be on a stable background therapy consisting of a maximum of one immunosuppressant, one antimalarial, or oral corticosteroids for a specified duration prior to the study.

This Phase II, randomised, placebo-controlled, double-blind, parallel-group study is designed to evaluate the efficacy and safety of oral BI 3000202 in patients diagnosed with moderate to severe systemic lupus erythematosus. The primary objective is to demonstrate a non-flat dose response curve and evaluate the treatment effect of various dose regimens compared to a matching placebo. The primary endpoint is the achievement of the Systemic Lupus Erythematosus Responder Index (SRI)-4 response at Week 32. Secondary endpoints include the achievement of SRI-4 response at Week 52, reduction of oral corticosteroids to ≤5 mg/day prednisone equivalent at Week 32, and achievement of the Lupus Low Disease Activity State (LLDAS) at Week 32. The study involves a screening period to confirm eligibility based on criteria such as age, confirmed diagnosis, specific antibody profiles, and stable background therapy. Following screening, participants will undergo treatment and follow-up assessments to monitor clinical responses and safety.

The experimental treatment consists of BI 3000202 administered in the form of a film-coated tablet. This substance is intended for oral use. The specific dosage regimens for the active substance are evaluated to determine the efficacy and safety in patients with moderate to severe systemic lupus erythematosus.

The control group receives a placebo designed to match the BI 3000202 administration. This placebo is utilized as a comparator in this randomized, double-blind, parallel-group study design.

The efficacy of oral BI 3000202 in patients with moderate to severe systemic lupus erythematosus will be evaluated using specific clinical endpoints. The primary endpoint is the achievement of the Systemic Lupus Erythematosus Responder Index (SRI)-4 response at Week 32.

Secondary efficacy assessments include:

• Achievement of SRI-4 response at Week 52.
• Achievement of SRI-4 response and oral corticosteroid reduction to ≤5 mg/day prednisone or equivalent at Week 32.
• Achievement of Lupus Low Disease Activity State (LLDAS) at Week 32.