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Clinical Trials in the EU / 2025-523488-39-00
Completed Phase II

Randomised, placebo-controlled, double-blind, parallel-group Phase II study to evaluate the efficacy and safety of oral BI 3000202 in patients with moderate to severe systemic lupus erythematosus (SLE)

2025-523488-39-00 · tracked via the Priya Life Science EU tracker
Sponsor
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.
Sponsor type
Pharmaceutical company, Pharmaceutical company
Therapeutic area
Immune System Diseases
Decision date
04/05/2026
Enrollment target
106
Sites
Bulgaria, Romania, Germany, Spain, Hungary, Poland, Croatia

Condition studied

Systemic lupus erythematosus

Investigational medicinal product(s)

BI 3000202BI 3000202Placebo matching BI 3000202

Eligibility

Age group
18-64 years, 65+ years
Sex
Female, Male

Primary endpoint

Achievement of a Systemic Lupus Erythematosus Responder Index (SRI)-4 response at Week 32

Endpoint detail

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

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-523488-39-00 on CTIS ↗ ← All trials in the EU