NCT07409181

A Study to Test Whether Different Doses of BI 3000202 Help People With Systemic Lupus Erythematosus (SLE)

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)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 405 (estimated)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	BI 3000202	BI 3000202 at different doses
DRUG	Placebo	Placebo matching BI 3000202

Timeline

• Start date: 2026-04-07
• Primary completion: 2029-02-04
• Completion: 2029-06-24
• First posted: 2026-02-13
• Last updated: 2026-04-15

Locations

130 sites across 21 countries: United States, Argentina, Australia, Brazil, Bulgaria, China, Colombia, Croatia, Germany, Hungary, India, Japan, Mexico, Netherlands, Poland, Romania, Serbia, South Africa, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study