At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- BI 3000202 (drug), Placebo (drug)
- How long the study runs
- Study runs about 39 months (dates as stated)
- About the drug or intervention
- BI 3000202 — drug: BI 3000202 at different doses · Placebo — drug: Placebo matching BI 3000202
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years to 74 Years
- Who
- All
- Number of participants
- 405
- Started
- 2026-04-20
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for systemic lupus erythematosus
- • Phase2 - 405 participants
- • This study is open to adults with systemic lupus erythematosus (SLE)
Who can take part?
- • Ages 18 Years to 74 Years
- • Diagnosed with systemic lupus erythematosus
Where?
- • Basingstoke - Basingstoke and North Hampshire Hospital
- • Belfast - Belfast City Hospital
- • Cambridge - Addenbrooke's Hospital
- • Doncaster - Doncaster Royal Infirmary
- • +1 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 74 Years
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Male and female adult patients from ≥18 years (or alternative age for adults based on local regulations) to \<75 years
- ✓At least one of the following positive at screening: Antinuclear Antibodies (ANA) ≥1:80 or anti-double-stranded...
- ✓\- Total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥6 points and clinical SLEDAI-2K...
- ✓At least 1 British Isles Lupus Assessment Group (BILAG) A and/or 1 BILAG B grade at screening, with sufficient...
Who cannot take part
- ✗Drug-induced SLE
- ✗Oral corticosteroids (prednisone or equivalent) \>30 mg/day at screening Further exclusion criteria apply.
See the full criteria
Where Is This Study? (5 UK sites)
Basingstoke and North Hampshire Hospital
Basingstoke RG24 9NA, United Kingdom
Belfast City Hospital
Belfast BT9 7AB, United Kingdom
Addenbrooke's Hospital
Cambridge CB2 0QQ, United Kingdom
Doncaster Royal Infirmary
Doncaster DN2 5LTT, United Kingdom
Guy's Hospital
London SE1 9RT, United Kingdom
How to Get in Touch
Boehringer Ingelheim
Sponsor contactCONTACT
