Testing Different Doses of BI 3000202 in Systemic Lupus Erythematosus
Tests different doses of an oral drug against placebo in adults with lupus.
Plain-language title generated from the registry record
Registry title: A Study to Test Whether Different Doses of BI 3000202 Help People With Systemic Lupus Erythematosus (SLE)
Key facts
- Where
- Haskovo, Pleven, Plovdiv, Sofia, and Sofiya, BulgariaSee the 8 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 74 years old?
Source: NCT07409181, who can take part
Where in Bulgaria
- Medical Center MedTech Services Ltd.Haskovo, BulgariaTaking people
- Military Medical AcademyPleven, BulgariaTaking people
- Multiprofile Hospital For Active Treatment Medical Complex Sveti Ivan Rilski EOODPlovdiv, BulgariaTaking people
- University Multiprofessional Hospital For Active Treatment Plovdiv ADPlovdiv, BulgariaTaking people
- Medici Sofia Medical Centre Ltd.Sofia, BulgariaTaking people
- University Multiprofile Hospital For Active Treatment St. Ivan Rilski EADSofia, BulgariaTaking people
- Diagnostic-Consultative Center Alexandrovska EOODSofiya, BulgariaTaking people
- Medical Center Hera EOODSofiya, BulgariaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Boehringer Ingelheim
- Trial code
- NCT07409181EU 2025-523488-39-00
- Record updated
- 28 October 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: Male and female adult patients from ≥18 years (or alternative age for adults based on local regulations) to <75 years; Confirmed Systemic Lupus Erythematosus (SLE) diagnosis meeting the European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria at least 24 weeks prior to screening; At least one of the following positive at screening: Antinuclear Antibodies (ANA) ≥1:80 or anti-double-stranded Deoxyribonucleic Acid (dsDNA) antibody or anti-Smith antibody; Total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥6 points and clinical SLEDAI-2K score ≥4 points; At least 1 British Isles Lupus Assessment Group (BILAG) A and/or 1 BILAG B grade at screening, with sufficient disease activity according to both investigator and adjudicator; On SLE background therapy with a maximum of 1 immunosuppressant and/or 1 antimalarial for ≥8 weeks and at a stable dose for ≥4 weeks before screening and/or oral corticosteroids at a dose of ≤30 mg/day prednisone or equivalent, stable for ≥2 weeks before screening (Visit 1) Further inclusion criteria apply.
Exclusion: Drug-induced SLE; Oral corticosteroids (prednisone or equivalent) >30 mg/day at screening Further exclusion criteria apply; Scleroderma (except linear scleroderma that does not interfere with assessments of SLE disease activity) or in the opinion of the investigator or adjudicator elements of other connective tissue disease that would interfere with interpretation of test results or SLE clinical assessments; Active or unstable lupus neuropsychiatric manifestations, including but not limited to any condition as defined by BILAG A criteria in the neuropsychiatric system, with the exception of mononeuritis/mononeuropathy multiplex, chorea, and polyneuropathy; Lupus nephritis that may require a change in immune-modulating treatment or which demonstrates serum creatinine that is unstable or >2 × Upper Limit of Normal (ULN) and/or Urine Protein Creatinine Ratio (UPCR) that is unstable or > 3mg/mg (339 mg/mmol).