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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Systemic Lupus Erythematosus

In brief

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.

Key facts

Study ID

NCT07409181

Run by

Boehringer Ingelheim

People needed

405

Starts

2026-04-20

Expected to finish

2029-07-08

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Drug-induced SLE
• 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)
• Oral corticosteroids (prednisone or equivalent) >30 mg/day at screening Further exclusion criteria apply.

Where it is running

• Peking Union Medical College Hospital — Beijing, China (enrolling)
• Renji Hospital Shanghai Jiaotong Univesrity School of Medicine — Shanghai, China (enrolling)
• Instituto Médico Especializado — Capital Federal, Argentina (enrolling)
• Medical Center MedTech Services Ltd. — Haskovo, Bulgaria (enrolling)
• Linfen Central Hospital — Linfen, China (enrolling)
• Huashan Hospital, Fudan University — Shanghai, China (enrolling)
• Precision Comprehensive Clinical Research Solutions — Euless, Texas, United States (enrolling)
• Instituto de Investigación Clínica TyT — CABA, Argentina (enrolling)
• Instituto de Investigaciones Clinicas Quilmes — Quilmes, Argentina (enrolling)
• Azidus Centro de Pesquisa Clinica Avancada — Valinhos, Brazil (enrolling)
• Jilin Province People's Hospital — Changchun, China (enrolling)
• The third affiliated hospital of Sun Yat-Sen University — Guangzhou, China (enrolling)
• Nanjing Drum Tower Hospital — Nanjing, China (enrolling)
• The First Affiliated Hospital of Ningbo University — Ningbo, China (enrolling)
• Boeson Research - Great Falls — Great Falls, Montana, United States (enrolling)
• AARDS Research, Inc. — Aventura, Florida, United States (enrolling)
• Centro Medico Reumatologico - OMI — CABA, Argentina (enrolling)
• Paramount Medical Research and Consulting — Middleburg Heights, Ohio, United States (enrolling)
• Sanatorio Maipú — Maipu, Argentina (enrolling)
• Altoona Arthritis & Osteoporosis Center - Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States (enrolling)
• Centro de Investigaciones Médicas Tucumán — San Miguel de Tucumán, Argentina (enrolling)
• CEPIC - Centro Paulista de Investigacao Clinica e Servicos — São Paulo, Brazil (enrolling)
• Clinical Research of West Florida, Inc. - Tampa — Tampa, Florida, United States (enrolling)
• Amarillo Center for Clinical Research — Amarillo, Texas, United States (enrolling)
• The Second Affiliated Hospital of Soochow University — Suzhou, China (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.