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Clinical Trials in the UK / NCT07409181
Recruiting Phase 2

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

NCT07409181 · tracked via the Priya Life Science UK tracker
Sponsor
Boehringer Ingelheim
Phase
Phase 2
Started
2026-04-20
Last updated
2026-09-17

Condition(s) studied

Systemic Lupus Erythematosus

Investigational drug(s) / intervention(s)

BI 3000202Placebo

BI 3000202: BI 3000202 at different doses

Placebo: Placebo matching BI 3000202

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
74 Years
Healthy volunteers
No
Inclusion Criteria: 1. Male and female adult patients from ≥18 years (or alternative age for adults based on local regulations) to \<75 years 2. 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 3. 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 4. 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 5. 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 Criteria: 1. Drug-induced SLE 2. 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 3. 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 4. 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) 5. Oral corticosteroids (prednisone or equivalent) \>30 mg/day at screening Further exclusion criteria apply.

Primary outcome measure(s)

Trial sites (140)

FacilityCityRegionStatus
Wallace & Lee Center Beverly Hills California Not Yet Recruiting
Arthritis & Osteoporosis Medical Center, Inc - La Palma La Palma California Recruiting
University of California San Diego San Diego California Not Yet Recruiting
University of California Los Angeles Torrance California Not Yet Recruiting
Inland Rheumatology Clinical Trials, Inc Upland California Recruiting
Focus Clinical Research West Hills California Recruiting
Denver Arthritis Clinic - Lowry Denver Colorado Not Yet Recruiting
AARDS Research, Inc. Aventura Florida Recruiting
Meris Clinical Research-Brandon-69466 Brandon Florida Not Yet Recruiting
Clinical Research of West Florida, Inc. Clearwater Florida Not Yet Recruiting
Integral Rheumatology and Immunology Specialist Plantation Florida Not Yet Recruiting
Clinical Research of West Florida, Inc. - Tampa Tampa Florida Recruiting
AA MRC LLC - Grand Blanc Grand Blanc Michigan Not Yet Recruiting
June DO, PC Lansing Michigan Not Yet Recruiting
Oscar Clinical Trials Jackson Mississippi Recruiting
Boeson Research - Great Falls Great Falls Montana Recruiting
DJL Clinical Research, PLLC Charlotte North Carolina Not Yet Recruiting
Cross Creek Medical Clinic, PA Fayetteville North Carolina Not Yet Recruiting
Paramount Medical Research and Consulting Middleburg Heights Ohio Recruiting
Oklahoma Medical Research Foundation Oklahoma City Oklahoma Not Yet Recruiting
Altoona Arthritis & Osteoporosis Center - Altoona Center for Clinical Research Duncansville Pennsylvania Recruiting
West Tennessee Research Institute Jackson Tennessee Not Yet Recruiting
Shelby Research LLC Memphis Tennessee Recruiting
Amarillo Center for Clinical Research Amarillo Texas Recruiting
Precision Comprehensive Clinical Research Solutions - Colleyville Colleyville Texas Recruiting
Precision Comprehensive Clinical Research Solutions Euless Texas Recruiting
Arthritis & Rheumatology Institute - Frisco Frisco Texas Recruiting
The University of Texas Health Science Center at Houston Houston Texas Not Yet Recruiting
R&H Clinical Research - Katy Katy Texas Recruiting
SouthWest Rheumatology Research Mesquite Texas Not Yet Recruiting
Centro Medico Reumatologico - OMI CABA Argentina Recruiting
Instituto de Investigacion Clinica TyT CABA Argentina Recruiting
Instituto Medico Especializado Capital Federal Argentina Recruiting
Consultora integral en Salud SRL. General Paz Argentina Recruiting
Sanatorio Maipu Maipu Argentina Recruiting
Instituto de Investigaciones Clinicas Quilmes Quilmes Argentina Recruiting
Centro de Investigaciones Medicas Tucuman San Miguel de Tucumán Argentina Recruiting
Austin Health Heidelberg Victoria Recruiting
Fiona Stanley Hospital Murdoch Western Australia Recruiting
SAPIENS - Instituto de Estudos e Pesquisa Clínica Curitiba Brazil Recruiting

+ 100 more sites — see the full list on the official registry below.

Official registry record

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

View NCT07409181 on ClinicalTrials.gov ↗ ← All trials in the UK