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

RecruitingPhase 2

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)

Who can join

Ages 18 to 74 · All sexes

Full eligibility criteria
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.

About the study

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.

What is being tested

Sponsor: Boehringer Ingelheim · Participants: 405 · Started: Apr 20, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07409181

Locations in the U.S.

CaliforniaWallace & Lee Center, Beverly Hills (Not yet recruiting)
Arthritis & Osteoporosis Medical Center, Inc - La Palma, La Palma
University of California San Diego, San Diego (Not yet recruiting)
University of California Los Angeles, Torrance (Not yet recruiting)
Inland Rheumatology Clinical Trials, Inc, Upland
Focus Clinical Research, West Hills
ColoradoDenver Arthritis Clinic - Lowry, Denver (Not yet recruiting)
FloridaAARDS Research, Inc., Aventura
Meris Clinical Research-Brandon-69466, Brandon (Not yet recruiting)
Clinical Research of West Florida, Inc., Clearwater (Not yet recruiting)
Integral Rheumatology and Immunology Specialist, Plantation (Not yet recruiting)
Clinical Research of West Florida, Inc. - Tampa, Tampa
MichiganAA MRC LLC - Grand Blanc, Grand Blanc (Not yet recruiting)
June DO, PC, Lansing (Not yet recruiting)
MississippiOscar Clinical Trials, Jackson
MontanaBoeson Research - Great Falls, Great Falls
North CarolinaDJL Clinical Research, PLLC, Charlotte (Not yet recruiting)
Cross Creek Medical Clinic, PA, Fayetteville (Not yet recruiting)
OhioParamount Medical Research and Consulting, Middleburg Heights
OklahomaOklahoma Medical Research Foundation, Oklahoma City (Not yet recruiting)
PennsylvaniaAltoona Arthritis & Osteoporosis Center - Altoona Center for Clinical Research, Duncansville
TennesseeWest Tennessee Research Institute, Jackson (Not yet recruiting)
Shelby Research LLC, Memphis
TexasAmarillo Center for Clinical Research, Amarillo
Precision Comprehensive Clinical Research Solutions - Colleyville, Colleyville
Precision Comprehensive Clinical Research Solutions, Euless
Arthritis & Rheumatology Institute - Frisco, Frisco
The University of Texas Health Science Center at Houston, Houston (Not yet recruiting)
R&H Clinical Research - Katy, Katy
SouthWest Rheumatology Research, Mesquite (Not yet recruiting)

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.