A Study to Test Whether Different Doses of BI 3000202 Help People With Systemic Lupus Erythematosus (SLE)
Boehringer Ingelheim · NCT07409181
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–74 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 2
- Target enrollment
- 405
- US sites recruiting
- 16
- Study start
- April 20, 2026
- Record last updated
- October 14, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: BI 3000202; Placebo
Conditions: Systemic Lupus Erythematosus
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- 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 Criteria
- 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.
Recruiting US locations
Arthritis & Osteoporosis Medical Center, Inc - La Palma
La Palma, CA 90623
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Inland Rheumatology Clinical Trials, Inc
Upland, CA 91786
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Focus Clinical Research
West Hills, CA 91307
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
AARDS Research, Inc.
Aventura, FL 33180
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Clinical Research of West Florida, Inc. - Tampa
Tampa, FL 33606
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Oscar Clinical Trials
Jackson, MS 39206
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Boeson Research - Great Falls
Great Falls, MT 59405
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Cross Creek Medical Clinic, PA
Fayetteville, NC 28304
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Paramount Medical Research and Consulting
Middleburg Heights, OH 44130
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Altoona Arthritis & Osteoporosis Center - Altoona Center for Clinical Research
Duncansville, PA 16635
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Shelby Research LLC
Memphis, TN 38119
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Amarillo Center for Clinical Research
Amarillo, TX 79124
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Precision Comprehensive Clinical Research Solutions - Colleyville
Colleyville, TX 76034
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Precision Comprehensive Clinical Research Solutions
Euless, TX 76040
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Arthritis & Rheumatology Institute - Frisco
Frisco, TX 75035
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
R&H Clinical Research - Katy
Katy, TX 77449
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Study contacts (from the official record)
- Boehringer Ingelheim · 1-800-243-0127 · clintriage.rdg@boehringer-ingelheim.com