Recruiting
Phase 2

BI 3000202

Sponsor:

Boehringer Ingelheim

Code:

NCT07409181

Conditions

Systemic Lupus Erythematosus

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

BI 3000202

Placebo

Study Details

Brief 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.

Conditions

Systemic Lupus Erythematosus

Study ID

NCT07409181

Start date

Apr 20, 2026

Status verified date

Sep, 2026

Completion date

Jul 8, 2029

Anticipated

Primary completion date

Feb 4, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

405 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm 1: BI 3000202 dose 1

experimental: Arm 2: BI 3000202 dose 2

experimental: Arm 3: BI 3000202 dose 3

experimental: Arm 4: BI 3000202 dose 4

placebo comparator: Arm 5: Placebo

Interventions

BI 3000202

BI 3000202 at different doses

Placebo

Placebo matching BI 3000202

Primary outcome measure

  • Achievement of a Systemic Lupus Erythematosus Responder Index (SRI)-4 response [ Time Frame: At Week 32 ]

Central Contacts and Locations

Central contacts

Locations

Arthritis & Osteoporosis Medical Center, Inc - La Palma

Recruiting

La Palma, California, United States, 90623

Contacts

Inland Rheumatology Clinical Trials, Inc

Recruiting

Upland, California, United States, 91786

Contacts

Focus Clinical Research

Recruiting

West Hills, California, United States, 91307

Contacts

AARDS Research, Inc.

Recruiting

Aventura, Florida, United States, 33180

Contacts

Clinical Research of West Florida, Inc. - Tampa

Recruiting

Tampa, Florida, United States, 33606

Contacts

Oscar Clinical Trials

Recruiting

Jackson, Mississippi, United States, 39206

Contacts

Boeson Research - Great Falls

Recruiting

Great Falls, Montana, United States, 59405

Contacts

Cross Creek Medical Clinic, PA

Recruiting

Fayetteville, North Carolina, United States, 28304

Contacts

Paramount Medical Research and Consulting

Recruiting

Middleburg Heights, Ohio, United States, 44130

Contacts

Altoona Arthritis & Osteoporosis Center - Altoona Center for Clinical Research

Recruiting

Duncansville, Pennsylvania, United States, 16635

Contacts

Shelby Research LLC

Recruiting

Memphis, Tennessee, United States, 38119

Contacts

Amarillo Center for Clinical Research

Recruiting

Amarillo, Texas, United States, 79124

Contacts

Precision Comprehensive Clinical Research Solutions - Colleyville

Recruiting

Colleyville, Texas, United States, 76034

Contacts

Precision Comprehensive Clinical Research Solutions

Recruiting

Euless, Texas, United States, 76040

Contacts

Arthritis & Rheumatology Institute - Frisco

Recruiting

Frisco, Texas, United States, 75035

Contacts

R&H Clinical Research - Katy

Recruiting

Katy, Texas, United States, 77449

Contacts

More Information

Sponsor

Boehringer Ingelheim

Last update posted

Oct 1, 2026

Last verified

Sep, 2026

Keywords

  • Lupus

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by Boehringer Ingelheim on 2026-10-01. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.