A Study to Test Whether Different Doses of BI 3000202 Help People With Systemic Lupus…

Systemic Lupus ErythematosusImmune and autoimmuneDrugPhase 2

What this study is

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's being tested

BI 3000202
Intervention · DRUG
BI 3000202 at different doses
Placebo
Intervention · DRUG
Placebo matching BI 3000202

Study details

Official title: 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)
Sponsor: Boehringer Ingelheim
Conditions: Systemic Lupus Erythematosus
Enrolling: 405 people
Starts: 2026-04-20
Est. completion: 2029-07-08
Design: Quadruple-blind, randomized, parallel groups, Phase 2
Record: View on ClinicalTrials.gov ↗

Who can join

Age 18 Years – 74 YearsSex ALLHealthy 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 can't join 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.

A drug (BI 3000202) for moderate to severe lupus

What this study is

What's being tested

Study details

Who can join

Monitoring & Endpoints

Study locations (139)

Study team

Boehringer Ingelheim

Boehringer Ingelheim

Frequently asked questions