Shelby Research

Systemic Lupus Erythematosus (SLE) 1509-0004 Study

Boehringer Ingelheim clinical trial for Systemic Lupus Erythematosus (SLE)

NOW ENROLLING

This study will evaluate the Efficacy and Safety of oral BI 3000202 in adults with moderate to severe Systemic Lupus Erythematosus (SLE), and to find the best dose for people with this condition.

Trial 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. Approximately 405 participants will be enrolled in the study.

Condition or disease
Systemic Lupus Erythematosus (SLE)

Intervention/treatment
Drug: BI 3000202
Drug: Placebo

Phase
Phase 2

Inclusion Criteria

  • Male and female adult patients from 18 years to under 75 years of age.

  • 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 higher, or anti-double-stranded Deoxyribonucleic Acid (dsDNA) antibody, or anti-Smith antibody. Total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of 6 points or more and clinical SLEDAI-2K score of 4 points or more.

  • 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 at least 8 weeks and at a stable dose for at least 4 weeks before screening, and/or oral corticosteroids at a dose of 30 mg/day prednisone or equivalent or less, stable for at least 2 weeks before screening.

    • ***Additional inclusion criteria are defined in the protocol.

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 greater than 2 times the Upper Limit of Normal (ULN), and/or Urine Protein Creatinine Ratio (UPCR) that is unstable or greater than 3 mg/mg (339 mg/mmol).

  • Oral corticosteroids (prednisone or equivalent) greater than 30 mg/day at screening.

    • ***Other protocol-defined inclusion/exclusion criteria may apply

View Trial on ClinicalTrials.gov website: NCT07409181