Summary

Eligibility
for people ages 18-74 (full criteria)
Location
at Torrance, California and other locations
Dates
study started
study ends around

Description

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.

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)

Keywords

Systemic Lupus Erythematosus, Lupus

Eligibility

You can join if…

Open to people ages 18-74

  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.

You CAN'T join if...

  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.

Locations

  • University of California Los Angeles not yet accepting patients
    Torrance California 90509 United States
  • Wallace & Lee Center not yet accepting patients
    Beverly Hills California 90210 United States
  • Focus Clinical Research not yet accepting patients
    West Hills California 91307 United States
  • Arthritis & Osteoporosis Medical Center, Inc - La Palma not yet accepting patients
    La Palma California 90623 United States
  • CEPIC - Centro Paulista de Investigacao Clinica e Servicos accepting new patients
    São Paulo 04266-010 Brazil
  • Azidus Centro de Pesquisa Clinica Avancada not yet accepting patients
    Valinhos 13271-130 Brazil
  • Hospital de Galdakao accepting new patients
    Galdakao 48960 Spain
  • Hospital Universitario Ramon Y Cajal not yet accepting patients
    Madrid 28034 Spain
  • Hospital Universitario de Araba not yet accepting patients
    Vitoria-Gasteiz 01009 Spain

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Boehringer Ingelheim
Links
Related Info
ID
NCT07409181
Phase
Phase 2 Lupus Research Study
Study Type
Interventional
Participants
Expecting 405 study participants
Last Updated