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RecruitingPhase 2

A Study to Test Whether Different Doses of BI 3000202 Help People With Systemic Lupus Erythematosus (SLE)

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 74 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 1 year
  • Procedures mentioned: Pills

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants take the tablets for 1 year."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether different doses of BI 3000202 help adults with systemic lupus erythematosus (SLE), also called lupus, and which dose works best. Participants take study medicine or a placebo (a pill with no medicine) for 1 year while continuing their regular lupus treatment.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 to 74, or meet the local minimum age for adults.
  • Have a confirmed lupus diagnosis that met the required medical standards at least 24 weeks before screening.
  • Have at least one positive lupus antibody blood test: ANA at 1:80 or higher, anti-dsDNA, or anti-Smith.
  • Have lupus activity scores of at least 6 overall and at least 4 for clinical signs on the SLEDAI-2K scale.
  • Have at least one grade A or B on the BILAG lupus activity scale, with enough active disease agreed on by the study doctor and reviewer.
  • Meet the regular lupus treatment rules: no more than one immune-suppressing drug and/or one antimalarial drug for at least 8 weeks, with a steady dose for at least 4 weeks; and/or oral steroids at no more than 30 mg daily of prednisone or an equal dose, steady for at least 2 weeks before screening.
  • Other entry rules also apply.

Who can't join

  • Have lupus caused by a medicine.
  • Have scleroderma, a disease that hardens skin, or another connective tissue disease that could affect lupus test results. Linear scleroderma is allowed if it does not affect lupus checks.
  • Have active or unstable lupus affecting the brain, nerves, or mental health. Certain nerve disorders and chorea, which causes unwanted movements, are exceptions.
  • Have lupus kidney disease that may need a change in immune treatment; an unstable blood creatinine level or one over twice the normal upper limit; or an unstable urine protein-to-creatinine ratio or one over 3 mg/mg. These tests help check kidney health.
  • Take more than 30 mg daily of prednisone or an equal dose of another oral steroid at screening.
  • Other rules for who cannot join also apply.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (30)

CA

CO

FL

MI

MS

MT

NC

OH

OK

PA

TN

TX