Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 74
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
405 (estimated)
Sponsor
Boehringer Ingelheim · Industry
Who this trial is looking for
This trial is looking for adults with systemic lupus erythematosus (SLE) to see if a medicine called BI 3000202 can help them. Participants will take the medicine or a placebo for one year while continuing their regular SLE treatment.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 75 years old.
I have been diagnosed with systemic lupus erythematosus (SLE).
I have positive antibody tests.
I have certain disease activity scores.
I have at least one BILAG A or B grade.
I am on stable SLE treatments for at least 4 weeks.
You may not be able to join if
I have drug-induced systemic lupus erythematosus.
I have scleroderma or conditions that affect SLE assessments.
I have active or unstable neuropsychiatric symptoms.
I have lupus nephritis that requires changing treatment.
I am taking more than 30 mg/day of oral corticosteroids.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 g…
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.
Trial Locations
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Status
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) classif…
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.
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