BridgeMD
A study to test whether different doses of BI 3000202 help people with systemic lupus erythematosus (SLE)
EU CTIS ID: 2025-523488-39-00
What this study is testing
The primary objectives are to demonstrate a non-flat dose response curve and to evaluate the treatment effect of different dose regimens of BI 3000202 vs. placebo based on the primary endpoint of achievement of SRI-4 response at Week 32 in patients with moderate to severe SLE.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Male and female adult patients from ≥18 years (or alternative age for adults based on local regulations) to <75 years
- 2. Confirmed SLE diagnosis meeting the 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-dsDNA antibody or anti-Smith antibody
- 4. Total SLEDAI-2K score ≥6 points and clinical SLEDAI-2K score ≥4 points
- 5. At least 1 BILAG A and/or 1 BILAG B grade at screening, with sufficient disease activity according to both investigator and adjudicator
- 6. 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)
You likely 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 × ULN and/or 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.
See the full eligibility criteria
- 1. Male and female adult patients from ≥18 years (or alternative age for adults based on local regulations) to <75 years
- 2. Confirmed SLE diagnosis meeting the 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-dsDNA antibody or anti-Smith antibody
- 4. Total SLEDAI-2K score ≥6 points and clinical SLEDAI-2K score ≥4 points
- 5. At least 1 BILAG A and/or 1 BILAG B grade at screening, with sufficient disease activity according to both investigator and adjudicator
- 6. 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.
- 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 × ULN and/or 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.
The study team makes the final eligibility decision.
Where it's taking place
- Argentina
- Mexico
- Brazil
- Philippines
- Japan
- Serbia
- United Kingdom
- India
- China
- United States
- Colombia
- South Africa
- Taiwan
- Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Argentina; Mexico; Brazil; Philippines; Japan; Serbia and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.