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New treatment option for Systemic Lupus Erythematosus
Official title A Study to Test Whether Different Doses of BI 3000202 Help People With Systemic Lupus Erythematosus (SLE)
ClinicalTrials.gov ID: NCT07409181
What this study is testing
What is BI 3000202?
BI 3000202 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for systemic lupus erythematosus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 74
You may be able to join if
- Male and female adult patients from ≥18 years (or alternative age for adults based on local regulations) to \<75 years
- Confirmed Systemic Lupus Erythematosus (SLE) diagnosis meeting the European League Against Rheumatism/American College of Rheumatology (EULAR/ACR)...
- At least one of the following positive at screening: Antinuclear Antibodies (ANA) ≥1:80 or anti-double-stranded Deoxyribonucleic Acid (dsDNA)...
- 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...
- 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...
You likely can't join if
- 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...
- Active or unstable lupus neuropsychiatric manifestations, including but not limited to any condition as defined by BILAG A criteria in the...
- Lupus nephritis that may require a change in immune-modulating treatment or which demonstrates serum creatinine that is unstable or \>2 × Upper Limit...
- 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
- Beverly Hills, California, United States
- La Palma, California, United States
- San Diego, California, United States
- Torrance, California, United States
- Upland, California, United States
- West Hills, California, United States
- Denver, Colorado, United States
- Aventura, Florida, United States
- Brandon, Florida, United States
- Clearwater, Florida, United States
- Plantation, Florida, United States
- Tampa, Florida, United States
- Grand Blanc, Michigan, United States
- Lansing, Michigan, United States
- Jackson, Mississippi, United States
- Great Falls, Montana, United States
- Charlotte, North Carolina, United States
- Fayetteville, North Carolina, United States
- Middleburg Heights, Ohio, United States
- Oklahoma City, Oklahoma, United States
+ 97 more site(s).
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, 18 years to 74 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beverly Hills, California, United States; La Palma, California, United States; San Diego, California, United States; Torrance, California, United States; Upland, California, United States; West Hills, California, United States and 111 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 ClinicalTrials.gov; the study team decides eligibility.