Systemic Lupus Erythematosus study: BI
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 oral tablet 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 testing whether BI 3000202 can help people with SLE. It looks at which dose might work best.
- Who it's for
- You may be able to join if you are an adult with systemic lupus erythematosus (SLE).
- What's involved
- You will take a tablet of BI 3000202 or a pretend tablet for one year. You will keep your usual SLE medicines and visit the study site regularly for check‑ups. Doctors will watch your health and note any side effects.
- Time commitment
- The study lasts a little over one year, with regular visits to the study site for health checks.
- 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 is enrolling
- La Palma, California, United States
- Torrance, California, United States
- Upland, California, United States
- West Hills, California, United States
- Aventura, Florida, United States
- Tampa, Florida, United States
- Jackson, Mississippi, United States
- Great Falls, Montana, United States
- Fayetteville, North Carolina, United States
- Middleburg Heights, Ohio, United States
- Oklahoma City, Oklahoma, United States
- Duncansville, Pennsylvania, United States
- Memphis, Tennessee, United States
- Amarillo, Texas, United States
- Colleyville, Texas, United States
- Euless, Texas, United States
- Frisco, Texas, United States
- Katy, Texas, United States
- CABA, Argentina
- Capital Federal, Argentina
+ 59 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, but 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?
This study is enrolling now at La Palma, California, United States; Torrance, California, United States; Upland, California, United States; West Hills, California, United States; Aventura, Florida, United States; Tampa, Florida, United States and 73 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.