BI 3000202 for Lupus

Not yet recruiting at 114 trial locations
BI
Overseen ByBoehringer Ingelheim
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Boehringer Ingelheim
Must be taking: Immunosuppressants, Antimalarials
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial is studying a new medication, BI 3000202, to determine its effectiveness for people with systemic lupus erythematosus (SLE), a condition where the immune system attacks the body. The researchers aim to identify the optimal dose by testing four different doses against a placebo, which resembles the medication but contains no active ingredients. Participants will continue their regular treatment while taking the trial tablets for about a year. This trial suits those with a confirmed SLE diagnosis who are on stable treatment and have certain positive antibody tests, such as Antinuclear Antibodies. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

No, you can continue your regular treatment for lupus while participating in this trial.

Is there any evidence suggesting that BI 3000202 is likely to be safe for humans?

Research has shown that BI 3000202 is being tested for its potential to help people with systemic lupus erythematosus (SLE), a condition where the immune system mistakenly attacks the body's tissues. So far, participants generally tolerate the treatment well, but it remains in the early stages of testing, so limited information exists about its long-term safety. No major safety issues have been reported yet, but like any new treatment, some side effects might occur.

Researchers place participants into groups to test different doses of BI 3000202. This process helps determine the optimal dose that works effectively with the fewest side effects. Regular health check-ups during the study will quickly identify any unwanted effects.

While more research is needed, current data suggests that BI 3000202 is safe enough for further testing. However, participants should discuss any concerns with their healthcare provider.12345

Why do researchers think this study treatment might be promising for lupus?

Most treatments for lupus focus on suppressing the immune system to reduce inflammation. But BI 3000202 stands out because it potentially targets a specific pathway involved in the disease, which may lead to more precise management with fewer side effects. Researchers are particularly excited about the possibility that BI 3000202 could offer multiple dosage options, allowing for tailored treatments based on individual patient needs. This personalized approach could mark a significant advancement over the one-size-fits-all nature of many current lupus therapies.

What evidence suggests that this trial's treatments could be effective for lupus?

Research has shown that BI 3000202 is under study for its potential to help people with systemic lupus erythematosus (SLE). Early results suggest that BI 3000202 may work by affecting certain parts of the immune system, potentially reducing inflammation and symptoms in SLE. This trial includes multiple arms testing different doses of BI 3000202 to determine the most effective and safe dose. Previous studies in similar conditions have shown that the drug is generally well-tolerated, which is encouraging for its use in SLE. As more information becomes available, researchers hope to confirm its benefits for those dealing with this challenging autoimmune disease.12567

Are You a Good Fit for This Trial?

Adults aged 18 to less than 75 with confirmed systemic lupus erythematosus (SLE) can join this study. They must have active disease, be on stable SLE medication for at least 8 weeks, and if taking corticosteroids, no more than the equivalent of 30 mg/day prednisone for at least 2 weeks.

Inclusion Criteria

5. 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 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.
I have been diagnosed with lupus for at least 6 months.
My lupus activity score is high, showing active disease.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive different doses of BI 3000202 or placebo for 1 year

52 weeks
Regular visits to the study site

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • BI 3000202

Trial Overview

The trial is testing BI 3000202 in different doses to see if it helps people with SLE. Participants are randomly assigned to either one of four dose groups or a placebo group and will continue their regular SLE treatments alongside the study tablets for a year.

How Is the Trial Designed?

5

Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm 4: BI 3000202 dose 4Experimental Treatment1 Intervention
Group II: Arm 3: BI 3000202 dose 3Experimental Treatment1 Intervention
Group III: Arm 2: BI 3000202 dose 2Experimental Treatment1 Intervention
Group IV: Arm 1: BI 3000202 dose 1Experimental Treatment1 Intervention
Group V: Arm 5: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials
2,566
Recruited
16,150,000+

Citations

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