BI 3000202 for Lupus

Not yet recruiting at 114 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Boehringer Ingelheim

Must be taking: Immunosuppressants, Antimalarials

Disqualifiers: Drug-induced SLE, Scleroderma, Lupus nephritis, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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.

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?

Group I: Arm 4: BI 3000202 dose 4 Experimental Treatment 1 Intervention

Group II: Arm 3: BI 3000202 dose 3 Experimental Treatment 1 Intervention

Group III: Arm 2: BI 3000202 dose 2 Experimental Treatment 1 Intervention

Group IV: Arm 1: BI 3000202 dose 1 Experimental Treatment 1 Intervention

Group V: Arm 5: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+