BI 3000202 for Aicardi-Goutières Syndrome

Recruiting in Palo Alto (17 mi)

+16 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Boehringer Ingelheim

No Placebo Group

Trial Summary

What is the purpose of this trial?This study is open to adults with selected type 1 interferonopathies. People can join the study if they have Aicardi-Goutières syndrome (AGS), Coatomer subunit alpha (COPA) syndrome, Familial chilblain lupus (FCL), or another type 1 interferonopathy with a specific gene mutation. The purpose of this study is to find out how BI 3000202 is tolerated in people with selected type 1 interferonopathies. Participants take a lower dose of BI 3000202 as tablets for 4 weeks. Afterwards, they take a higher dose of BI 3000202 as tablets for 8 weeks. The participants may continue their regular treatment for their condition during the study. Participants are in the study for about 6 months. During this time, they visit the study site 9 times. The doctors check the health of the participants and note any health problems that could have been caused by BI 3000202.

Eligibility Criteria

Adults with type 1 interferonopathies like Aicardi-Goutières syndrome, COPA syndrome, Familial chilblain lupus, or those with specific gene mutations can join. They must be able to take BI 3000202 tablets and continue their regular treatments.

Inclusion Criteria

My genetic test results are already in my medical records.

Women of childbearing potential must be ready and able to use highly effective methods of birth control

I am between 18 and 74 years old.

+3 more

Exclusion Criteria

Increased risk of infectious complications based on investigator's judgement

Further exclusion criteria apply

AGS Severity Scale >3 for patients diagnosed with Aicardi-Goutières syndrome or other interferonopathy with neurological involvement

+3 more

Participant Groups

The trial tests the tolerability of a drug called BI 3000202 at two different doses in people with certain autoimmune disorders. Participants first take a low dose for 4 weeks followed by a high dose for another 8 weeks.

1Treatment groups

Experimental Treatment

Group I: BI 3000202Experimental Treatment2 Interventions