A Study to Test How Well BI 3000202 is Tolerated by People With Type 1 Interferonopathies

Conditions

• Type 1 Interferonopathies

Eligibility Criteria

Sex

ALL

Age

18 Years - 74 Years

Healthy Volunteers

Not accepted

Interventions

• BI 3000202_low dose — DRUG
  BI 3000202\_low dose
• BI 3000202_high dose — DRUG
  BI 3000202\_high dose

Study Details

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 36 weeks. They may continue with the study treatment until every participant has completed 40 weeks of treatment (about 9 months). The participants may also continue their regular treatment for their condition during the study. During this study, participants visit the study site 13 times or more, depending on when they start their participation. The doctors check the health of the participants and note any health problems that could have been caused by BI 3000202.

Key Dates

Start date

Jul 29, 2025

Status verified

Jun 2026

Primary completion

Dec 6, 2026

Completion

Dec 7, 2026

Study Design

Enrollment

16 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: BI 3000202

Primary Outcome Measure

Occurrence of any treatment-emergent adverse events assessed as related to study drug [ Time Frame: Approximately 72 weeks ]

Locations (3)

Find similar trials in San Francisco, CA