1509-0003: A study to test how well BI 3000202 is tolerated by people with type 1 interferonopathies
Research type
Research Study
Full title
Single-arm open-label trial to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 3000202 in adult patients with selected type 1 interferonopathies.
IRAS ID
1011165
Contact name
Medical Information N/A
Contact email
Sponsor organisation
Boehringer Ingelheim Limited
Clinicaltrials.gov Identifier
Research summary
Lay Title\nA study to test how well BI 3000202 is tolerated by people with type 1 interferonopathies\nBrief Summary\nThis study is open to adults with selected type 1 interferonopathies. People can join the \nstudy if they have Aicardi-Goutières syndrome (AGS), Coatomer subunit alpha (COPA) \nsyndrome, Familial chilblain lupus (FCL), or another type 1 interferonopathy with a specific \ngene mutation.\nThe purpose of this study is to find out how BI 3000202 is tolerated in people with selected \ntype 1 interferonopathies. Participants take a lower dose of BI 3000202 as tablets for 4 \nweeks. Afterwards, they take a higher dose of BI 3000202 as tablets for 36 weeks. They may \ncontinue with the study treatment until every participant has completed 40 weeks of \ntreatment (about 9 months). The participants may also continue their regular treatment for \ntheir condition during the study.\nDuring this study, participants visit the study site 13 times or more, depending on when they \nstart their participation. The doctors check the health of the participants and note any \nhealth problems that could have been caused by BI 3000202.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
25/YH/0018
Date of REC Opinion
17 Mar 2025
REC opinion
Further Information Favourable Opinion