A Study to Test How Well BI 3000202 is Tolerated by People With Type 1 Interferonopathies (NCT06878365)
Single-arm Open-label Trial to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BI 3000202 in Adult Patients With Selected Type 1 Interferonopathies
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of California San Francisco — San Francisco, California
Age range: 18 Years to 74 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (20 Sites)
- University of California San Francisco — San Francisco, California
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania
- Texas Children's Hospital — Houston, Texas
- Universitair Ziekenhuis Gent — Ghent,
- Hôpital Gui de Chauliac — Montpellier,
- Hopital Necker — Paris,
- HOP Tenon — Paris,
- Universitätsklinikum Carl Gustav Carus Dresden — Dresden,
- Medizinische Hochschule Hannover — Hanover,
- Universitätsklinikum Tübingen — Tübingen,
- Barzilai Medical Center — Ashkelon,
- ASST degli Spedali Civili di Brescia — Brescia,
- Azienda Sanitaria Universitaria Giuliano Isontina — Trieste,
- ULS de Santa Maria, E.P.E — Lisbon,
- ULS de Santo Antônio, E.P.E - Centro Hospitalar Universitário de Santo António — Porto,
- Hospital Universitari Vall d'Hebron — Barcelona,
- Hospital Universitario La Paz — Madrid,
- Hospital Virgen del Rocío — Seville,
- Royal Infirmary of Edinburgh — Edinburgh,
- Royal Free Hospital — London,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Type 1 Interferonopathies clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.