A Study to Test How Well BI 3000202 is Tolerated by People With Type 1 Interferonopathies
Condition(s) studied
Investigational drug(s) / intervention(s)
BI 3000202_low dose: BI 3000202\_low dose
BI 3000202_high dose: BI 3000202\_high dose
Study summary
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.
Eligibility
Primary outcome measure(s)
- Occurrence of any treatment-emergent adverse events assessed as related to study drug — Approximately 72 weeks
Trial sites (20)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 | Belgium | |
| Hôpital Gui de Chauliac | Montpellier | France | |
| Hopital Necker | Paris | France | |
| HOP Tenon | Paris | France | |
| Universitätsklinikum Carl Gustav Carus Dresden | Dresden | Germany | |
| Medizinische Hochschule Hannover | Hanover | Germany | |
| Universitätsklinikum Tübingen | Tübingen | Germany | |
| Barzilai Medical Center | Ashkelon | Israel | |
| ASST degli Spedali Civili di Brescia | Brescia | Italy | |
| Azienda Sanitaria Universitaria Giuliano Isontina | Trieste | Italy | |
| ULS de Santa Maria, E.P.E | Lisbon | Portugal | |
| ULS de Santo Antônio, E.P.E - Centro Hospitalar Universitário de Santo António | Porto | Portugal | |
| Hospital Universitari Vall d'Hebron | Barcelona | Spain | |
| Hospital Universitario La Paz | Madrid | Spain | |
| Hospital Virgen del Rocio | Seville | Spain | |
| Royal Infirmary of Edinburgh | Edinburgh | United Kingdom | |
| Royal Free Hospital | London | United Kingdom |
More Boehringer Ingelheim trials in the UK
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06878365 on ClinicalTrials.gov ↗ ← All trials in the UK