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NCT06878365 · ClinicalTrials.gov registry record · Phase 1
A Study to Test How Well BI 3000202 is Tolerated by People With Type 1 Interferonopathies
A Phase 1 study of Type 1 Interferonopathies, sponsored by Boehringer Ingelheim.
- Active
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 20
- Study locations
NCT06878365: Active Phase 1 study of Type 1 Interferonopathies, sponsored by Boehringer Ingelheim.
NCT06878365 is a Phase 1 study of Type 1 Interferonopathies that is active but no longer recruiting, run by Boehringer Ingelheim. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06878365, a Phase 1 study of Type 1 Interferonopathies, is active but no longer recruiting, sponsored by Boehringer Ingelheim.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 20
- Study locations
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.
Conditions Studied
Interventions
- DRUG BI 3000202_low dose
- DRUG BI 3000202_high dose
Study Locations (20)
Other
- Universitair Ziekenhuis Gent - Ghent
- HOP Gui de Chauliac - Montpellier
- Hôpital 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
California
- University of California San Francisco - San Francisco
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Texas
- Texas Children's Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2025-07-29 |
| Est. Completion | 2026-12-07 |
| Phase | Phase 1 |
What the registry record for NCT06878365 still lists
NCT06878365 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 1 condition, with Type 1 Interferonopathies appearing as the primary indexed condition, and to 2 interventions - of which BI 3000202_low dose is the first listed.
NCT06878365 names 20 study sites across 4 states, led by Other, California, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06878365 about?
NCT06878365 is a clinical study titled "A Study to Test How Well BI 3000202 is Tolerated by People With Type 1 Interferonopathies". 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 thi...
What is the current status of trial NCT06878365?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2025-07-29. Estimated completion is 2026-12-07.
What conditions does trial NCT06878365 study?
This clinical trial studies the following conditions: Type 1 Interferonopathies.
What interventions are being tested in trial NCT06878365?
The interventions under investigation include: BI 3000202_low dose (DRUG), BI 3000202_high dose (DRUG).
Who is sponsoring clinical trial NCT06878365?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06878365 being conducted?
This trial has 20 study locations across California, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06878365's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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