Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
A Study to Test How Well BI 3000202 is Tolerated by People With Type 1 Interferonopathies
NCT06878365 · View on ClinicalTrials.gov ↗
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 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06878365
The ClinicalTrials.gov registry entry for NCT06878365 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 203 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06878365 reports 20 study locations spanning 4 distinct geographic areas — top geographies include Other, California, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06878365?
The interventions under investigation include: BI 3000202_low dose (DRUG), BI 3000202_high dose (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06878365?
This trial is sponsored by Boehringer Ingelheim, which has 203 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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 Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.