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NCT06878365
A Study to Test How Well BI 3000202 is Tolerated by People With Type 1 Interferonopathies
Phase 1 trial testing BI 3000202_low dose in Type 1 Interferonopathies in 16 participants. Participants enrolled and being followed up; not accepting new ones.
6 December 2026
Quick facts
| Lead sponsor | Boehringer Ingelheim |
|---|---|
| Phase | Phase 1 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 16 |
| Start date | 29 July 2025 |
| Primary completion | 6 December 2026 |
| Estimated completion | 7 December 2026 |
| Sites | 20 locations across France, Italy, Belgium, United Kingdom, Israel, Germany, Portugal, United States |
Drugs / interventions tested
- BI 3000202_low dose — full drug profile →
- BI 3000202_high dose — full drug profile →
Conditions studied
- Type 1 Interferonopathies — all drugs for Type 1 Interferonopathies →
Sponsor
Boehringer Ingelheim — full company profile →
Who can join
Adults 18 to 74, any sex, with Type 1 Interferonopathies. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06878365
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Type 1 Interferonopathies
Currently open trials in the same condition.
- NCT07364513 — Phase 1b Safety Study of IMSB301 in Type 1 Interferonopathies · Phase 1 · recruiting
Other Boehringer Ingelheim trials
Trials by the same sponsor.
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- NCT07366034 — A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With I · Phase 3 · not yet recruiting
- NCT07531628 — A Study to Test How Verducatib is Taken up in the Body of Healthy Chinese Participants · Phase 1 · not yet recruiting
- NCT07497087 — A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis · Phase 3 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06878365 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
- Last refreshed: 2 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06878365.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing