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NCT06878365

A Study to Test How Well BI 3000202 is Tolerated by People With Type 1 Interferonopathies

StatusActive, Not Recruiting
PhasePhase 1
Primary completion (estimated)

At risk: Primary completion moved at least 3 years later.

See at-risk trials from Boehringer Ingelheim

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Record History

All 33 versions: 28 with changes below, 5 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Dec 6, 2026 to Dec 10, 2029
    • Study completion pushed from Dec 7, 2026 to Dec 20, 2029
    • Study sites revised (20)
  2. Eligibility criteria expanded, about 11 words
    • Study sites revised (20)
  3. Study sites revised (20)v29
  4. Study sites revised (20)v25
  5. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 18 to confirmed 16
    • Site details revised at 20 of 20 sites
    v24
Show 22 earlier versionsHide 22 earlier versions
  1. Site details revised at 1 of 20 sitesv23
  2. Site details revised at 2 of 20 sitesv22
  3. Study sites: 19 to 20v21
  4. Study sites revised (19)v20
  5. Site details revised at 1 of 19 sitesv19
  6. Study sites revised (19)v18
  7. Study sites: 18 to 19v17
  8. Study sites revised (18)v16
  9. Site details revised at 1 of 18 sitesv15
  10. Study sites: 19 to 18v14
  11. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 18 to 19
    • Start date changed from estimate of Jul 30, 2025 to Jul 29, 2025
    v13
  12. Start date: Jul 25, 2025 to Jul 30, 2025v12
  13. Start date: Jul 15, 2025 to Jul 25, 2025v11
  14. Eligibility criteria expanded, about 6 words
    • Start date: Jun 30, 2025 to Jul 15, 2025
    • Secondary endpoints revised (6)
    v10
  15. Start date: Jun 16, 2025 to Jun 30, 2025v9
  16. Start date: Jun 10, 2025 to Jun 16, 2025v8
  17. Start date: May 26, 2025 to Jun 10, 2025v7
  18. Start date: May 16, 2025 to May 26, 2025v6
  19. Start date: May 1, 2025 to May 16, 2025v5
  20. Primary completion date: Jun 1, 2026 to Dec 6, 2026
    • Study sites: 17 to 18
    • Study completion date: Sep 2, 2026 to Dec 7, 2026
    • Start date: Apr 14, 2025 to May 1, 2025
    v4
  21. Start date: Apr 4, 2025 to Apr 14, 2025v3
  22. Study sites: 16 to 17
    • Start date: Mar 28, 2025 to Apr 4, 2025
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Occurrence of any treatment-emergent adverse events assessed as related to study drug
Timeframe: Approximately 72 weeks

Secondary (6)

Area under the concentration-time curve of BI 3000202 in plasma from time 0 to 4 hours after administration of the first dose ( AUC0-4)
Maximum measured concentration of BI 3000202 in plasma after administration of the first dose (Cmax)
Area under the concentration-time curve of BI 3000202 in plasma from time 0 to 4 hours at steady state (AUC0-4,ss)
Maximum measured concentration of BI 3000202 in plasma at steady state (Cmax,ss)
Predose concentration of BI 3000202 in plasma at steady state immediately before administration of the next dose (Cpre,ss)
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Change from baseline in interferon gene score (IGS)

Arms and interventions

BI 3000202Experimental

Drugs: BI 3000202_low dose, BI 3000202_high dose

Sites

20 sites in 9 countries

France 3, Germany 3, Spain 3, United States 3, Italy 2, Portugal 2, United Kingdom 2, Belgium 1, Israel 1