A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia

StatusRecruiting
PhasePhase 1/2
Started

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Record History

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  1. Site details revised at 2 of 43 sites
  2. Primary completion moved earlier from May 2028 to Feb 2028 Show 4 more changesShow less
    • Study completion moved earlier from May 2029 to Feb 2029
    • Study sites: 45 to 43
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 5 of 8 entries
  3. Primary completion pushed from Dec 2026 to May 2028v22 Show 4 more changesShow less
    • Enrollment increased: 58 → 68 participants
    • Study completion pushed from Feb 2027 to May 2029
    • Eligibility criteria revised
    • Secondary endpoints: 7 to 8
  4. Study sites revised (45)v21
  5. Site details revised at 2 of 45 sitesv20
Show 18 earlier versionsHide 18 earlier versions
  1. Study sites revised (45)v19
  2. Site details revised at 2 of 45 sitesv18
  3. Site details revised at 1 of 45 sitesv17
  4. Site details revised at 3 of 45 sitesv16
  5. Site details revised at 1 of 45 sitesv15
  6. Study sites: 42 to 45v14
  7. Site details revised at 4 of 42 sitesv13
  8. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 5 to 42
    • Start date changed from estimate of Aug 2025 to Jul 30, 2025
    v12
  9. Study sites: 4 to 5v11
  10. Site contacts updated at 4 of 4 sitesv10
  11. Primary completion date: Feb 2027 to Dec 2026v9
  12. Start date: May 2025 to Aug 2025
    • Site contacts updated at 4 of 4 sites
    v8
  13. Start date: Mar 2025 to May 2025
    • Study sites: 2 to 4
    v7
  14. Site contacts updated at 2 of 2 sitesv6
  15. Study sites: 1 to 2v5
  16. Study Status, Contacts/Locations, Referencesv4
  17. Re-verified, no change to tracked fieldsv3
  18. Primary endpoints revised (6)
    • Secondary endpoints revised (7)
    • Site contact updated
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Eli Lilly
363 trials monitored
See 16 trials at risk
The purpose of the phase 1 part of this study was to evaluate how well pirtobrutinib is tolerated and what side effects may occur. The phase 2 part of the study will further investigate efficacy and safety of multiple pirtobrutinib dosages versus placebo. The study drug will be administered orally in participants with Primary Immune Thrombocytopenia (ITP). Blood tests will be performed to check how much pirtobrutinib gets into the bloodstream and how long it takes the body to eliminate it. The study will last up to approximately 16 weeks for phase 1 dose-escalation and 28 weeks for phase 2 dose-optimization, excluding screening.
Trial Details
NCT Number NCT06721013
Lead Sponsor Eli Lilly and Company
Conditions
(from sponsor)		 Immune Thrombocytopenia (ITP)
Related terms Purpura, Thrombocytopenic, Idiopathic
Enrollment 68 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov