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(HARBOR) Study to Evaluate Efficacy and Safety of BLU-263 Versus Placebo in Patients With Indolent Systemic Mastocytosis

StatusRecruiting
PhasePhase 2/3
Started
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Record History

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  1. Trial sites expanded: 76 → 88 locations
  2. Study sites: 75 to 76
    • Eligibility criteria expanded, about 12 words
  3. Trial sites expanded: 71 → 75 locationsv33
  4. Trial sites expanded: 68 → 71 locationsv32
  5. Trial sites expanded: 64 → 68 locationsv31
  6. Study sites: 63 to 64v30
  7. Trial sites expanded: 59 → 63 locationsv29
  8. Study sites: 57 to 59v28
  9. Study sites: 54 to 57v27
  10. Study sites revised (54)v26
  11. Study sites: 53 to 54v25
  12. Primary and study completion dates: Jun 30, 2028 to Sep 30, 2032v24 Show 5 more changesShow less
    • Primary endpoints: 3 to 5
    • Enrollment target: 463 to 534
    • Study sites: 52 to 53
    • Eligibility criteria shortened, about 200 words
    • Secondary endpoints: 15 to 40
  13. Study sites: 49 to 52v23
  14. Primary endpoints: 4 to 3v22 Show 5 more changesShow less
    • Enrollment target: 443 to 463
    • Interventions: BLU-263 (Drug), Placebo (Drug) to Elenestinib (Drug), Placebo (Drug)
    • Eligibility criteria expanded, about 32 words
    • Secondary endpoints: 21 to 15
    • Study arms: 9 to 10
  15. Primary completion date: Aug 31, 2023 to Jun 30, 2028
    • Site contacts updated at 49 of 49 sites
    v21
  16. Study sites: 47 to 49v20
  17. Study sites: 46 to 47v19
  18. Study sites: 44 to 46v18
  19. Study sites: 42 to 44v17
  20. Study sites: 38 to 42v16
  21. Study sites: 36 to 38v15
  22. Study sites: 34 to 36
    • Primary completion date: Aug 2023 to Aug 31, 2023
    • Study completion date: Jun 2028 to Jun 30, 2028
    v14
  23. Study sites: 28 to 34v13
  24. Study sites: 26 to 28v12
  25. Study sites: 23 to 26v11
  26. Study sites: 19 to 23v10
  27. Study sites: 16 to 19v9
  28. Study sites: 9 to 16v8
  29. Study sites: 4 to 9v7
  30. Enrollment target: 403 to 443v6 Show 4 more changesShow less
    • Study sites: 3 to 4
    • Start date changed from estimate of Oct 6, 2021 to Nov 30, 2021
    • Secondary endpoints: details revised at 5 of 21 entries
    • Eligibility criteria shortened, about 4 words
  31. Start date: Jul 23, 2021 to Oct 6, 2021
    • Study sites: 1 to 3
    v5
  32. Start date: Jul 1, 2021 to Jul 23, 2021
    • Site contact updated
    v4
  33. Start date: Jun 2021 to Jul 1, 2021v3
  34. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v2
  35. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
This is a randomized, double-blind, placebo-controlled, Phase 2/3 study comparing the efficacy and safety of elenestinib (BLU-263) + symptom directed therapy (SDT) with placebo + SDT in participants with indolent systemic mastocytosis (ISM) whose symptoms are not adequately controlled by SDT. Parts 1 and 2 will enroll participants with ISM. Participants enrolled in Part 2 will roll over onto Part 3 to receive treatment with elenestinib in an open-label fashion following completion of the earlier Part. Part K will enroll participants with ISM who have previously received an approved selective KIT inhibitor. The study also includes pharmacokinetic (PK) groups that will enroll participants with ISM.
Trial Details
NCT Number NCT04910685
Lead Sponsor Blueprint Medicines Corporation
Conditions
(from sponsor)		 Indolent Systemic Mastocytosis, Smoldering Systemic Mastocytosis
Related terms Mastocytosis, Systemic
Enrollment 534 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov