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A Study of JNJ-88549968 for the Treatment of Calreticulin (CALR)-Mutated Myeloproliferative Neoplasms

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Lead sponsor: Janssen Research & Development, LLC to Janssen Research & Development, LLC Trial sites expanded: 41 → 44 locations · Eligibility criteria expanded, about 12 words Show 2 more changesShow less
    • Trial sites expanded: 41 → 44 locations
    • Eligibility criteria expanded, about 12 words
  2. Enrollment increased: 241 → 300 participants Study sites: 39 to 41v39 Show 1 more changeShow less
    • Study sites: 39 to 41
  3. Trial sites expanded: 36 → 39 locationsv38
  4. Trial sites expanded: 33 → 36 locations Completion pushed from May 12, 2028 to Jun 14, 2028 · Enrollment target: 220 to 241v37 Show 2 more changesShow less
    • Completion pushed from May 12, 2028 to Jun 14, 2028
    • Enrollment target: 220 to 241
  5. Completion pushed from Apr 12, 2028 to May 12, 2028 Study sites: 31 to 33v36 Show 1 more changeShow less
    • Study sites: 31 to 33
Show 34 earlier versionsHide 34 earlier versions
  1. 2 versions Re-verified since Apr 9, 2026, no change to tracked fieldsv34-v35
  2. Study sites: 29 to 31 Completion date: Dec 15, 2027 to Apr 12, 2028v33 Show 1 more changeShow less
    • Completion date: Dec 15, 2027 to Apr 12, 2028
  3. Primary endpoints revised (3) Interventions: JNJ-88549968 (Drug), Ruxolitinib (Drug) to JNJ-88549968 (Drug), Momelotinib (Drug), Ruxolitinib (Drug) · Eligibility criteria expanded, about 20 words · Secondary endpoints revised (7)v32 Show 3 more changesShow less
    • Interventions: JNJ-88549968 (Drug), Ruxolitinib (Drug) to JNJ-88549968 (Drug), Momelotinib (Drug), Ruxolitinib (Drug)
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints revised (7)

    See this version in full on ClinicalTrials.gov ↗

  4. Interventions: JNJ-88549968 (Drug) to JNJ-88549968 (Drug), Ruxolitinib (Drug) Site details revised at 1 of 29 sitesv31 Show 1 more changeShow less
    • Site details revised at 1 of 29 sites
  5. Re-verified, no change to tracked fieldsv30
  6. Enrollment target: 100 to 220 Site details revised at 1 of 29 sitesv29 Show 1 more changeShow less
    • Site details revised at 1 of 29 sites
  7. Study sites: 26 to 29v28
  8. Study sites: 24 to 26 Completion date: Dec 4, 2026 to Dec 15, 2027v27 Show 1 more changeShow less
    • Completion date: Dec 4, 2026 to Dec 15, 2027
  9. Study sites: 23 to 24v26
  10. Study sites: 22 to 23v25
  11. Re-verified, no change to tracked fieldsv24
  12. Primary completion date: Oct 1, 2025 to Dec 4, 2026 Study sites: 19 to 22 · Completion date: Sep 3, 2026 to Dec 4, 2026v23 Show 2 more changesShow less
    • Study sites: 19 to 22
    • Completion date: Sep 3, 2026 to Dec 4, 2026
  13. 3 versions Re-verified since Mar 27, 2025, no change to tracked fieldsv20-v22
  14. Completion date: Jun 4, 2026 to Sep 3, 2026v19
  15. Study sites: 17 to 19v18
  16. Completion date: Nov 19, 2026 to Jun 4, 2026v17
  17. 2 versions Re-verified since Dec 3, 2024, no change to tracked fieldsv15-v16
  18. Study sites: 16 to 17v14
  19. Study sites revised (16)v13 See this version in full on ClinicalTrials.gov ↗
  20. Study sites: 15 to 16v12
  21. Study sites: 14 to 15v11
  22. Study sites: 13 to 14v10
  23. Study sites: 10 to 13v9
  24. Study sites: 9 to 10v8
  25. Study sites: 4 to 9v7
  26. Re-verified, no change to tracked fieldsv6
  27. Study sites revised (4)v5 See this version in full on ClinicalTrials.gov ↗
  28. Study sites: 2 to 4v4
  29. Study sites: 1 to 2 Start date changed from estimate of Dec 11, 2023 to Dec 20, 2023v3 Show 1 more changeShow less
    • Start date changed from estimate of Dec 11, 2023 to Dec 20, 2023
  30. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Completion date: Oct 23, 2025 to Nov 19, 2026v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Completion date: Oct 23, 2025 to Nov 19, 2026
  1. 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.
The purpose of this study is to characterize safety and to determine the Recommended Phase 2 Dose (RP2D\[s\]) and optimal dosing schedule(s) of JNJ-88549968 in part 1 (Dose Escalation); to characterize the safety of JNJ- 88549968 at RP2D(s) in part 2 (Cohort Expansion). For U.S. sites: the purpose of this study is to characterize the safety and to determine the RP2D(s) and optimal dosing schedule(s) of JNJ-88549968 in Part 1 and part 1b (Dose Escalation), and to characterize the safety of JNJ-88549968 at the RP2D(s) in Part 2 and part 2b (Cohort Expansion), when given as monotherapy in essential thrombocythemia (ET) or myelofibrosis (MF), and with ruxolitinib or momelotinib in MF only.
Trial Details
NCT Number NCT06150157
Lead Sponsor Janssen Research & Development, LLC
Conditions Neoplasms
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov