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A Phase I/II Study of ITU512 in Healthy Participants and Patients With Sickle Cell Disease

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 10 → 13 locations Eligibility criteria expanded, about 10 words · Secondary endpoints: details revised at 4 of 13 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 4 of 13 entries
  2. Study sites: 9 to 10 Completion date: Feb 19, 2030 to Mar 19, 2030v14 Show 1 more changeShow less
    • Completion date: Feb 19, 2030 to Mar 19, 2030
  3. Study sites: 7 to 9v13
  4. Study sites: 6 to 7v12
  5. Study sites: 5 to 6v11
  6. Study sites: 4 to 5v10
  7. Completion pushed from Dec 31, 2029 to Feb 19, 2030 Study sites: 3 to 4v9 Show 1 more changeShow less
    • Study sites: 3 to 4
  8. Completion date: Dec 31, 2029 to Feb 19, 2030v8
  9. Completion pushed from Nov 12, 2029 to Dec 31, 2029 Study sites: 1 to 3v7 Show 1 more changeShow less
    • Study sites: 1 to 3
  10. Primary endpoints revised (6) Primary completion date: Jul 12, 2028 to May 1, 2028 · Completion date: Dec 19, 2029 to Nov 12, 2029 · Secondary endpoints revised (13) · 2 morev6 Show 5 more changesShow less
    • Primary completion date: Jul 12, 2028 to May 1, 2028
    • Completion date: Dec 19, 2029 to Nov 12, 2029
    • Secondary endpoints revised (13)
    • Study description expanded, about 10 words
    • Study arms: 4 to 6

    See this version in full on ClinicalTrials.gov ↗

  11. Primary completion date: Nov 10, 2027 to Jul 12, 2028 Completion date: Apr 18, 2029 to Dec 19, 2029 · Site contact updatedv5 Show 2 more changesShow less
    • Completion date: Apr 18, 2029 to Dec 19, 2029
    • Site contact updated
  12. Site contact updatedv4
  13. Primary completion date: Oct 26, 2027 to Nov 10, 2027 Completion date: Apr 3, 2029 to Apr 18, 2029v3 Show 1 more changeShow less
    • Completion date: Apr 3, 2029 to Apr 18, 2029
  14. Trial status: Not Yet Recruiting to Recruiting Enrollment target: 138 to 161 · Study sites: 0 to 1 · Start date changed from estimate of Sep 26, 2024 to Aug 15, 2024v2 Show 3 more changesShow less
    • Enrollment target: 138 to 161
    • Study sites: 0 to 1
    • Start date changed from estimate of Sep 26, 2024 to Aug 15, 2024
  15. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Novartis
555 trials monitored
See 31 trials at risk
Sickle Cell Disease
357 trials monitored
See 25 trials at risk
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary food effect of ITU512 as well as the fetal hemoglobin (HbF)-inducing capacity of ITU512. This will be the first evaluation of the potential therapeutic effect of ITU512 in healthy participants and patients with sickle cell disease (SCD).
Trial Details
NCT Number NCT06546670
Lead Sponsor Novartis Pharmaceuticals
Conditions Sickle Cell Disease
Enrollment 161 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov