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A Study of Etavopivat in Adults and Adolescents With Sickle Cell Disease (HIBISCUS)

Study acronym: HIBISCUS
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date changed from estimate of Feb 20, 2026 to Feb 6, 2026 Study sites revised (142)v38 Show 1 more changeShow less
    • Study sites revised (142)

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  2. Study sites: 133 to 142 Collaborator revisedv37 Show 1 more changeShow less
    • Collaborator revised

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  3. Study sites: 140 to 133v36
  4. Lead sponsor: Novo Nordisk A/S to Forma Therapeutics, Inc. Collaborators expanded, about 3 wordsv35 Show 1 more changeShow less
    • Collaborators expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  5. Lead sponsor: Forma Therapeutics, Inc. to Novo Nordisk A/S Study sites: 147 to 140 · Collaborators shortened, about 3 wordsv34 Show 2 more changesShow less
    • Study sites: 147 to 140
    • Collaborators shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

Show 32 earlier versionsHide 32 earlier versions
  1. Study sites: 214 to 147 Start date: Mar 23, 2022 to Jan 29, 2021v33 Show 1 more changeShow less
    • Start date: Mar 23, 2022 to Jan 29, 2021
  2. Study sites: 229 to 214v32
  3. Start date: Mar 26, 2021 to Mar 23, 2022 Study sites: 231 to 229v31 Show 1 more changeShow less
    • Study sites: 231 to 229
  4. Primary completion date: Mar 31, 2026 to Feb 20, 2026 Completion date: Mar 31, 2027 to Mar 19, 2027 · Study sites revised (231)v30 Show 2 more changesShow less
    • Completion date: Mar 31, 2027 to Mar 19, 2027
    • Study sites revised (231)

    See this version in full on ClinicalTrials.gov ↗

  5. Trial status: Recruiting to Active, Not Recruiting Study sites: 246 to 231v29 Show 1 more changeShow less
    • Study sites: 246 to 231
  6. Primary completion date: Mar 31, 2025 to Mar 31, 2026 Study sites: 164 to 246v28 Show 1 more changeShow less
    • Study sites: 164 to 246
  7. Phase: Phase 2/3 to Phase 3 Enrollment target: 344 to 450 · Study sites: 104 to 164 · Primary completion date: Mar 2, 2026 to Mar 31, 2025 · 4 morev27 Show 7 more changesShow less
    • Enrollment target: 344 to 450
    • Study sites: 104 to 164
    • Primary completion date: Mar 2, 2026 to Mar 31, 2025
    • Completion date: Apr 30, 2027 to Mar 31, 2027
    • Eligibility criteria revised
    • Secondary endpoints: 8 to 6
    • Study description shortened, about 15 words

    See this version in full on ClinicalTrials.gov ↗

  8. Study sites: 87 to 104v26
  9. Primary completion date: Dec 2025 to Mar 2, 2026 Completion date: Dec 2026 to Apr 30, 2027 · Site details revised at 17 of 87 sitesv25 Show 2 more changesShow less
    • Completion date: Dec 2026 to Apr 30, 2027
    • Site details revised at 17 of 87 sites
  10. Site contacts updated at 1 of 87 sitesv24
  11. Re-verified, no change to tracked fieldsv23
  12. Lead sponsor: Novo Nordisk A/S to Forma Therapeutics, Inc. Collaborators expanded, about 3 wordsv22 Show 1 more changeShow less
    • Collaborators expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  13. Lead sponsor: Forma Therapeutics, Inc. to Novo Nordisk A/Sv21
  14. Study sites: 78 to 87v20
  15. Re-verified, no change to tracked fieldsv19
  16. Study sites: 57 to 78v18
  17. Interventions: Etavopivat Tablets (Drug), Etavopivat Tablets (Drug), Etavopivat Tablets (Drug), Placebo Tablets (Drug) to Etavopivat Tablets (Drug), Etavopivat Tablets High dose (Drug), Etavopivat Tablets Low dose (Drug), Placebo Tablets (Drug)v17
  18. Secondary endpoints: 6 to 8 Eligibility criteria shortened, about 5 wordsv16 Show 1 more changeShow less
    • Eligibility criteria shortened, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  19. Study sites: 32 to 57v15
  20. Primary endpoints revised (2) Interventions: FT-4202 Tablets (Drug), FT-4202 Tablets (Drug), FT-4202 Tablets (Drug), Placebo Tablets (Drug) to Etavopivat Tablets (Drug), Etavopivat Tablets (Drug), Etavopivat Tablets (Drug), Placebo Tablets (Drug) · Eligibility criteria expanded, about 64 words · Secondary endpoints: 4 to 6 · 2 morev14 Show 5 more changesShow less
    • Interventions: FT-4202 Tablets (Drug), FT-4202 Tablets (Drug), FT-4202 Tablets (Drug), Placebo Tablets (Drug) to Etavopivat Tablets (Drug), Etavopivat Tablets (Drug), Etavopivat Tablets (Drug), Placebo Tablets (Drug)
    • Eligibility criteria expanded, about 64 words
    • Secondary endpoints: 4 to 6
    • Study description revised
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  21. Study sites: 23 to 32v13
  22. Study sites: 14 to 23v12
  23. Study sites: 9 to 14v11
  24. Start date changed from estimate of Mar 2021 to Mar 26, 2021 Study description expanded, about 24 words · Study title expanded, about 1 wordv10 Show 2 more changesShow less
    • Study description expanded, about 24 words
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  25. Study sites: 8 to 9v9
  26. Study sites: 5 to 8 Start date: Feb 2021 to Mar 2021v8 Show 1 more changeShow less
    • Start date: Feb 2021 to Mar 2021
  27. Study sites: 4 to 5 Start date: Jan 2021 to Feb 2021v7 Show 1 more changeShow less
    • Start date: Jan 2021 to Feb 2021
  28. Site details revised at 1 of 4 sitesv6
  29. Trial status: Not Yet Recruiting to Recruiting Start date: Dec 2020 to Jan 2021 · Site details revised at 4 of 4 sitesv5 Show 2 more changesShow less
    • Start date: Dec 2020 to Jan 2021
    • Site details revised at 4 of 4 sites
  30. Study sites: 3 to 4v4
  31. Study sites: 1 to 3 Start date: Nov 2020 to Dec 2020v3 Show 1 more changeShow less
    • Start date: Nov 2020 to Dec 2020
  32. Secondary endpoints: details revised at 1 of 4 entriesv2
  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.
This clinical trial is a Phase 2/3 study that will evaluate the efficacy and safety of etavopivat and test how well etavopivat works compared to placebo to improve the amount of hemoglobin in the blood and to reduce the number of vaso-occlusive crises (times when the blood vessels become blocked and cause pain).
Trial Details
NCT Number NCT04624659
Lead Sponsor Forma Therapeutics, Inc.
Collaborators: This study is currently undergoing a sponsor transition from Forma to Novo Nordisk. Sponsor field will be updated once the transition is complete.
Conditions Sickle Cell Disease
Enrollment 450 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov