Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05031780 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

A Study Evaluating the Efficacy and Safety of Mitapivat (AG-348) in Participants With Sickle Cell Disease (RISE UP)

StatusActive, Not Recruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 56 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. 3 versions Re-verified since Apr 22, 2026, no change to tracked fieldsv54-v56
  2. Study sites: 90 to 91v53
  3. 3 versions Re-verified since Dec 24, 2025, no change to tracked fieldsv50-v52
  4. Primary completion date changed from estimate of Dec 2025 to Oct 30, 2025v49
  5. Primary completion date: Oct 2025 to Dec 2025v48
Show 41 earlier versionsHide 41 earlier versions
  1. 6 versions Re-verified since Apr 23, 2025, no change to tracked fieldsv42-v47
  2. Enrollment target: 267 to 286 Primary completion date: Dec 2025 to Oct 2025v41 Show 1 more changeShow less
    • Primary completion date: Dec 2025 to Oct 2025
  3. Study sites: 100 to 90v40
  4. 2 versions Re-verified since Dec 19, 2024, no change to tracked fieldsv38-v39
  5. Trial status: Recruiting to Active, Not Recruiting Site details revised at 100 of 100 sitesv37 Show 1 more changeShow less
    • Site details revised at 100 of 100 sites
  6. Study sites revised (100)v36 See this version in full on ClinicalTrials.gov ↗
  7. Site details revised at 13 of 100 sitesv35
  8. Site details revised at 18 of 100 sitesv34
  9. Re-verified, no change to tracked fieldsv33
  10. Site details revised at 1 of 100 sitesv32
  11. Study sites: 101 to 100v31
  12. Study sites: 69 to 101v30
  13. Enrollment target: 277 to 267 Study sites: 63 to 69 · Eligibility criteria shortened, about 2 wordsv29 Show 2 more changesShow less
    • Study sites: 63 to 69
    • Eligibility criteria shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  14. Study sites: 58 to 63v28
  15. Trial status: Active, Not Recruiting to Recruiting Site details revised at 58 of 58 sitesv27 Show 1 more changeShow less
    • Site details revised at 58 of 58 sites
  16. Study sites: 57 to 58v26
  17. Re-verified, no change to tracked fieldsv25
  18. Enrollment target: 267 to 277 Primary completion date: Sep 2025 to Dec 2025 · Completion date: Nov 2029 to Feb 2030 · Start date: Jan 19, 2022 to Feb 11, 2022v24 Show 3 more changesShow less
    • Primary completion date: Sep 2025 to Dec 2025
    • Completion date: Nov 2029 to Feb 2030
    • Start date: Jan 19, 2022 to Feb 11, 2022
  19. Re-verified, no change to tracked fieldsv23
  20. Study sites: 55 to 57v22
  21. 3 versions Re-verified since Feb 16, 2023, no change to tracked fieldsv19-v21
  22. Study sites: 54 to 55v18
  23. Trial status: Recruiting to Active, Not Recruiting Site details revised at 54 of 54 sitesv17 Show 1 more changeShow less
    • Site details revised at 54 of 54 sites
  24. Study sites: 39 to 54v16
  25. Study sites: 30 to 39v15
  26. Study sites: 25 to 30 Completion date: Jan 2030 to Nov 2029v14 Show 1 more changeShow less
    • Completion date: Jan 2030 to Nov 2029
  27. Study sites: 20 to 25 Study title expanded, about 2 wordsv13 Show 1 more changeShow less
    • Study title expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  28. Study sites: 15 to 20v12
  29. Study sites: 9 to 15v11
  30. Study sites: 8 to 9v10
  31. Study sites: 6 to 8v9
  32. Study sites: 4 to 6 Eligibility criteria expanded, about 2 wordsv8 Show 1 more changeShow less
    • Eligibility criteria expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  33. Study sites: 2 to 4 Eligibility criteria expanded, about 32 wordsv7 Show 1 more changeShow less
    • Eligibility criteria expanded, about 32 words

    See this version in full on ClinicalTrials.gov ↗

  • 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 determine the recommended dose of mitapivat and evaluate the efficacy and safety of mitapivat in sickle cell disease by testing how well mitapivat works compared to placebo to increase the amount of hemoglobin in the blood and to reduce or prevent the occurrence of sickle cell pain crises. In addition, the long-term effect of mitapivat on efficacy and safety will be explored in an open-label extension portion.
Trial Details
NCT Number NCT05031780
Lead Sponsor Agios Pharmaceuticals, Inc.
Conditions Sickle Cell Disease
Enrollment 286 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov