A Study Evaluating the Efficacy and Safety of Mitapivat (AG-348) in Participants With Sickle Cell Disease (RISE UP)
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Phase
Phase 2/3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
286actual
Sites
91
Countries
Belgium, Brazil, Canada +13
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-02-11 | actual | When the study began enrolling |
| Primary completion | 2025-10-30 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Feb 2030 | estimated | The whole study's end, after follow-up |
| First posted | 2021-09-02 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-23 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Sickle Cell Disease
Interventions
- Drug: Mitapivat — also filed as AG-348, Mitapivat Sulfate
- Other: Mitapivat-matching placebo
- Other: Mitapivat-matching placebo
Primary outcomes
what the primary-completion date above is the date OFPhase 2: Percentage of Participants With Hemoglobin (Hb) Response
measured Week 12
Phase 2: Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Treatment-Emergent Serious AEs (SAEs)
measured Up to Week 12
Phase 3: Percentage of Participants With Hb Response
measured Week 52
Phase 3: Annualized Rate of Sickle Cell Pain Crises (SCPCs)
measured Up to Week 52
Publications
- PMID 41809202 — linked by the registry
- PMID 39644907 — linked by the registry
- PMID 37934880 — linked by the registry
- PMID 37254256 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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