NCT05031780Phase 2, phase 3Active not recruiting

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

Study sponsor: Agios Pharmaceuticals, Inc. · AGIO

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2025-10-30Actual

Enrollment · participants286Actual

Source updated2026-06-23Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2025-11-28 · 2 fields changed

Completion date type changed

− Before

~~Estimated~~

+ After

Actual

Primary completion date changed

− Before

~~Dec 2025~~

+ After

30 Oct 2025

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Posted 2025-10-28 · 1 field changed

Primary completion date changed

− Before

~~Oct 2025~~

+ After

Dec 2025

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Study details

Conditions studied

Sickle Cell Disease

Treatments or interventions studied

MitapivatDrugAlso known as AG-348, Mitapivat Sulfate

Primary outcomes · main study measures

Read the study measures

measure: Phase 2: Percentage of Participants With Hemoglobin (Hb) Response; timeFrame: Week 12; measure: Phase 2: Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Treatment-Emergent Serious AEs (SAEs); timeFrame: Up to Week 12; measure: Phase 3: Percentage of Participants With Hb Response; timeFrame: Week 52; measure: Phase 3: Annualized Rate of Sickle Cell Pain Crises (SCPCs); timeFrame: Up to Week 52

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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