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NCT05031780 · ClinicalTrials.gov registry record · Phase 2
A Study Evaluating the Efficacy and Safety of Mitapivat (AG-348) in Participants With Sickle Cell Disease (RISE UP)
A Phase 2 study of Sickle Cell Disease, sponsored by Agios Pharmaceuticals.
- Active
- Registry status
- Phase 2
- Development phase
- 286
- Enrollment target
- 20
- Study locations
NCT05031780: Active Phase 2 study of Sickle Cell Disease, sponsored by Agios Pharmaceuticals.
NCT05031780 is a Phase 2 study of Sickle Cell Disease that is active but no longer recruiting, run by Agios Pharmaceuticals. The registered enrollment target is 286 participants, roughly in line with the 291-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target. The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05031780, a Phase 2 study of Sickle Cell Disease, is active but no longer recruiting, sponsored by Agios Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 286 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Mitapivat
- OTHER Mitapivat-matching placebo
Study Locations (20)
California
- University of California San Diego - La Jolla
- UCLA Health - Los Angeles
- Children's Hospital Oakland - Oakland
Massachusetts
- Massachusetts General Hospital - Boston
- Boston Children's Hospital - Boston
- Boston Medical Center & Boston University School of Medicine - Boston
District of Columbia
- Children's National Hospital - Washington D.C.
- MedStar Washington Hospital Center - Washington D.C.
Maryland
- National Heart Lung and Blood Institute - Bethesda
- Kaiser Permanente - Largo Medical Center - Largo
Michigan
- University of Michigan - Ann Arbor
- Children's Hospital of Michigan - Detroit
Mississippi
- Southern Specialty Clinic - Flowood
- Mississippi Center for Advanced Medicine - Madison
Connecticut
- University of Connecticut Health Center - Farmington
Florida
- Sylvester Comprehensive Cancer Center-Miami - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 286 participants |
| Start Date | 2022-02-11 |
| Est. Completion | 2030-02 |
| Phase | Phase 2 |
What the registry record for NCT05031780 still lists
NCT05031780 is an interventional study that assigns participants to a tested intervention. The registered 286 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 291-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target.
The record links to 1 condition, with Sickle Cell Disease appearing as the primary indexed condition, and to 2 interventions - of which Mitapivat is the first listed.
NCT05031780 names 20 study sites across 12 states, led by California, Massachusetts, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT05031780 about?
NCT05031780 is a clinical study titled "A Study Evaluating the Efficacy and Safety of Mitapivat (AG-348) in Participants With Sickle Cell Disease (RISE UP)". 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 t...
What is the current status of trial NCT05031780?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 286 participants. The study started on 2022-02-11. Estimated completion is 2030-02.
What conditions does trial NCT05031780 study?
This clinical trial studies the following conditions: Sickle Cell Disease.
What interventions are being tested in trial NCT05031780?
The interventions under investigation include: Mitapivat (DRUG), Mitapivat-matching placebo (OTHER).
Who is sponsoring clinical trial NCT05031780?
This trial is sponsored by Agios Pharmaceuticals, which has 44 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05031780 being conducted?
This trial has 20 study locations across California, Connecticut, District of Columbia, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05031780's enrollment target sits among peer trials
286 23rd of 213 higher than 191 of 213 other Sickle Cell Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sickle Cell Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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