A Study Evaluating the Efficacy and Safety of Mitapivat (AG-348) in Participants With Sickle Cell Disease (RISE UP)
Public ClinicalTrials.gov record NCT05031780. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Mitapivat in Subjects With Sickle Cell Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05031780
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 286 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 16 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 11, 2022 (Actual)
- Primary completion
- Oct 30, 2025 (Actual)
- Completion
- Feb 2030 (Estimated)
- Last update posted
- Jun 23, 2026
2022 – 2030
United States locations
- U.S. sites
- 28
- U.S. states
- 18
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California San Diego | La Jolla | California | 92037-1337 | — |
| UCLA Health | Los Angeles | California | 90095-1678 | — |
| Children's Hospital Oakland | Oakland | California | 94609 | — |
| University of Connecticut Health Center | Farmington | Connecticut | 06030-0001 | — |
| Children's National Hospital | Washington D.C. | District of Columbia | 20010-2916 | — |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | — |
| Sylvester Comprehensive Cancer Center-Miami | Miami | Florida | 33101 | — |
| University of Chicago Medical Center | Chicago | Illinois | 60637-1443 | — |
| Riley Hospital For Children | Indianapolis | Indiana | 46202-5109 | — |
| LSU Health Sciences Center - Shreveport | Shreveport | Louisiana | 71103-4228 | — |
| National Heart Lung and Blood Institute | Bethesda | Maryland | 20814 | — |
| Kaiser Permanente - Largo Medical Center | Largo | Maryland | 20774-5374 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114-2621 | — |
| Boston Children's Hospital | Boston | Massachusetts | 02115-5724 | — |
| Boston Medical Center & Boston University School of Medicine | Boston | Massachusetts | 02118 | — |
| University of Michigan | Ann Arbor | Michigan | 48109-5000 | — |
| Children's Hospital of Michigan | Detroit | Michigan | 48201 | — |
| Southern Specialty Clinic | Flowood | Mississippi | 39232 | — |
| Mississippi Center for Advanced Medicine | Madison | Mississippi | 39110-6115 | — |
| Cure 4 The Kids Foundation, A Division of Roseman University of Health Sciences | Las Vegas | Nevada | 89106 | — |
| East Carolina University - Brody School of Medicine | Greenville | North Carolina | 27834 | — |
| Penn Medicine - University of Pennsylvania Health System | Philadelphia | Pennsylvania | 19104-5127 | — |
| St. Christopher's Hospital for Children | Philadelphia | Pennsylvania | 19134-1011 | — |
| Lifespan at Rhode Island Hospital | Providence | Rhode Island | 02903 | — |
| University of Texas Health Science Center of Houston | Houston | Texas | 77030-1501 | — |
| Texas Children's Hospital | Houston | Texas | 77030 | — |
| Virginia Commonwealth University | Richmond | Virginia | 23298-5058 | — |
| Seattle Cancer Care Alliance, University of Washington | Seattle | Washington | 98195 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 63 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05031780, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 23, 2026 · Synced Oct 17, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05031780 live on ClinicalTrials.gov.