Trial · NCT05031780
A Study Evaluating the Efficacy and Safety of Mitapivat (AG-348) in Participants With Sickle Cell Disease (RISE UP)
NCT05031780, Phase 2, Phase 3, Active not recruiting, Agios Pharmaceuticals, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study Evaluating the Efficacy and Safety of Mitapivat (AG-348) in Participants With Sickle Cell Disease (RISE UP). Trials, record NCT05031780. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05031780
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Evaluating the Efficacy and Safety of Mitapivat (AG-348) in Participants With Sickle Cell Disease (RISE UP)
- NCT number
- NCT05031780
- Status
- Active not recruiting
- Phases
- Phase 2, Phase 3
- Enrollment
- 286 participants, actual
- Lead sponsor
- Agios Pharmaceuticals, Inc.
- Conditions
- Sickle Cell Disease
- Interventions
- Mitapivat, Mitapivat-matching placebo, Mitapivat-matching placebo
- First posted
- 2021-09-02
- Last updated
- 2026-10-26
- Other registries' IDs
- eudract:2021-001674-34
Source ClinicalTrials.gov
Registered outcomes40
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 2: Percentage of Participants With Hemoglobin (Hb) Response | Week 12 | |
| Primary | Phase 2: Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Treatment-Emergent Serious AEs (SAEs) | Up to Week 12 | |
| Primary | Phase 3: Percentage of Participants With Hb Response | Week 52 | |
| Primary | Phase 3: Annualized Rate of Sickle Cell Pain Crises (SCPCs) | Up to Week 52 | |
| Secondary | Phase 2: Change From Baseline in Hb Concentration | Baseline, Week 10 up to Week 12 | |
| Secondary | Phase 2: Change From Baseline in Indirect Bilirubin | Baseline, Week 10 up to Week 12 | |
| Secondary | Phase 2: Change From Baseline in Lactate Dehydrogenase (LDH) | Baseline, Week 10 up to Week 12 | |
| Secondary | Phase 2: Change From Baseline in Absolute Reticulocytes Count | Baseline, Week 10 up to Week 12 | |
| Secondary | Phase 2: Change From Baseline in Percent Reticulocytes | Baseline, Week 10 up to Week 12 | |
| Secondary | Phase 2: Change From Baseline in Erythropoietin | Baseline, Week 10 up to Week 12 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05031780
GET https://conductscience.org/api/trials/v1/NCT05031780/registered?page=2