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NCT04717414 · ClinicalTrials.gov registry record · Phase 3
An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis on Concomitant JAK2 Inhibitor Therapy and Who Require Red Blood Cell Transfusions
A Phase 3 study of Anemia and Myelofibrosis, sponsored by Celgene.
- Active
- Registry status
- Phase 3
- Development phase
- 313
- Enrollment target
- 20
- Study locations
NCT04717414: Active Phase 3 study of Anemia and Myelofibrosis, sponsored by Celgene.
NCT04717414 is a Phase 3 study of Anemia and Myelofibrosis that is active but no longer recruiting, run by Celgene. The registered enrollment target is 313 participants, below the 423-participant average among 72 other Anemia trials with a reported enrollment target (26% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04717414, a Phase 3 study of Anemia and Myelofibrosis, is active but no longer recruiting, sponsored by Celgene.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 313 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this Phase 3 study is to evaluate the efficacy and safety of Luspatercept compared with placebo in subjects with myeloproliferative neoplasm (MPN)-associated Myelofibrosis (MF) and anemia on concomitant Janus kinase 2 (JAK2) inhibitor therapy and who require red blood cell count (RBC) transfusions. The study is divided into Screening Period, a Treatment Phase (consisting of a Blinded Core Treatment Period, a Day 169 Response Assessment, a Blinded Extension Treatment Period, and an Open-label Extension Treatment Period), and a Posttreatment Follow-up Period. Following the Day 169 Response Assessment, subjects who did not show clinical benefit will have the option to unblind. Subjects who were on placebo during the Blinded Core Treatment Period will have the opportunity to crossover into the Open-Label Extension Treatment Period and receive Luspatercept.
Primary Outcome
Percentage of participants who become RBC-transfusion free over any consecutive 12-week period starting in first 24 weeks.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG ACE-536
Study Locations (20)
Florida
- Local Institution - 135 - Orlando
- Local Institution - 133 - Plantation
Pennsylvania
- University of Pittsburg Medical Center - Pittsburgh
- Allegheny Health Network - Pittsburgh
Buenos Aires
- Local Institution - 172 - Ciudad Autónoma de BuenosAires
- Hospital Italiano de La Plata - La Plata
Victoria
- Monash Medical Centre - Clayton
- The Alfred Hospital - Melbourne
California
- Local Institution - 110 - Los Angeles
Illinois
- Local Institution - 112 - Chicago
Kentucky
- Local Institution - 124 - Lexington
Michigan
- Local Institution - 114 - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 313 participants |
| Start Date | 2021-02-25 |
| Est. Completion | 2032-08-18 |
| Phase | Phase 3 |
What the registry record for NCT04717414 still lists
NCT04717414 is an interventional study that assigns participants to a tested intervention. The registered 313 participants enrollment target is mid-sized for trials with a published cap, below the 423-participant average among 72 other Anemia trials with a reported enrollment target (26% lower).
The record links to 5 conditions, with Anemia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04717414 names 20 study sites across 16 states, led by Florida, Pennsylvania, Buenos Aires.
Frequently Asked Questions
What is clinical trial NCT04717414 about?
NCT04717414 is a clinical study titled "An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis on Concomitant JAK2 Inhibitor Therapy and Who Require Red Blood Cell Transfusions". The purpose of this Phase 3 study is to evaluate the efficacy and safety of Luspatercept compared with placebo in subjects with myeloproliferative neoplasm (MPN)-associated Myelofibrosis (MF) and anemia on concomitant Janus kinase 2 (JAK2) inhibitor therapy and who require red blood cell count (RBC)...
What is the current status of trial NCT04717414?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 313 participants. The study started on 2021-02-25. Estimated completion is 2032-08-18.
What conditions does trial NCT04717414 study?
This clinical trial studies the following conditions: Anemia, Myelofibrosis, Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, Myeloproliferative Disorders.
What interventions are being tested in trial NCT04717414?
The interventions under investigation include: Placebo (OTHER), ACE-536 (DRUG).
Who is sponsoring clinical trial NCT04717414?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04717414 being conducted?
This trial has 20 study locations across California, Florida, Illinois, Kentucky, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04717414's enrollment target sits among peer trials
313 24th of 72 higher than 49 of 72 other Anemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anemia 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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