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ACTIVE NOT RECRUITING 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

NCT04717414 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 313 participants
Start Date 2021-02-25
Est. Completion 2032-08-18
Phase Phase 3

Sponsor

Celgene

73 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04717414

The ClinicalTrials.gov registry entry for NCT04717414 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 313 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celgene, which has 73 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04717414 reports 20 study locations spanning 16 distinct geographic areas — top geographies include Florida, Pennsylvania, Buenos Aires. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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, Myeloproliferative Disorders, Post-Polycythemia Vera Myelofibrosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04717414?

The interventions under investigation include: Placebo (OTHER), ACE-536 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04717414?

This trial is sponsored by Celgene, which has 73 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial