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ACTIVE NOT RECRUITING Phase 1

INCB000928 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Anemia Due to Myeloproliferative Disorders

NCT04455841 · View on ClinicalTrials.gov ↗

Study Summary

This Phase 1/2, open-label, dose-finding study is intended to evaluate the safety and tolerability, PK, PD, and efficacy of INCB000928 administered as monotherapy or in combination with ruxolitinib in participants with MF who are transfusion-dependent or presenting with symptomatic anemia. This study will consist of 2 parts: dose escalation and expansion.

Interventions

  • DRUG INCB000928
  • DRUG ruxolitinib

Study Locations (20)

California

  • City of Hope National Medical Center — Duarte
  • City of Hope Orange County — Irvine
  • Usc Norris Comprehensive Cancer Center — Los Angeles
  • Stanford Cancer Center — Palo Alto
  • Prebys Cancer Center — San Diego

Other

  • Centre Hospitalier D'Angers — Angers
  • Institut Paoli Calmettes — Marseille
  • Hospital Saint Louis — Paris
  • Azienda Ospedaliera Papa Giovanni Xxiii — Bergamo
  • S Orsolas University Hospital Seragnoli Institute of Hematology — Bologna

Georgia

  • Emory University - Winship Cancer Institute — Atlanta
  • Emory University-Winship Cancer Institute — Atlanta

Michigan

  • Start Midwest — Grand Rapids

Missouri

  • Washington University School of Medicine — St Louis

New York

  • Weill Cornell Medical Centers — New York

North Carolina

  • Duke University Medical Center, Department of Hematologic Malignancies and Cellular Therapy — Durham

Tennessee

  • Vanderbilt University Medical Center — Nashville

Trial Details

FieldValue
Enrollment Target 84 participants
Start Date 2021-03-19
Est. Completion 2027-11-26
Phase Phase 1

Sponsor

Incyte Corporation

163 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04455841

The ClinicalTrials.gov registry entry for NCT04455841 describes a study currently listed as active not recruiting. It is categorized as Phase 1, 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 84 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Incyte Corporation, which has 163 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Anemia appearing as the primary indexed condition, and to 2 interventions — of which INCB000928 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: NCT04455841 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, Other, Georgia. 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 NCT04455841 about?

NCT04455841 is a clinical study titled "INCB000928 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Anemia Due to Myeloproliferative Disorders". This Phase 1/2, open-label, dose-finding study is intended to evaluate the safety and tolerability, PK, PD, and efficacy of INCB000928 administered as monotherapy or in combination with ruxolitinib in participants with MF who are transfusion-dependent or presenting with symptomatic anemia. This stud...

What is the current status of trial NCT04455841?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 84 participants. The study started on 2021-03-19. Estimated completion is 2027-11-26.

What conditions does trial NCT04455841 study?

This clinical trial studies the following conditions: Anemia, Post-essential Thrombocythemia Myelofibrosis, 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 NCT04455841?

The interventions under investigation include: INCB000928 (DRUG), ruxolitinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04455841?

This trial is sponsored by Incyte Corporation, which has 163 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04455841 being conducted?

This trial has 20 study locations across California, Georgia, Michigan, Missouri, New York. 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