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New hope for myelofibrosis anemia: experimental drug enters human trials

NCT ID NCT04455841

Disease control Sponsor: Incyte Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial tests an experimental drug called INCB000928, given alone or with the standard drug ruxolitinib, for people with myelofibrosis who have severe anemia or need regular blood transfusions. The main goals are to check the drug's safety, find the right dose, and see if it can improve red blood cell counts. About 84 participants are being studied to determine if this approach can help manage anemia without curing the underlying disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

84 people

The number who actually took part.

Started

Mar 2021

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participants with MF who are transfusion-dependent or present with symptomatic anemia, defined as follows: 1. Anemia: An Hgb value \< 10 g/dL demonstrated during screening recorded on 3 separate occasions with at least 7 days between measurements (Note: RBC transfusion must be at least 2 weeks before the Hgb measurement during screening). 2. Transfusion-dependent: Participant has received at least 4 units of RBC transfusions during the 28 days immediately preceding Cycle 1 Day 1 OR has received an average of at least 4 units of RBC transfusions in the 8 weeks immediately preceding Cycle 1 Day 1, for an Hgb level of \< 8.5 g/dL, in the absence of bleeding or treatment-induced anemia. In addition, the most recent transfusion episode must have occurred in the 28 days before Cycle 1 Day 1. * ECOG performance status score of the following: 1. 0 or 1 for the dose-escalation stages. 2. 0, 1, or 2 for the dose-expansion stage. * Life expectancy is greater than 6 months * Agreement to avoid pregnancy or fathering children. * Ineligible to receive or have not responded to available therapies for anemia such as ESAs. * For TGA: * Participants previously treated with JAK inhibitors for at least 12 weeks. * Participants with intermediate-2 or high DIPSS MF according to IWG-MRT criteria. * For TGB: * Participants must have been on a therapeutic and stable regimen of ruxolitinib for at least 12 consecutive weeks immediately preceding the first dose of study treatment. * Participants with intermediate-1, intermediate-2, or high DIPSS MF according to IWG-MRT criteria. * For TGC: * Participants must be JAK inhibitor treatment naive (no prior treatment with any JAK inhibitor) and have an indication for initiation of ruxolitinib treatment. * Participants with intermediate-1, intermediate-2, or high DIPSS MF according to IWG-MRT criteria. Exclusion Criteria: * Undergone any prior allogenic or autologous stem cell transplantation or a candidate for such transplantation. * Any prior chemotherapy, immunomodulatory drug therapy, immunosuppressive therapy, biological therapy, endocrine therapy, targeted therapy, antibody or hypomethylating agent to treat the participant's disease, with the exception of ruxolitinib for TGB only, within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment. * Laboratory Values outside of protocol defined range at screening.

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Conditions

The condition(s) this trial relates to.

anemia myelofibrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anemia Post-essential thrombocythemia myelofibrosis Post-polycythemia vera myelofibrosis

Contacts and locations

Locations

  • Azienda Ospedaliera Papa Giovanni Xxiii

    Bergamo, 24127, Italy

  • Azienda Ospedaliera Universitaria San Luigi Gonzaga Orbassano

    Orbassano, 10043, Italy

  • Azienda Ospedaliero-Universitaria Careggi (Aouc)

    Florence, 50134, Italy

  • Centre Hospitalier D'Angers

    Angers, 49033, France

  • Chiba Cancer Center

    Chiba, 260-8717, Japan

  • City of Hope National Medical Center

    Duarte, California, 91010, United States

  • City of Hope Orange County

    Irvine, California, 92618, United States

  • Comitato Di Bioetica Della Fondazione Irccs Policlinico San Matteo

    Pavia, 27100, Italy

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

    Durham, North Carolina, 27705, United States

  • Emory University - Winship Cancer Institute

    Atlanta, Georgia, 30322, United States

  • Emory University-Winship Cancer Institute

    Atlanta, Georgia, 30322, United States

  • Gifu Municipal Hospital

    Gifu, 500-8513, Japan

  • Hospital Saint Louis

    Paris, 75010, France

  • Institut Paoli Calmettes

    Marseille, 13273, France

  • Kansai Medical University Hospital

    Hirakata, 573-1191, Japan

  • Kumamoto Shinto General Hospital

    Kumamoto, 862-8655, Japan

  • Lincoln County Hospital

    Lincoln, LN2 5QY, United Kingdom

  • McGill University Jewish General Hospital

    Montreal, Quebec, H3T1E2, Canada

  • Md Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Osaka International Cancer Institute

    Osaka, 541-8567, Japan

  • Ospedale Santa Maria Della Misericordia Perugia

    Perugia, 06124, Italy

  • Prebys Cancer Center

    San Diego, California, 92103, United States

  • Princess Margaret Cancer Center

    Toronto, Ontario, M5G 2M9, Canada

  • Royal Cornwall Hospital Truro Sunrise Centre

    Truro, TR1 3LJ, United Kingdom

  • S Orsolas University Hospital Seragnoli Institute of Hematology

    Bologna, 40138, Italy

  • Stanford Cancer Center

    Palo Alto, California, 94304, United States

  • Start Midwest

    Grand Rapids, Michigan, 49546, United States

  • Tokyo Medical and Dental University Hospital

    Bunkyō City, 113-8519, Japan

  • United Lincolnshire Hospitals

    Boston, PE21 9QS, United Kingdom

  • University Hospital of Wales

    Cardiff, WLS, CF14 4XW, United Kingdom

  • Usc Norris Comprehensive Cancer Center

    Los Angeles, California, 90089, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • Weill Cornell Medical Centers

    New York, New York, 10065, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.