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Study on KER-050 and Ruxolitinib for Patients with Myelofibrosis and Anemia

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition called Myelofibrosis, which is a type of blood cancer that affects the bone marrow. The study is exploring the use of a treatment called KER-050, which is being tested both on its own and in combination with another medication called Ruxolitinib. Ruxolitinib is also known by its code name INCB018424. The purpose of the study is to evaluate the safety and effectiveness of these treatments in people with Myelofibrosis who also have anemia, a condition where there is a lack of healthy red blood cells.

The study is divided into different parts. Initially, participants will receive increasing doses of KER-050 to determine the safest and most effective dose. This phase will help understand how well participants tolerate the treatment. In the next phase, the study will expand to include more participants to further assess the safety of the chosen dose. There is also a long-term extension part of the study to evaluate the ongoing safety of KER-050, with or without Ruxolitinib, over a longer period.

Participants in the study will receive either KER-050 alone or in combination with Ruxolitinib. The study will monitor the participants for any side effects and measure how the treatments affect their condition. The study aims to find out if these treatments can help manage Myelofibrosis symptoms, improve blood cell counts, and reduce the need for blood transfusions. The study will also look at changes in spleen size using imaging techniques like CT or MRI. The trial is expected to continue until 2029, providing valuable information on the long-term effects of these treatments.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant will be informed about the trial's objectives and procedures. The participant will be required to provide informed consent, confirming their understanding and willingness to participate.

  2. Step 2

    Part 1: Dose Escalation

    This phase involves evaluating the safety and tolerability of increasing doses of KER-050 alone or in combination with ruxolitinib in participants with myelofibrosis who have anemia.

    Participants will receive KER-050 as a solution for injection and ruxolitinib in tablet form. The dosage and frequency will be adjusted based on the participant's response and tolerance.

    The goal is to determine the recommended dose for the next phase.

  3. Step 3

    Part 2: Dose Expansion

    In this phase, the safety and tolerability of the dose(s) selected in Part 1 will be further evaluated.

    Participants will continue to receive KER-050 and ruxolitinib at the determined dose levels.

    The focus will be on monitoring any adverse effects and assessing the treatment's impact on the condition.

  4. Step 4

    Long Term Extension

    Participants who continue in the study will enter the long-term extension phase.

    The objective is to evaluate the long-term safety and tolerability of KER-050 with or without ruxolitinib.

    Regular assessments will be conducted to monitor the participant's health and response to the treatment over an extended period.

Who can join the trial?

8 criteria

  • Must be a male or female who is at least 18 years old.
  • Must have an ECOG performance score of 2 or less. This score is a way to measure how well a person can perform daily activities.
  • Must have a life expectancy of at least 12 months, as assessed by the doctor.
  • Must have a confirmed diagnosis of primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (post-PV MF), or post-essential thrombocythemia myelofibrosis (post-ET MF). These are specific types of blood disorders.
  • Must have anemia, which means having low levels of red blood cells. This can be shown by needing a certain number of blood transfusions or having low hemoglobin levels in blood tests.
  • For certain study groups, must have been previously treated with a JAK inhibitor (a type of medication) and stopped for specific reasons like the disease coming back, not responding to treatment, or having side effects.
  • For other study groups, must have been taking ruxolitinib (a specific medication) for at least 8 weeks and on a stable dose for at least 4 weeks. The treatment might not be fully controlling the disease, or the disease might need additional therapy.
  • Females who can have children and sexually active males must agree to use highly effective birth control methods.

Who cannot join the trial?

10 criteria

  • Patients who do not have **myelofibrosis**. Myelofibrosis is a condition where scar tissue forms in the bone marrow, affecting blood cell production.
  • Patients who do not have **anemia**. Anemia is when you have fewer red blood cells than normal, which can make you feel tired and weak.
  • Patients who are not adults. The study is for adults only.
  • Patients who are not able to safely take the study medication due to other health conditions.
  • Patients who are pregnant or breastfeeding.
  • Patients who are participating in another clinical trial.
  • Patients who have had a recent major surgery or are planning to have surgery during the study.
  • Patients who have a history of certain other medical conditions that might interfere with the study.
  • Patients who have allergies to the study medication or its ingredients.
  • Patients who have not agreed to follow the study rules and procedures.
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Investigated drugs

  • KER-050

    is a medication being studied for its potential to treat myelofibrosis, a type of bone marrow disorder. In this trial, KER-050 is being tested both as a standalone treatment and in combination with another medication. The goal is to see how safe and tolerable KER-050 is for patients, as well as to understand how it behaves in the body and its effectiveness in treating the condition.

  • Ruxolitinib

    is a medication that is already used to treat myelofibrosis. In this trial, it is being combined with KER-050 to see if the combination is safe and effective for patients with myelofibrosis who also have anemia. The study aims to determine if using these two medications together can improve treatment outcomes for these patients.

What is already known about the treatment

KER-050 – KER-050 is administered as an injection and is currently being studied in clinical trials for its safety and effectiveness in treating myelofibrosis, a type of bone marrow disorder. It is being evaluated both as a standalone treatment and in combination with another medication called Ruxolitinib. The main therapeutic indication for KER-050 is to address anemia in patients with different forms of myelofibrosis. At the molecular level, KER-050 works by targeting specific pathways involved in blood cell production, aiming to improve blood counts and reduce symptoms. It is classified pharmacologically as a therapeutic agent for hematological conditions.

Investigated diseases

Myelofibrosis – Myelofibrosis is a rare bone marrow disorder characterized by the replacement of bone marrow with fibrous tissue, leading to a decrease in the production of blood cells. This condition can result in anemia, fatigue, and an enlarged spleen due to the body's attempt to produce blood cells outside the bone marrow. Over time, myelofibrosis can cause significant changes in blood cell counts, leading to symptoms such as weakness, weight loss, and night sweats. The disease may progress slowly, but it can also lead to more severe complications if the bone marrow becomes increasingly fibrotic. Myelofibrosis can occur on its own or as a progression from other blood disorders like essential thrombocythemia or polycythemia vera.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-507468-38-00Protocol codeKER050-MF-301Estimated enrolment112 patientsSponsorTakeda Development Center Americas Inc.

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