INCB000928 + Ruxolitinib for Myelofibrosis
(LIMBER Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but if you are in the TGB group, you must have been on a stable regimen of ruxolitinib for at least 12 weeks before starting the study treatment. Other medications, especially those used to treat your disease, may need to be stopped if they were taken within a certain time frame before the study.
What data supports the effectiveness of the drug INCB000928 + Ruxolitinib for Myelofibrosis?
Ruxolitinib, a key component of the treatment, has been shown to be effective for myelofibrosis, as it was the first approved drug for this condition and remains a standard treatment. It works by targeting specific pathways involved in the disease, and its effectiveness has been demonstrated in various studies, including the phase 3 COMFORT-I/II trials.12345
What is known about the safety of ruxolitinib for myelofibrosis?
Ruxolitinib has been used for over a decade to treat myelofibrosis, and studies show it is generally safe, with common side effects being anemia (low red blood cell count) and thrombocytopenia (low platelet count). These side effects rarely lead to stopping the treatment, and no new safety concerns have been identified in recent large studies.13467
What makes the drug INCB000928 + Ruxolitinib unique for treating myelofibrosis?
INCB000928 combined with Ruxolitinib is unique because it represents a new combination approach to treating myelofibrosis, potentially offering benefits beyond Ruxolitinib alone, which has been the standard treatment for over a decade. This combination may target additional pathways involved in the disease, providing an option for patients who do not respond optimally to Ruxolitinib alone.13489
What is the purpose of this trial?
This trial is testing a new drug called INCB000928, either alone or with ruxolitinib, to see if it is safe and effective. It targets people with Myelofibrosis who need regular blood transfusions or have severe anemia. The goal is to see if the drug can reduce the need for transfusions and improve anemia symptoms.
Research Team
Amanda McBride, MD
Principal Investigator
Incyte Corporation
Eligibility Criteria
This trial is for people with myeloproliferative disorders causing anemia who've had prior treatment with JAK inhibitors, are dependent on blood transfusions, and have a life expectancy over 6 months. They must not be pregnant or fathering children and should not have received certain other treatments recently.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive escalating doses of INCB000928 to evaluate safety and tolerability
Expansion
Participants receive INCB000928 as monotherapy or in combination with ruxolitinib to further assess efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- INCB000928
- ruxolitinib
INCB000928 is already approved in United States for the following indications:
- Fibrodysplasia ossificans progressiva (Orphan Drug Designation)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Incyte Corporation
Lead Sponsor
Steven Stein
Incyte Corporation
Chief Medical Officer since 2015
MD from University of Witwatersrand
Hervé Hoppenot
Incyte Corporation
Chief Executive Officer since 2014
MBA from ESSEC Business School