A Clinical Trial of Bomedemstat in Participants With Polycythemia Vera (MK-3543-025)
20 juli 2026 bijgewerkt door: Merck Sharp & Dohme LLC
A Phase 2/3, Randomized, Open-label, Active-comparator-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Bomedemstat (MK-3543) Versus Best Available Therapy in Participants With Polycythemia Vera Who Have an Inadequate Response to or Are Intolerant to Hydroxyurea
Researchers are looking for new ways to treat polycythemia vera (PV). People with PV may receive treatment to lower the number of red blood cells in the blood, but the usual treatments may not work for everyone. Researchers want to learn if a trial medicine called bomedemstat, also called MK-3543, can treat PV. In this study, researchers will compare bomedemstat to 2 usual treatments for PV.
The goal of this study is to learn if more participants who take bomedemstat reach healthy blood cell counts and avoid major health problems from PV, compared to those who receive a usual treatment.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
380
Fase
- Fase 2
- Fase 3
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
- Has confirmed local diagnosis of polycythemia vera (PV) per World Health Organization (WHO) diagnostic criteria for PV
- Must have discontinued prior cytoreductive therapy for condition under study for protocol specified duration
- Has failed at least one prior line of cytoreductive therapy to lower hematocrit
- Has a history of inadequate response, resistance to, or intolerant to hydroxyurea (HU) per protocol specified criteria
- Has no evidence of splenomegaly and no symptoms attributable to splenomegaly, including early satiety, left upper quadrant discomfort, or splenic pain
- Has locally assessed bone marrow (BM) fibrosis score of Grade 0 or Grade 1 as per modified version of the European Consensus Criteria for Grading Myelofibrosis
- Human Immunodeficiency Virus (HIV)-infected participants have well controlled HIV on antiretroviral therapy (ART)
- Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load
- Participants with history of Hepatitis C Virus (HCV) infection are eligible if HCV viral load is undetectable
- Participants must be able to swallow oral medication and follow instructions for at home dosing of bomedemstat
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
- Has history of any illness/impairment of gastrointestinal (GI) function that might interfere with drug absorption
- Has evidence at the time of screening of increased risk of bleeding
- Has history of malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Is currently receiving anticancer therapy
- Has an active infection requiring systemic therapy
- Has had major surgical procedure ≤4 weeks before first dose of study intervention or has not recovered from side effects of major surgical procedure
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Bomedemstat
Participants will receive bomedemstat daily for up to approximately 52 weeks.
Per protocol, dosage may be adjusted within specified time parameters for each participant to achieve and maintain protocol-specified platelet and hematocrit target ranges.
Eligible participants who do not discontinue study treatment at Week 52, may continue to receive study treatment.
|
Orale capsule
Andere namen:
|
|
Actieve vergelijker: Best Available Therapy (BAT)
Participants will receive either ropeinterferon alfa-2b or ruxolitinib as determined by investigator.
All participants will be treated per respective approved product labels for up to approximately 52 weeks.
|
Orale tablet
Subcutaneous Solution
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Clinicohematologic Response (CHR) Rate
Tijdsspanne: Up to approximately Week 52
|
CHR Rate is defined as all of the following: (i) a confirmed hematologic remission sustained for at least 12 consecutive weeks by Week 40 through Week 52, (ii) and absence of any of the following as assessed by the adjudication committee Week 52: thrombotic event; major hemorrhagic events; disease progression to myelofibrosis (MF) or myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML).
CHR will begin on the date of the first confirmed assessment achieving CHR criteria and will end on the earliest date of the following: 1) day of the first confirmed assessment not achieving CHR criteria, 2) date of first major hemorrhagic event or thrombotic event as assessed by the adjudication committee, or 3) disease progression as assessed by the adjudication committee.
The CHR rate will be presented.
|
Up to approximately Week 52
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Clinicohematologic Response Sustained for a 24-Week Time Period (CHR24)
Tijdsspanne: Up to approximately Week 52
|
CHR24 is defined as all of the following: (i) a confirmed hematologic remission sustained for at least 24 consecutive weeks by Week 52, (ii) and absence of any of the following as assessed by the adjudication committee Week 52: thrombotic event; major hemorrhagic events; disease progression to MF or MDS/AML.
CHR24 will begin on the date of the first confirmed assessment achieving CHR24 criteria and will end on the earliest date of the following: 1) day of the first confirmed assessment not achieving CHR24 criteria, 2) date of first major hemorrhagic event or thrombotic event as assessed by the adjudication committee, or 3) disease progression as assessed by the adjudication committee.
The CHR24 will be presented.
|
Up to approximately Week 52
|
|
Number of Participants Who Experience an Adverse Event (AE)
Tijdsspanne: Up to approximately Week 52
|
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
The number of participants who experience AE will be reported.
|
Up to approximately Week 52
|
|
Number of Participants Who Discontinue Study Treatment Due to an AE
Tijdsspanne: Up to approximately Week 52
|
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
The number of participants who discontinue study treatment due to an AE will be reported.
|
Up to approximately Week 52
|
|
Duration of Clinicohematologic Response Sustained for a 24-Week Time Period (DOCHR24)
Tijdsspanne: Up to approximately Week 52
|
For participants who show CHR24, DOCHR24 is defined as the time from the first confirmed hematologic remission to first documented evidence of: 1) confirmed platelet increase, confirmed WBC increase, or a required phlebotomy (defined as a confirmed HCT reduction) after latest confirmed hematologic remission date, 2) thrombotic event as assessed by the adjudication committee, 3) major hemorrhagic event as assessed by the adjudication committee, or 4) disease progression to MF or MDS/AML as assessed by the adjudication committee.
|
Up to approximately Week 52
|
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Duration of Clinicohematologic Response (DOCHR)
Tijdsspanne: Up to approximately Week 52
|
For participants who show CHR, DOCHR is defined as the time from the first confirmed hematologic remission to first documented evidence of: 1) confirmed platelet increase, confirmed WBC increase, or a required phlebotomy (defined as a confirmed HCT reduction) after latest confirmed hematologic remission date, 2) thrombotic event as assessed by the adjudication committee, 3) major hemorrhagic event as assessed by the adjudication committee, or 4) disease progression to MF or MDS/AML as assessed by the adjudication committee.
|
Up to approximately Week 52
|
|
Duration of Hematologic Remission (DOHR)
Tijdsspanne: Up to approximately Week 52
|
For participants who show confirmed hematologic remission, DOHR is defined as the time from the first hematologic remission until loss of hematologic remission.
|
Up to approximately Week 52
|
|
Number of Participants Who Experience Phlebotomies
Tijdsspanne: Up to approximately Week 52
|
Per protocol, a required phlebotomy is defined as confirmed hematocrit (HCT) ≥45% with a ≥3% increase from baseline HCT or confirmed HCT ≥48%.
The number of participants who experienced phlebotomies will be presented.
|
Up to approximately Week 52
|
|
Disease Progression Rate
Tijdsspanne: Up to approximately Week 52
|
Disease progression is defined as the transformation to post polycythemia vera myelofibrosis, myelodysplastic syndrome, or acute myeloid leukemia as assessed by the adjudication committee.
The disease progression rate will be presented.
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Up to approximately Week 52
|
|
Number of Participants Who Experience Thrombotic Events
Tijdsspanne: Up to approximately Week 52
|
Thrombotic events are defined as new or recurrent acute myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), deep venous thrombosis (DVT), pulmonary embolism (PE), thrombotic digital ischemia, other thrombotic events such as peripheral limb ischemia or Budd-Chiari syndrome assessed to be due to underlying polycythemia vera (PV), and other vascular occlusive events such as symptoms of cardiac, abdominal, or peripheral limb ischemia supported by objective evidence of vessel disease and/or ischemia.
The number of participants who experience thrombotic events will be presented.
|
Up to approximately Week 52
|
|
Number of Participants Who Experience Major Hemorrhagic Events
Tijdsspanne: Up to approximately Week 52
|
Major hemorrhagic events include but are not limited to fatal bleeding, symptomatic bleeding in a critical area or organ (including intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, pericardial, or intramuscular with compartment syndrome), or bleeding causing a decrease in hemoglobin of 2 g/dL or more or leading to transfusion of 2 or more units of whole blood or red cells, and clinically relevant non-major bleeding events leading to hospitalization or increased level of care or clinically important bleeding prompting a face-to-face medical evaluation.
|
Up to approximately Week 52
|
|
Change From Baseline in Myelofibrosis Symptom Assessment Form version 4.0 (MFSAF v4) Total Symptom Score
Tijdsspanne: Up to approximately Week 52
|
The MFSAF v4.0 is a 7-item participant-reported symptom assessment that asks respondents to report symptom severity at its worst for each of the 7 items on a 0 (Absent) to 10 (Worst Imaginable) numeric rating scale.
The MFSAF v4.0 7-day recall format is used.
Individual symptoms are assessed on an 11-point numeric rating scale with a total symptom score range of 0 (absent) to 70 (worst imaginable).
The change from baseline in MFSAF total score for all symptoms will be presented
|
Up to approximately Week 52
|
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Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form (SF) 7a Total Fatigue Score
Tijdsspanne: Up to approximately Week 52
|
The PROMIS Fatigue SF is a 7-item participant-reported assessment that measures both the experience of fatigue and the interference of fatigue on daily activities over the past week.
Response options are on a 5-point Likert scale, ranging from 1 (never) to 5 (always).
A total score is obtained by summing the responses to the seven items [range 7 (never) to 35 (always)] and converting to a standardized T-score.
The change from baseline in PROMIS Fatigue SF-7a Total Fatigue Score will be presented.
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Up to approximately Week 52
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie directeur: Medical Director, Merck Sharp & Dohme LLC
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
21 september 2026
Primaire voltooiing (Geschat)
25 juni 2032
Studie voltooiing (Geschat)
30 november 2032
Studieregistratiedata
Eerst ingediend
20 juli 2026
Eerst ingediend dat voldeed aan de QC-criteria
20 juli 2026
Eerst geplaatst (Werkelijk)
23 juli 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
23 juli 2026
Laatste update ingediend die voldeed aan QC-criteria
20 juli 2026
Laatst geverifieerd
1 juli 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 3543-025
- MK-3543-025 (Andere identificatie: MSD)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Ja
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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