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Bomedemstat hos pasienter med polycytemi Vera

16. april 2026 oppdatert av: Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)

En fase 2 multisenter, åpen etikettstudie for å vurdere sikkerheten, effekten, farmakokinetikken og farmakodynamikken til Bomedemstat hos pasienter med polycytemi Vera (PV)

Dette er en fase 2 åpen studie av en oralt administrert LSD1-hemmer, bomedemstat (IMG-7289), hos pasienter med polycytemi vera.

Denne studien undersøker følgende:

  • Sikkerheten og toleransen til bomedemstat
  • Den farmakodynamiske effekten av bomedemstat

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Dette er en fase 2 multisenter, åpen studie som evaluerer sikkerheten, effekten, farmakokinetikken og farmakodynamikken til bomedemstat administrert oralt én gang daglig hos pasienter med polycytemia vera.

Pasienter vil motta 36 ukers dosering og kan kvalifisere for tilleggsbehandling deretter.

Pasienter vil bli fulgt nøye gjennom hele studien for begge bivirkninger ved hyppig overvåking av kliniske tegn og symptomer samt sikkerhetslaboratorier. Effekt og farmakodynamiske effekter vil bli nøye overvåket ved hyppige hematologiske vurderinger av perifert blod. Gjennom hele doseringen kan transfusjoner eller flebotomi gis om nødvendig i samsvar med standard institusjonelle retningslinjer.

For å ivareta sikkerheten vil et sikkerhetsråd utføre periodiske gjennomganger av sikkerhetsparametere og farmakodynamiske markører.

Studietype

Intervensjonell

Registrering (Faktiske)

20

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Australia
    • Queensland
      • Sunshine Coast, Queensland, Australia, 4556
        • Sunshine Coast Hematology and Oncology Clinic (Site 0506)
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Medical Centre ( Site 0006)
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • Royal Perth Hospital ( Site 0504)
  • Forente stater
    • Florida
      • Plantation, Florida, Forente stater, 33322
        • BRCR Global ( Site 0120)
    • Illinois
      • Skokie, Illinois, Forente stater, 60076-1264
        • Hematology Oncology of the North Shore ( Site 0104)
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48109
        • University of Michigan Comprehensive Cancer Center ( Site 0008)
    • Nevada
      • Las Vegas, Nevada, Forente stater, 89128
        • Comprehensive Cancer Centers of Nevada - Peak ( Site 0118)
    • North Carolina
      • Durham, North Carolina, Forente stater, 27705
        • Duke University Medical Center ( Site 0016)
    • Ohio
      • Columbus, Ohio, Forente stater, 43203
        • Ohio State University Comprehensive Cancer Center ( Site 0103)
    • Oregon
      • Portland, Oregon, Forente stater, 97239-4503
        • OHSU Knight Cardiovascular Institute Cardiology Clinic - South Waterfront ( Site 0102)
    • Utah
      • Salt Lake City, Utah, Forente stater, 84112
        • Huntsman Cancer Hospital at the University of Utah ( Site 0119)
  • Storbritannia
    • England
      • Gloucester, England, Storbritannia, GL1 3NN
        • Gloucestershire Royal Hospital ( Site 0205)
    • Great Britain
      • Lincoln, Great Britain, Storbritannia, LN2 5QY
        • United Lincolnshire Hospitals NHS Trust ( Site 0204)
      • London, Great Britain, Storbritannia, W12 0HS
        • Imperial College London ( Site 0025)
    • Lincolnshire
      • Boston, Lincolnshire, Storbritannia, PE21 9QS
        • Boston Pilgrim Hospital ( Site 0207)
    • London, City of
      • London, London, City of, Storbritannia, SE1 9RT
        • Guys and St Thomas NHS Foundation Trust - Guys Hospital ( Site 0020)
    • Wales
      • Newport, Wales, Storbritannia, NP9 2UB
        • Royal Gwent Hospital ( Site 0201)

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Beskrivelse

Inklusjonskriterier:

  • Diagnose av polycytemi Vera i henhold til Verdens helseorganisasjon (WHO) diagnostiske kriterier for myeloproliferative neoplasmer
  • Benmargsfibrosepoengsum av grad 0 eller grad 1
  • Pasienter som har mislyktes i minst én standard cytoreduktiv behandling for å senke hematokrit
  • Blodplateantall ≥250 x 10ˆ9/L
  • Absolutt nøytrofiltall (ANC) ≥1,5 x 10ˆ9/L
  • Forventet levealder >36 uker.
  • Må ha avbrutt tidligere cytoreduktiv behandling i 2 uker (4 uker for interferon) før studiestart.

Ekskluderingskriterier:

  • Eastern Cooperative Oncology Group (ECOG) ytelsesstatus på 3 eller høyere
  • Uavklarte behandlingsrelaterte toksisiteter fra tidligere terapier (med mindre det er løst til ≤ grad 1).
  • Ukontrollert aktiv infeksjon.
  • Nåværende bruk av forbudte medisiner
  • Kjent HIV-infeksjon eller aktiv Hepatitt B- eller Hepatitt C-virusinfeksjon
  • Bevis på økt risiko for blødning, inkludert kjente blødningsforstyrrelser
  • Andre hematologiske/biokjemikrav, i henhold til protokoll
  • Drektige eller ammende kvinner

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Bomedemstat
Deltakerne vil motta bomedemstat daglig i 36 uker og kan kvalifisere for tilleggsbehandling gjennom uke 52 hvis de oppnår klinisk fordel.
Legemiddel: Bomedemstat
Oral kapsel
Andre navn:
  • IMG-7289
  • MK-3543

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Participants With Adverse Events (AEs)
Tidsramme: Up to approximately 52 weeks
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with one or more AEs are reported.
Up to approximately 52 weeks
Number of Participants Who Discontinued Study Intervention Due to AEs
Tidsramme: Up to approximately 52 weeks
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinued study intervention due to an AE are reported.
Up to approximately 52 weeks
Percentage of Participants With Sustained 12-week Reduction of Hematocrit (Hct) to <45% Without Concomitant Phlebotomy by Week 36
Tidsramme: Up to approximately 36 weeks
Hematocrit (Hct) was analyzed by taking blood samples from participants at designated time points during the study. Participants were considered responders if they achieved a sustained reduction of Hct to <45% for 12 weeks (84 calendar days) by Week 36 AND there was no concomitant phlebotomy performed during the sustained reduction. Baseline data was defined as the data most recently collected prior to the first dose. A Clopper-Pearson (exact binomial) two-sided 95% confidence interval for the percentage of responders was presented. The percentage of participants who achieved a sustained 12-week reduction of Hct to <45% without concomitant phlebotomy at Week 36 are reported.
Up to approximately 36 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Duration of Reduction of Hematocrit (Hct) to <45% Without Phlebotomy
Tidsramme: Up to approximately 22 months
Total response duration was defined as the summation of all Hct <45% response durations, where an individual response duration starts at the timepoint where the Hct <45% and ends at the first subsequent occurrence of phlebotomy or Hct >=45%. Hct was analyzed by taking blood samples from participants at designated time points during the study. Duration of reduction of Hct to <45% without phlebotomy was presented.
Up to approximately 22 months
Percentage of Participants With Platelet Count ≤ 450 x 10^9/L by Week 36
Tidsramme: Up to approximately 36 weeks
Platelet count was analyzed by taking blood samples from participants at designated time points during the study. Participants who enter the study with platelet counts ≤450 X 10^9/L must achieve an additional on-study platelet count ≤450 X 10^9/L to be considered responders. A Clopper-Pearson (exact binomial) two-sided 95% confidence interval for the percentage of responders is presented. Baseline data was defined as the data most recently collected prior to the first dose. The percentage of participants who have a platelet count ≤450 X 10^9/L by week 36 are reported.
Up to approximately 36 weeks
Duration of Platelet Count ≤ 450 x 10^9/L
Tidsramme: Up to approximately 22 months
Total response duration was defined as the summation of all platelet ≤450 x 10^9/L response durations, where an individual response duration starts at the timepoint where platelet count ≤450 x 10^9/L and ends at the first subsequent occurrence of platelet >450 x 10^9/L. Platelet counts were analyzed by taking blood samples from participants at designated time points during the study. The duration of platelet count ≤450 X 10^9/L in participants are reported.
Up to approximately 22 months
Percentage of Participants With White Blood Cell (WBC) Count <10 x 10^9/L by Week 36
Tidsramme: Up to approximately 36 weeks
WBC count was analyzed by taking blood samples from participants at designated time points during the study. Participants who enter the study with WBC counts <10 X 10^9/L must achieve an additional on-study WBC count <10 X 10^9/L to be considered responders. A Clopper-Pearson (exact binomial) two-sided 95% confidence interval for the percentage of responders is presented. Baseline data was defined as the data most recently collected prior to the first dose. The percentage of participants who have a WBC count <10 X 10^9/L week 36 are reported.
Up to approximately 36 weeks
Duration of White Blood Cell (WBC) Count <10 x 10^9/L
Tidsramme: Up to approximately 22 months
Total response duration was defined as the summation of all WBC <10 x 10^9/L response durations, where an individual response duration starts at the timepoint when WBC <10 x 10^9/L and ends at the first subsequent occurrence of WBC ≥ 10 x 10^9/L. WBC count was analyzed by taking blood samples from participants at designated time points during the study. The duration of WBC count <10 X 10^9/L in participants are reported.
Up to approximately 22 months
Number of Participants With Thrombotic Events
Tidsramme: Up to approximately 22 months
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 that are assessed to be due to underlying polycythemia vera (PV); other vascular occlusive events such as symptoms of cardiac, abdominal or peripheral limb ischemia supported by objective evidence of vessel disease and/or ischemia. Baseline data was defined as the data most recently collected prior to the first dose. The number of participants with thrombotic events are reported.
Up to approximately 22 months
Number of Participants With Major Hemorrhagic Events
Tidsramme: Up to approximately 22 months
Hemorrhagic events were defined as: Major Bleeding (MB) Events such as fatal bleeding, and/or symptomatic bleeding in a critical area or organ such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, and/or bleeding causing a fall in hemoglobin level of 2 g/dL or more, or leading to transfusion of 2 or more units of whole blood or red cells; Clinically Relevant Non-Major Bleeding (CRNMB) Events Leading to hospitalization or increased level of care or clinically important, prompting a face-to-face medical evaluation. Baseline data was defined as the data most recently collected prior to the first dose. The number of participants with major hemorrhagic events are reported.
Up to approximately 22 months
Number of Participants With an Enlarged Spleen at Baseline Who Had a Reduction in Splenic Volume by 36 Weeks
Tidsramme: Up to approximately 36 weeks
Spleen volume was measured by magnetic resonance imaging (MRI) (or computerized tomography [CT] if participant is not a candidate for MRI) of the abdomen according to standard procedures. Baseline data was defined as the data most recently collected prior to the first dose. The number of participants with an enlarged spleen at baseline (volume >450 cm^3) who achieved any reduction in spleen volume by Week 36 are reported.
Up to approximately 36 weeks
Number of Participants With Progressive Disease (PD)
Tidsramme: Up to approximately 52 weeks
PD was defined as the worsening of Polycythemia Vera (PV) to post-PV myelofibrosis, myelodysplastic syndrome or transformation to acute myeloid leukemia. Baseline data was defined as the data most recently collected prior to the first dose. The number of participants with PD are reported.
Up to approximately 52 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)

Etterforskere

  • Studieleder: Medical Director, Merck Sharp & Dohme LLC

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

7. september 2023

Primær fullføring (Faktiske)

24. mars 2025

Studiet fullført (Faktiske)

10. juli 2025

Datoer for studieregistrering

Først innsendt

20. september 2022

Først innsendt som oppfylte QC-kriteriene

26. september 2022

Først lagt ut (Faktiske)

28. september 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

7. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. april 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 3543-004
  • IMG-7289-CTP-203 (Annen identifikator: Imagobio ID)
  • MK-3543-004 (Annen identifikator: MSD)
  • 2022-002262-32 (EudraCT-nummer)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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