IMG-7289 in Patients With Essential Thrombocythemia

  • STATUS
    Recruiting
  • End date
    Jun 30, 2022
  • participants needed
    40
  • sponsor
    Imago BioSciences,Inc.
Updated on 31 July 2021
thrombosis
platelet count
interferon
thrombocytosis

Summary

This is a Phase 2b open label study of an orally administered LSD1 inhibitor, IMG-7289, in patients with essential thrombocythemia.

This study investigates the following:

  • The safety and tolerability of IMG-7289
  • The pharmacodynamic effect of IMG-7289

Description

This is a Phase 2 multi-center, open-label study evaluating the safety, efficacy and pharmacodynamics of IMG-7289 administered orally once daily in patients with essential thrombocythemia (ET). Patients will be dosed with IMG-7289 for 169 consecutive days in the Initial Treatment Period (ITP). Qualifying patients may continue to receive IMG-7289 in the Additional Treatment Period (ATP).

Safety will be evaluated by clinical assessments of safety parameters i.e. safety laboratory testing, adverse event reporting, physical examination and vital sign assessments. Pharmacodynamics will be evaluated by hematology assessment, patient reported symptom burden, change in spleen size by palpation and other measures.

To ensure safety, a Safety Advisory Board will perform periodic reviews of safety parameters and pharmacodynamic markers.

Details
Condition ESSENTIAL THROMBOCYTHEMIA
Treatment IMG-7289
Clinical Study IdentifierNCT04254978
SponsorImago BioSciences,Inc.
Last Modified on31 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of Essential Thrombocythemia per World Health Organization (WHO) diagnostic criteria for myeloproliferative neoplasms
Requires treatment in order to lower platelet count based on patient age over 60 or history of thrombosis
Have failed at least one standard therapy
Must have discontinued ET therapy at least 1 week (4 weeks for interferon) prior to study drug initiation

Exclusion Criteria

Has undergone major surgery 4 weeks prior to starting study drug or has not recovered from side effects of such surgery
Unresolved treatment related toxicities from prior therapies (unless resolved to Grade 1)
Uncontrolled active infection
Current use of prohibited medications
Known HIV infection or active Hepatitis B or Hepatitis C virus infection
Other hematologic/biochemistry requirements, as per protocol
Use of investigational agent within last 14 days
Pregnant or lactating females
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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