A Phase 3 Study of Rusfertide in Patients With Polycythemia Vera (VERIFY)

  • STATUS
    Recruiting
  • End date
    Jun 9, 2025
  • participants needed
    250
  • sponsor
    Protagonist Therapeutics, Inc.
Updated on 9 August 2022
phlebotomy
jak2 v617f

Summary

The study is designed to evaluate the safety and efficacy of rusfertide in subjects with polycythemia vera (PV) in maintaining hematocrit control and in improving symptoms of PV.

Description

Phase 3 study in approximately 250 subjects previously diagnosed with polycythemia vera (PV) who require phlebotomy on a routine basis. There is a 32-week period during which rusfertide or placebo will be added-on to each subject's ongoing therapy for polycythemia vera which may include phlebotomy only or phlebotomy plus stable doses of either of hydroxyurea, interferon and/or ruxolitinib. All subjects who successfully complete the double blind 32-week portion of the study will receive rusfertide for 124 weeks.

Details
Condition Polycythemia Vera
Treatment Placebo, Rusfertide
Clinical Study IdentifierNCT05210790
SponsorProtagonist Therapeutics, Inc.
Last Modified on9 August 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

All subjects must meet ALL of the following inclusion
criteria to
be enrolled. There are additional inclusion criteria
Male and female subjects aged 18 (or the country specific minimum age of consent >18) years or older
Meet revised 2016 World Health Organization (WHO) criteria for the diagnosis of polycythemia vera and have either JAK2 V617F mutation or JAK2 exon 12 mutation
At least 3 phlebotomies due to inadequate hematocrit control in 6 months before randomization or at least 5 phlebotomies due to inadequate hematocrit control in 1 year before randomization
CBC values immediately prior to randomization
Hematocrit <45%
WBC 4000/μL to 20,000/μL (inclusive), and
Platelets 100,000/μL to 1,000,000/μL (inclusive)
Subjects receiving cytoreductive therapy at randomization must be on a stable PV
therapy regimen
Subjects treated with phlebotomy alone at randomization must have stopped cytoreductive therapy 2 to 6 months before screening

Exclusion Criteria

Subjects must meet NONE of the following exclusion criteria to be
enrolled. There are additional exclusion criteria
Clinically meaningful laboratory abnormalities at Screening
Subjects who require phlebotomy at hematocrit levels lower than 45%
Clinically significant thrombosis (e.g., deep vein thrombosis or splenic vein
thrombosis) within 2 months prior to randomization
Active or chronic bleeding within 2 months prior to randomization
History of invasive malignancies within the last 5 years, except localized cured
prostate cancer and cervical cancer
Subjects with non-invasive non-melanomatous (e.g., squamous cell or basal cell
carcinoma) skin cancer during screening unless adequately treated before
randomization
Received Busulfan, Pipobroman or 32Phosphorus within 7 months prior to screening
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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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