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

August 4, 2025 updated by: Protagonist Therapeutics, Inc.

A Phase 3 Study of the Hepcidin Mimetic Rusfertide (PTG-300) in Patients With Polycythemia Vera

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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. Approximately 6 and 12 months after their last dose of rusfertide, subjects will have a post-study contact (e.g. by phone) for safety.

Study Type

Interventional

Enrollment (Actual)

293

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Perth
      • Nedlands, Perth, Australia
        • One Clinical Research
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital
  • Austria
      • Graz, Austria, 8036
        • Medizinische Universitaet Graz
      • Linz, Austria, A-4020
        • Krankenhaus der Elisabethinen Linz
      • Linz, Austria, 4021
        • Kepler Universitaets Klinikum GmbH
      • Vienna, Austria, 1130
        • Wiener Gesundheitsverbund-Klinik Hietzing 5-Med.
      • Wels, Austria, 4600
        • Klinikum Wels-Grieskirchen Gmb
      • Wien, Austria, 1090
        • Medizinische Universitaet Wien
  • Belgium
      • Antwerp, Belgium, 2060
        • ZNA Stuivenberg
      • Gent, Belgium, 9000
        • University Hospital Gent
      • Leuven, Belgium, 3000
        • Campus Gasthuisberg
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2G3
        • The University of Alberta - Edmonton
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre
      • Toronto, Ontario, Canada, M5G 2C4
        • Princess Margaret Hospital
    • Quebec
      • Montréal, Quebec, Canada, H3T 1E2
        • Jewish General Hospital
  • Chile
      • Concepción, Chile, 4070196
        • Biocenter Centro Clinico de Investigacion
    • Santiago
      • Las Condes, Santiago, Chile, 7580206
        • Centro Medico Inmunocel
      • Providencia, Santiago, Chile, 7500653
        • Centro de Estudios Clínicos SAGA
  • Czechia
      • Brno, Czechia
        • Fakultní nemocnice Brno
      • Olomouc, Czechia
        • Fakultni nemocnice Olomouc
      • Prague, Czechia, 128 00
        • Vseobecna fakultni nemocnice v Praze
  • France
      • Amiens, France
        • Chu Amiens Picardie - Hopital Sud
      • Argenteuil, France, 95107
        • Centre Hospitalier D'Argenteuil
      • Béziers, France, 34500
        • Centre Hospitalier de Beziers
      • Paris, France, 75010
        • AP-HP Hôpital Saint-Louis
      • Pierre-Bénite, France
        • HCL Centre Hospitalier Lyon Sud
    • Cedex
      • Poitiers, Cedex, France, 86000
        • CHU Poitiers
    • Cedex 09
      • Angers, Cedex 09, France
        • CHU Angers
    • Cedex 15
      • Paris, Cedex 15, France, 75743
        • AP-HP Hospital Necker-Enfants Malades
  • Germany
      • Aachen, Germany, 52074
        • Uniklinik RWTH Aachen - Klinik fuer Haematologie, Onkologie, Haemostaseologie und Stammzelltransplantation (Med. Klinik IV)
      • Berlin, Germany, 10117
        • Charité Universitaetsmedizin Berlin
      • Dresden, Germany, 01307
        • Gemeinschaftspraxis Haematologie - Onkologie - Hauptstelle
      • Greifswald, Germany, 17489
        • Universitaetsmedizin Greifswald
      • Hamburg, Germany, 22081
        • OncoResearch Lerchenfeld GmbH
      • Koblenz, Germany, 56068
        • InVo-Institut fuer Versorgungsforschung in der Onkologie GbR
      • Mainz, Germany, 55131
        • Universitaetsmedizin der Johannes Gutenberg - Universitaet Mainz
  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
  • Hungary
      • Budapest, Hungary, 1085
        • Semmelweis Egyetem
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont
      • Eger, Hungary, 3300
        • Markhot Ferenc Oktatokorhaz es Rendelointezet
  • Israel
      • Haifa, Israel, 3109601
        • Rambam Health Care Campus
      • Jerusalem, Israel, 9103102
        • Shaare Zedek Medical Center
      • Jerusalem, Israel, 121000
        • Hadassah Medical Center Ein Karem
      • Kfar Saba, Israel, 4428164
        • Meir Medical Center
      • Petach Tikva, Israel, 4941492
        • Rabin Medical Center - Davidoff Hematology Center
      • Tel Aviv, Israel, 6423906
        • Sourasky Medical Center
      • Zerifin, Israel, 70300
        • Shamir Medical Center (Assaf Harofe)
  • Italy
      • Bergamo, Italy, 24127
        • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
      • Bologna, Italy, 40138
        • IRCCS Azienda Ospedaliero-Universtaria di Bologna
      • Brescia, Italy, 25123
        • UOC Ematologia - ASST Spedail Civill Brescia
      • Firenze, Italy, 50134
        • Azienda Ospedaliero - Universitaria Careggi
      • Milano, Italy, 35-20122
        • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, SC Ematologia (Padiglione Marcora),
      • Pavia, Italy
        • Fondazione IRCCS Policlinico San Matteo
      • Pesaro, Italy, 61122
        • UOC Ematologia e Centro Trapianti AST Pesaro Urbino, Stabilimento Muraglia
      • Roma, Italy, 00168
        • Fondazione Policlinico Univ. A . Gemelli IRCCS
      • Torino, Italy, 10126
        • AOU Citta della Salute e della Scienza di Torino
      • Torino, Italy, 10043
        • AOU San Luigi Gonzaga Orbassano
      • Varese, Italy, 21100
        • Azienda ASST-SETTELAGHI, Ospedale di Circolo e Fond. Macchi di Varese Ospedael Vecchio
    • Forli-Cesena
      • Meldola, Forli-Cesena, Italy, 47014
        • IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadon"
  • Mexico
      • Madero, Mexico, 89450
        • Centro de Estudios de Investigacion SIYODE
      • Mexico City, Mexico, ZC 03100
        • Superare Centro de Infusion S.A. de C.V.
      • Mexico City, Mexico, ZC01120
        • Boca Clinical Trials Mexico S.C. - Ciudad de Mexico
  • Netherlands
      • Dordrecht, Netherlands, 3318 AT
        • Albert Schweitzer Ziekenhuis
      • Rotterdam, Netherlands, 3015 GD
        • Erasmus MC
  • Poland
      • Brzozów, Poland, 36-200
        • Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny im.ks.B.Markiewicza
      • Bydgoszcz, Poland, 85-065
        • MICS Centrum Medyczne Bydgoszcz
      • Gdańsk, Poland, 80-214
        • Klinika Hematologii I Transplantologii - Uniwersyteckie Centrum Kliniczne
      • Krakow, Poland, 31-513
        • Promed P.Lach R.Glowacki Spolka Jawna
      • Lodz, Poland, 93-513
        • Wojewodzkie Wielospecjalistyczne Centrum, Onkologii i Traumatologii im. M Kopernika w Lodzi
      • Toruń, Poland, 87-100
        • MICS Centrum Medyczne Torun
      • Warszawa, Poland, 02-172
        • MTZ Clinical Research Powered by Pratia
      • Wrocław, Poland, 50-449
        • Centrum Medyczne Melita Medical
      • Łódź, Poland, 93-510
        • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi Oddział
  • Portugal
      • Almada, Portugal, 2801-951
        • Conde Hospital Garcia de Orta
      • Braga, Portugal, 4710-243
        • Hospital de Braga
      • Lisboa, Portugal, 1649-035
        • CHULN - Hospital de Santa Maria
      • Porto, Portugal, 4200-072
        • Instituto Português de Oncologia do Porto Francisco Gentil, EPE
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall d'Hebron
      • Barcelona, Spain, 08036
        • Hospital Clinic Barcelona
      • Barcelona, Spain, 8003
        • Hospital del Mar
      • Barcelona, Spain, 08916
        • Hospital Germans Trias i Pujol
      • Madrid, Spain, 28034
        • Hospital Universitario Ramón y Cajal
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañón
      • Madrid, Spain
        • Hospital Universitario 12 de Octubre
      • Valencia, Spain, 46026
        • Hospital Universitari i Politècnic La Fe
      • Zaragoza, Spain
        • Hospital QuironSalud de Zaragoza
  • Turkey
      • Gaziantep, Turkey, 27410
        • Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi
      • Istanbul, Turkey, 34899
        • Marmara University Pendik Training & Research Hospital
      • Kayseri, Turkey, 38039
        • Erciyes Universitesi Tip Fakultesi Hastanesi, Dedeman Hospital
    • Ankara
      • Balkiraz, Ankara, Turkey, 06620
        • Ankara Universitesi Tip Fakultesi Hematologi Bilim dali Ankara
      • Yenimahalle, Ankara, Turkey, 06560
        • Gazi University Medical Faculty
    • Denizli
      • Pamukkale, Denizli, Turkey, 20160
        • Pamukkale University Hospitals
    • Izmir
      • Bornova, Izmir, Turkey, 35100
        • Ege University Hospital Department of Hematology
    • Ortahisar
      • Trabzon, Ortahisar, Turkey, 61080
        • Karadeniz Technical University Medical Faculty Farabi Hospital
    • Sehitkamil
      • Gaziantep, Sehitkamil, Turkey, 27090
        • Sanko Universitesi tip Fakultesi Ic Hastaliklari Anabilim Dali
  • United Kingdom
      • Barnet, United Kingdom, EN5 3DJ
        • Barnet Hospital
      • Boston, United Kingdom, PE21 9QS
        • Pilgrim Hospital
      • Harrow, United Kingdom, HA1 3UJ
        • Northwick Park Hospital
      • London, United Kingdom, E1 1BB
        • The Royal London Hospital
      • London, United Kingdom, NW1 2PG
        • University College London Hospital
      • London, United Kingdom, NW3 2QG
        • Royal Free Hospital, Royal Free London NHSFT
      • Oxford, United Kingdom, OX3 7LE
        • Churchill Hospital
    • Middlesex
      • Uxbridge, Middlesex, United Kingdom, U38 3NN
        • Hillingdon Hospital
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36607
        • Infirmary Cancer Care
    • Arizona
      • Glendale, Arizona, United States, 85304
        • Palo Verde Hematology-Oncology
    • California
      • Duarte, California, United States, 91010
        • City of Hope Medical Center, Duarte
      • Fresno, California, United States, 93720
        • California Cancer Associates for Research and Excellence - Fresno
      • Greenbrae, California, United States, 94904
        • Marin Cancer Care
      • Irvine, California, United States, 92618
        • City of Hope Medical Center, Lenner
      • La Jolla, California, United States, 92037
        • University of California, San Diego (UCSD) - Moores Cancer Center
      • Los Angeles, California, United States, 90095
        • University of California, Los Angeles (UCLA) - Medical Center
      • Palo Alto, California, United States, 94304
        • Stanford University
      • Pomona, California, United States, 91767
        • Pomona Valley Hospital Medical Center
      • San Diego, California, United States, 92123
        • Sharp Memorial Hospital
      • San Francisco, California, United States, 94117
        • University of California, San Francisco
      • Upland, California, United States, 91786
        • City of Hope Medical Center, Upland
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Rocky Mountain Cancer Centers
      • Aurora, Colorado, United States, 80045
        • University of Colorado - Aurora Cancer Center
      • Boulder, Colorado, United States, 80303
        • Rocky Mountain Cancer Centers - Boulder
      • Colorado Springs, Colorado, United States, 80907
        • Rocky Mountain Cancer Centers
      • Colorado Springs, Colorado, United States, 80923
        • Rocky Mountain Cancer Centers
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Centers
      • Lakewood, Colorado, United States, 80228
        • Rocky Mountain Cancer Centers
      • Littleton, Colorado, United States, 80120
        • Rocky Mountain Cancer Centers
      • Lone Tree, Colorado, United States, 80124
        • Rocky Mountain Cancer Centers
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University School of Medicine - Yale Cancer Center
    • Florida
      • Plantation, Florida, United States, 33322
        • BRCR Medical Center
      • Saint Petersburg, Florida, United States, 33705
        • BayCare Suncoast Medical Clinic - Hematology/Oncology
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital
      • Lake Forest, Illinois, United States, 60045
        • Northwestern Medicine Lake Forest Hospital
      • Rolling Meadows, Illinois, United States, 60008
        • Northwest Oncology and Hematology
      • Skokie, Illinois, United States, 60046
        • Orchard Healthcare Research Inc
    • Indiana
      • Fort Wayne, Indiana, United States, 46845
        • Fort Wayne Medical Oncology and Hematology
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • Mission Cancer & Blood
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Cancer Center
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • Pontchartrain Cancer Center
      • Hammond, Louisiana, United States, 70403
        • Pontchartrain Cancer Center
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • American Oncology Partners of Maryland PA (Center for Cancer & Blood Disorders)
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • Nevada
      • Reno, Nevada, United States, 89511
        • Cancer Care Specialists
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Memorial Sloan Kettering Cancer Center - Basking Ridge
      • Lakewood, New Jersey, United States, 08701
        • Monmouth Medical Center Southern Campus
      • Long Branch, New Jersey, United States, 07740
        • Monmouth Medical Center
      • Middletown, New Jersey, United States, 07748
        • Memorial Sloan Kettering Cancer Center - Monmouth
      • Montvale, New Jersey, United States, 07645
        • Memorial Sloan Kettering Cancer Center - Bergen
      • New Brunswick, New Jersey, United States, 08901
        • Rutgers Cancer Institute of New Jersey
    • New York
      • Babylon, New York, United States, 11702
        • New York Cancer and Blood Specialists
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
      • Bronx, New York, United States, 10461
        • Montefiore Einstein Center for Cancer Care
      • Bronx, New York, United States, 10469
        • New York Cancer and Blood Specialists
      • Buffalo, New York, United States, 14263
        • Roswell Park Comprehensive Cancer Center
      • Commack, New York, United States, 11725
        • Memorial Sloan Kettering Cancer Center - Commack
      • Harrison, New York, United States, 10604
        • Memorial Sloan Kettering Cancer Center - Westchester
      • New Hyde Park, New York, United States, 11042
        • New York Cancer and Blood Specialists
      • New York, New York, United States, 10029
        • Ichan School of Medicine at Mount Sinai
      • New York, New York, United States, 10065
        • New York Presbyterian Hospital/Weill Cornell Medical Center
      • New York, New York, United States, 10028
        • New York Cancer and Blood Specialists
      • New York, New York, United States, 10021
        • Memorial Sloan Kettering Cancer Center - KOCH
      • Patchogue, New York, United States, 11772
        • New York Cancer and Blood Specialists
      • Port Jefferson Station, New York, United States, 11776
        • New York Cancer and Blood Specialists
      • Riverhead, New York, United States, 11901
        • New York Cancer and Blood Specialists
      • Rochester, New York, United States, 14642
        • Wilmot Cancer Institute, University of Rochester
      • Uniondale, New York, United States, 11553
        • Memorial Sloan Kettering Cancer Center - Nassau
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Greenville, North Carolina, United States, 27858
        • East Carolina University
    • Ohio
      • Canton, Ohio, United States, 44718
        • Gabrail Cancer Center
      • Cincinnati, Ohio, United States, 45220
        • TriHealth Cancer Institute - Good Samaritan Hospital
      • Cincinnati, Ohio, United States, 45236
        • Good Samaritan Infusion Center - Kenwood
      • Cincinnati, Ohio, United States, 45242
        • Good Samaritan Infusion Center - Thomas
      • Columbus, Ohio, United States, 43210
        • The Ohio State University
      • Columbus, Ohio, United States, 43214
        • Ohio Health Research Institute
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Oncology Associates of Oregon
      • Portland, Oregon, United States, 97210
        • Oregon Health and Science University (OHSU) Knight Cancer Institute
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburgh Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
      • San Antonio, Texas, United States, 78240
        • Texas Oncology San Antonio
    • Utah
      • Ogden, Utah, United States, 84405
        • Community Cancer Trials of Utah
    • Washington
      • Seattle, Washington, United States, 98019
        • University of Washington - Fred Hutchinson Cancer Center
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54301
        • HSHS St. Vincent Hospital
      • Green Bay, Wisconsin, United States, 54303
        • HSHS St. Mary's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Main 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.
  • 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:

    1. Hematocrit <45%,
    2. WBC 4000/μL to 20,000/μL (inclusive), and
    3. 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.

Main 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 in situ or stage 1 squamous cell carcinoma of the skin, in situ or stage 1 basal cell carcinoma of the skin, or in situ melanoma of the skin identified during screen unless the cancer is adequately treated before randomization.
  • Received Busulfan, Pipobroman or 32Phosphorus within 7 months prior to screening.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rusfertide
Rusfertide (32 Weeks) - Rusfertide (124 Weeks Open-label)
Drug: Rusfertide
Experimental drug
Experimental: Placebo
Placebo (32 Weeks) - Rusfertide (124 Weeks Open-label)
Drug: Placebo
Placebo
Drug: Rusfertide
Experimental drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of subjects achieving a response who receive rusfertide compared to placebo.
Time Frame: Week 20 through Week 32
Response is defined as absence of phlebotomy eligibility.
Week 20 through Week 32

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparison of mean number of phlebotomies between rusfertide and placebo.
Time Frame: Week 0 to Week 32
Week 0 to Week 32
Proportion of subjects with HCT values <45% for rusfertide and placebo.
Time Frame: Week 0 to Week 32
Week 0 to Week 32
Comparison mean change from baseline in total fatigue score based on PROMIS Short Form between rusfertide and placebo.
Time Frame: Week 32
Week 32
Comparison of mean change from baseline in total MFSAF total score.
Time Frame: Week 32
Week 32

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Protagonist Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Actual)

February 21, 2025

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

January 14, 2022

First Submitted That Met QC Criteria

January 14, 2022

First Posted (Actual)

January 27, 2022

Study Record Updates

Last Update Posted (Actual)

August 7, 2025

Last Update Submitted That Met QC Criteria

August 4, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTG-300-11

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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