TriangleNCT05210790 · CITED IN SOURCE DOCUMENTS
A Phase 3 Study of Rusfertide in Patients With Polycythemia Vera
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- ACTIVE NOT RECRUITING
- Registry last update
- 2025-08-07
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
No posted result sections were captured. Registered plans do not establish that a treatment works.
Who could take part
- eligibility Criteria
- 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.
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Rusfertide (32 Weeks) - Rusfertide (124 Weeks Open-label)
- intervention Names
- Drug: Rusfertide
- label
- Rusfertide
- type
- EXPERIMENTAL
- description
- Placebo (32 Weeks) - Rusfertide (124 Weeks Open-label)
- intervention Names
- Drug: Placebo
- Drug: Rusfertide
- label
- Placebo
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Placebo
- description
- Placebo
- name
- Placebo
- type
- DRUG
- arm Group Labels
- Placebo
- Rusfertide
- description
- Experimental drug
- name
- Rusfertide
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- intervention Model Description
- Randomized, Double-blind (Part 1a): Subjects will be randomized in a blinded fashion to 32 weeks of rusfertide or placebo added-on to each subject's ongoing treatment for polycythemia vera. Open-label (Part 1b + Part 2): Open-label treatment phase during which all subjects who complete Part 1a successfully will receive rusfertide for 124 weeks.
- masking Info
- masking
- TRIPLE
- who Masked
- PARTICIPANT
- INVESTIGATOR
- OUTCOMES_ASSESSOR
- primary Purpose
- TREATMENT
Enrollment
- count
- 293
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Response is defined as absence of phlebotomy eligibility.
- measure
- Proportion of subjects achieving a response who receive rusfertide compared to placebo.
- time Frame
- Week 20 through Week 32
- secondary Outcomes
- measure
- Comparison of mean number of phlebotomies between rusfertide and placebo.
- time Frame
- Week 0 to Week 32
- measure
- Proportion of subjects with HCT values <45% for rusfertide and placebo.
- time Frame
- Week 0 to Week 32
- measure
- Comparison mean change from baseline in total fatigue score based on PROMIS Short Form between rusfertide and placebo.
- time Frame
- Week 32
- measure
- Comparison of mean change from baseline in total MFSAF total score.
- time Frame
- Week 32
Full study description
- brief 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.
- 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.
Source references
Source notices and limitations
Discovery and provenance
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- occurrences
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- TUDIES VERIFY The efficacy of MIMRYLO was evaluated in a multicenter, randomized, double-blind, placebo-controlled Phase 3 study in 293 adult patients with PV [NCT05210790]. Eligible patients required at least 3 phlebotomies in the 28 weeks or 5 phlebotomies in 1 year prior to randomization due to inadequate hematocrit control wh
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Preserved source evidence · Not medical advice