Actively Recruiting
A Phase 2, Open-Label Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of DISC-3405 in Participants With Polycythemia Vera (PV)
Led by Disc Medicine, Inc · Updated on 2026-05-28
60
Participants Needed
15
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating DISC-3405 in adults with polycythemia vera (PV), a blood condition. This open-label, multicenter Phase 2 study will examine up to two dose levels of DISC-3405 to assess its safety, tolerability, effects on the body, and how the body processes the drug. The study aims to gather detailed information about these aspects to better understand the potential role of DISC-3405 in treating PV. The treatment involves subcutaneous administration of DISC-3405 with a dose escalation design within participants. Participants will receive up to two different dose levels during the study period. This open-label approach means both researchers and participants know the treatment being given. The study does not include placebo or control groups and focuses on individual participant responses to these doses. Participants will be monitored closely for up to 365 days to assess safety through vital signs, physical exams, electrocardiograms, and laboratory tests. Researchers will track treatment-related adverse events and therapeutic responses, including blood parameters like hematocrit levels and the need for phlebotomies. The study also evaluates drug levels in the blood and other pharmacokinetic and pharmacodynamic measures. Participants will provide informed consent and comply with study procedures throughout the trial duration.
CONDITIONS
Brief Title
A Phase 2, Open-Label Study of DISC-3405 in Participants With Polycythemia Vera (PV)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older at the time of signing informed consent
- Meet revised 2022 WHO criteria for diagnosis of polycythemia vera
- Screening blood counts with hematocrit less than 45%, or less than 48% if phlebotomy within 2 weeks
- White blood cells between 4000/µL and 20,000/µL inclusive
- Platelets between 100,000/µL and 1,000,000/µL inclusive
- At least 3 phlebotomies in 26 weeks or 5 phlebotomies in 52 weeks before screening, with at least 1 in the last 12 weeks
- Stable cytoreductive therapy for at least 6 months and stable dose for at least 2 months, or stopped cytoreductive therapy 6 months before screening if treated with phlebotomy alone
- ECOG performance status 0 or 1, or 2 with medical approval
- If male with female partners of childbearing potential, agrees to use acceptable contraception during study and 120 days after last dose
- If female, postmenopausal, surgically sterile, or agrees to use highly effective contraception during study and 120 days after last dose
- Negative pregnancy test if female of childbearing potential
- Able to understand study and provide informed consent
- Able to comply with all study procedures
You will not qualify if you...
- Clinically significant lab abnormalities at screening
- Need for phlebotomy at hematocrit levels below 45%
- Significant thrombosis within 2 months before treatment
- Active or chronic bleeding within 6 months before treatment
- Severe kidney dysfunction (eGFR less than 30 mL/min/1.73 m2)
- History of invasive malignancies within 5 years except certain treated skin and prostate cancers
- Recent use of certain chemotherapy agents within 7 months before screening
- Major surgery within 8 weeks or incomplete recovery from surgery
- Known allergic reactions to investigational product ingredients or history of anaphylaxis
- History of alcohol dependence or excessive use
- Active HIV, hepatitis B or C infection
- Medical or psychiatric conditions that increase risk or interfere with study
- Pregnancy or breastfeeding
- Participation in other investigational studies with experimental therapy within 30 days or 5 half-lives
- Prior use of hepcidin inducing agents affecting TMPRSS6 not allowed; hepcidin mimetics may be allowed with sponsor approval
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 365 days
Participants receive the study drug DISC-3405 through subcutaneous administration with dose escalation up to 2 dose levels within each participant.
Visits occur throughout dosing and monitoring during treatment
Trial Site Locations
Total: 15 locations
1
Mayo Clinic in Arizona
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
3
UCLA Health
Los Angeles, California, United States, 90095
Actively Recruiting
4
Keck Medicine of USC - Cancer Clinic- Newport Beach
Newport Beach, California, United States, 92663
Actively Recruiting
5
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
6
Mayo Clinic in Minnesota
Rochester, Minnesota, United States, 55905
Actively Recruiting
7
Siteman Cancer Center - Washington University St. Louis
St Louis, Missouri, United States, 63110
Actively Recruiting
8
Atrium Health - Levine Cancer Center
Charlotte, North Carolina, United States, 28204
Actively Recruiting
9
Duke University
Durham, North Carolina, United States, 27705
Actively Recruiting
10
Atrium Health Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
11
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
12
Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
13
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
14
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
15
University of Washington - Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
D
Disc Medicine Clinical Trials
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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