NCT06985147 · Disc Medicine, Inc
A Phase 2, Open-Label Study of DISC-3405 in Participants With Polycythemia Vera (PV)
What this study is about
This where both patients and doctors know the treatment given, conducted at multiple hospitals, within-participant gradually increasing doses study examining up to 2 dose levels of DISC-3405 will assess the safety, tolerability, effectiveness, how the drug moves through the body, and how the drug affects the body of DISC-3405 in participants with polycythemia vera (PV).
View original scientific description
This open-label, multicenter, within-participant dose escalation study examining up to 2 dose levels of DISC-3405 will assess the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of DISC-3405 in participants with polycythemia vera (PV).
Interventions
DRUG
DISC-3405
DISC-3405 is administered subcutaneously.
Primary outcome measures
Number of participants with treatment-related adverse events as assessed by CTCAE
Time frame: Up to 365 days
Proportion of participants with treatment-emergent adverse events
Incidence of clinically abnormal vital signs
Time frame: Up to 365 days
Proportion of participants with changes in vital signs
Incidence of clinically abnormal physical exam
Time frame: Up to 365 days
Proportion of participants with changes in physical examinations
Incidence of clinically abnormal electrocardiograms
Time frame: Up to 365 days
Proportion of participants with changes in electrocardiograms (ECGs)
Incidence of abnormal laboratory test results
Time frame: Up to 365 days
Proportion of participants with changes in clinical laboratory results
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Aged 18 years or older at the time of signing the informed consent form (ICF). 2. Meet revised 2022 World Health Organization (WHO) criteria for the diagnosis of PV. 3. Complete blood count values prior to Day 1 of HCT \<45% or HCT \<48% if followed by a phlebotomy within 2 weeks prior to baseline, white blood cells 4000/μL to 20,000/μL (inclusive), and platelets 100,000/μL to 1,000,000/μL (inclusive). 4. At least 3 phlebotomies in 26 weeks before Screening or at least 5 phlebotomies in 52 weeks before Screening. At least 1 phlebotomy must be within the 12 weeks prior to Screening. 5. Participants receiving cytoreductive therapy must have been taking for at least 6 months and be on a stable PV therapy regimen for at least 2 months for hydroxyurea, interferon or ruxolitinib with no anticipated need for dose adjustments during the study, or have decreasing dose (with medical monitor approval). 6. Participants treated with phlebotomy alone must have stopped cytored
Where
- Phoenix, Arizona
- Los Angeles, California
- Newport Beach, California
- Jacksonville, Florida
- Rochester, Minnesota
- St Louis, Missouri
- Charlotte, North Carolina
- Durham, North Carolina
- Winston-Salem, North Carolina
- Cleveland, Ohio
- Columbus, Ohio
- Portland, Oregon
And 2 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 28, 2026 · Source of record for eligibility and locations