SLN124 for Polycythemia Vera
(SLN Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called SLN124 for individuals with Polycythemia Vera (PV), a condition characterized by the overproduction of red blood cells. The study aims to determine the safety of SLN124, how the body processes it, and its effectiveness in managing PV. Participants will receive either SLN124 or a placebo (a substance with no active treatment). Suitable candidates for this trial are adults diagnosed with PV who have a history of needing regular blood draws and do not plan to change their current treatment soon. As a Phase 1, Phase 2 trial, this research focuses on understanding how SLN124 works in people and measuring its effectiveness in an initial, smaller group.
Will I have to stop taking my current medications?
If you are not on cytoreductive therapy, you must have stopped any previous cytoreductive medications at least 24 weeks before starting the trial. If you are on cytoreductive therapy like hydroxyurea, interferon, busulfan, or ruxolitinib, you need to be on a stable dose for at least 12 weeks before starting the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that SLN124, also known as divesiran, appears safe for use. Studies have found it to be safe and well-tolerated in people with Polycythemia Vera (PV). Early research reported no major safety issues, indicating that participants generally did not experience serious side effects. The treatment also demonstrated some positive effects in initial tests. These findings suggest that SLN124 could be a safe option for those considering joining a clinical trial.12345
Why do researchers think this study treatment might be promising for Polycythemia Vera?
Most treatments for polycythemia vera, like phlebotomy and hydroxyurea, focus on reducing blood cell counts or controlling symptoms. But SLN124 works differently, targeting the body's iron regulation to potentially reduce the production of red blood cells. This innovative approach could offer a new way to manage polycythemia vera by directly influencing the underlying mechanism of the disease. Researchers are excited about SLN124 because it introduces a novel mechanism of action, which might lead to more effective and targeted treatments with potentially fewer side effects.
What evidence suggests that SLN124 might be an effective treatment for Polycythemia Vera?
Research has shown that SLN124, also known as Divesiran, could help treat polycythemia vera (PV). It increases a protein called hepcidin, which controls iron levels in the body, by turning off a gene called TMPRSS6. This process reduces iron in the blood, aiding in PV management. Early studies suggest that SLN124 is safe and shows promising effectiveness in patients with PV. In this trial, participants will receive either SLN124 or a placebo to further evaluate its potential as a treatment for polycythemia vera. Overall, these initial results support further research into SLN124 as a potential treatment for polycythemia vera.12345
Are You a Good Fit for This Trial?
Adults with Polycythemia Vera (PV) who've had a skin check in the last 6 months, meet specific PV diagnostic criteria, and have stable phlebotomy history. They must not be on or have recently used certain drugs for PV, agree to contraception, and have an acceptable level of physical functioning.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Open-label Dose Escalation
Participants receive SLN124 in an open-label dose escalation to assess safety, tolerability, and pharmacokinetics
Randomized Double-blind Phase
Participants are randomized to receive either SLN124 or placebo in a double-blind manner to assess efficacy and pharmacodynamics
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Placebo
- SLN124
Find a Clinic Near You
Who Is Running the Clinical Trial?
Silence Therapeutics plc
Lead Sponsor