Purpose of this Study
We are doing this study to find the most effective, safe dose of an experimental drug called SLN124 (the study drug). We want to know how well this study drug works in people with PV.
Who Can Participate?
Eligibility
Adults ages 18+ who:<ul>
<li>Are diagnosed with PV</li>
<li>Have had a dermatological examination within 6 months prior to screening</li>
<li>Do not have a known primary or secondary immunodeficiency</li>
<li>Have no history of major bleeding events or have needed a blood transfusion in the last 6 months before joining the study</li>
<li>Do not plan to change their dose of cytoreductive therapy if they are using hydroxyurea, interferon, busulfan, or ruxolitinib</li></ul>
For more information about who can join this study, please contact the study team at 919-660-7262.
<li>Are diagnosed with PV</li>
<li>Have had a dermatological examination within 6 months prior to screening</li>
<li>Do not have a known primary or secondary immunodeficiency</li>
<li>Have no history of major bleeding events or have needed a blood transfusion in the last 6 months before joining the study</li>
<li>Do not plan to change their dose of cytoreductive therapy if they are using hydroxyurea, interferon, busulfan, or ruxolitinib</li></ul>
For more information about who can join this study, please contact the study team at 919-660-7262.
What is Involved?
If you choose to join this study, you will go through a screening period to find out if you are eligible. During this screening period, you will:<ul>
<li>Have a physical exam</li>
<li>Have a heart scan (ECG)</li>
<li>Have blood draws</li></ul>
If you are eligible, you will enter the study drug phase. There are 2 separate study drug phases for this trial. Phase 1 is the dose escalation phase. Phase 2 is the randomized phase. Whether you participate in Phase 1 or Phase 2 will depend on when you join the study.
In Phase 1, different people taking part in this study will get different doses of the study drug. The plan is to test the dose levels one at a time, increasing from the lowest dose to highest dose. Every participant in Phase 1 will receive the study drug and get up to 4 doses of the study drug under the skin, once every 6 weeks
In Phase 2, study participants will get a random assignment (like a coin flip) to 1 of 2 groups:<ul>
<li>Group 1: If you are in this group, you will get up to 4 doses of the study drug under the skin, once every 6 weeks.</li>
<li>Group 2: If you are in this group, you will get up to 4 doses of placebo (inactive substance) under the skin, once every 6 weeks.</li></ul>
The study drug dose participants receive in Phase 2 will be decided by the results of Phase 1. Your participation in the study will last for up to 35 weeks.
<li>Have a physical exam</li>
<li>Have a heart scan (ECG)</li>
<li>Have blood draws</li></ul>
If you are eligible, you will enter the study drug phase. There are 2 separate study drug phases for this trial. Phase 1 is the dose escalation phase. Phase 2 is the randomized phase. Whether you participate in Phase 1 or Phase 2 will depend on when you join the study.
In Phase 1, different people taking part in this study will get different doses of the study drug. The plan is to test the dose levels one at a time, increasing from the lowest dose to highest dose. Every participant in Phase 1 will receive the study drug and get up to 4 doses of the study drug under the skin, once every 6 weeks
In Phase 2, study participants will get a random assignment (like a coin flip) to 1 of 2 groups:<ul>
<li>Group 1: If you are in this group, you will get up to 4 doses of the study drug under the skin, once every 6 weeks.</li>
<li>Group 2: If you are in this group, you will get up to 4 doses of placebo (inactive substance) under the skin, once every 6 weeks.</li></ul>
The study drug dose participants receive in Phase 2 will be decided by the results of Phase 1. Your participation in the study will last for up to 35 weeks.
Study Details
Full Title
Phase 1/2 study with an open-label dose escalation phase followed by a randomized, double-blind phase of SLN124 in patients with Polycythemia Vera
Principal Investigator
Lindsay
Rein
Protocol Number
PRO00112820
NCT ID
NCT05499013
Phase
I/II
Enrollment Status
Open to Enrollment