The IMPRSSION trial is a clinical study of an investigational antisense medicine for people living with polycythemia vera (PV)
About the Study
The purpose of the IMPRSSION clinical trial is to determine if sapablursen, an investigational antisense drug, is safe and effective in reducing the frequency of phlebotomy and in improving quality of life for people living with PV.
The IMPRSSION clinical trial is an “open-label” study, and participants will receive the study drug (sapablursen) via subcutaneous injection(s) (under the skin) every 4 weeks over about 16 months.
Participation in this study will last approximately 21 months, including a screening period of up to 7 weeks, a 17-month study treatment period and a 3-month post-treatment period.
Condition
Phlebotomy Dependent Polycythemia Vera (PD-PV)
Eligibility Criteria
You may be eligible to participate in the IMPRSSION clinical trial if you:
Have been clinically diagnosed with polycythemia vera (PV)
Have approximately 6 phlebotomies a year
Are between 18 years and 90 years of age
Are on a stable dose or are not taking cytoreductive therapy
Conditions that may exclude individuals from study participation include:
- Known primary or secondary immunodeficiency
- Post-polycythemia vera myelofibrosis
Study Type
Interventional
Phase
Phase 2
ClinicalTrials.gov Identifier
NCT05143957 Take me there »
Frequently Asked Questions
What is sapablursen?
Sapablursen is an investigational antisense medicine being studied as a potential treatment for PV. Sapablursen is designed to reduce the production of transmembrane protease (also known as TMPRSS6), a protein produced in the liver. Inhibition of this protein leads to increased production of hepcidin, which reduces iron availability and results in reduced red blood cell production (erythropoiesis) in the bone marrow.
How often is sapablursen dosed?
In the study, sapablursen is administered via subcutaneous injection (under the skin) every 4 weeks over about 16 months.
Will everyone receive the study medication?
Yes. Because there is no placebo group, all participants will receive the study drug (sapablursen). The IMPRSSION clinical trial is an “open label” study, so you can be sure that you are getting the study drug (sapablursen).
What does participation in the IMPRSSION clinical trial involve?
Before you begin the study, you will go through a screening period of up to 7 weeks to determine your eligibility for the trial. After screening, the physician conducting the study will confirm if you are eligible for the trial.
Eligible participants will be assigned to receive one of 2 dosing levels — a higher or lower dose level — of sapablursen. You will have an equal chance of being assigned to either dose level during the treatment period, which lasts about 16 months plus a 4-week post-last dose visit. You will not know whether you are assigned to the high or the low dose level. Everyone will receive drug, there is no placebo.
The study will also involve a post-treatment period of 13 weeks. More details will be provided to you by the physician.
Who can join the study?
You may qualify for the study if you meet the following requirements:
- You are 18-90 years old
- You have been clinically diagnosed with PV
- You have approximately 6 phlebotomies (blood collections) a year
In addition to the requirements above, other tests and information will be required to determine your eligibility.
Who is not eligible to join the study?
If you currently have one of the following conditions, you may be excluded from participating in the study:
- Known primary or secondary immunodeficiency
- Post-polycythemia vera myelofibrosis
If I am on cytoreductive therapy, am I allowed to participate?
You may be eligible to participate in the IMPRSSION clinical trial if you are currently on a stable dose of cytoreductive therapy (a treatment used to control the blood cell count).
Where will the IMPRSSION clinical trial take place?
The IMPRSSION clinical trial is a multinational study and is enrolling participants in several countries, including the United States, Canada, Australia, Hungary, Poland, and the United Kingdom.
When is the study expected to start?
This study is currently enrolling.
How much will it cost to participate in the IMPRSSION clinical trial?
There is no cost associated with participation in this study. Travel expenses (such as transportation and hotel, if required) will be provided. You may also be reimbursed for certain travel expenses that are related to your study visits (such as meals, parking, and taxi fares).
