VERIFY Study | Polycythemia Vera

What is the VERIFY study?

The purpose of the VERIFY clinical trial is to evaluate how safe and effective rusfertide is in maintaining hematocrit control and improving PV symptoms.

What is rusfertide?

Rusfertide, also known as PTG-300, is an investigational drug designed to slow the release of iron into the blood. The body needs iron to make red blood cells. With less iron in the blood, the body is not able to make as many red blood cells. As a result, rusfertide may help keep hematocrit levels under control. Investigational means the study medication is not approved by regulatory authorities like the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA), and it can only be used in clinical research studies like the VERIFY study.

The VERIFY study

This study is evaluating the ability for rusfertide to control the number of red blood cells (hematocrit level) to reduce, delay or eliminate phlebotomy, and improve patients’ quality of life.

Participation in the VERIFY study is divided into three parts and can last up to 166 weeks (slightly over 3 years).

Study participants can expect to:

Complete a screening visit with assessments to confirm you meet the study requirements.
Continue your current PV therapy.
Receive injections every week under the skin for up to 3 years. You will receive initial doses by the study team during a visit. You will be trained to do the injections and when you are comfortable you will do the weekly injections at home.
Depending on how long you have been in the study, you will visit the study clinic every 2, 4, 6, or 12 weeks for study assessments.
Attend 1 follow-up visit at the study clinic 4 weeks after your final dose of rusfertide.

The study layout below explains the 3 parts of the study in more detail:

Part 1a

Part 1b

Part 2

Description

Participants will be randomized and will have a 50% chance to receive rusfertide drug or a 50% chance to receive placebo. Participants continue to receive their current PV therapy.

All participants receive rusfertide. Participants continue to receive their current PV therapy.

All participants receive rusfertide. Participants continue current PV therapy. Your study doctor may adjust your PV therapies or begin new PV therapies as necessary.

Duration

32 weeks

(Weeks 0-32)

20 weeks

(Weeks 32-52)

104 weeks

(Weeks 52-156)

Visit Frequency

Once every 2 weeks through week 8; once every 4 weeks through week 32

Once every 4 weeks

Once every 12 weeks

Participation in a clinical study is voluntary. You can ask any questions you have and may leave the study at any time, for any reason.

Can I receive other PV therapies?

For the first year you will continue to receive the therapy you received before participating in the study. After the first year, your doctor may adjust your existing PV therapies or begin new PV therapies as necessary.