RecruitingPHASE2INTERVENTIONAL

A Clinical Study to Assess Sutacimig in Participants With Congenital Factor VII Deficiency

This study is looking at a new medicine called Sutacimig for people who have a rare inherited bleeding disorder called Factor VII Deficiency (FVIID). In FVIID, your blood doesn't clot properly, leading to bleeding problems. This study wants to find out if Sutacimig is safe, how the body handles it, and if it helps reduce bleeding. Participants will receive a single dose of Sutacimig, and doctors will carefully check them afterwards. This is an ‘open-label’ study, meaning everyone involved will know what treatment is being given. The main goal is to understand more about this new medicine for FVIID.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Hemab ApS

Enrolment target

Start

11 Mar 2026

Estimated completion

01 Jul 2026

Congenital Factor VII Deficiency

What is this study about?

This study is designed for individuals who have a condition called Congenital Factor VII Deficiency, often shortened to FVIID. This is a rare, inherited bleeding disorder where your body doesn't produce enough of a specific protein, Factor VII, which is essential for blood clotting. When you don't have enough Factor VII, you might experience unusual bleeding or bruising.

The new medicine being tested in this study is called Sutacimig. The main purpose of this study is to see if Sutacimig is safe for people with FVIID and to understand how it works in the body after a single dose. Researchers will also look at whether it helps with the symptoms of FVIID.

This is an early-stage study, called a Phase 2 trial, which focuses on gathering important information about the drug. Understanding how Sutacimig works and if it's safe is a crucial step in potentially developing new treatments for FVIID. Your participation could help researchers learn more and potentially improve care for others with this condition in the future.

Key takeaways

Tests a new medicine (Sutacimig) for Factor VII Deficiency.
Aims to check safety and how the medicine works.
Participants get a single dose of the new medicine.
Open-label study: everyone knows what treatment is given.
For adults aged 18 to 60 with diagnosed FVIID and bleeding history.
Participation helps future treatments for FVIID.

Who may be eligible?

To join this study, you would need to be between 18 and 60 years old. You must also have a confirmed diagnosis of Factor VII Deficiency (FVIID), meaning your Factor VII levels are quite low (less than 10%) based on at least two separate blood tests. Another important requirement is a history of significant bleeding problems, or have needed treatments like special blood products (recombinant activated FVII or fresh frozen plasma) for bleeding in the past.

There are also some reasons why you might not be able to join. For example, if you have certain problems with your immune system, a history of serious blood clots (thrombosis), or if you're taking specific medicines that could interfere with the study drug. Pregnant or breastfeeding women also cannot take part.

The study team will carefully review your medical history to make sure that taking part is safe and appropriate for you. They will explain everything clearly, and you'll have the chance to ask any questions you have.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 60 years old?
Have you been diagnosed with Factor VII Deficiency (FVIID) with low factor levels?
Do you have a history of significant bleeding or needed treatment for bleeding?
Are you able to provide your consent to take part?
Do you have any history of serious blood clots or reactions to similar medicines?
Are you pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to participate, you will receive a single dose of the study medicine, Sutacimig. The study is 'open-label', which means both you and the study team will know that you are receiving Sutacimig. The research team will regularly check how you are doing, looking at things like your safety, how your body processes the medicine, and how it affects your Factor VII levels and any bleeding. This will involve appointments at the study clinic, likely including blood tests, physical examinations, and detailed discussions about your health and any side effects. The total length of your participation, including follow-up appointments after receiving the dose, will be explained to you by the study team.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit could be access to a new experimental medicine for your Factor VII Deficiency that isn't widely available yet. Your participation also helps medical science advance, potentially leading to better treatments for FVIID in the future. However, there are potential risks, including side effects from the medicine, which could be mild or more serious, though the study aims to identify and monitor these closely. There's also the chance the medicine might not work for you. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Royal London Hospital
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is Factor VII Deficiency?

It's a rare inherited bleeding disorder where your blood doesn't clot properly because you don't have enough of a protein called Factor VII.

What is Sutacimig?

Sutacimig is a new experimental medicine being tested in this study to see if it helps people with Factor VII Deficiency.

Will I know if I'm getting the active medicine?

Yes, this is an 'open-label' study, meaning everyone involved, including you, will know you are receiving Sutacimig.

How long will I be involved in the study?

The study involves receiving a single dose of Sutacimig, followed by a period of monitoring and follow-up appointments. The study team will tell you the exact duration.

Can I stop participating if I want to?

Yes, you have the right to leave the study at any time, for any reason, and it will not affect your regular medical care.

How to find out more

Hemab Aps

clinicaltrials@hemab.com +44 (0) 808 304 6409 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.