A study looking at the safety of switching from emicizumab to denecimig in adults and adolescents with haemophilia A with or without inhibitors

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What is this study about?

This study involves people with haemophilia A, a condition where blood does not clot properly because the body lacks enough of a specific clotting protein. This condition can occur with or without the presence of inhibitors, which are substances in the blood that can block the clotting protein from working. The study will use a medication called denecimig, also known by its code name NNC0365-3769 or Mim8, which is given as an injection under the skin. Participants will be switching from their current medication called emicizumab to the study medication.

The purpose of this study is to look at how safe it is for people with haemophilia A to switch from emicizumab to Mim8. The study will observe what happens during the time when emicizumab is leaving the body while people are starting treatment with Mim8. This includes watching for any unwanted effects that might occur during this switch.

During the study, participants will receive Mim8 injections under the skin for up to 26 weeks. They will need to attend regular visits and keep track of their experiences using an electronic diary. The study will also ask participants to complete questionnaires about how they find using the injection device and how the treatment affects their daily life. The study involves adults and adolescents aged 12 years and older who have been taking emicizumab for at least 8 weeks and who have decided with their doctor to stop taking emicizumab.

1 Starting treatment with Mim8

Upon joining the study, treatment with Mim8 (denecimig) will begin. This medication is administered as a subcutaneous injection, which means it is injected under the skin.

The study involves switching directly from previous treatment with emicizumab to Mim8. During this transition period, the emicizumab will gradually leave the body, a process called washout.

Mim8 is provided as a solution for injection and will be used for preventive treatment, also known as prophylaxis, to reduce bleeding episodes.

2 Regular monitoring and safety assessments

Throughout the study, regular monitoring will take place to evaluate the safety of Mim8 treatment during the period when emicizumab is leaving the body.

Any treatment-emergent adverse events, which are unwanted medical occurrences that happen during treatment, will be recorded and assessed.

Scheduled visits will be required to track health status and ensure the treatment is proceeding safely.

3 Completing questionnaires and diary entries

An electronic diary will need to be completed regularly to record information about treatment and any symptoms or events.

The haemophilia device assessment tool questionnaire will be completed to evaluate experience with handling the injection device.

The haemophilia treatment experience measure questionnaire will be completed to assess any changes in treatment burden, which refers to the impact and effort involved in managing the treatment.

4 Continuing prophylaxis treatment

Mim8 prophylaxis treatment will continue throughout the study period to prevent bleeding episodes.

The study is designed to assess the safety of this treatment approach in individuals with haemophilia A, a bleeding disorder caused by a lack of coagulation factor VIII, a protein that helps blood clot.

This applies to individuals both with and without FVIII inhibitors, which are antibodies that can interfere with clotting factor treatment.

5 Study completion

The study will continue until the estimated completion date in February 2025.

Final assessments will be conducted to evaluate the overall safety experience with Mim8 during the transition from emicizumab treatment.

Who Can Join the Study?

You must provide your informed consent (agreement to participate) before any study activities begin. Study activities are any procedures done as part of the study, including tests to see if you are suitable.
You must be male or female with a diagnosis of congenital haemophilia A (a bleeding disorder you were born with that affects blood clotting) of any severity, confirmed in your medical records.
You must be 12 years of age or older at the time you sign the consent form.
You must have been treated with emicizumab (a medicine used to prevent bleeding episodes) given once weekly, once every two weeks, or once every four weeks as prescribed for at least 8 weeks before the screening visit.
The decision to stop your emicizumab treatment must have already been made by your doctor.
You and your caregiver (if applicable) must be willing and able to follow the study schedule and complete all study procedures, including filling out an electronic diary (a digital record of your health information) and questionnaires about your health.

Who Cannot Join the Study?

The source data does not contain specific exclusion criteria (reasons why a patient cannot participate in the study) for this clinical trial.
If you are interested in participating, the research team will need to evaluate your individual medical situation to determine if you meet all requirements for participation.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medical University Of Vienna	Vienna	Austria
Medizinische Universitaet Innsbruck	Innsbruck	Austria
Azienda Ospedaliero Universitaria Careggi	Florence	Italy

Other Sites

Site Name	City	Country
L’Azienda Ospedaliera Di Rilievo Nazionale Santobono-Pausilipon	Naples	Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany
Hospices Civils De Lyon	Lyon	France
Hefonlwr Ufmuohpbxfouu Rhhbmgfy Dg Mzcfuo	Malaga	Spain
Vlxeexor Nbmrboub fvpy Gnbxmctlql Ghss	Berlin	Germany
Ctlhkbebv Uhptcgyhjgbcmr Stjnhftwy	Woluwe-Saint-Lambert	Belgium
Frusagosx Pvgx Lj Ifzwaqrobxyox Bylspjxjw Dpm Hoiaxrcs Upglxcztmypmt Lz Puy	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	26.06.2023
Belgium	Not recruiting	26.06.2023
France	Not recruiting	26.06.2023
Germany	Not recruiting	26.06.2023
Italy	Not recruiting	26.06.2023
Spain	Not recruiting	26.06.2023

Trial locations

Mim8 (also known as NNC0365-3769) is an investigational medication being studied as a preventive treatment for hemophilia A. It is designed to help blood clot properly in people with hemophilia A, whether or not they have developed inhibitors (antibodies that block standard treatments). In this trial, participants are switching from their current preventive medication to Mim8 to see how safe it is during the transition period.

Emicizumab is a medication used to prevent bleeding episodes in people with hemophilia A. It works by helping the blood clotting process in patients whose bodies may not produce enough clotting factor or who have developed inhibitors. In this study, participants were previously receiving emicizumab as their regular preventive treatment before switching to the investigational medication.

Haemophilia A – Haemophilia A is a bleeding disorder caused by a lack of clotting factor VIII in the blood. People with this condition experience prolonged bleeding because their blood does not clot properly. The disease is inherited and passed from parents to children through genes. Bleeding can occur after injuries or surgeries, but sometimes it happens spontaneously without any obvious cause. Internal bleeding into joints and muscles is common and can cause pain and swelling. Over time, repeated bleeding into joints can lead to joint damage and reduced movement.

Trial ID:

2022-502450-13-00

Protocol code:

NN7769-4728

Trial Phase:

Therapeutic confirmatory (Phase III)

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A study looking at the safety of switching from emicizumab to denecimig in adults and adolescents with haemophilia A with or without inhibitors

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?