At the beginning of the study, your first visit will take place at week 0. This marks the start of your participation in the long-term treatment phase.

During this visit, baseline assessments will be performed to establish your starting health status.

You will receive instructions on how to administer the study medication and how to complete your daily diary to record any bleeding episodes or side effects.

You will receive denecimig, also referred to as Mim8, as your preventive treatment for haemophilia A. Haemophilia A is a bleeding disorder caused by low levels of a clotting protein called factor VIII.

The medication is a solution for injection that will be administered under the skin (subcutaneous injection).

The treatment will continue for up to 262 weeks (approximately 5 years).

The exact dosage and frequency of injections will be determined based on the treatment plan established for you in the previous study you participated in.

Throughout the study, you will attend scheduled visits at the study site for monitoring and assessments.

During these visits, blood samples will be collected to measure the concentration of Mim8 in your blood and to check for the development of anti-Mim8 antibodies (proteins your immune system might produce in response to the medication).

The study team will examine any injection site reactions, such as redness, swelling, or pain at the location where you administered the medication.

All side effects and adverse events will be recorded and evaluated from the first visit at week 0 until the end of the study at up to 283 weeks.

You will be required to record all bleeding episodes that occur during the study in your diary.

This includes spontaneous bleeding episodes (bleeding that occurs without any known injury), traumatic bleeding episodes (bleeding caused by an injury), and joint bleeding episodes (bleeding into your joints).

If you have a target joint (a joint that has experienced repeated bleeding), any bleeding episodes in that joint will also be recorded separately.

All bleeding episodes that require treatment will be documented from week 0 until the end of treatment at up to 262 weeks.

If applicable to your treatment group, you may be asked to complete a Haemophilia Device Assessment Tool questionnaire.

This tool evaluates your experience with handling and using the injection device for administering the medication.

The assessment helps to understand how easy or difficult it is for you to use the device at home.

After up to 262 weeks of treatment, you will attend an end of treatment visit.

During this visit, final assessments will be performed, including blood tests and evaluation of any side effects.

You will stop receiving denecimig at this point.

After the end of treatment visit, you will enter a follow-up period that lasts for approximately 21 weeks.

During this time, continued monitoring for any late side effects or adverse events will occur.

The total study duration, including treatment and follow-up, will be up to 283 weeks (approximately 5.5 years).

The study is expected to be completed by April 2028.

At the final visit, all remaining assessments will be completed, and your participation in the study will conclude.

Any ongoing safety concerns will be addressed, and you will receive information about your future treatment options.