A multinational, open-label, randomised, controlled trial to investigate efficacy and safety of NNC0365-3769 (Mim8) in adults and adolescents with haemophilia A with or without inhibitors.

- Informed consent obtained before any trial-related activities. Trial related
activities are any procedures that are carried out as part of the trial,
including activities to determine suitability for the trial
- Male or female with diagnosis of congenital haemophilia A of any severity
based on medical records
- Patient has been prescribed, or in need of, treatment with factor VIII or
bypassing agent in the last 26 weeks prior to screening
- Age above or equal to 12 years at the time of signing informed consent.
Germany, Japan and Taiwan: Local requirements apply
- Body weight above or equal to 30 kg
- Applicable to patients on emicizumab prophylaxis: patient is willing to
discontinue emicizumab at the time of screening
- Applicable to patients treated with no prophylaxis prior to enrolment: 5 or
more bleeds in the last 26 weeks prior to screening visit
- Applicable to patients with FVIII activity above 1% who are on prophylactic
treatment: 1 or more bleeds in the last 26 weeks prior to screening visit
- Willingness and ability to comply with scheduled visits and study procedures,
including the completion of diary and patient-reported outcomes questionnaires

- Previous participation in this trial. Participation is defined as signed
informed consent
- Participation in any clinical trial of an approved or non-approved
investigational medicinal product, within 30 days (or 5 half-lives of the
investigational medicinal product, whichever is greater) before
screening
- Female who is pregnant, breast-feeding or intends to become pregnant or is of
child-bearing potential and not using a highly effective contraceptive method
(highly effective contraceptive measures as defined in the protocol or as
required by local regulation or practice). Breast feeding is allowed only
during the run-in period
- Any disorder, except for conditions associated with haemophilia A, which in
the investigator's opinion might jeopardise subject's safety or compliance with
the protocol
- Known or suspected hypersensitivity to trial product(s), any constituents of
the product or to related products
- Receipt of gene therapy at any given time point
- Ongoing or planned immune tolerance induction (ITI) therapy
- Major surgery planned at the time of screening
- Known congenital or acquired coagulation disorders other than haemophilia A
- Hepatic dysfunction defined as aspartate aminotransferase (AST) and/or
alanine aminotransferase (ALT) above 3 times the upper limit combined with
total bilirubin above 1.5 times the upper limit measured at screening
- Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) below
or equal to 30 ml/min/1.73 m^2 for serum creatinine measured at screening
- Previous or current thromboembolic disease or events (includes arterial and
venous thrombosis including myocardial infarction, thrombotic microangiography
(TMA), pulmonary embolism, cerebral
infarction/thrombosis, deep vein thrombosis, other clinically significant
thromboembolic events and peripheral artery occlusion) (with the exception of
previous catheter-associated thrombosis for which antithrombotic treatment is
not currently ongoing) or risk of thromboembolic disease, as evaluated by
investigator
- Mental incapacity, unwillingness to cooperate, or a language barrier
precluding adequate understanding and cooperation
- Other conditions (e.g. autoimmune disease) or laboratory abnormality that may
increase risk of bleeding or thrombosis as evaluated by the investigator