A Research Study Investigating Mim8 in Adults and Adolescents With Haemophilia A With or Without Inhibitors

Inclusion Criteria:

1. Informed consent obtained before any study-related activities. Study-relatedactivities are any procedures that are carried out as part of the study, includingactivities to determine suitability for the study.

2. Male or female participants with diagnosis of congenital haemophilia A of anyseverity based on medical records.

3. Participant has been prescribed treatment with factor VIII concentrates or bypassingagent in the last 26 weeks prior to screening.

4. Age above or equal to 12 years at the time of signing informed consent.

5. Body weight greater than or equal to 30 kg.

6. Applicable to participants treated with on-demand/no prophylaxis prior to enrolment: ≥5 bleeds in the last 26 weeks prior to screening visit, for which factor VIIIconcentrates or bypassing agent has been prescribed.

7. Applicable to participants with FVIII activity ≥1% who are on prophylactictreatment: ≥1 bleed in the last 26 weeks prior to screening visit, for which factorVIII concentrates or bypassing agent has been prescribed.

8. Willingness and ability to comply with scheduled visits and study procedures,including the completion of diary and patient-reported outcomes questionnaires.

Exclusion Criteria:

1. Previous participation in this study. Participation is defined as signed informedconsent.

2. Participation (i.e., signed informed consent) in any interventional clinical studywith receipt of the last dose within 6 months (or 5 half-lives of theinvestigational medicinal product, whichever is shorter) before plannedrandomisation.

3. Exposure to non-factor haemostatic products for bleeding prophylaxis within 6 months (or 5 half-lives of the medicinal product, whichever is shorter) before plannedrandomisation, for participants not included in the run-in.

4. Female who is pregnant, breast-feeding or intends to become pregnant or is ofchild-bearing potential and not using a highly effective contraceptive method.Breast feeding is allowed only during the run-in period.

5. Any disorder, except for conditions associated with haemophilia A, which in theinvestigator's opinion might jeopardise participant's safety or compliance with theprotocol.

6. Known or suspected hypersensitivity to trial product(s), any constituents of theproduct or to related products.

7. Receipt of gene therapy at any given time point.

8. Ongoing or planned immune tolerance induction (ITI) therapy.

9. Major surgery planned to take place after screening.

10. Known congenital or acquired coagulation disorders other than haemophilia A.

11. Hepatic dysfunction defined as aspartate aminotransferase (AST) and/or alanineaminotransferase (ALT) above 3 times the upper limit combined with total bilirubinabove1.5 times the upper limit measured at screening.

12. Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) below orequal to 30 ml/min/1.73 m^2 for serum creatinine measured at screening.

13. Previous or current thromboembolic disease or events (with the exception of previouscatheter-associated thrombosis for which anti-thrombotic treatment is not currentlyongoing) or risk of thromboembolic disease, as evaluated by investigator.

14. Mental incapacity, unwillingness to cooperate, or a language barrier precludingadequate understanding and cooperation.

15. Other conditions (e.g., autoimmune disease) or laboratory abnormality that mayincrease risk of bleeding or thrombosis as evaluated by the investigator.