A research study investigating denecimig (Mim8) in adults with acquired haemophilia A

Prior treatment

• Previous or current thromboembolic disease or events (with the exception of previous catheter associated thrombosis for which anti-thrombotic treatment is not currently ongoing) or risk of thromboembolic disease.
• Therapy with immunosuppressive or immune modulating drugs for treatment of AHA (other than ≤2 days of prednisolone (or equivalent) for AHA at a dose ≤100 mg per day), prior to screening. - IST initiated prior to AHA diagnosis for other medical conditions (e.g., other autoimmune disorders) is permitted, provided it was intitiated ≥6 months prior to screening, has been maintained at a stable dose and regimen since initiation, and is expected to remain at a stable dose and regimen at least during main treatment period (Weeks 0-12).

Other

• Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate and highly effective contraceptive method.
• Life expectancy <3 months at the time of screening, as evaluated by the investigator.

• Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
• Male or female participants (sex assigned at birth, inclusive of all gender identities) newly diagnosed with AHA prior to signing the informed consent form, with AHA diagnosis (FVIII activity <50% and FVIII inhibitors >0.6 BU) confirmed at screening.
• Treatment-requiring bleed(s) due to AHA from diagnosis and until screening.
• The participant is capable of following study procedures and able to seek medical attention when needed.