A phase 3b open-label, multicenter study evaluating physical activity and joint health in previously treated patients ≥12 years of age with severe haemophilia A treated with intravenous recombinant coagulation factor VIII Fc-von Willebrand Factor-XTEN fusion protein (rFVIIIFc-VWF-XTEN; efanesoctocog alfa) for 24 months

Haemophilia A

Change from baseline in IPAQ scoring [at month 24]

Physical activity • Change from baseline in IPAQ scoring [at month 12] • IPAQ score • Change in mean daily minutes of tracker-recorded physical activity • Mean daily minutes of tracker-recorded physical activity, • Change in patient-reported workout • Change in tracker-recorded workout • Mean value in patient-reported workout • Mean value in tracker-recorded workout • Change in mean daily number of tracker-recorded steps, • Mean daily number of tracker-recorded steps • Achieving WHO-recommended levels (33) of tracker-recorded MVPA • Occurrence of bleeds • Occurrence of pain • Occurrence of injuries • Occurrence of bleeding episodes impacting daily activity (Missed work/school, missed other activities, nothing missed), Joint & musculoskeletal status • Change from baseline in HJHS and HEAD-US and MRI at a total/joint and item domain level. • Target joint development, resolution and recurrence, Efanesoctocog alfa efficacy • Number of bleeding episodes • ABR by type and location • Total annualized efanesoctocog alfa consumption • Number of injections and dose to treat a bleeding episode, PROs • Pain (ePD reported, PROMIS Pain Intensity, PROMIS-SF Pain Interference) • QoL assessed by EQ-5D-5L • Treatment Preference Survey [EoS], Safety • The occurrence of AEs and SAEs • The occurrence of clinically significant changes from baseline in physical examination • Development of inhibitors (neutralizing antibodies directed against factor VIII [FVIII]) as determined via the Nijmegen modified Bethesda assay • The occurrence of thrombotic and embolic events, Healthcare Resources • Number and duration of non-study medical care encounters (outpatient, inpatient, emergency room)

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