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RecruitingPhase 2NCT07347249

A Clinical Study to Assess Sutacimig in Participants With Congenital Factor VII Deficiency

A Clinical Study to Assess the Safety and Efficacy of Sutacimig in Participants With Congenital Factor VII Deficiency

Sponsor

Hemab ApS

Enrollment

18 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

Congenital Factor VII Deficiency

Summary

Open-label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of a single dose of sutacimig monotherapy in participants with congenital FVII deficiency (FVIID).

Eligibility

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria4

  • Age 18 to 60 years, inclusive, at the time of signing informed consent.
  • Diagnosis of FVIID defined by Factor VII:C activity \< 10% documented on ≥ 2 different laboratory measurements by local laboratory assessment.
  • Severe bleeding history characterized by history of a major bleeding event and/or receipt of recombinant activated FVII or fresh frozen plasma as treatment for bleeding or a severe clinical bleeding history as defined by the Investigator.
  • Has the ability to provide informed consent to participate in the trial.

Exclusion Criteria7

  • Presence of known inhibitors to FVII or FVIIa
  • History of clinically significant hypersensitivity associated with monoclonal antibody therapies.
  • History of venous or arterial thrombosis or thromboembolic disease, with the exception of catheter-associated superficial vein thrombosis.
  • Known thrombophilia risk by the following criteria: Homozygous Factor V Leiden (FVL), compound heterozygous FVL/Prothrombin gene mutation, antithrombin \<50%, congenital protein C, and protein S deficiency with levels \<50%.
  • Clinically significant comorbidity that may interfere with study participation.
  • Use of concomitant therapy not permitted during the study (i.e., other platelet inhibitors, desmopressin, fibrinolysis inhibitors, except if used as local treatment \[e.g., for oral bleeds\])
  • Female participants who are pregnant or breastfeeding.
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Interventions

DRUGSutacimig

Sutacimig is a subcutaneously administered, bispecific antibody being developed as a prophylactic treatment option for congenital bleeding disorders.

DRUGSutacimig

Sutacimig is a subcutaneously administered, bispecific antibody being developed as a prophylactic treatment option for congenital bleeding disorders.

Locations(1)

Royal London Hospital

London, United Kingdom

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NCT07347249