Sutacimig for adults with congenital Factor VII deficiency

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label Phase 2 trial gives a single dose of sutacimig as monotherapy to adults with congenital Factor VII deficiency and follows them for safety, tolerability, pharmacokinetics, pharmacodynamics, and signs of efficacy. Participants are separated into two cohorts based on FVII(a) activity (<10% versus ≥10%). Key data collected will include adverse events, drug levels, biomarker changes related to coagulation, and any bleeding outcomes. The study enrolls adults aged 18–60 with documented low FVII activity and a history of clinically significant bleeding.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 18 to 60 years, inclusive, at the time of signing informed consent.
2. Diagnosis of FVIID defined by Factor VII:C activity \< 10% documented on ≥ 2 different laboratory measurements by local laboratory assessment.
3. 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.
4. Has the ability to provide informed consent to participate in the trial.

Exclusion Criteria:

1. Presence of known inhibitors to FVII or FVIIa
2. History of clinically significant hypersensitivity associated with monoclonal antibody therapies.
3. History of venous or arterial thrombosis or thromboembolic disease, with the exception of catheter-associated superficial vein thrombosis.
4. 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%.
5. Clinically significant comorbidity that may interfere with study participation.
6. Use of concomitant therapy not permitted during the study (i.e., other platelet inhibitors, desmopressin, fibrinolysis inhibitors, except if used as local treatment \[e.g., for oral bleeds\])
7. Female participants who are pregnant or breastfeeding.

Where it's running

• Royal London Hospital
  London, United Kingdom Recruiting

Study contacts

• Study coordinator: Hemab Aps
• Email: clinicaltrials@hemab.com
• Phone: +44 (0) 808 304 6409

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.