A Phase 2 interventional study of Sutacimig and Sutacimig in Congenital Factor VII Deficiency, sponsored by Hemab ApS. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by Hemab ApS · Phase 2, Interventional, and Treatment
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).
The objective is to administer a single dose of sutacimig and to evaluate safety, pharmacokinetics, and pharmacodynamics. Two cohorts may be evaluated. Cohort A is defined by participants with a FVII(a) level of \< 10%. Cohort B is defined by participants with a FVII(a) level of ≥10%.
Hemab ApS is the lead sponsor of 5 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Sutacimig
Drug: Sutacimig
Sutacimig is a subcutaneously administered, bispecific antibody being developed as a prophylactic treatment option for congenital bleeding disorders.
Sutacimig is a subcutaneously administered, bispecific antibody being developed as a prophylactic treatment option for congenital bleeding disorders.
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Day 1 through Day 57
Pharmacokinetic Parameter: Maximum observed plasma concentration (Cmax) of sutacimig
Time frame: Day 1 through Day 57
Pharmacokinetic Parameter: Time to reach maximum observed plasma concentration (Tmax)
Time frame: Baseline through Day 57
Pharmacokinetic Parameter: Area under the plasma concentration-time curve from time zero to last quantifiable concentration (AUClast)
Time frame: Day 1 through Day 57
Pharmacokinetic Parameter: Area under the curve from time zero to extrapolated infinite time (AUCinf)
Time frame: Day 1 through Day 57
Pharmacokinetic Parameter: Terminal elimination phase half-life (T1/2)
Time frame: Day 1 through Day 57
Pharmacodynamic Parameter: Total Factor VII
Time frame: Day 1 through Day 57
Pharmacodynamic Parameter: Factor VII Activity
Time frame: Day 1 through Day 57
Pharmacodynamic Parameter: Prothrombin time (PT) Measurement
Time frame: Day 1 through Day 57
Pharmacodynamic Parameter: Activated partial thromboplastin time (aPTT) Measurement
Time frame: Day 1 through Day 57
Anti-drug antibody levels
Time frame: Day 1 through Day 57
Started Mar 2026 (actual). Primary completion is estimated for Nov 2027, 20 months after the start.
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Factor VII Deficiency
Hemab ApS