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Clinical Trials/NCT07347249
NCT07347249
Recruiting
Phase 2

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

Hemab ApS1 site in 1 country18 target enrollmentStarted: January 1, 2026Last updated:
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InterventionsSutacimig

Overview

Phase
Phase 2
Status
Recruiting
Sponsor
Hemab ApS
Enrollment
18
Locations
1
Primary Endpoint
Incidence of treatment-emergent adverse events (TEAEs)
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief 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).

Detailed Description

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%.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Sequential
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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 Criteria

  • •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.

Arms & Interventions

Participants with a FVII(a) level of < 10%

Experimental

Intervention: Sutacimig (Drug)

Participants with a FVII(a) level of ≥10%

Experimental

Intervention: Sutacimig (Drug)

Outcomes

Primary Outcomes

Incidence of treatment-emergent adverse events (TEAEs)

Time Frame: Day 1 through Day 57

Secondary Outcomes

  • Pharmacokinetic Parameter: Maximum observed plasma concentration (Cmax) of sutacimig(Day 1 through Day 57)
  • Pharmacokinetic Parameter: Time to reach maximum observed plasma concentration (Tmax)(Baseline through Day 57)
  • Pharmacokinetic Parameter: Area under the plasma concentration-time curve from time zero to last quantifiable concentration (AUClast)(Day 1 through Day 57)
  • Pharmacokinetic Parameter: Area under the curve from time zero to extrapolated infinite time (AUCinf)(Day 1 through Day 57)
  • Pharmacokinetic Parameter: Terminal elimination phase half-life (T1/2)(Day 1 through Day 57)
  • Pharmacodynamic Parameter: Total Factor VII(Day 1 through Day 57)
  • Pharmacodynamic Parameter: Factor VII Activity(Day 1 through Day 57)
  • Pharmacodynamic Parameter: Prothrombin time (PT) Measurement(Day 1 through Day 57)
  • Pharmacodynamic Parameter: Activated partial thromboplastin time (aPTT) Measurement(Day 1 through Day 57)
  • Anti-drug antibody levels(Day 1 through Day 57)

Investigators

Sponsor
Hemab ApS
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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