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

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).

Study Overview

• Status: Recruiting
• Conditions: Congenital Factor VII Deficiency
• Intervention / Treatment: Drug: Sutacimig

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 Type: Interventional
• Enrollment (Estimated): 18
• Phase: Phase 2

Contacts and Locations

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

Study Locations

• United Kingdom
  • London, United Kingdom, E1 2ES
    • Recruiting
    • Royal London Hospital
    • Contact: Suthesh Sivapalarantnam; Phone Number: +44 (0) 020 3594 3327; Email: s.sivapalaratnam@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Participants with a FVII(a) level of < 10%	Drug: Sutacimig; Sutacimig is a subcutaneously administered, bispecific antibody being developed as a prophylactic treatment option for congenital bleeding disorders.
Experimental: Participants with a FVII(a) level of ≥10%	Drug: Sutacimig; Sutacimig is a subcutaneously administered, bispecific antibody being developed as a prophylactic treatment option for congenital bleeding disorders.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of treatment-emergent adverse events (TEAEs)	Day 1 through Day 57

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Hemab ApS

Publications and helpful links

Helpful Links

• Sponsor Website

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: December 23, 2025
• First Submitted That Met QC Criteria: January 8, 2026
• First Posted (Actual): January 16, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Congenital Factor VII Deficiency; Factor VII Deficiency; FVIID; Congenital coagulation factor VII (FVII) deficiency
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Hematologic Diseases; Blood Coagulation Disorders; Hemorrhagic Disorders; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hemic and Lymphatic Diseases; Factor VII Deficiency
• Other Study ID Numbers: HMB-001-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No