Study to test the safety and effectiveness of sutacimig for people with a rare bleeding condition called congenital factor VII deficiency

A clinical study to assess the safety and efficacy of sutacimig in participants with congenital factor VII deficiency

Registry ID

ISRCTN16472226

Source registry

ISRCTN

Status

Recruiting

Phase

PHASE2

Study type

INTERVENTIONAL

Sponsor

Hemab Aps

Enrollment

18

Start date

2025-10-17

Completion date

2027-11-27

Last update

2026-08-17

Conditions

• Genetic Diseases

Summary

Congenital coagulation factor VII deficiency

Detailed description

Arms: 1. Experimental: Participants with a FVII(a) level of < 10% Assigned Interventions: Drug: Sutacimig: Sutacimig is a subcutaneously administered, bispecific antibody being developed as a prophylactic treatment option for congenital bleeding disorders. 2. Experimental: Participants with a FVII(a) level of ≥10% Assigned Interventions: Drug: Sutacimig: Sutacimig is a subcutaneously administered, bispecific antibody being developed as a prophylactic treatment option for congenital bleeding disorders. Duration of intervention and follow up is 57 days.

Interventions

• DRUG: Arms: 1. Experimental: Participants with a FVII(a) level of < 10% Assigned Interventions: Drug: Sutacimig: Sutacimig is a subcutaneously administered, bispecific antibody being developed as a prophylactic treatment option for congenital bleeding disorders. 2. Experimental: Participants with a FVII(a) level of ≥10% Assigned Interventions: Drug: Sutacimig: Sutacimig is a subcutaneously administered, bispecific antibody being developed as a prophylactic treatment option for congenital bleeding dis

Inclusion criteria

1. Age 18 to 60 years 2. Diagnosis of FVIID 3. Severe bleeding history 4. Ability to provide informed consent

Exclusion criteria

1. History of thrombosis or thromboembolic disease, or cardiovascular disease 2. Thrombophilia risk factors 3. Use of prohibited medications 4. Women who are pregnant or breastfeeding

Locations

• , , United Kingdom
• , , England

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