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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16472226

Enrollment

Registered

2026-03-17

Start date

2025-10-17

Completion date

Unknown

Last updated

2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital coagulation factor VII deficiency Genetic Diseases

Interventions

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 prophyl

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Safety assessed by the incidence of treatment-emergent adverse events and changes in physical examinations, vital signs, clinical laboratory assessments, and electrocardiogram (ECG) parameters from Day 1 through Day 57	—

Secondary

Measure	Time frame
1. Pharmacokinetic Parameter: Maximum observed plasma concentration (Cmax) of sutacimig from Day 1 through Day 57 2. Pharmacokinetic Parameter: Time to reach maximum observed plasma concentration (Tmax) from Day 1 through Day 57 3. Pharmacokinetic Parameter: Area under the plasma concentration-time curve from time zero to last quantifiable concentration (AUClast) from Day 1 through Day 57 4. Pharmacokinetic Parameter: Area under the curve from time zero to extrapolated infinite time (AUCinf) from Day 1 through Day 57 5. Pharmacokinetic Parameter: Terminal elimination phase half-life (T1/2) from Day 1 through Day 57 6. Pharmacodynamic Parameter: Total Factor VII from Day 1 through Day 57 7. Pharmacodynamic Parameter: Factor VII Activity from Day 1 through Day 57 8. Pharmacodynamic Parameter: Prothrombin time (PT) Measurement from Day 1 through Day 57 9. Pharmacodynamic Parameter: Activated partial thromboplastin time (aPTT) Measurement from Day 1 through Day 57 10. Anti-drug antibody levels from Day 1 through Day 57	—

Measure

Time frame

1. Pharmacokinetic Parameter: Maximum observed plasma concentration (Cmax) of sutacimig from Day 1 through Day 57 2. Pharmacokinetic Parameter: Time to reach maximum observed plasma concentration (Tmax) from Day 1 through Day 57 3. Pharmacokinetic Parameter: Area under the plasma concentration-time curve from time zero to last quantifiable concentration (AUClast) from Day 1 through Day 57 4. Pharmacokinetic Parameter: Area under the curve from time zero to extrapolated infinite time (AUCinf) from Day 1 through Day 57 5. Pharmacokinetic Parameter: Terminal elimination phase half-life (T1/2) from Day 1 through Day 57 6. Pharmacodynamic Parameter: Total Factor VII from Day 1 through Day 57 7. Pharmacodynamic Parameter: Factor VII Activity from Day 1 through Day 57 8. Pharmacodynamic Parameter: Prothrombin time (PT) Measurement from Day 1 through Day 57 9. Pharmacodynamic Parameter: Activated partial thromboplastin time (aPTT) Measurement from Day 1 through Day 57 10. Anti-drug antibody levels from Day 1 through Day 57

—

Countries

England, United Kingdom

Contacts

Public Contact- Hemab Aps

clinicaltrials@hemab.com+44 808 304 6409

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 23, 2026