NCT07347249

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_2

Timeline
2mo left

Started Jan 2026

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Jan 2026Jul 2026

First Submitted

Initial submission to the registry

December 23, 2025

Completed
9 days until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 16, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

December 23, 2025

Last Update Submit

January 29, 2026

Conditions

Congenital Factor VII Deficiency

Keywords

Congenital Factor VII DeficiencyFactor VII DeficiencyFVIIDCongenital coagulation factor VII (FVII) deficiency

Outcome Measures

Primary Outcomes (1)

  • Incidence of treatment-emergent adverse events (TEAEs)

    Day 1 through Day 57

Secondary Outcomes (10)

  • 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

  • +5 more secondary outcomes

Study Arms (2)

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

EXPERIMENTAL
Drug: Sutacimig

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

EXPERIMENTAL
Drug: Sutacimig

Interventions

SutacimigDRUG

Sutacimig is a subcutaneously administered, bispecific antibody being developed as a prophylactic treatment option for congenital bleeding disorders.

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

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal London Hospital

London, E1 2ES, United Kingdom

RECRUITING

Related Links

MeSH Terms

Conditions

Factor VII Deficiency

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Hemab Aps

CONTACT

+44 (0) 808 304 6409clinicaltrials@hemab.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2025

First Posted

January 16, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

January 30, 2026

Record last verified: 2026-01

Locations

GB(1)