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Sutacimig

Phase 2

Congenital Factor VII Deficiency | Small molecule | Rare Disease |Hemab Therapeutics Holdings, Inc.|Last Updated: Jul 22, 2026

Success Probability
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Market & Valuation
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Trial Design
CONTROLLEDDMC
Total Trials1
Total Enrollment18
FDA Designations
BREAKTHROUGH_THERAPYFAST_TRACKORPHAN_DRUG
Clinical trial landscape

Sutacimig · 1 trial · 1 indication

Phase 2 1
NCT07347249A Clinical Study to Assess Sutacimig in Participants With Congenital Factor VII DeficiencyCongenital Factor VII Deficiency
RECRUITING18 Analytics
PHASE2RECRUITING
A Clinical Study to Assess Sutacimig in Participants With Congenital Factor VII Deficiency
Congenital Factor VII Deficiency
NCT0734724918
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Study Endpoints
Primary Endpoints
Incidence of treatment-emergent adverse events (TEAEs)
Day 1 through Day 57
Secondary Endpoints
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
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Participants with a FVII(a) level of < 10%EXPERIMENTAL -
Participants with a FVII(a) level of ≥10%EXPERIMENTAL -
Interventions
NameTypeDescription
SutacimigDRUGSutacimig is a subcutaneously administered, bispecific antibody being developed as a prophylactic treatment option for congenital bleeding disorders.
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Eligibility Criteria
Age Range18 Years to 60 Years
SexALL
Healthy VolunteersNo
Study Sites1

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 m...

Countries:United Kingdom
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Recent Changes (Last 90 Days)
MEDIUMJul 26, 2026NCT07347249primaryCompletionDate: changed
LOWMay 29, 2026NCT07347249startDate: changed
LOWMay 29, 2026NCT07347249startDate: changed
LOWMay 26, 2026NCT07347249primaryCompletionDate: changed
LOWMay 24, 2026NCT07347249studyFirstPostDate: changed