Congenital Factor VII DeficiencyPhase 2NCT07347249
A Clinical Study to Assess Sutacimig in Participants With Congenital Factor VII Deficiency
A Phase 2 study testing Sutacimig in people with Congenital Factor VII Deficiency, run by Hemab ApS at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Congenital Factor VII Deficiency
- What is being tested?
- Sutacimig
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Mar 2026to Nov 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal London Hospital
London, E1 2ES
Suthesh Sivapalarantnam, +44 (0) 020 3594 3327, s.sivapalaratnam@nhs.net
About this study
Official title: 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).
Read the 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%.
- Conditions
- Congenital Factor VII Deficiency
- Being tested
- Sutacimig
- Keywords
- Congenital Factor VII Deficiency, Factor VII Deficiency, FVIID, Congenital coagulation factor VII (FVII) deficiency
- Medical subject headings
- Factor VII Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SutacimigDrug
Sutacimig is a subcutaneously administered, bispecific antibody being developed as a prophylactic treatment option for congenital bleeding disorders.
SutacimigDrug
Sutacimig is a subcutaneously administered, bispecific antibody being developed as a prophylactic treatment option for congenital bleeding disorders.
| Study group | Role | What they receive |
|---|---|---|
| Participants with a FVII(a) level of < 10% | Experimental | Not described Receives: Drug: Sutacimig |
| Participants with a FVII(a) level of ≥10% | Experimental | Not described Receives: Drug: Sutacimig |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (TEAEs)
Measured: Day 1 through Day 57
Secondary outcomes (10)
Pharmacokinetic Parameter: Maximum observed plasma concentration (Cmax) of sutacimig
Measured: Day 1 through Day 57
Pharmacokinetic Parameter: Time to reach maximum observed plasma concentration (Tmax)
Measured: Baseline through Day 57
Pharmacokinetic Parameter: Area under the plasma concentration-time curve from time zero to last quantifiable concentration (AUClast)
Measured: Day 1 through Day 57
Pharmacokinetic Parameter: Area under the curve from time zero to extrapolated infinite time (AUCinf)
Measured: Day 1 through Day 57
Pharmacokinetic Parameter: Terminal elimination phase half-life (T1/2)
Measured: Day 1 through Day 57
Pharmacodynamic Parameter: Total Factor VII
Measured: Day 1 through Day 57
Pharmacodynamic Parameter: Factor VII Activity
Measured: Day 1 through Day 57
Pharmacodynamic Parameter: Prothrombin time (PT) Measurement
Measured: Day 1 through Day 57
Pharmacodynamic Parameter: Activated partial thromboplastin time (aPTT) Measurement
Measured: Day 1 through Day 57
Anti-drug antibody levels
Measured: Day 1 through Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start11 Mar 2026
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Factor VII DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hemab ApS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07347249
- Sponsor's protocol ID
- HMB-001-201
- Status last verified
- Jul 2026
- First submitted
- 23 Dec 2025
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Assess the Safety and Efficacy of Sutacimig in Participants With Congenital Factor VII Deficiency
- ClinicalTrials.gov ID
- NCT07347249
- Acronym / sponsor ID
- HMB-001-201
- Conditions
- Congenital Factor VII Deficiency
- Keywords
- Congenital Factor VII Deficiency, Factor VII Deficiency, FVIID, Congenital coagulation factor VII (FVII) deficiency
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Hemab ApSIndustry (pharma, biotech, devices)
- Study start
- 11 Mar 2026 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with a FVII(a) level of < 10% | Experimental | Drug: Sutacimig |
| Participants with a FVII(a) level of ≥10% | Experimental | Drug: Sutacimig |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SutacimigSutacimig is a subcutaneously administered, bispecific antibody being developed as a prophylactic treatment option for congenital bleeding disorders. | Drug | Participants with a FVII(a) level of < 10% |
| SutacimigSutacimig is a subcutaneously administered, bispecific antibody being developed as a prophylactic treatment option for congenital bleeding disorders. | Drug | Participants with a FVII(a) level of ≥10% |
Primary outcome
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Day 1 through Day 57
10 secondary outcomes
Pharmacokinetic Parameter: Maximum observed plasma concentration (Cmax) of sutacimig
Time frame: Day 1 through Day 57
Pharmacokinetic Parameter: Time to reach maximum observed plasma concentration (Tmax)
Time frame: Baseline through Day 57
Pharmacokinetic Parameter: Area under the plasma concentration-time curve from time zero to last quantifiable concentration (AUClast)
Time frame: Day 1 through Day 57
Pharmacokinetic Parameter: Area under the curve from time zero to extrapolated infinite time (AUCinf)
Time frame: Day 1 through Day 57
Pharmacokinetic Parameter: Terminal elimination phase half-life (T1/2)
Time frame: Day 1 through Day 57
Pharmacodynamic Parameter: Total Factor VII
Time frame: Day 1 through Day 57
Pharmacodynamic Parameter: Factor VII Activity
Time frame: Day 1 through Day 57
Pharmacodynamic Parameter: Prothrombin time (PT) Measurement
Time frame: Day 1 through Day 57
Pharmacodynamic Parameter: Activated partial thromboplastin time (aPTT) Measurement
Time frame: Day 1 through Day 57
Anti-drug antibody levels
Time frame: Day 1 through Day 57
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Sponsor WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sutacimig in people with Congenital Factor VII Deficiency, run by Hemab ApS at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hemab Aps (+44 (0) 808 304 6409, clinicaltrials@hemab.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (TEAEs) (time frame: Day 1 through Day 57). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.