Haemophilia APhase 3FRONTIER 5NCT05878938
A Research Study Looking at How Safe it is to Switch From Emicizumab to Mim8 in People With Haemophilia A (FRONTIER 5)
A Phase 3 study testing NNC0365-3769 (Mim8) PPX in people with Haemophilia A and Haemophilia A With Inhibitors, run by Novo Nordisk A/S at 36 sites in 12 countries.
Trial summary
This study is looking at how safe it is to switch from emicizumab to Mim8, in people with haemophilia A. Mim8 is a new medicine that is used to prevent bleeding episodes in people with haemophilia A. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Haemophilia A, Haemophilia A With Inhibitors
- What is being tested?
- NNC0365-3769 (Mim8) PPX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 36 sitesin 12 countries
- Study dates
- 26 Jun 2023to 19 Jul 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- Male or female with diagnosis of congenital haemophilia A of any severity based on medical records.
- Age 12 years or above at the time of signing the informed consent.
- Participants treated with emicizumab once-weekly (QW), once every two weeks (Q2W), or once every four weeks (Q4W) according to the label for at least 8 weeks prior to screening.
- Participants choosing to discontinue emicizumab treatment and switch to Mim8 QW, Q2W, or once-monthly (QM) treatment for 26 weeks from start of treatment (Visit 2).
- Participant and/or caregiver willingness and ability to comply with scheduled visits and study procedures, including the completion of an electronic diary and patient-reported outcomes (PRO) questionnaires.
Who cannot join
- Participation (i.e., signed informed consent) in any interventional, clinical study, with the exception of emicizumab, with receipt of the last dose within 8 weeks (or 5 half-lives of the investigational medicinal product [IMP], whichever is longer) before screening.
- Any disorder, which in the investigator's opinion might jeopardise the participant's compliance with the protocol or safety, including ongoing Adverse Events (AEs) associated with emicizumab.
- Previous participation in this study. Participation is defined as signed informed consent.
- Known congenital or acquired coagulation disorders other than haemophilia A.
- Previous or current thromboembolic disease or events (with the exception of previous catheter associated thrombosis for which anti-thrombotic treatment is not currently ongoing) or risk of thromboembolic disease, as evaluated by investigator.
- Neutralising antibodies towards emicizumab have been detected or, for patients adherent to emicizumab therapy, are suspected based on clinical and laboratory assessments.
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- Receipt of FVIII gene therapy at any time.
- Ongoing or planned immune tolerance induction therapy.
- Minor or major surgery planned to take place after screening and during the 26-week treatment period.
- Known or suspected hypersensitivity to study intervention, related products, any constituents of the product or to other monoclonal antibodies.
- Hepatic dysfunction defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) greater than (>) 3 times the upper limit combined with total bilirubin >1.5 times the upper limit measured at screening.
- Renal impairment defined as estimated glomerular filtration rate (eGFR) lesser than or equal to (≤) 30 milliliter per minute per 1.73 square meter (mL/min/1.73 m^2) for serum creatinine measured at screening.
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method.
- Mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate understanding and cooperation.
- Other conditions (e.g. autoimmune disease) or laboratory abnormality that may increase risk of bleeding or thrombosis as evaluated by the investigator.
Trial locations and contacts
36 sites in 12 countries.
36 sites in 12 countries
United States13 sites
Augusta Univ/Childrens Hosp-GA
Augusta, Georgia, 30912
UC Denver Hemoph & Thrombo Ctr
Aurora, Colorado, 80045
Rush University Med. Cntr
Chicago, Illinois, 60612
Univ Hosp Cleveland Med Ctr
Cleveland, Ohio, 44106
Nationwide Children's Hospital
Columbus, Ohio, 43205
Central Michigan University
Detroit, Michigan, 48201
Michigan State University
East Lansing, Michigan, 48824
Penn State MS Hershey Med Ctr
Hershey, Pennsylvania, 17033-2360
University of Iowa_Iowa City
Iowa City, Iowa, 52242
Children's Hospital Los Angeles - Endocrinology
Los Angeles, California, 90027
Vanderbilt U Med Ctr_Nashville
Nashville, Tennessee, 37212
UC Davis Medical Center
Sacramento, California, 95817
St Joseph's Hospital Foundation
Tampa, Florida, 33607
United Kingdom6 sites
Belfast City Hospital
Belfast, BT9 78B
Birmingham Children's Hospital
Birmingham
Arthur Bloom Haemophilia Centre
Cardiff, CF14 4XW
Royal Free Haemophilia Comprehensive Care Center
London, NW3 2QG
Royal Free Haemophilia Comprehensive Care Centre
London, NW3 2QG
Royal Hallamshire Hospital
Sheffield, S10 2JF
Italy4 sites
AOU Careggi Firenze
Florence, Tuscany, 50134
Fondazione IRCSS Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122
Azienda Ospedaliera di Rilievo Nazionale Santobono Pausilipon
Naples, 80122
Azienda Ospedaliera Santobono Pausilipon - U.S.D. Centro Regionale Pediatrico Malattie della Coagulazione
Naples, 80122
Austria2 sites
Universitätsklinik für Innere Medizin V
Innsbruck, 6020
AKH - Klin. Abt. f. Haematologie u. Haemostaseologie
Vienna, 1090
Germany2 sites
Vivantes Netzwerk für Gesundheit GmbH - Vivantes Klinikum im Friedrichshain
Berlin, 10249
Universitätsklinikum Bonn - Institut für Experimentelle Hämatologie
Bonn, 53127
South Korea2 sites
Severance Hospital, Yonsei University Health System
Seoul, 03722
Kyung Hee University Hospital at Gangdong
Seoul, 05278
Spain2 sites
Hospital Universitario La Paz
Madrid, 28046
Hospital Regional Universitario de Málaga
Málaga, 29010
Belgium1 site
Cliniques universitaires Saint-Luc - Service Hématologie
Brussels, 1200
South Africa1 site
Charlotte Maxeke Johannesburg Academic Hospital
Parktown, Johannesburg, Gauteng, 2193
About this study
Official title: Open-label Safety Study in Adults and Adolescents With Haemophilia A With and Without FVIII Inhibitors Switching Directly From Emicizumab Prophylaxis to NNC0365-3769 (Mim8) Prophylaxis
This study is looking at how safe it is to switch from emicizumab to Mim8, in people with haemophilia A. Mim8 is a new medicine that is used to prevent bleeding episodes in people with haemophilia A. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). Mim8 will be injected under the skin using a pen-injector either once every week, once every two weeks or once every month. The participants will be trained in using the pen injector. The participants can choose themselves, in collaboration with the study doctor how often they get Mim8 in this study. When the participant will get their first Mim8 injection depends on their current treatment with emicizumab. The participants will get their first Mim8 injection at Visit 2. Participants will have between 6 and 27 Mim8 injections. The total number of injections participants will have depends on their dosing frequency. The study will last for about 6-12 months. While taking part in this study, there are some restrictions about what medicine participant can use. The study doctor will tell the participants more about this. In case the participants experience bleeds, these can be treated with additional haemostatic medicine as agreed with the study doctor. Female participants cannot take part if they are pregnant, breast-feeding or plan to get pregnant during the study period.
- Conditions
- Haemophilia A, Haemophilia A With Inhibitors
- Being tested
- NNC0365-3769 (Mim8) PPX
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC0365-3769 (Mim8) PPXDrug
Participants will receive Mim8 PPX once-weekly dosing (QW), once every two weeks dosing (Q2W), or once-monthly dosing s.c. injection using a prefilled fixed dose DV3407-C1 pen-injector for 26 weeks.
| Study group | Role | What they receive |
|---|---|---|
| NNC0365-3769 (Mim8) PPX | Experimental | Participants will receive Mim8 prophylaxis (PPX) subcutaneous (s.c.) injection using a prefilled fixed dose DV3407-C1 pen-injector. Receives: Drug: NNC0365-3769 (Mim8) PPX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment-emergent adverse events
Measured as count of events.
Measured: From Visit 2 (week 0) until week 26
Secondary outcomes (2)
Device handling experience using the Hemophilia Device Handling and Preference Assessment (HDHPA) questionnaire
Measured as percentage of participants. HDHPA measures device handling experience and device preference. The measure consists of 26 items that are reported individually. it is measures in units: Percentage of participants = the distribution of participant answers within each response category, for each of the 26 individual items.
Measured: Visit 8 (after 26 weeks of treatment)
Change in participants' treatment burden using the Hemophilia treatment experience measure (Hemo-TEM) total score
Measured as score points. Hemo-TEM measures treatment burden. The measure consists of 26 items yielding 5 domain scores and 1 total score. Domain scores (score range): Injection difficulties (0-100), physical impact (0-100), treatment bother (0-100), interference with daily life (0-100), and emotional impact (0-100). Total score ranges 0-100. Higher scores indicate greater treatment burden.
Measured: From Visit 2 (week 0) until end of treatment (up to 26 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start26 Jun 2023
- Primary completion18 Jul 2024
- Study completion19 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haemophilia AStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05878938
- Sponsor's protocol ID
- NN7769-4728
- Other IDs
- U1111-1281-9323, 2022-003053-66
- Acronym
- FRONTIER 5
- Status last verified
- Dec 2025
- First submitted
- 12 May 2023
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Safety Study in Adults and Adolescents With Haemophilia A With and Without FVIII Inhibitors Switching Directly From Emicizumab Prophylaxis to NNC0365-3769 (Mim8) Prophylaxis
- ClinicalTrials.gov ID
- NCT05878938
- Acronym / sponsor ID
- FRONTIER 5 / NN7769-4728
- Conditions
- Haemophilia A, Haemophilia A With Inhibitors
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 26 Jun 2023 (actual)
- Primary completion
- 18 Jul 2024 (actual)
- Study completion
- 19 Jul 2024 (actual)
- First posted
- 30 May 2023 (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.
This study is looking at how safe it is to switch from emicizumab to Mim8, in people with haemophilia A. Mim8 is a new medicine that is used to prevent bleeding episodes in people with haemophilia A. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). Mim8 will be injected under the skin using a pen-injector either once every week, once every two weeks or once every month. The participants will be trained in using the pen injector. The participants can choose themselves, in collaboration with the study doctor how often they get Mim8 in this study. When the participant will get their first Mim8 injection depends on their current treatment with emicizumab. The participants will get their first Mim8 injection at Visit 2. Participants will have between 6 and 27 Mim8 injections. The total number of injections participants will have depends on their dosing frequency. The study will last for about 6-12 months. While taking part in this study, there are some restrictions about what medicine participant can use. The study doctor will tell the participants more about this. In case the participants experience bleeds, these can be treated with additional haemostatic medicine as agreed with the study doctor. Female participants cannot take part if they are pregnant, breast-feeding or plan to get pregnant during the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NNC0365-3769 (Mim8) PPX | Experimental | Drug: NNC0365-3769 (Mim8) PPXParticipants will receive Mim8 prophylaxis (PPX) subcutaneous (s.c.) injection using a prefilled fixed dose DV3407-C1 pen-injector. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- Male or female with diagnosis of congenital haemophilia A of any severity based on medical records.
- Age 12 years or above at the time of signing the informed consent.
- Participants treated with emicizumab once-weekly (QW), once every two weeks (Q2W), or once every four weeks (Q4W) according to the label for at least 8 weeks prior to screening.
- Participants choosing to discontinue emicizumab treatment and switch to Mim8 QW, Q2W, or once-monthly (QM) treatment for 26 weeks from start of treatment (Visit 2).
Key exclusion criteria (15 listed)
- Participation (i.e., signed informed consent) in any interventional, clinical study, with the exception of emicizumab, with receipt of the last dose within 8 weeks (or 5 half-lives of the investigational medicinal product [IMP], whichever is longer) before screening.
- Any disorder, which in the investigator's opinion might jeopardise the participant's compliance with the protocol or safety, including ongoing Adverse Events (AEs) associated with emicizumab.
- Previous participation in this study. Participation is defined as signed informed consent.
- Known congenital or acquired coagulation disorders other than haemophilia A.
- Previous or current thromboembolic disease or events (with the exception of previous catheter associated thrombosis for which anti-thrombotic treatment is not currently ongoing) or risk of thromboembolic disease, as evaluated by investigator.
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 |
|---|---|---|
| NNC0365-3769 (Mim8) PPXParticipants will receive Mim8 PPX once-weekly dosing (QW), once every two weeks dosing (Q2W), or once-monthly dosing s.c. injection using a prefilled fixed dose DV3407-C1 pen-injector for 26 weeks. | Drug | NNC0365-3769 (Mim8) PPX |
Primary outcome
Number of treatment-emergent adverse events
Time frame: From Visit 2 (week 0) until week 26
Measured as count of events.
2 secondary outcomes
Device handling experience using the Hemophilia Device Handling and Preference Assessment (HDHPA) questionnaire
Time frame: Visit 8 (after 26 weeks of treatment)
Change in participants' treatment burden using the Hemophilia treatment experience measure (Hemo-TEM) total score
Time frame: From Visit 2 (week 0) until end of treatment (up to 26 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Related trials for Haemophilia A
RecruitingPhase 1/2
A First-in Human Study of ARD001 in Healthy Volunteers and People With Hemophilia A
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RecruitingPhase 3
A Research Study Investigating Denecimig (Mim8) in Adults With Acquired Haemophilia A
Haemophilia A
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A Study to Investigate the Efficacy and Safety of Fitusiran Prophylaxis in Male Participants Aged 1 to Less Than 12 Years With Hemophilia A or B
Hemophilia
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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. This study is not recruiting at the moment.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
36 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NNC0365-3769 (Mim8) PPX in people with Haemophilia A and Haemophilia A With Inhibitors, run by Novo Nordisk A/S at 36 sites in 12 countries.
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 6 inclusion and 15 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: finished, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, United Kingdom, Italy, Austria, Germany and 7 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of treatment-emergent adverse events (time frame: From Visit 2 (week 0) until week 26). 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 8 Dec 2025.