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NCT05878938CompletedPhase 3

A Research Study Looking at How Safe it is to Switch From Emicizumab to Mim8 in People With Haemophilia A (FRONTIER 5)

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

Source: ClinicalTrials.gov · Last updated 8 Dec 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
61 (actual)
First submitted
12 May 2023
Start date
26 Jun 2023
Primary completion date
18 Jul 2024
Lead sponsor
Novo Nordisk A/S
Diseases
Haemophilia
NCT number
NCT05878938
EU CT number
2022-502450-13-00
EudraCT number
2022-003053-66

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 61
  • From 26 Jun 2023 to the primary completion date, 18 Jul 2024
  • 35 sites in 12 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous participation in this study. Participation is defined as signed informed consent.
  • 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.
  • 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.

Other illness

  • 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.
  • Known congenital or acquired coagulation disorders other than haemophilia A.
  • Known or suspected hypersensitivity to study intervention, related products, any constituents of the product or to other monoclonal antibodies.

Lab values

  • Neutralising antibodies towards emicizumab have been detected or, for patients adherent to emicizumab therapy, are suspected based on clinical and laboratory assessments.
  • 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.
  • Other conditions (e.g. autoimmune disease) or laboratory abnormality that may increase risk of bleeding or thrombosis as evaluated by the investigator.

Other

  • 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.
  • 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.

Who the study is looking for

  • 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.

Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (35)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medizinische Universitaet Innsbruck
Coordinator of this site? Confirm its status
InnsbruckAustriaCompleted
Allgemeines Krankenhaus Der Stadt Wien Universitatskliniken
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ViennaAustriaCompleted
Cliniques Universitaires Saint-Luc
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Sint-Lambrechts-WoluweBelgiumCompleted
McMaster University
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HamiltonCanadaUnknown status
Vivantes Netzwerk fuer Gesundheit GmbH
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BerlinGermanyCompleted
Universitaetsklinikum Bonn AöR
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BonnGermanyCompleted
Hospital Universitario La Paz
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MadridSpainCompleted
Hospital Universitario Regional de Málaga
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MálagaSpainCompleted
Hospices Civils de Lyon
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BronFranceCompleted
Belfast City Hospital
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BelfastUnited KingdomUnknown status
Birmingham Children's Hospital
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BirminghamUnited KingdomUnknown status
Arthur Bloom Haemophilia Centre
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CardiffUnited KingdomUnknown status
Royal Free Haemophilia Comprehensive Care Centre
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LondonUnited KingdomUnknown status
Royal Free Haemophilia Comprehensive Care Center
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LondonUnited KingdomUnknown status
Royal Hallamshire Hospital
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SheffieldUnited KingdomUnknown status
Careggi University Hospital
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FlorenceItalyCompleted
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
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MilanItalyCompleted
L'Azienda Ospedaliera Di Rilievo Nazionale Santobono-Pausilipon
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NaplesItalyCompleted
Nara Medical University Hospital_Pediatrics
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NaraJapanUnknown status
Kyung Hee University Hospital at Gangdong
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SeoulSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaUnknown status
Augusta Univ/Childrens Hosp-GA
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AugustaUnited StatesUnknown status
UC Denver Hemoph & Thrombo Ctr
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AuroraUnited StatesUnknown status
Rush University Med. Cntr
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ChicagoUnited StatesUnknown status
Univ Hosp Cleveland Med Ctr
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ClevelandUnited StatesUnknown status
Nationwide Children's Hospital
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ColumbusUnited StatesUnknown status
Central Michigan University
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DetroitUnited StatesUnknown status
Michigan State University
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East LansingUnited StatesUnknown status
Penn State MS Hershey Med Ctr
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HersheyUnited StatesUnknown status
University Of Iowa_Iowa City
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Iowa CityUnited StatesUnknown status
Children's Hospital Los Angeles - Endocrinology
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Los AngelesUnited StatesUnknown status
Vanderbilt U Med Ctr_Nashville
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NashvilleUnited StatesUnknown status
UC Davis Medical Center
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SacramentoUnited StatesUnknown status
St Joseph's Hospital Foundation
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TampaUnited StatesUnknown status
Charlotte Maxeke Johannesburg Academic Hospital
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Parktown, JohannesburgSouth AfricaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.