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

Last updated: December 5, 2025
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

3

Condition

Hemophilia

Treatment

NNC0365-3769 (Mim8) PPX

Clinical Study ID

NCT05878938
NN7769-4728
2022-003053-66
U1111-1281-9323
  • Ages > 12
  • All Genders

Study 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). 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Informed consent obtained before any study-related activities. Study-relatedactivities are any procedures that are carried out as part of the study, includingactivities to determine suitability for the study.

  2. Male or female with diagnosis of congenital haemophilia A of any severity based onmedical records.

  3. Age 12 years or above at the time of signing the informed consent.

  4. 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 toscreening.

  5. 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).

  6. Participant and/or caregiver willingness and ability to comply with scheduled visitsand study procedures, including the completion of an electronic diary andpatient-reported outcomes (PRO) questionnaires.

Exclusion

Exclusion Criteria:

  1. 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 5half-lives of the investigational medicinal product [IMP], whichever is longer)before screening.

  2. Any disorder, which in the investigator's opinion might jeopardise the participant'scompliance with the protocol or safety, including ongoing Adverse Events (AEs)associated with emicizumab.

  3. Previous participation in this study. Participation is defined as signed informedconsent.

  4. Known congenital or acquired coagulation disorders other than haemophilia A.

  5. Previous or current thromboembolic disease or events (with the exception of previouscatheter associated thrombosis for which anti-thrombotic treatment is not currentlyongoing) or risk of thromboembolic disease, as evaluated by investigator.

  6. Neutralising antibodies towards emicizumab have been detected or, for patientsadherent to emicizumab therapy, are suspected based on clinical and laboratoryassessments.

  7. Receipt of FVIII gene therapy at any time.

  8. Ongoing or planned immune tolerance induction therapy.

  9. Minor or major surgery planned to take place after screening and during the 26-weektreatment period.

  10. Known or suspected hypersensitivity to study intervention, related products, anyconstituents of the product or to other monoclonal antibodies.

  11. Hepatic dysfunction defined as aspartate aminotransferase (AST) and/or alanineaminotransferase (ALT) greater than (>) 3 times the upper limit combined with totalbilirubin >1.5 times the upper limit measured at screening.

  12. Renal impairment defined as estimated glomerular filtration rate (eGFR) lesser thanor equal to (≤) 30 milliliter per minute per 1.73 square meter (mL/min/1.73 m^2) forserum creatinine measured at screening.

  13. Female who is pregnant, breast-feeding or intends to become pregnant or is ofchildbearing potential and not using highly effective contraceptive method.

  14. Mental incapacity, unwillingness to cooperate, or a language barrier precludingadequate understanding and cooperation.

  15. Other conditions (e.g. autoimmune disease) or laboratory abnormality that mayincrease risk of bleeding or thrombosis as evaluated by the investigator.

Study Design

Total Participants: 61
Treatment Group(s): 1
Primary Treatment: NNC0365-3769 (Mim8) PPX
Phase: 3
Study Start date:
June 26, 2023
Estimated Completion Date:
July 19, 2024

Connect with a study center

  • Novo Nordisk Investigational Site

    Innsbruck, A 6020
    Austria

    Active - Recruiting

  • Universitätsklinik für Innere Medizin V

    Innsbruck, 6020
    Austria

    Site Not Available

  • Universitätsklinik für Innere Medizin V

    Innsbruck 2775220, 6020
    Austria

    Site Not Available

  • AKH - Klin. Abt. f. Haematologie u. Haemostaseologie

    Vienna 2761369, 1090
    Austria

    Site Not Available

  • AKH - Klin. Abt. f. Haematologie u. Haemostaseologie

    Wien, 1090
    Austria

    Site Not Available

  • Novo Nordisk Investigational Site

    Wien, 1090
    Austria

    Site Not Available

  • Cliniques universitaires Saint-Luc - Service Hématologie

    Brussels 2800866, 1200
    Belgium

    Site Not Available

  • Cliniques universitaires Saint-Luc - Service Hématologie

    Bruxelles, 1200
    Belgium

    Site Not Available

  • Novo Nordisk Investigational Site

    Bruxelles, 1200
    Belgium

    Active - Recruiting

  • McMaster University

    Hamilton, Ontario L8N 3Z5
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Hamilton, Ontario L8N 3Z5
    Canada

    Active - Recruiting

  • McMaster University

    Hamilton 5969782, Ontario 6093943 L8N 3Z5
    Canada

    Site Not Available

  • Hospices Civils de Lyon-Hopital Cardiologique Louis Pradel-1

    Bron, 69500
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Bron, 69500
    France

    Active - Recruiting

  • Hospices Civils de Lyon- Hopital Louis Pradel-1

    Bron 3029931, 69500
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Bron Cedex, 69500
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Berlin, 10249
    Germany

    Active - Recruiting

  • Vivantes Klinikum am Friedrichshain

    Berlin, 10249
    Germany

    Site Not Available

  • Vivantes Klinikum am Friedrichshain - Innere Medizin - Angiologie und Hämostaseologie

    Berlin, 10249
    Germany

    Site Not Available

  • Vivantes Netzwerk für Gesundheit GmbH - Vivantes Klinikum im Friedrichshain

    Berlin 2950159, 10249
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Bonn, 53127
    Germany

    Active - Recruiting

  • Rheinische Friedrich-Wilhelms-Universität Bonn

    Bonn, 53127
    Germany

    Site Not Available

  • Universitätsklinikum Bonn - Institut für Experimentelle Hämatologie

    Bonn, 53127
    Germany

    Site Not Available

  • Universitätsklinikum Bonn - Institut für Experimentelle Hämatologie

    Bonn 2946447, 53127
    Germany

    Site Not Available

  • AOU Careggi Firenze

    Firenze, Toscana 50134
    Italy

    Site Not Available

  • AOU Careggi Firenze

    Florence 3176959, Tuscany 3165361 50134
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Firenze, 50134
    Italy

    Active - Recruiting

  • Fondazione IRCSS Ca' Granda Ospedale Maggiore Policlinico

    Milan 6951411, 20122
    Italy

    Site Not Available

  • Fondazione IRCSS Ca' Granda Ospedale Maggiore Policlinico

    Milano, 20122
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Milano, 20122
    Italy

    Active - Recruiting

  • Azienda Ospedaliera di Rilievo Nazionale Santobono Pausilipon

    Napoli, 80122
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Napoli, 80122
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Santobono Pausilipon - U.S.D. Centro Regionale Pediatrico Malattie della Coagulazione

    Napoli 9031661, 80122
    Italy

    Site Not Available

  • Azienda Ospedaliera di Rilievo Nazionale Santobono Pausilipon

    Napoli 9031661, 80122
    Italy

    Site Not Available

  • Nara Medical University Hospital_Pediatrics

    Nara, 634-8522
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Nara, 634-8522
    Japan

    Active - Recruiting

  • Nara Medical University Hospital_Pediatrics

    Nara 1855612, 634-8522
    Japan

    Site Not Available

  • Gangdong Kyung Hee University Hospital

    Seoul, 05278
    Korea, Republic of

    Site Not Available

  • Novo Nordisk Investigational Site

    Seoul, 05278
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722
    Korea, Republic of

    Site Not Available

  • Novo Nordisk Investigational Site

    Parktown, Johannesburg, Gauteng 2193
    South Africa

    Active - Recruiting

  • Charlotte Maxeke Johannesburg Academic Hospital

    Parktown, Johannesburg, Gauteng 1085594 2193
    South Africa

    Site Not Available

  • Kyung Hee University Hospital at Gangdong

    Seoul 1835848, 05278
    South Korea

    Site Not Available

  • Severance Hospital, Yonsei University Health System

    Seoul 1835848, 03722
    South Korea

    Site Not Available

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Site Not Available

  • Novo Nordisk Investigational Site

    Madrid, 28046
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz

    Madrid 3117735, 28046
    Spain

    Site Not Available

  • Hospital Regional Universitario de Málaga

    Málaga, 29010
    Spain

    Site Not Available

  • Hospital Universitario Regional de Málaga

    Málaga, 29010
    Spain

    Site Not Available

  • Novo Nordisk Investigational Site

    Málaga, 29010
    Spain

    Active - Recruiting

  • Hospital Regional Universitario de Málaga

    Málaga 2514256, 29010
    Spain

    Site Not Available

  • Belfast City Hospital

    Belfast, BT9 78B
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Belfast, BT9 78B
    United Kingdom

    Site Not Available

  • Belfast City Hospital

    Belfast 2655984, BT9 78B
    United Kingdom

    Site Not Available

  • Birmingham Children's Hospital

    Birmingham 2655603,
    United Kingdom

    Site Not Available

  • Arthur Bloom Haemophilia Centre

    Cardiff, CF14 4XW
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Cardiff, CF14 4XW
    United Kingdom

    Active - Recruiting

  • Arthur Bloom Haemophilia Centre

    Cardiff 2653822, CF14 4XW
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    London, NW3 2QG
    United Kingdom

    Site Not Available

  • Royal Free Haemophilia Comprehensive Care Center

    London, NW3 2QG
    United Kingdom

    Site Not Available

  • Royal Free Haemophilia Comprehensive Care Centre

    London, NW3 2QG
    United Kingdom

    Site Not Available

  • Royal Free Haemophilia Comprehensive Care Center

    London 2643743, NW3 2QG
    United Kingdom

    Site Not Available

  • Royal Free Haemophilia Comprehensive Care Centre

    London 2643743, NW3 2QG
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Sheffield, S10 2JF
    United Kingdom

    Site Not Available

  • Royal Hallamshire Hospital

    Sheffield, S10 2JF
    United Kingdom

    Site Not Available

  • Royal Hallamshire Hospital

    Sheffield 2638077, S10 2JF
    United Kingdom

    Site Not Available

  • Children's Hosp-Los Angeles

    Los Angeles, California 90027
    United States

    Site Not Available

  • Children's Hospital Los Angeles - Endocrinology

    Los Angeles, California 90027
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Los Angeles, California 90027
    United States

    Site Not Available

  • Children's Hospital Los Angeles - Endocrinology

    Los Angeles 5368361, California 5332921 90027
    United States

    Site Not Available

  • UC Davis Medical Center

    Sacramento 5389489, California 5332921 95817
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • UC Denver Hemoph & Thrombo Ctr

    Aurora, Colorado 80045
    United States

    Site Not Available

  • UC Denver Hemoph & Thrombo Ctr

    Aurora 5412347, Colorado 5417618 80045
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Tampa, Florida 33607
    United States

    Active - Recruiting

  • St Joseph's Children's Hospita

    Tampa, Florida 33607
    United States

    Site Not Available

  • St Joseph's Hospital Foundation

    Tampa 4174757, Florida 4155751 33607
    United States

    Site Not Available

  • Augusta Univ/Childrens Hosp-GA

    Augusta 4180531, Georgia 4197000 30912
    United States

    Site Not Available

  • Rush University Med. Cntr

    Chicago 4887398, Illinois 4896861 60612
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • University of Iowa_Iowa City

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • University of Iowa_Iowa City

    Iowa City 4862034, Iowa 4862182 52242
    United States

    Site Not Available

  • Central Michigan University

    Detroit, Michigan 48201
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Detroit, Michigan 48201
    United States

    Site Not Available

  • Michigan State University

    East Lansing, Michigan 48824
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    East Lansing, Michigan 48824
    United States

    Active - Recruiting

  • Novo Nordisk Investigational Site

    Mount Pleasant, Michigan 48859
    United States

    Site Not Available

  • Central Michigan University

    Detroit 4990729, Michigan 5001836 48201
    United States

    Site Not Available

  • Michigan State University

    East Lansing 4991640, Michigan 5001836 48824
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • Univ Hosp Cleveland Med Ctr

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Univ Hosp Cleveland Med Ctr

    Cleveland 5150529, Ohio 5165418 44106
    United States

    Site Not Available

  • Nationwide Children's Hospital

    Columbus 4509177, Ohio 5165418 43205
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Hershey, Pennsylvania 17033-2360
    United States

    Active - Recruiting

  • Penn State MS Hershey Med Ctr

    Hershey, Pennsylvania 17033-2360
    United States

    Site Not Available

  • Penn State MS Hershey Med Ctr

    Hershey 5193342, Pennsylvania 6254927 17033-2360
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Nashville, Tennessee 37212
    United States

    Active - Recruiting

  • Vanderbilt U Med Ctr_Nashville

    Nashville, Tennessee 37212
    United States

    Site Not Available

  • Vanderbilt U Med Ctr_Nashville

    Nashville 4644585, Tennessee 4662168 37212
    United States

    Site Not Available

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