A Research Study Looking at Long-term Treatment With Mim8 in People With Haemophilia A (FRONTIER 4) (FRONTIER4)

Open-label, Long-term Safety and Efficacy Study of Mim8 in Participants With Haemophilia A With or Without Inhibitors

This study is looking at how Mim8 works in people with haemophilia A, who either have inhibitors or do not have inhibitors. Mim8 is a new medicine that will be used to avoid bleeding episodes. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). The study will last for up to 5.5 years. The duration of the study depends on when the participant enrolled in this study. The study will end if Mim8 is approved and marketed in participant's country during the study, or the study will end in June 2028, whichever comes first. Participants will get up to 262 injections; the number of injections depends on how often participants will get injections and how long time participants take part in the study. While taking part in this study, there are some restrictions about what medicine participants 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 Overview

• Status: Active, not recruiting
• Conditions: Haemophilia A With Inhibitors; Haemophilia A
• Intervention / Treatment: Drug: Mim8

• Study Type: Interventional
• Enrollment (Estimated): 451
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Innsbruck, Austria, 6020
    • Universitätsklinik für Innere Medizin V
  • Innsbruck, Austria, A 6020
    • Universitätsklinik für Innere Medizin V
  • Vienna, Austria, 1090
    • AKH - Klin. Abt. f. Haematologie u. Haemostaseologie
• Belgium
  • Brussels, Belgium, 1200
    • Cliniques universitaires Saint-Luc - Service Hématologie
  • Leuven, Belgium, 3000
    • UZ Leuven - Kindergeneeskunde
• Bulgaria
  • Sofia, Bulgaria, 1797
    • SHAT of Haematological Diseases EAD, Clinic of Paediatric Clinical Haematology
• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 3Z5
      • McMaster University
    • Toronto, Ontario, Canada, M5G 1X8
      • The Hospital for Sick Children
• China
  • Jinan, China, 250062
    • Jinan Central Hospital
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100045
      • Beijing Children's Hospital, Capital Medical University
    • Beijing, Beijing Municipality, China, 100045
      • Beijing Children's Hospital，Capital Medical University
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Haemotology, Nanfang Hospital, Southern Medical University
    • Guangzhou, Guangdong, China, 510515
      • Nanfang Hospital, Southern Medical University-Haematology
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital, Tongji Medical College of HUST
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital, Tongji Medical College of HUST-Hematology
  • Hunan
    • Changsha, Hunan, China, 410008
      • Xiangya Hospital Central-South University
  • Shandong
    • Jinan, Shandong, China, 250062
      • Jinan Central Hospital
    • Jinan, Shandong, China, 250062
      • Jinan Central Hospital Affiliated to Shandong University
  • Sichuan
    • Chengdu, Sichuan, China, 610074
      • Chengdu Women's and Children's Central Hospital
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300020
      • Institute of Hematology and Blood Diseases Hospital, Tianjin-Hematology
  • Zhejiang
    • Huzhou, Zhejiang, China, 313200
      • Children's Hospital, Zhejiang University School of Medicine-Hematology
• Denmark
  • København Ø, Denmark, 2100
    • Rigshospitalet - Department of Haematology, 2081
• France
  • Bron, France, 69500
    • Hospices Civils de Lyon- Hopital Louis Pradel
  • Le Kremlin-Bicêtre, France, 94275
    • Ap-Hp-Hopital de Bicetre-1
  • Le Kremlin-Bicêtre, France, 94275
    • Ap-Hp-Hopital de Bicetre
  • Lille, France, 59037
    • Centre Hospitalier Universitaire de Lille-Institut Coeur Poumon
  • Nantes, France, Nantes
    • Centre Hospitalier Universitaire de Nantes-Hopital Hotel-Dieu
  • Nantes, France, 44000
    • Centre Hospitalier Universitaire de Nantes-Hopital Hotel-Dieu
• Germany
  • Berlin, Germany, 10249
    • Vivantes Netzwerk für Gesundheit GmbH - Vivantes Klinikum im Friedrichshain
  • Bonn, Germany, 53127
    • Universitätsklinikum Bonn - Institut für Experimentelle Hämatologie
  • Frankfurt am Main, Germany, 60596
    • HZRM Haemophilie-Zentrum Rhein Main GmbH
• India
  • Mumbai, India, 400012
    • Seth GS medical college and KEM Hospital
  • Gujarat
    • Surat, Gujarat, India, 395002
      • Nirmal Hospital Pvt. Ltd.
  • Maharashtra
    • Mumbai, Maharashtra, India, 400012
      • Seth GS medical college and KEM Hospital
    • Pune, Maharashtra, India, 411004
      • Sahyadri Clinical Research And Development Center
  • Punjab
    • Ludhiana, Punjab, India, 141008
      • Christian Medical College and Hospital
  • Rajasthan
    • Jaipur, Rajasthan, India, 302004
      • SMS Medical College & Hospital
  • Tamil Nadu
    • Ranipet, Tamil Nadu, India, 632517
      • CMCV
  • Uttar Pradesh
    • Noida, Uttar Pradesh, India, 201303
      • Post Graduate Institute of Child Health
• Ireland
  • Leinster
    • Dublin, Leinster, Ireland, D08 A978
      • St James's CRF
• Israel
  • Tel Litwinsky, Israel, 52621
    • Sheba MC - The Israeli National Hemophilia Center
• Italy
  • Florence, Italy, 50134
    • AOU Careggi Firenze
  • Milan, Italy, 20122
    • Fondazione IRCSS Ca' Granda Ospedale Maggiore Policlinico
  • Milan, Italy, 20089
    • IRCCS Humanitas Research Hospital - Centro Trombosi e Malattie Emorragiche
  • Naples, Italy, 80122
    • Azienda Ospedaliera di Rilievo Nazionale Santobono Pausilipon
  • Naples, Italy, 80122
    • Azienda Ospedaliera Santobono Pausilipon - U.S.D. Centro Regionale Pediatrico Malattie della Coagulazione
  • Roma, Italy, 00165
    • Ospedale Pediatrico Bambino Ges
  • Rome, Italy, 00161
    • A.O.U. Policlinico Umberto I
  • Torino, Italy, 10126
    • AOU Città della Salute e della Scienza di Torino - Ospedale Regina Margherita
  • Lazio
    • Rome, Lazio, Italy, 00161
      • A.O.U. Policlinico Umberto I
• Japan
  • Aichi, Japan, 466-8560
    • Nagoya University Hospital_Blood Transfusion
  • Gunma, Japan, 373-8585
    • Ota Memorial Hospital_Pediatrics
  • Nara, Japan, 634-8522
    • Nara Medical University Hospital_Pediatrics
  • Saitama, Japan, 330-8777
    • Saitama Children's Med Centre_Hematology-Oncology
  • Tochigi, Japan, 329-0498
    • Jichi Medical University Hospital_Hematology
  • Tochigi, Japan, 329-0498
    • Jichi Medical University Hospital_Pediatrics
  • Tokyo, Japan, 167-0035
    • Ogikubo Hospital_Pediatries & Blood
  • Tokyo, Japan, 157-8535
    • National Center for Child Health and Development_Hematology
  • Tokyo, Japan, 160-0023
    • Tokyo Medical Univ. Hospital_Laboratory Medicine
• Latvia
  • Riga, Latvia, 1002
    • Stradini Clinic of Oncology
  • Riga, Latvia, 1004
    • Children University Clinical Hospital
• Lithuania
  • Vilnius, Lithuania, 08661
    • Vilnius University Hospital Santaros Klinikos
  • Vilnius, Lithuania, LT-08406
    • Centre of Oncology and Hematology, Vilnius University
• Malaysia
  • Sabah
    • Kota Kinabalu, Sabah, Malaysia, 88586
      • Hospital Queen Elizabeth 1
  • Selangor
    • Ampang, Selangor, Selangor, Malaysia, 68000
      • Hospital Ampang
• Mexico
  • Mérida, Mexico, 97130
    • Centro Multidisciplinario Para El Desarrollo Especializado De La Investigación Clínica En Yucatán S.C.P. (CEMDEICY S.C.P.)
• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • AmsterdamUMC AMC
  • Utrecht, Netherlands, 3584 CX
    • UMC Utrecht, Van Creveldkliniek
• Poland
  • Krakow, Poland, 30-688
    • Szpital Uniwersytecki, Oddzial Kliniczny Hematologii
  • Lublin, Poland, 20-093
    • Uniwersytecki Szpital Dzieciecy, Dzial Krwiolecznictwa
  • Wroclaw, Poland, 50-556
    • Uniwersytecki Szpital Kliniczny im. J.Mikulicza-Radeckiego
  • Greater Poland Voivodeship
    • Poznan, Greater Poland Voivodeship, Poland, 60-569
      • Uniwersytecki Szpital Kliniczny w Poznaniu
  • Lower Silesian Voivodeship
    • Wroclaw, Lower Silesian Voivodeship, Poland, 50-556
      • Uniwersytecki Szpital Kliniczny im. J.Mikulicza-Radeckiego
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 02-776
      • Instytut Hematologii i Transfuzjologii
    • Warsaw, Masovian Voivodeship, Poland, 02-776
      • Intytut Hematologii i Transfuzjologii
• Portugal
  • Coimbra, Portugal, 3000-459
    • Unidade Local de Saúde de Coimbra, E.P.E.
  • Lisbon, Portugal, 1169-045
    • Unidade Local De Saúde De São José, E.P.E.- Hospital D. Estefânia
  • Porto, Portugal, 4200-319
    • ULS De São João, E.P.E. - Hospital de São João
  • Porto, Portugal, 4050-342
    • ULS De Santo António, E.P.E. _H.Santo António_ Imunohemoterapia
• Romania
  • Cluj-Napoca, Romania, 400015
    • Institut Oncologic "Prof. Dr. Ion Chiricuta" Cluj Napoca
• Saudi Arabia
  • Riyadh, Saudi Arabia, 12713
    • King Faisal Specialist Hospital & Research Centre, Riyadh
• Serbia
  • Belgrade, Serbia, 11000
    • Clinical Centre of Serbia, Institute for Haematology
  • Novi Sad, Serbia, 21000
    • Clinical Centre of Vojvodina
• Slovakia
  • Martin, Slovakia, 036 59
    • Univerzitná nemocnica Martin
  • Rimavská Sobota, Slovakia, 979 01
    • Vseobecna nemocnica Rimavska Sobota
  • Vranov nad Topľou, Slovakia, 09327
    • Vranovska nemocnica, a.s.
• South Africa
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 2013
      • Wits Bara Clinical Trial Site
    • Parktown, Johannesburg, Gauteng, South Africa, 2193
      • Charlotte Maxeke Johannesburg Academic Hospital
• South Korea
  • Daejeon, South Korea, 35233
    • Daejeon Eulji Medical Center, Eulji University
  • Seoul, South Korea, 03722
    • Severance Hospital, Yonsei University Health System
  • Seoul, South Korea, 05278
    • Kyung Hee University Hospital at Gangdong
  • Seoul, South Korea, 05278
    • Gangdong Kyung Hee University Hospital
• Spain
  • Barcelona, Spain, 08035
    • Hospital Vall d'Hebron
  • Esplugues Llobregat, Spain, 08950
    • Hospital Sant Joan de Déu
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Málaga, Spain, 29010
    • Hospital Regional Universitario de Malaga
  • Málaga, Spain, 29010
    • Hospital Carlos Haya
• Switzerland
  • Bern, Switzerland, 3010
    • Universitätsklinik für Hämatologie
  • Lucerne, Switzerland, 6000
    • Pädiatrische Onkologie-Hämatologie
  • Sankt Gallen, Switzerland, 9008
    • Zentrum für Labormedizin
  • Zurich, Switzerland, 8091
    • Universitätsspital Zürich - Klinik für Medizinische Onkologie und Hämatologie
• Taiwan
  • Taichung, Taiwan, 402
    • Chung Shan Medical University Hospital
  • Taichung, Taiwan, 407
    • Taichung Veterans General Hospital
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital_main
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 01130
    • Acıbadem Adana Hastanesi-Hematoloji
  • Ankara, Turkey (Türkiye), 06100
    • Hacettepe Universitesi
  • Ankara, Turkey (Türkiye), 06100
    • Hacettepe Üniversitesi Hastanesi- Hematoloji
  • Antalya, Turkey (Türkiye), 01010
    • Akdeniz Universitesi
  • Bornova-IZMIR, Turkey (Türkiye), 35100
    • Ege Universitesi Tip Fakultesi
  • Bornova-IZMIR, Turkey (Türkiye), 35100
    • Ege Üniversitesi Hastanesi- Hematoloji
  • Edirne, Turkey (Türkiye), 22030
    • Trakya University
  • Edirne, Turkey (Türkiye), 22030
    • Trakya Üniversitesi Tıp Fakültesi Hastanesi-Hematoloji
  • Beşevler/Ankara
    • Ankara, Beşevler/Ankara, Turkey (Türkiye), 06500
      • Gazi University
    • Ankara, Beşevler/Ankara, Turkey (Türkiye), 06500
      • Gazi Üniversitesi Hastanesi- Hematoloji
  • Capa-ISTANBUL
    • Capa-ISTANBUL, Capa-ISTANBUL, Turkey (Türkiye), 34093
      • Istanbul University Oncology Institute
    • Capa-ISTANBUL, Capa-ISTANBUL, Turkey (Türkiye), 34093
      • İstanbul Üniversitesi İstanbul Tıp Fakültesi Hastanesi- Onkoloji Enstitüsü
  • Konyaaltı/ Antalya
    • Antalya, Konyaaltı/ Antalya, Turkey (Türkiye), 01010
      • Akdeniz Üniversitesi Hastanesi- Hematoloji
• United Kingdom
  • Belfast, United Kingdom, BT9 78B
    • Belfast City Hospital
  • Cardiff, United Kingdom, CF14 4XW
    • University Hospital of Wales - Haemophilia
  • London, United Kingdom, NW3 2QG
    • Royal Free Haemophilia Comprehensive Care Center
  • London, United Kingdom, SE1 7EH
    • St Thomas' Hospital - Haemostasis and Thrombosis Centre
  • London, United Kingdom, NW3 2QG
    • Royal Free Hospital - Haemophilia
  • London, United Kingdom, SE1 7EH
    • Evelina London Children's Hospital - Haemophilia
  • Sheffield, United Kingdom, S10 2JF
    • Royal Hallamshire Hospital
• United States
  • California
    • Los Angeles, California, United States, 90027
      • Children's Hospital Los Angeles - Endocrinology
  • Colorado
    • Aurora, Colorado, United States, 80045
      • UC Denver Hemoph & Thrombo Ctr
  • Florida
    • Miami, Florida, United States, 33136
      • Univ of Miami/SCCC
    • Tampa, Florida, United States, 33607
      • St Joseph's Hospital Foundation
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Children's Healthcare Atlanta
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Chicago, Illinois, United States, 60612
      • Rush University Med. Cntr
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Indiana Hemophilia-Thromb Ctr
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa_Iowa City
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Central Michigan University
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Univ Hosp Cleveland Med Ctr
    • Dayton, Ohio, United States, 45404
      • Dayton Children Hemostati Ctr
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033-2360
      • Penn State MS Hershey Med Ctr
    • Philadelphia, Pennsylvania, United States, 19134
      • St Christopher Hosp for Child
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • Vanderbilt U Med Ctr_Nashville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Arm 1 & 2:

Inclusion Criteria:

1. 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.
2. Male or female with diagnosis of congenital haemophilia A based on medical records.

3. Ongoing participation in study NN7769-4513, NN7769-4514, NN7769-4516, or NN7769-4728 at the time of transfer. Participant should qualify either of the following criteria:

   1. Participant from study NN7769-4513, who has participated in the extension part of the study for at least 12 weeks prior to enrolment in study NN7769-4532, or,
   2. Participant has completed the end of treatment visit for study NN7769-4514, NN7769-4516 or NN7769-4728.
4. Participant and/or participant's parent(s)/participant's Legally acceptable representative (LAR) willingness and ability to comply with scheduled visits and study procedures, including the completion of diary.

Exclusion Criteria:

1. Any disorder, except for conditions associated with haemophilia A, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
2. Participant who has discontinued or been withdrawn from studies NN7769-4513, NN7769-4514, NN7769-4516, or NN7769-4728.
3. Previous participation in this study. Participation is defined as signed informed consent.
4. Female who is pregnant, breast-feeding or intends to become pregnant.
5. Female of child-bearing potential and not using a highly effective contraceptive method (highly effective contraceptive measures or as required by local regulation or practice).
6. Participation (i.e., signed informed consent) in any interventional, clinical study (except from study NN7769-4513, NN7769-4514, NN7769-4516, or NN7769-4728) of an approved or non-approved investigational medicinal product.
7. Any planned major surgery, during part 1 of the study.
8. Mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate understanding and cooperation.

Arm 3:

Inclusion criteria

1. 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.
2. Male or female with diagnosis of congenital severe haemophilia A (endogenous FVIII activity less than (<) 1 percentage [%]) with or without FVIII inhibitors based on medical records.
3. Aged <1 year at the time of signing informed consent.
4. Body weight greater than or equal to (≥) 3.2 kilograms at the time of signing informed consent.
5. previously untreated patients (PUPs) or minimally treated patients (MTPs) (i.e., up to 5 days of exposure to haemophilia-related treatment such as plasma-derived FVIII, recombinant FVIII, fresh frozen plasma, cryoprecipitate, or whole blood products).
6. Full-term pregnancy (gestational age ≥37 weeks).
7. Participant's parent(s)/LAR(s) willingness and ability to comply with scheduled visits and Arm 3 (infant) procedures, including the completion of diary and patient reported outcome (PRO) questionnaire.
8. Participants <3 months of age must show no signs of active intracranial haemorrhage at screening. This is confirmed by cranial ultrasound performed according to local practice and regardless of delivery method.
9. Receipt of vitamin K prophylaxis (as per local standard practice).

10. Availability of historical results in medical records for:

    1. activated partial thromboplastin time (aPTT)
    2. FVIII levels.

11. Availability of historical results in medical records or pre-dose sample taken for:

    1. fibrinogen
    2. haematology parameters
    3. biochemistry parameters (aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT), bilirubin and creatinine).

Exclusion criteria

1. Known or suspected hypersensitivity to trial product or related products.
2. Previous participation in study 4532. Participation is defined as signed informed consent.
3. Participation (i.e., signed informed consent) in any interventional clinical study with receipt of the last dose within 6 months (or 5 half-lives of the investigational medicinal product, whichever is shorter) before planned enrolment.
4. Exposure to non-factor haemostatic products for bleeding prophylaxis within 6 months (or 5 half-lives of the medicinal product, whichever is shorter) before planned enrolment.
5. Known congenital or acquired coagulation disorders other than haemophilia A.
6. Other conditions (e.g., autoimmune disease) or laboratory abnormality that may increase the risk of bleeding or thrombosis, as evaluated by the investigator. Any disorder, except for conditions associated with haemophilia A, that in the investigator's opinion might jeopardise the participant's safety or compliance with the protocol.
7. Lack of adequate parental/legally acceptable representative (LAR) support to enter accurately and timely information regarding treatment and bleeding episodes into an (electronic) diary.
8. Previous or current treatment for thromboembolic disease (with the exception of previous catheter-associated thrombosis for which anti-thrombotic treatment is not currently ongoing) or signs of thromboembolic disease.
9. Any planned major surgery, during part 1 of Arm 3 (infant). For definition of major surgery.
10. Immune tolerance induction planned to take place after treatment initiation.
11. Hepatic dysfunction defined as AST and/or ALT greater than (>) 3 times the upper limit of normal (ULN) combined with total bilirubin >1.5 times the ULN.
12. Serum creatinine above 1.5 times the ULN.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; Participants entering from the multiple ascending dose (MAD) part of study NN7769-4513. In part 1, participants will receive Mim8 prophylaxis (PPX) subcutaneous (s.c.) administration using enhanced cartridge for 26 weeks. In part 2, participants will receive Mim8 PPX s.c. administration using enhanced cartridge or DV3407 pen-injector once it is approved.	Drug: Mim8; Participants in arm 1 will administer Mim8 using an enhanced cartridge and switch to the DV3407 pen-injector once it is approved. Participants in arm 2 and 3 will use the DV3407 pen injector.
Experimental: Arm 2; Participants entering from study NN7769-4514, NN7769-4728 and NN7769-4516. In part 1, participants will receive Mim8 PPX s.c. administration using DV3407 pen-injector for 26 weeks. In part 2, participants will receive Mim8 PPX s.c. administration using DV3407 pen-injector.	Drug: Mim8; Participants in arm 1 will administer Mim8 using an enhanced cartridge and switch to the DV3407 pen-injector once it is approved. Participants in arm 2 and 3 will use the DV3407 pen injector.
Experimental: Arm 3; In part 1 and 2, participants will receive Mim8 PPX s.c. administration using DV3407 pen-injector.	Drug: Mim8; Participants in arm 1 will administer Mim8 using an enhanced cartridge and switch to the DV3407 pen-injector once it is approved. Participants in arm 2 and 3 will use the DV3407 pen injector.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arm 1 and 2: Number of treatment emergent adverse events	Measured as count of events.	From week 0 until end of study (up to 283 weeks)
Arm 3: Number of treatment emergent adverse events	Measured as count of events.	From treatment initiation (week 0) until end of study (up to 124 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arm 1 and 2: Number of injection site reactions	Measured as count of reactions.	From week 0 until end of treatment (up to 262 weeks)
Arm 1 and 2: Occurrence of anti Mim8 antibodies	Measured as count of participants.	From week 0 until end of treatment (up to 262 weeks)
Arm 1 and 2: Number of treated bleeding episodes	Measured as count of bleeds.	From week 0 until end of treatment (up to 262 weeks)
Arm 1 and 2: Number of treated spontaneous bleeding episodes	Measured as count of bleeds.	From week 0 until end of treatment (up to 262 weeks)
Arm 1 and 2: Number of treated traumatic bleeding episodes	Measured as count of bleeds.	From week 0 until end of treatment (up to 262 weeks)
Arm 1 and 2: Number of treated joint bleeding episodes	Measured as count of bleeds.	From week 0 until end of treatment (up to 262 weeks)
Arm 2: Number of treated target joint bleeding episodes	Measured as count of bleeds.	From week 0 until end of treatment (up to 262 weeks)
Arm 1 and 2: Mim8 plasma concentration	Measured as micrograms per milliliter (µg/mL).	From week 0 until end of treatment (up to 262 weeks)
Arm 2: Device handling using haemophilia device assessment tool (HDAT) (applicable for participants in arm 2 only)	Measured as percentage of participants.	From week 26 until end of treatment (up to 262 weeks)
Arm 3: Number of injection site reactions	Measured as count of reactions.	From treatment initiation (week 0) until end of treatment (up to 103 weeks)
Arm 3: Occurrence of anti Mim8 antibodies	Measured as count of participants.	From treatment initiation (week 0) until end of treatment (up to 103 weeks)
Arm 3: Number of treated bleeding episodes	Measured as count of bleeds.	From treatment initiation (week 0) until end of treatment (up to 103 weeks)
Arm 3: Number of treated spontaneous bleeding episodes	Measured as count of bleeds.	From treatment initiation (week 0) until end of treatment (up to 103 weeks)
Arm 3: Number of treated traumatic bleeding episodes	Measured as count of bleeds.	From treatment initiation (week 0) until end of treatment (up to 103 weeks)
Arm 3: Mim8 plasma concentration	Measured as µg/mL.	From treatment initiation (week 0) until end of treatment (up to 103 weeks)
Arm 3: Device handling using haemophilia device assessment tool (HDAT)	Measured as percentage of participants.	At week 26 and week 52

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency dept. 2834, Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2023
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: January 4, 2023
• First Submitted That Met QC Criteria: January 4, 2023
• First Posted (Actual): January 17, 2023

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Hematologic Diseases; Blood Coagulation Disorders; Hemorrhagic Disorders; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hemic and Lymphatic Diseases; Hemophilia A
• Other Study ID Numbers: NN7769-4532; U1111-1274-4426 (Other Identifier: World Health Organization (WHO)); 2022-502215-10 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No