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AzTrials

Haemophilia APhase 3NCT05053139

A Research Study Investigating Mim8 in Adults and Adolescents With Haemophilia A With or Without Inhibitors

A Phase 3 study testing NNC0365-3769 (Mim8) in people with Haemophilia A and Haemophilia A With Inhibitors, run by Novo Nordisk A/S at 163 sites in 34 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study is investigating how Mim8 works compared to other medicines in people with haemophilia A, who either have inhibitors or do not have inhibitors. Mim8 is a new medicine that will be used for prevention of bleeding episodes. 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)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
281 participants
Where
163 sitesin 34 countries
Study dates
2 Dec 2021to 17 Dec 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 participants with diagnosis of congenital haemophilia A of any severity based on medical records.
  • Participant has been prescribed treatment with factor VIII concentrates or bypassing agent in the last 26 weeks prior to screening.
  • Age above or equal to 12 years at the time of signing informed consent.
  • Body weight greater than or equal to 30 kg.
  • Applicable to participants treated with on-demand/no prophylaxis prior to enrolment: ≥5 bleeds in the last 26 weeks prior to screening visit, for which factor VIII concentrates or bypassing agent has been prescribed.
  • Applicable to participants with FVIII activity ≥1% who are on prophylactic treatment: ≥1 bleed in the last 26 weeks prior to screening visit, for which factor VIII concentrates or bypassing agent has been prescribed.
  • Willingness and ability to comply with scheduled visits and study procedures, including the completion of diary and patient-reported outcomes questionnaires.

Who cannot join

  • Previous participation in this study. Participation is defined as signed informed consent.
  • 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 randomisation.
  • 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 randomisation, for participants not included in the run-in.
  • Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method. Breast feeding is allowed only during the run-in period.
  • 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.
  • Known or suspected hypersensitivity to trial product(s), any constituents of the product or to related products.
Show all 15Show fewer
  • Receipt of gene therapy at any given time point.
  • Ongoing or planned immune tolerance induction (ITI) therapy.
  • Major surgery planned to take place after screening.
  • Known congenital or acquired coagulation disorders other than haemophilia A.
  • Hepatic dysfunction defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) above 3 times the upper limit combined with total bilirubin above1.5 times the upper limit measured at screening.
  • Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) below or equal to 30 ml/min/1.73 m^2 for serum creatinine measured at screening.
  • 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.
  • 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

163 sites in 34 countries.

163 sites in 34 countries

United States34 sites

  • University Of Michigan

    Ann Arbor, Michigan, 48109

  • Children HC Atlanta-Adv Pediat

    Atlanta, Georgia, 30329

  • Augusta University

    Augusta, Georgia, 30912

  • Univ of Colorado Sch of Med

    Aurora, Colorado, 80045

  • Torrence Hemby Ped Hem/Onc Ctr

    Charlotte, North Carolina, 28203

  • St. Jude Clinic Novant Health

    Charlotte, North Carolina, 28204

  • Rush University Med. Cntr

    Chicago, Illinois, 60612

  • Cincinnati Child's Hsp Med Ctr

    Cincinnati, Ohio, 45229

  • Univ Hosp Cleveland Med Ctr

    Cleveland, Ohio, 44106

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205

  • Children's Medical Center_Dallas

    Dallas, Texas, 75235

  • Dayton Children Hemostati Ctr

    Dayton, Ohio, 45404

  • Michigan State University

    East Lansing, Michigan, 48823

  • Penn State MS Hershey Med Ctr

    Hershey, Pennsylvania, 17033-2360

  • Univ TX Hlth Sci Ctr Houston

    Houston, Texas, 77030

  • Indiana Hemophilia-Thromb Ctr

    Indianapolis, Indiana, 46260

  • University of Iowa_Iowa City

    Iowa City, Iowa, 52242

  • University Of Iowa

    Iowa City, Iowa, 52242

  • Balad Hlth Sys-Welmont CardCVA

    Kingsport, Tennessee, 37660

  • Cure 4 the Kids Foundation

    Las Vegas, Nevada, 89135

  • Hemophilia Treatment Center

    Los Angeles, California, 90007

  • Children's Hospital Los Angeles - Endocrinology

    Los Angeles, California, 90027

  • Univ of Miami/SCCC

    Miami, Florida, 33136

  • Children's Hospital of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Vanderbilt Hemostasis Thrombosis Clinic

    Nashville, Tennessee, 37232-9830

  • Children's Hosp-New Orleans

    New Orleans, Louisiana, 70118-5720

  • Univ of NE Med Center_Omaha

    Omaha, Nebraska, 68105

  • Arnold Palmer Hospital for Children

    Orlando, Florida, 32806

  • St Christopher Hosp for Child

    Philadelphia, Pennsylvania, 19134

  • Arizona H&T Phoenix Child Hosp

    Phoenix, Arizona, 85016-7710

  • Memorial Health Univ Med Ctr

    Savannah, Georgia, 31404

  • Providence Sacred Heart Medical Center & Children's Hospital

    Spokane, Washington, 99204

  • Washington University School of Medicine_St. Louis

    St Louis, Missouri, 63110

  • St Joseph's Hospital Foundation

    Tampa, Florida, 33607

Other trials in United States

China14 sites

  • Beijing Children's Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100045

  • Xiangya Hospital Central-South University

    Changsha, Hunan, 410008

  • Chengdu Women's and Children's Central Hospital

    Chengdu, Sichuan, 610074

  • Haemotology, Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong, 510515

  • Nanfang Hospital, Southern Medical University-Haematology

    Guangzhou, Guangdong, 510515

  • Children's Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310052

  • The Children's Hospital, Zhejiang University school of medicine

    Hangzhou, Zhejiang, 310052

  • Jinan Central Hospital

    Ji'Nan, Shandong, 250000

  • Jinan Central Hospital

    Jinan, Shandong, 250000

  • The Second Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650101

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

  • Institute of Hematology and Blood Diseases Hospital, Tianjin-Hematology

    Tianjin, Tianjin Municipality, 300020

  • Tongji Hospital, Tongji Medical College of HUST-Hematology

    Wuhan, Hubei, 430030

  • Tongji Hospital, Tongji Medical College of HUST

    Wuhan, Hubei, 430030

Other trials in China

Japan10 sites

  • Nagoya University Hospital_Blood Transfusion

    Aichi, 466-8560

  • Hospital of the University of Occupational And Environmental Health Japan, Pediatrics

    Kitakyusyu-shi, Fukuoka, 807 8555

  • Nanbu Medical Center & Children's Medical Center

    Okinawa, 901-1193

  • Saitama Children's Med Centre_Hematology-Oncology

    Saitama, 330-8777

  • Shizuoka Children's Hospital, Hematology-Oncology

    Shizuoka, 420-8660

  • Jichi Medical University Hospital_Hematology

    Tochigi, 329-0498

  • Jichi Medical University Hospital_Pediatrics

    Tochigi, 329-0498

  • National Center for Child Health and Development_Hematology

    Tokyo, 157-8535

  • Tokyo Medical Univ. Hospital_Laboratory Medicine

    Tokyo, 160-0023

  • Ogikubo Hospital_Pediatries & Blood

    Tokyo, 167-0035

Other trials in Japan

Canada9 sites

  • McMaster University Medical Center

    Hamilton, Ontario, L8N 3Z5

  • McMaster University

    Hamilton, Ontario, L8N 3Z5

  • London Health Sciences Center Ontario

    London, Ontario, N6A 5W9

  • Hopital Maisonneuve Rosemont

    Montreal, Quebec, HIT 2M4

  • St. John Regional Hospital

    Saint John, New Brunswick, E2L 4L4

  • Royal University Hospital

    Saskatoon, Saskatchewan, S7N 0W8

  • Eastern Health Authority

    St. John's, Newfoundland and Labrador, A1B 3V6

  • The Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

  • University of Manitoba

    Winnipeg, Manitoba, R3T 2N2

Other trials in Canada

Turkey (Türkiye)9 sites

  • Acıbadem Adana Hastanesi-Hematoloji

    Adana, 01130

  • Gazi University

    Ankara, Beşevler/Ankara, 06500

  • Gazi Üniversitesi Hastanesi- Hematoloji

    Ankara, Beşevler/Ankara, 06500

  • Akdeniz Üniversitesi Hastanesi- Hematoloji

    Antalya, Konyaaltı/ Antalya, 01010

  • Akdeniz Universitesi

    Antalya, 01010

  • Ege Universitesi Tip Fakultesi

    Bornova-IZMIR, 35100

  • Ege Üniversitesi Hastanesi- Hematoloji

    Bornova-IZMIR, 35100

  • Istanbul University Oncology Institute

    Capa-ISTANBUL, Capa-ISTANBUL, 34093

  • İstanbul Üniversitesi İstanbul Tıp Fakültesi Hastanesi- Onkoloji Enstitüsü

    Capa-ISTANBUL, Capa-ISTANBUL, 34093

Other trials in Turkey (Türkiye)

France8 sites

  • Centre Hospitalier Universitaire de Bordeaux-Hopital Pellegrin

    Bordeaux, 33076

  • Hospices Civils de Lyon- Hopital Louis Pradel-1

    Bron, 69500

  • Hôpital Cardiologique Louis Pradel

    Bron, 69500

  • Ap-Hp-Hopital de Bicetre-1

    Le Kremlin-Bicêtre, 94275

  • Centre Hospitalier Universitaire de Lille-Institut Coeur Poumon

    Lille, 59037

  • Centre Hospitalier Universitaire de Nantes-Hopital Hotel-Dieu

    Nantes, Nantes

  • Ap-Hp-Hopital Necker-1

    Paris, 75015

  • Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

    Rennes, 35033

Other trials in France

Russia7 sites

  • Reg. State Budget Healthc. Inst. Regional Clinical Hospital

    Barnaul, 656024

  • SAHI Kuzbass Hospital(former Regional clinical hospital)

    Kemerovo, 650066

  • Children Regional Clinical Hospital

    Krasnodar, 350007

  • Morozovskaya municipal children hospital

    Moscow, 119049

  • National Medical Research institution of haemotology

    Moscow, 125167

  • Republican Hospital n.a. V. A. Baranov

    Petrozavodsk, 185019

  • City out-patient clinic 37, City Hemophilia Centre

    Saint Petersburg, 191186

Other trials in Russia

India5 sites

  • Christian medical college

    Ludhiana, Punjab, 141008

  • Seth GS Medical College & KEM Hospital

    Mumbai, Maharashtra, 400012

  • Post Graduate Institute of Child Health

    Noida, Uttar Pradesh, 201303

  • CMCV

    Ranipet, Tamil Nadu, 632517

  • Nirmal Hospital Pvt. Ltd.

    Surat, Gujarat, 395002

Other trials in India

Slovakia5 sites

  • Nemocnica sv. Cyrila a Metoda, UNB,Klinika hemat. a transfuz

    Bratislava, 851 07

  • Unilabs Slovensko, s. r. o.

    Košice, 04001

  • Univerzitna Nemocnica Martin

    Martin, 036 59

  • Vseobecna nemocnica Rimavska Sobota

    Rimavská Sobota, 979 12

  • Vranovska nemocnica, a.s.

    Vranov nad Topľou, 09327

Other trials in Slovakia

Portugal4 sites

  • Unidade Local de Saúde de Coimbra, E.P.E.

    Coimbra, 3000-561

  • Unidade Local de Saúde de Santo António, E.P.E

    Porto, 4099-001

  • Centro Hospitalar de São João_Porto

    Porto, 4200-319

  • ULS São João, E.P.E.

    Porto, 4200-319

Other trials in Portugal

Romania4 sites

  • Institutul Clinic Fundeni

    Bucharest, 022328

  • Institut Oncologic "Prof. Dr. Ion Chiricuta" Cluj Napoca

    Cluj-Napoca, 400015

  • Spitalul Clinic Municipal Filantropia Craiova

    Craiova, Dolj, 200143

  • Spitalul Clinic Municipal de Urgenta Timisoara

    Timișoara, 300254

Other trials in Romania

Taiwan4 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital_Dept of Pediatrics

    Kaohsiung City, 807

  • Chung Shan Medical University Hospital

    Taichung, 402

  • Taichung Veterans General Hospital

    Taichung, 407

  • National Taiwan University Hospital_Dept of Hematology

    Taipei, 100

Other trials in Taiwan

United Kingdom4 sites

  • Arthur Bloom Haemophilia Centre

    Cardiff, CF14 4XW

  • Royal Free Haemophilia Comprehensive Care Centre

    London, NW3 2QG

  • St Thomas' Hospital - Haemostasis and Thrombosis Centre

    London, SE1 7EH

  • Oxford Haemophilia Comprehensive Care Center

    Oxford, OX3 7LJ

Other trials in United Kingdom

Belgium3 sites

  • Cliniques universitaires Saint-Luc - Service Hématologie

    Brussels, 1200

  • UZ Antwerpen - UZA - Kinderhemato-Oncologie

    Edegem, 2650

  • UZ Leuven - Kindergeneeskunde

    Leuven, 3000

Other trials in Belgium

Germany3 sites

  • Vivantes Netzwerk für Gesundheit GmbH - Vivantes Klinikum im Friedrichshain

    Berlin, 10249

  • Universitätsklinikum Bonn - Institut für Experimentelle Hämatologie

    Bonn, 53127

  • HZRM Haemophilie-Zentrum Rhein Main GmbH

    Frankfurt am Main, 60596

Other trials in Germany

Lithuania3 sites

  • Hospital of LUHS "Kauno Klinikos"

    Kaunas, LT-50161

  • Children Oncohaematology department Children's Hospital,

    Vilnius, 08406

  • Vilnius University hospital Santaros klinikos

    Vilnius, LT-08661

Other trials in Lithuania

Malaysia3 sites

  • Hospital Ampang

    Ampang, Selangor, 68000

  • Hospital Queen Elizabeth 1

    Kota Kinabalu, Sabah, 88586

  • Hospital Ampang

    Selangor Darul Ehsan, 68000

Other trials in Malaysia

Netherlands3 sites

  • Academisch Medisch Centrum

    Amsterdam, 1105 AZ

  • Erasmus MC

    Rotterdam, 3015 GD

  • UMC Utrecht, Van Creveldkliniek

    Utrecht, 3584 CX

Other trials in Netherlands

Poland3 sites

  • Szpital Uniwersytecki, Oddzial Kliniczny Hematologii

    Krakow, Lesser Poland Voivodeship, 30-688

  • Uniwersytecki Szpital Dzieciecy, Dzial Krwiolecznictwa

    Lublin, 20-093

  • Uniwersytecki Szpital Kliniczny im. J.Mikulicza-Radeckiego

    Wroclaw, Lower Silesian Voivodeship, 50-556

Other trials in Poland

South Korea3 sites

  • Daejeon Eulji Medical Center, Eulji University

    Daejeon, 35233

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Kyung Hee University Hospital at Gangdong

    Seoul, 05278

Other trials in South Korea

Spain3 sites

  • Hospital Vall d'Hebron

    Barcelona, 08035

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Regional Universitario de Málaga

    Málaga, 29009

Other trials in Spain

Switzerland3 sites

  • Universitätsklinik für Hämatologie

    Bern, 3010

  • Zentrum für Labormedizin

    Sankt Gallen, 9008

  • Universitätsspital Zürich - Klinik für Medizinische Onkologie und Hämatologie

    Zurich, 8091

Other trials in Switzerland

Austria2 sites

  • Universitätsklinik für Innere Medizin V

    Innsbruck, 6020

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

    Vienna, 1090

Other trials in Austria

Ireland2 sites

  • St James's CRF

    Dublin, Leinster, D08 A978

  • CHI Crumlin Haematology

    Dublin, D12 N512

Other trials in Ireland

Italy2 sites

  • Dipartimento di Ematologia Univ. Firenze

    Florence, 50134

  • IRCCS Humanitas Research Hospital - Centro Trombosi e Malattie Emorragiche

    Milan, 20089

Other trials in Italy

Latvia2 sites

  • Stradini Clinic of Oncology

    Riga, 1002

  • Children University Clinical Hospital

    Riga, 1004

Other trials in Latvia

Serbia2 sites

  • Clinical Centre of Serbia, Institute for Haematology

    Belgrade, 11000

  • Clinical Centre of Vojvodina

    Novi Sad, 21000

Other trials in Serbia

South Africa2 sites

  • Wits Bara Clinical Trial Site

    Johannesburg, Gauteng, 2013

  • Charlotte Maxeke Johannesburg Academic Hospital

    Parktown, Johannesburg, Gauteng, 2193

Other trials in South Africa

Ukraine2 sites

  • City Clinical Hospital #4 (Dnipro) - Haematology centre

    Dnipro, 49102

  • Institute of blood pathology and transfusion medicine of NAMSU - General and haematol. surgery

    Lviv, 79044

Other trials in Ukraine

Czechia1 site

  • Ustav Hematologie a krevni tranfuze

    Prague, 128 20

Other trials in Czechia

Denmark1 site

  • Rigshospitalet - Department of Haematology, 2081

    København Ø, 2100

Other trials in Denmark

Israel1 site

  • Sheba MC - The Israeli National Hemophilia Center

    Tel HaShomer, 52621

Other trials in Israel

Mexico1 site

  • Centro Multidisciplinario Para El Desarrollo Especializado De La Investigación Clínica En Yucatán S.C.P. (CEMDEICY S.C.P.)

    Mérida, 97130

Other trials in Mexico

Saudi Arabia1 site

  • King Faisal Specialist Hospital & Research Centre, Riyadh

    Riyadh, 12713

Other trials in Saudi Arabia

About this study

Official title: A Multinational, Open-label, Randomised, Controlled Study to Investigate Efficacy and Safety of NNC0365-3769 (Mim8) in Adults and Adolescents With Haemophilia A With or Without Inhibitors

This study is investigating how Mim8 works compared to other medicines in people with haemophilia A, who either have inhibitors or do not have inhibitors. Mim8 is a new medicine that will be used for prevention of bleeding episodes. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII).

When and how often participants will receive Mim8 is dependent on their previous treatment - but is otherwise decided by chance. Mim8 will be injected into a skinfold on the stomach with a thin needle either once a week or once a month.

The study will last 54-124 weeks (12-29 months) depending on how long participants will be followed in run-in before they start treatment and if they continue in the follow period or transfer to an open label extension study. Participants will have 12-17 clinic visits.

Being tested
NNC0365-3769 (Mim8)
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)Drug

    Mim8 will be injected into a skinfold on the stomach with a thin needle either once a week or once a month.

Study groups in NCT05053139
Study groupRoleWhat they receive
no PPX- no PPX - Mim8 PPXQW/QMExperimentalParticipants not receiving prophylaxis will not enter the run-in period. In arm 1, participants will be randomised to continue no prophylaxis (on-demand treatment with their Standard of Care products) or Mim8 once-weekly or once-monthly prophylaxis in agreement with investigators in the main part of the study (26 weeks). After the main part, participants will continue in the extension part of the study (26 weeks) in agreement with the investigator, either weekly or monthly Mim8 prophylaxis regimen.
Receives: Drug: NNC0365-3769 (Mim8)
no PPX - Mim8 PPXQW - Mim8 PPXQWExperimentalParticipants not receiving prophylaxis will not enter the run-in period. In arm 2a, participants will be randomised to Mim8 once-weekly prophylaxis in the main part of the study (26 weeks). After the main part, participants will continue in the extension part of the study (26 weeks) on once-weekly Mim8 prophylaxis regimen.
Receives: Drug: NNC0365-3769 (Mim8)
no PPX - Mim8 PPXQM - Mim8 PPXQMExperimentalParticipants not receiving prophylaxis will not enter the run-in period. In arm 2b, participants will be randomised to Mim8 once-monthly prophylaxis in the main part of the study (26 weeks). After the main part, participants will continue in the extension part of the study (26 weeks) on once-monthy Mim8 prophylaxis regimen.
Receives: Drug: NNC0365-3769 (Mim8)
PPX - Mim8 PPXQWExperimentalParticipants on coagulation factor prophylaxis prior to enrolment will preferably continue the same product type and dosing frequency in the run-in period for at least 26 weeks before they can be randomised into the main part of the study. These participants will only be allowed to receive coagulation factor prophylaxis. In arm 3, participants will be randomised to once-weekly Mim8 prophylaxis regimen in the main part of the study (26 weeks). After the main part, participants will continue in the extension part of the study (26 weeks) on once-weekly Mim8 prophylaxis regimen.
Receives: Drug: NNC0365-3769 (Mim8)
PPX- Mim8 PPXQMExperimentalParticipants on coagulation factor prophylaxis prior to enrolment will preferably continue the same product type and dosing frequency in the run-in period for at least 26 weeks before they can be randomised into the main part of the study. These participants will only be allowed to receive coagulation factor prophylaxis. In arm 4, participants will be randomised to once-monthly Mim8 prophylaxis regimen in the main part of the study (26 weeks). After the main part, participants will continue in the extension part of the study (26 weeks) on once-monthly Mim8 prophylaxis regimen.
Receives: Drug: NNC0365-3769 (Mim8)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of treated bleeds

    Count

    Measured: No prophylaxis treatment (Arms 1, 2a and 2b): From randomisation (week 0) to end of main (week 26)

  2. Number of treated bleeds

    Count

    Measured: Prophylaxis treatment (Arms 3 and 4): From initiation of run-in (26-52 weeks prior to week 0) to week 0 and from randomisation (week 0) to end of main (week 26)

Secondary outcomes (10)

  1. Number of injection site reactions

    Count

    Measured: All participants receiving Mim8 (Arms 2a, 2b, 3 and 4): From randomisation (week 0) to end of main (week 26)

  2. Occurrence of anti-Mim8 antibodies

    Count

    Measured: All participants receiving Mim8 (Arms 2a, 2b, 3 and 4): From randomisation (week 0) to end of extension (week 52)

  3. Number of treated spontaneous bleeds

    Count

    Measured: No prophylaxis treatment (Arms 1, 2a and 2b): From randomisation (week 0) to end of main (Week 26) Prophylaxis treatment (Arms 3 and 4): From initiation of run-in (26-52 weeks prior to week 0) to week 0 and from week 0 to end of main (week 26)

  4. Number of treated joint bleeds

    Count

    Measured: No prophylaxis treatment (Arms 1, 2a and 2b): From randomisation (week 0) to end of main (Week 26) Prophylaxis treatment (Arms 3 and 4): From initiation of run-in (26-52 weeks prior to week 0) to week 0 and from week 0 to end of main (week 26)

  5. Number of treated traumatic bleeds

    Count

    Measured: No prophylaxis treatment (Arms 1, 2a and 2b): From randomisation (week 0) to end of main (Week 26) Prophylaxis treatment (Arms 3 and 4): From initiation of run-in (26-52 weeks prior to week 0) to week 0 and from week 0 to end of main (week 26)

  6. Number of target joint bleeds

    Count

    Measured: No prophylaxis treatment (Arms 1, 2a and 2b): From randomisation (week 0) to end of main (Week 26) Prophylaxis treatment (Arms 3 and 4): From initiation of run-in (26-52 weeks prior to week 0) to week 0 and from week 0 to end of main (week 26)

  7. Consumption of factor product per bleed treatment (number of injections)

    Count

    Measured: No prophylaxis treatment (Arms 1, 2a and 2b): From randomisation (week 0) to end of main (Week 26) Prophylaxis treatment (Arms 3 and 4): From initiation of run-in (26-52 weeks prior to week 0) to week 0 and from week 0 to end of main (week 26)

  8. Change in physical function domain of PEDS-QL (pediatric quality of life inventory)

    Score points Minimum score per question (best) = 0 Maximum score per question (worst) = 4 Total score for 13 questions: 0 (best) to 92 (worst)

    Measured: All participants (Arms 1, 2a, 2b, 3 and 4): From randomisation (week 0) to the end of the main part (week 26)

  9. Change in patient's treatment burden using the Hemo-TEM (haemophilia treatment experience measure)

    Score points

    Ranges from 0 (best) - 4 (worst) representing answers ranging:

    'Not at all difficult' - 'Extremely difficult' 'Never' - 'always' 'Not at all bothered' - 'Extremely bothered' 'Not at all interfering' - 'Extremely interfering' 'Not at all burdened' - 'Extremely burdened'

    Measured: All participants (Arms 1, 2a, 2b, 3 and 4): From randomisation (week 0) to the end of the main part (week 26)

  10. Change in patient's joint pain score using Joint Pain Rating Scale

    Score points ranges from 0 = 'not at all' (best) to 4 = 'extremely' (worst)

    Measured: All participants (Arms 1, 2a, 2b, 3 and 4): From randomisation (week 0) to the end of the main part (week 26)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2021
  2. Study start2 Dec 2021
  3. Primary completion11 Mar 2024
  4. Study completion17 Dec 2024

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
281 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05053139
Sponsor's protocol ID
NN7769-4514
Other IDs
U1111-1249-4378, 2020-001048-24, jRCT2031210643
Status last verified
Dec 2025
First submitted
13 Sep 2021
Last updated
8 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Publications

  • Jimenez-Yuste V, Abraham A, Tomuleasa C, Alzahrani H, van Vulpen L, Yang R, Obaji S, Ahuja S, Susen S, Lentz SR, Hogh AR, Rakhmatullin I, Hermans C. Denecimig (Mim8) prophylaxis over 52 weeks in adolescents and adults with hemophilia A: FRONTIER2 extension study. Res Pract Thromb Haemost. 2026 Aug 27;10(6):106915. doi: 10.1016/j.rpth.2026.106915. eCollection 2026 Aug.

    PubMed 42824064

  • Mancuso ME, Chan AKC, Shanmukhaiah C, Lyu CJ, Zdziarska J, Mahlangu J, van Vulpen LFD, Chowdary P, Yang R, Lentz SR, Matsushita T, Clausen WHO, Rakhmatullin I, Oldenburg J; FRONTIER2 Investigators. Mim8 Bispecific Antibody Prophylaxis in Hemophilia A with or without Inhibitors. N Engl J Med. 2026 Apr 30;394(17):1696-1709. doi: 10.1056/NEJMoa2517384.

    PubMed 42054679

  • Ong Clausen WH, Latendorf T, Stehr R, Ezban M, Lund J. Comparative ex vivo analysis of Mim8 in thrombin generation assays triggered by activated factor XI or tissue factor. Res Pract Thromb Haemost. 2025 Oct 10;9(7):103209. doi: 10.1016/j.rpth.2025.103209. eCollection 2025 Oct.

    PubMed 41257207

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing NNC0365-3769 (Mim8) in people with Haemophilia A and Haemophilia A With Inhibitors, run by Novo Nordisk A/S at 163 sites in 34 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 8 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 163 sites in United States, China, Japan, Canada, Turkey (Türkiye) and 29 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 treated bleeds (time frame: No prophylaxis treatment (Arms 1, 2a and 2b): From randomisation (week 0) to end of main (week 26)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05053139, which also lists 3 linked publications.

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.

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