A Research Study Investigating Mim8 in People With Haemophilia A
NCT ID: NCT04204408
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
275 participants
INTERVENTIONAL
2020-01-10
2023-10-06
Brief Summary
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The study will last for up to 44 months. It consists of a main phase (part 1 and part 2) and an extension phase. In part 1, participants will be injected only once with either Mim8 or a "dummy" medicine (placebo) - which one will be decided by chance. In part 2 and the extension phase participants will get an Mim8 injection weekly or monthly.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Single dose (part 1) Mim8
Blinded. Single doses in healthy volunteers. Dose escalation. In each of the 6 cohorts, 6 participants will receive Mim8.
NNC0365-3769 (Mim8)
Mim8 administered subcutaneously (s.c., under the skin). The treatment period will consist of 12 once-weekly doses or 3 once-monthly doses
Single dose (part 1) placebo
Blinded. Single doses in healthy volunteers. In each of the 6 cohorts, 2 participants will receive placebo.
Placebo (Mim8)
Mim8 placebo administered subcutaneously (s.c., under the skin)
Multiple dose (part 2)
Open-label. There will be 4 cohorts receiving once-weekly doses (part 2 cohorts 1, 2, 3 and 5) and one cohort receiving once-monthly doses (part 2 cohort 4). Participants will continue into the part 2 extension on the same treatment regimen.
NNC0365-3769 (Mim8)
Mim8 administered subcutaneously (s.c., under the skin). The treatment period will consist of 12 once-weekly doses or 3 once-monthly doses
Interventions
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NNC0365-3769 (Mim8)
Mim8 administered subcutaneously (s.c., under the skin). The treatment period will consist of 12 once-weekly doses or 3 once-monthly doses
Placebo (Mim8)
Mim8 placebo administered subcutaneously (s.c., under the skin)
Eligibility Criteria
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Inclusion Criteria
* Male, aged 18-45 years (both inclusive) at the time of signing informed consent
* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator
Multiple ascending dose part 2:
* Male, aged 12-64 years (both inclusive) at the time of signing informed consent (Germany and Japan have local requirements)
* Diagnosis of congenital haemophilia A with FVIII activity below 1% based on medical records
Exploratory biomarker cohort:
* Male, aged equal to or above 12 years at the time of signing informed consent (Germany and Japan have local requirements)
* Diagnosis of congenital haemophilia A with FVIII activity below 1% based on medical recordsv
Exclusion Criteria
* Factor VIII activity equal to or above 150% at screening
* Increased risk of thrombosis, e.g. known history of personal or first degree relative(s) with unprovoked deep vein thrombosis
* Any clinical signs or established diagnosis of venous or arterial thromboembolic disease
Part 2:
* Known congenital or acquired coagulation disorders other than haemophilia A
* Increased risk of thrombosis as evaluated by the investigator. E.g. known history of personal or first degree relative(s) with unprovoked deep vein thrombosis with exception of previous catheter-associated thrombosis for which anti-thrombotic treatment is not currently ongoing
* Any clinical signs or established diagnosis of venous or arterial thromboembolic disease with exception of previous catheter-associated thrombosis for which anti-thrombotic treatment is not currently ongoing
* Advanced atherosclerotic disease (e.g. known history of ischemic heart disease, ischemic stroke) as evaluated by the investigator
* Any autoimmune disease that may increase the risk of thrombosis
* Receipt of emicizumab or drugs with similar modes of action within 5 half-lives before trial product administration
* Ongoing or planned immune tolerance induction therapy
Exploratory biomarker cohort:
* Known congenital or acquired coagulation disorders other than haemophilia A
* Increased risk of thrombosis as evaluated by the investigator. E.g. known history of personal or first degree relative(s) with unprovoked deep vein thrombosis with exception of previous catheter-associated thrombosis for which anti-thrombotic treatment is not currently ongoing
* Any clinical signs or established diagnosis of venous or arterial thromboembolic disease with exception of previous catheter-associated thrombosis for which anti-thrombotic treatment is not currently ongoing
* Advanced atherosclerotic disease (e.g. known history of ischemic heart disease, ischemic stroke) as evaluated by the investigator
* Any autoimmune disease that may increase the risk of thrombosis
* Ongoing or planned immune tolerance induction therapy
12 Years
MALE
Yes
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Reporting Anchor and Disclosure (1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Arizona H&T Phoenix Child Hosp
Phoenix, Arizona, United States
Children's Hospital Los Angeles - Endocrinology
Los Angeles, California, United States
Children's Healthcare Atlanta
Atlanta, Georgia, United States
Rush University Med. Cntr
Chicago, Illinois, United States
University of Iowa_Iowa City
Iowa City, Iowa, United States
University Of Michigan
Ann Arbor, Michigan, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
Michigan State University
East Lansing, Michigan, United States
St. Jude Clinic Novant Health
Charlotte, North Carolina, United States
Cincinnati Child's Hsp Med Ctr
Cincinnati, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Dayton Children Hemostati Ctr
Dayton, Ohio, United States
Penn State MS Hershey Med Ctr
Hershey, Pennsylvania, United States
Vanderbilt Hemostasis Thrombosis Clinic
Nashville, Tennessee, United States
Versiti, CCBD
Milwaukee, Wisconsin, United States
Universitätsklinik für Innere Medizin V
Innsbruck, , Austria
Universitätsklinik für Innere Medizin V
Innsbruck, , Austria
UMHAT Tsaritsa Yoanna - ISUL EAD, Pediatric clinical hematology and oncology
Sofia, , Bulgaria
Charité - Campus Charité Mitte - Charité Research Organisation GmbH
Berlin, , Germany
Vivantes Netzwerk für Gesundheit GmbH - Vivantes Klinikum im Friedrichshain
Berlin, , Germany
Istituto di Medicina Int. A. Bianchi Bonomi Univ. Milano
Milan, MI, Italy
Policlinico Umberto I Sezione Ematologia
Roma, , Italy
Nagoya University Hospital_Blood Transfusion
Aichi, , Japan
Nara Medical University Hospital_Pediatrics
Nara, , Japan
Tokyo Medical Univ. Hospital_Laboratory Medicine
Tokyo, , Japan
Uniwersytecki Szpital Kliniczny W Poznaniu
Poznan, Greater Poland Voivodeship, Poland
Instytut Hematologii i Transfuzjologii
Warsaw, Masovian Voivodeship, Poland
Szpital Uniwersytecki, Oddzial Kliniczny Hematologii
Krakow, , Poland
Charlotte Maxeke Johannesburg Academic Hospital
Parktown, Johannesburg, Gauteng, South Africa
Pietersburg Hospital
Polokwane, Limpopo, South Africa
Hospital Universitario La Paz
Madrid, , Spain
Hospital Regional Universitario de Málaga
Málaga, , Spain
Hospital La Fe - Hemostasia y Trombosis
Valencia, , Spain
Universitätsklinik für Hämatologie
Bern, , Switzerland
Universitätsspital Zürich - Klinik für Medizinische Onkologie und Hämatologie
Zurich, , Switzerland
Hacettepe Üniversitesi Hastanesi- Endokrinoloji
Ankara, , Turkey (Türkiye)
Trakya Üniversitesi Tıp Fakültesi Hastanesi- Kardiyoloji
Edirne, , Turkey (Türkiye)
Ege Üniversitesi Hastanesi- Hematoloji
Izmir, , Turkey (Türkiye)
Royal Free Haemophilia Comprehensive Care Centre
London, , United Kingdom
Oxford Haemophilia Comprehensive Care Center
Oxford, , United Kingdom
Countries
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References
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Chowdary P, Lentz SR, Gil L, Lopez-Jaime FJ, Windyga J, Ong Clausen WH, Laursen PN, Mahlangu J. FRONTIER1 multiple ascending dose extension: a safety, tolerability, pharmacokinetics, and pharmacodynamics study of Mim8 in people with hemophilia A. Res Pract Thromb Haemost. 2025 Oct 8;9(7):103207. doi: 10.1016/j.rpth.2025.103207. eCollection 2025 Oct.
Other Identifiers
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U1111-1227-4220
Identifier Type: OTHER
Identifier Source: secondary_id
2019-000465-20
Identifier Type: REGISTRY
Identifier Source: secondary_id
NN7769-4513
Identifier Type: -
Identifier Source: org_study_id