Haemophilia APhase 3FRONTIERAHANCT07830732
A Research Study Investigating Denecimig (Mim8) in Adults With Acquired Haemophilia A
A Phase 3 study testing Denecimig in people with Haemophilia A, run by Novo Nordisk A/S at 83 sites in 18 countries.
Trial summary
The purpose of this study is to find out if denecimig is safe and effective for treating people who have acquired haemophilia A. Participants will be in this study for up to around 1 year and 5 months (73 week). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Haemophilia A
- What is being tested?
- Denecimig
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 83 sitesin 18 countries
- Study dates
- 9 Oct 2026to 23 Mar 2029
- Phase
- Phase 3
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 18 years and older
- All sexes
- No healthy volunteers
- 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 (sex assigned at birth, inclusive of all gender identities) newly diagnosed with acquired haemophilia A (AHA) prior to signing the informed consent form, with AHA diagnosis (FVIII activity lesser than (<) 50 percentage (%) and FVIII inhibitors greater than (>) 0.6 Bethesda units [BU]) confirmed at screening.
- Treatment-requiring bleed(s) due to AHA from diagnosis and until screening.
- The participant is capable of following study procedures and able to seek medical attention when needed.
Who cannot join
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate and highly effective contraceptive method.
- Previous or current thromboembolic disease or eventsa (with the exception of previous catheter associated thrombosis for which anti-thrombotic treatment is not currently ongoing) or risk of thromboembolic disease.
- Life expectancy <3 months at the time of screening, as evaluated by the investigator.
- Therapy with immunosuppressive or immune modulating drugs for treatment of AHA (other than less than or equal to (≤) 2 days of prednisolone (or equivalent) for AHA at a dose ≤100 mg per day) prior to screening.
- Immunosuppressive therapy (IST) initiated prior to AHA diagnosis for other medical conditions (e.g., other autoimmune disorders) is permitted, provided it was initiated greater than or equal to (≥) 6 months prior to screening, has been maintained at a stable dose and regimen since initiation, and is expected to remain at a stable dose and regimen at least during the main treatment period (Weeks 0-12).
Trial locations and contacts
83 sites in 18 countries. Contact the study team or a site near you to ask about taking part.
83 sites in 18 countries
United States18 sites
University of Vermont Med Ctr
Burlington, Vermont, 05401
University of North Carolina
Chapel Hill, North Carolina, 27614
University of Virginia
Charlottesville, Virginia, 22903
UT Southwestern
Dallas, Texas, 75390
Duke University_Durham
Durham, North Carolina, 27710
Penn State MS Hershey Med Ctr
Hershey, Pennsylvania, 17033-2360
Univ Texas HSC-Houston
Houston, Texas, 77030
University of Iowa_Iowa City
Iowa City, Iowa, 52242
Tulane University School of Medicine
Metairie, Louisiana, 70001
University of Minnesota
Minneapolis, Minnesota, 55455
University of Oklahoma Health
Oklahoma City, Oklahoma, 73104
Univ of Pennsylvania Hospital
Philadelphia, Pennsylvania, 19104
Virginia Cwealth Univ Richmond
Richmond, Virginia, 23298
Mayo Clinic
Rochester, Minnesota, 55905
University of Utah Health
Salt Lake City, Utah, 84106
UT Health San Antonio
San Antonio, Texas, 78229
Washington Ctr Bleed Disorder
Seattle, Washington, 98195
Washington University
St Louis, Missouri, 63110
India6 sites
Victoria Hospital, Bangalore
Bangalore, 560002
IMS and SUM Hospital
Bhubaneswar, Odisha, 751003
Gauhati Medical College and Hospital
Guwahati, Assam, 781032
NIZAM'S Institute of Medical Sciences
Hyderabad, Telangana, 500082
Government Medical College, Kozhikode
Kozhikode, Kerala, 673008
All India Institute of Medical Sciences (AIIMS)
New Delhi, National Capital Territory of Delhi, 110029
Japan6 sites
Kansai Medical University Hospital_Hematology-Oncology
Hirakata-shi, Osaka, 573-1191
Gunma University Hospital_Hematology
Maebashi-shi, Gunma, 371-8511
Nara Medical University Hospital_Pediatrics
Nara, 634-8522
Niigata Cancer Center Hospital_Department of Internal Medicine
Niigata-shi, Niigata, 951-8566
Hyogo Medical University Hospital_Hematology
Nishinomiya-shi, Hyogo, 663-8501
Tokyo Medical Univ. Hospital_Laboratory Medicine
Tokyo, 160-0023
United Kingdom6 sites
Queen Elizabeth Hospital, Birmingham - Haemophilia
Birmingham, B15 2TH
University Hospital of Wales - Haemophilia
Cardiff, CF14 4XW
Royal Free Hospital - Haemophilia
London, NW3 2QG
St Thomas' Hospital - Haemostasis and Thrombosis Centre
London, SE1 7EH
Nuffield Orthopaedic Centre - Oxford Haemophilia and Thrombosis Centre
Oxford, OX3 7HE
Royal Hallamshire Hospital
Sheffield, S10 2JF
Brazil5 sites
Hemocentro UNICAMP
Distrito de Barão Geraldo - Campinas, São Paulo, 13083-878
Unidade de Pesquisa Clínica do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Ribeirão Preto, São Paulo, 14051-140
Hemorio-Fundarj
Rio de Janeiro, 20211-030
Hospital das Clínicas da Faculdade de Medicina da USP
São Paulo, São Paulo, 05403-000
Hospital Samaritano Higienópolis - Instituto de Conhecimento Ensino e Pesquisa (ICEP)
São Paulo, 01229-001
Germany5 sites
Vivantes Netzwerk für Gesundheit GmbH - Vivantes Klinikum im Friedrichshain
Berlin, 10249
Universitätsklinikum Bonn - Institut für Experimentelle Hämatologie
Bonn, 53127
Medizinische Hochschule Hannover - Hämatologie, Hämostaseologie, Onkologie
Hanover, 30625
Uniklinik Leipzig - Hämatologie, Zelltherapie, Hämostaseologie, Infektiologie
Leipzig, 04103
Universitätsklinikum Regensburg - Innere Med. III
Regensburg, 93053
Spain5 sites
Hospital Vall d'Hebron
Barcelona, 08035
Hospital Virgen de la Arrixaca - Hematología
El Palmar, Murcia, 30120
Hospital Universitario La Paz
Madrid, 28046
Hospital Universitario Virgen del Rocío
Seville, 41013
Hospital La Fe_Hemostasia y Trombosis
Valencia, 46026
France4 sites
HCL - HOPITAL LOUIS PRADEL - Unité d'hémostase Clinique
Bron, 69500
HOPITAL DE BICETRE_Centre de l'Hémophilie
Le Kremlin-Bicêtre, 94270
INSTITUT COEUR POUMON_Service d'hémostase et transfusion
Lille, 59037
CHU DE NANTES-HOPITAL HOTEL-DIEU_Centre régional de traitement de l'Hémophilie
Nantes, 44093
Italy4 sites
Azienda Ospedaliero Universitaria Careggi - Centro malattie emorragiche e della coagulazione
Florence, 50134
Centro Emofilia E Trombosi Angelo B Bonomi - Dep. Medicina Generale - Emostasi e Trombosi
Milan, 20122
AOU Federico II Di Napoli - Dipartimento di Medicina Clinica e Chirurgia
Naples, Campania, 80131
Azienda Ospedaliera di Padova - UOSD Malattie Trombotiche ed Emorragiche
Padova, 35128
Poland4 sites
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-214
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M.Kopernika w Lodzi
Lodz, 93-513
Uniwersytecki Szpital Kliniczny W Poznaniu
Poznan, 60-569
Instytut Hematologii i Transfuzjologii
Warsaw, 02-776
Argentina3 sites
Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Buenos Aires, 1426
Servicio de Hematologia - Hospital Italiano
Buenos Aires, C1199ABB
Instituto de Hematologia DR.Ruben Davoli
Rosario, Santa Fe Province, S2000
Australia3 sites
Royal Prince Alfred Hospital - Department of Haematology
Camperdown, New South Wales, 2050
Royal Brisbane and Women's Hospital - Integrated Cancer Research (I-CARE)
Herston, Queensland, 4029
The Alfred - Cancer Trials
Melbourne, Victoria, 3004
Canada3 sites
McMaster University
Hamilton, Ontario, L8N 3Z5
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
St Pauls Hospital
Vancouver, British Columbia, V6Z1Y6
Greece3 sites
Hippokration Hospital - Department of Hematology, Transfusion and Hemophilia Center
Athens, 115 27
Laiko General Hospital Of Athens - Blood Transfusion Service and National Reference Centre for Congenital Bleeding Disorders
Athens, 115 27
Ippokratio General Hospital Of Thessaloniki - Hemophilia Centre of Northern Greece
Thessaloniki, 546 42
Malaysia3 sites
Hospital Ampang
Ampang, Selangor, 68000
Hospital Queen Elizabeth 1
Kota Kinabalu, Sabah, 88586
Sarawak General Hospital
Kuching, Sarawak, 93586
Turkey (Türkiye)3 sites
Ankara Bilkent Şehir Hastanesi
Ankara, 06800
İstanbul Üniversitesi Cerrahpaşa Tıp Fakültesi Hastanesi
Istanbul, 34098
Ege Üniversitesi Hastanesi- Hematoloji
Izmir, 35100
South Africa1 site
Charlotte Maxeke Johannesburg Academic Hospital
Parktown, Johannesburg, Gauteng, 2193
About this study
Official title: A Multinational, Open-label Study to Investigate Efficacy and Safety of Denecimig (Mim8) in Adults With Acquired Haemophilia A
The purpose of this study is to find out if denecimig is safe and effective for treating people who have acquired haemophilia A. Participants will be in this study for up to around 1 year and 5 months (73 week).
- Conditions
- Haemophilia A
- Being tested
- Denecimig
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DenecimigDrug
Participants will receive subcutaneous (s.c.) injections of denecimig.
| Study group | Role | What they receive |
|---|---|---|
| Denecimig | Experimental | Denecimig will be administered subcutaneously. Receives: Drug: Denecimig |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treated bleeds
Measured as count of treated bleeds.
Measured: From treatment initiation (week 0) until end of main part (week 12)
Secondary outcomes (6)
Number of treated bleeds
Measured as count of treated bleeds.
Measured: From initiation of extension part (week 13) up until end of treatment (week 52)
Number of clinically relevant new bleeds
Measured as count of new bleeds.
Measured: From treatment initiation (week 0) up until end of treatment (week 52)
Days of treatment with bypassing agent (BPAs) or coagulation factor VIII (FVIII) products for management of bleeding episodes
Measured as count of bleeds.
Measured: From treatment initiation (week 0) up until end of treatment (week 52)
Occurrence of infections
Measured as count of infections.
Measured: From treatment initiation (week 0) up until end of study (week 73)
Occurrence of antidrug antibodies
Measured as count of antidrug antibodies.
Measured: From treatment initiation (week 0) up until end of study (week 73)
Denecimig plasma concentration
Measured as microgram per milliliter (μg/mL).
Measured: From treatment initiation (week 0) up until end of treatment (week 52)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start9 Oct 2026 (estimated)
- Primary completion23 Mar 2029 (estimated)
- Study completion23 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haemophilia AStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07830732
- Sponsor's protocol ID
- NN7769-7602
- Other IDs
- U1111-1318-7871, 2026-525529-19
- Acronym
- FRONTIERAHA
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 21 Sep 2026
- 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