A Multinational, Open-label Study to Investigate Efficacy and Safety of Denecimig (Mim8) in Adults With Acquired Haemophilia A
| Registry | NCT07830732, acronym FRONTIERAHA |
|---|---|
| Status | Not yet recruiting |
| Phase | Phase 3 |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 84 (Estimated) |
| Sponsor | Novo Nordisk A/S (Industry) |
| Conditions | Haemophilia A |
| Interventions | Denecimig (Drug) |
| Dates | start 2026-10-09 (estimated), primary completion 2029-03-23 (estimated), completion 2029-03-23 (estimated), first posted 2026-09-21, last updated 2026-09-21 |
| Locations | 83 sites in United States, Argentina, Australia, Brazil, Canada, Denmark, France, Germany and 10 more countries |
Related Papers Related Patents Related Grants Related Experts
All trials for Haemophilia A All trials of Denecimig
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).
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Denecimig | Experimental | Drug: Denecimig | Denecimig will be administered subcutaneously. |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * 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. Exclusion Criteria: * 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).
| Facility | City | Country | Status |
|---|---|---|---|
| University of Iowa_Iowa City | Iowa City, Iowa | United States | |
| Tulane University School of Medicine | Metairie, Louisiana | United States | |
| University of Minnesota | Minneapolis, Minnesota | United States | |
| Mayo Clinic | Rochester, Minnesota | United States | |
| Washington University | St Louis, Missouri | United States | |
| University of North Carolina | Chapel Hill, North Carolina | United States | |
| Duke University_Durham | Durham, North Carolina | United States | |
| University of Oklahoma Health | Oklahoma City, Oklahoma | United States | |
| Penn State MS Hershey Med Ctr | Hershey, Pennsylvania | United States | |
| Univ of Pennsylvania Hospital | Philadelphia, Pennsylvania | United States | |
| UT Southwestern | Dallas, Texas | United States | |
| Univ Texas HSC-Houston | Houston, Texas | United States | |
| UT Health San Antonio | San Antonio, Texas | United States | |
| University of Utah Health | Salt Lake City, Utah | United States | |
| University of Vermont Med Ctr | Burlington, Vermont | United States | |
| University of Virginia | Charlottesville, Virginia | United States | |
| Virginia Cwealth Univ Richmond | Richmond, Virginia | United States | |
| Washington Ctr Bleed Disorder | Seattle, Washington | United States | |
| Instituto de Hematologia DR.Ruben Davoli | Rosario, Santa Fe Province | Argentina | |
| Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich | Buenos Aires | Argentina | |
| Servicio de Hematologia - Hospital Italiano | Buenos Aires | Argentina | |
| Royal Prince Alfred Hospital - Department of Haematology | Camperdown, New South Wales | Australia | |
| Royal Brisbane and Women's Hospital - Integrated Cancer Research (I-CARE) | Herston, Queensland | Australia | |
| The Alfred - Cancer Trials | Melbourne, Victoria | Australia | |
| Hemocentro UNICAMP | Distrito de Barão Geraldo - Campinas, São Paulo | Brazil | |
| Unidade de Pesquisa Clínica do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo | Ribeirão Preto, São Paulo | Brazil | |
| Hospital das Clínicas da Faculdade de Medicina da USP | São Paulo, São Paulo | Brazil | |
| Hemorio-Fundarj | Rio de Janeiro | Brazil | |
| Hospital Samaritano Higienópolis - Instituto de Conhecimento Ensino e Pesquisa (ICEP) | São Paulo | Brazil | |
| St Pauls Hospital | Vancouver, British Columbia | Canada | |
| McMaster University | Hamilton, Ontario | Canada | |
| St. Michael's Hospital | Toronto, Ontario | Canada | |
| Skejby Blodsygdomme, blødercentret | Aarhus N | Denmark | |
| HCL - HOPITAL LOUIS PRADEL - Unité d'hémostase Clinique | Bron | France | |
| HOPITAL DE BICETRE_Centre de l'Hémophilie | Le Kremlin-Bicêtre | France | |
| INSTITUT COEUR POUMON_Service d'hémostase et transfusion | Lille | France | |
| CHU DE NANTES-HOPITAL HOTEL-DIEU_Centre régional de traitement de l'Hémophilie | Nantes | France | |
| Vivantes Netzwerk für Gesundheit GmbH - Vivantes Klinikum im Friedrichshain | Berlin | Germany | |
| Universitätsklinikum Bonn - Institut für Experimentelle Hämatologie | Bonn | Germany | |
| Medizinische Hochschule Hannover - Hämatologie, Hämostaseologie, Onkologie | Hanover | Germany | |
| Uniklinik Leipzig - Hämatologie, Zelltherapie, Hämostaseologie, Infektiologie | Leipzig | Germany | |
| Universitätsklinikum Regensburg - Innere Med. III | Regensburg | Germany | |
| Hippokration Hospital - Department of Hematology, Transfusion and Hemophilia Center | Athens | Greece | |
| Laiko General Hospital Of Athens - Blood Transfusion Service and National Reference Centre for Congenital Bleeding Disorders | Athens | Greece | |
| Ippokratio General Hospital Of Thessaloniki - Hemophilia Centre of Northern Greece | Thessaloniki | Greece | |
| Gauhati Medical College and Hospital | Guwahati, Assam | India | |
| Government Medical College, Kozhikode | Kozhikode, Kerala | India | |
| All India Institute of Medical Sciences (AIIMS) | New Delhi, National Capital Territory of Delhi | India | |
| IMS and SUM Hospital | Bhubaneswar, Odisha | India | |
| NIZAM'S Institute of Medical Sciences | Hyderabad, Telangana | India | |
| Victoria Hospital, Bangalore | Bangalore | India | |
| AOU Federico II Di Napoli - Dipartimento di Medicina Clinica e Chirurgia | Naples, Campania | Italy | |
| Azienda Ospedaliero Universitaria Careggi - Centro malattie emorragiche e della coagulazione | Florence | Italy | |
| Centro Emofilia E Trombosi Angelo B Bonomi - Dep. Medicina Generale - Emostasi e Trombosi | Milan | Italy | |
| Azienda Ospedaliera di Padova - UOSD Malattie Trombotiche ed Emorragiche | Padova | Italy | |
| Kansai Medical University Hospital_Hematology-Oncology | Hirakata-shi, Osaka | Japan | |
| Gunma University Hospital_Hematology | Maebashi-shi, Gunma | Japan | |
| Nara Medical University Hospital_Pediatrics | Nara | Japan | |
| Niigata Cancer Center Hospital_Department of Internal Medicine | Niigata-shi, Niigata | Japan | |
| Hyogo Medical University Hospital_Hematology | Nishinomiya-shi, Hyogo | Japan | |
| Tokyo Medical Univ. Hospital_Laboratory Medicine | Tokyo | Japan | |
| Hospital Queen Elizabeth 1 | Kota Kinabalu, Sabah | Malaysia | |
| Sarawak General Hospital | Kuching, Sarawak | Malaysia | |
| Hospital Ampang | Ampang, Selangor | Malaysia | |
| Uniwersyteckie Centrum Kliniczne | Gdansk | Poland | |
| Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M.Kopernika w Lodzi | Lodz | Poland | |
| Uniwersytecki Szpital Kliniczny W Poznaniu | Poznan | Poland | |
| Instytut Hematologii i Transfuzjologii | Warsaw | Poland | |
| Charlotte Maxeke Johannesburg Academic Hospital | Parktown, Johannesburg, Gauteng | South Africa | |
| Hospital Virgen de la Arrixaca - Hematología | El Palmar, Murcia | Spain | |
| Hospital Vall d'Hebron | Barcelona | Spain | |
| Hospital Universitario La Paz | Madrid | Spain | |
| Hospital Universitario Virgen del Rocío | Seville | Spain | |
| Hospital La Fe_Hemostasia y Trombosis | Valencia | Spain | |
| Ankara Bilkent Şehir Hastanesi | Ankara | Turkey (Türkiye) | |
| İstanbul Üniversitesi Cerrahpaşa Tıp Fakültesi Hastanesi | Istanbul | Turkey (Türkiye) | |
| Ege Üniversitesi Hastanesi- Hematoloji | Izmir | Turkey (Türkiye) | |
| Queen Elizabeth Hospital, Birmingham - Haemophilia | Birmingham | United Kingdom | |
| University Hospital of Wales - Haemophilia | Cardiff | United Kingdom | |
| Royal Free Hospital - Haemophilia | London | United Kingdom | |
| St Thomas' Hospital - Haemostasis and Thrombosis Centre | London | United Kingdom | |
| Nuffield Orthopaedic Centre - Oxford Haemophilia and Thrombosis Centre | Oxford | United Kingdom | |
| Royal Hallamshire Hospital | Sheffield | United Kingdom |