A Research Study Investigating Denecimig (Mim8) in Adults With Acquired Haemophilia A

NCT07830732 — Phase 3, Not yet recruiting, 84 participants, Novo Nordisk A/S

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A Multinational, Open-label Study to Investigate Efficacy and Safety of Denecimig (Mim8) in Adults With Acquired Haemophilia A

RegistryNCT07830732, acronym FRONTIERAHA
StatusNot yet recruiting
PhasePhase 3
Study typeInterventional; na, single group, masking: none, treatment
Enrollment84 (Estimated)
SponsorNovo Nordisk A/S (Industry)
ConditionsHaemophilia A
InterventionsDenecimig (Drug)
Datesstart 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
Locations83 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

-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).

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+Arms and interventions

ArmTypeInterventionsDescription
DenecimigExperimentalDrug: DenecimigDenecimig will be administered subcutaneously.
  • Denecimig (Drug): Participants will receive subcutaneous (s.c.) injections of denecimig.

+Outcome measures

Primary outcomes

  • Number of treated bleeds [From treatment initiation (week 0) until end of main part (week 12)]: Measured as count of treated bleeds.

Secondary outcomes

  • Number of treated bleeds [From initiation of extension part (week 13) up until end of treatment (week 52)]: Measured as count of treated bleeds.
  • Number of clinically relevant new bleeds [From treatment initiation (week 0) up until end of treatment (week 52)]: Measured as count of new bleeds.
  • Days of treatment with bypassing agent (BPAs) or coagulation factor VIII (FVIII) products for management of bleeding episodes [From treatment initiation (week 0) up until end of treatment (week 52)]: Measured as count of bleeds.
  • Occurrence of infections [From treatment initiation (week 0) up until end of study (week 73)]: Measured as count of infections.
  • Occurrence of antidrug antibodies [From treatment initiation (week 0) up until end of study (week 73)]: Measured as count of antidrug antibodies.
  • Denecimig plasma concentration [From treatment initiation (week 0) up until end of treatment (week 52)]: Measured as microgram per milliliter (μg/mL).

+Eligibility

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).

+Locations (83)

FacilityCityCountryStatus
University of Iowa_Iowa CityIowa City, IowaUnited States
Tulane University School of MedicineMetairie, LouisianaUnited States
University of MinnesotaMinneapolis, MinnesotaUnited States
Mayo ClinicRochester, MinnesotaUnited States
Washington UniversitySt Louis, MissouriUnited States
University of North CarolinaChapel Hill, North CarolinaUnited States
Duke University_DurhamDurham, North CarolinaUnited States
University of Oklahoma HealthOklahoma City, OklahomaUnited States
Penn State MS Hershey Med CtrHershey, PennsylvaniaUnited States
Univ of Pennsylvania HospitalPhiladelphia, PennsylvaniaUnited States
UT SouthwesternDallas, TexasUnited States
Univ Texas HSC-HoustonHouston, TexasUnited States
UT Health San AntonioSan Antonio, TexasUnited States
University of Utah HealthSalt Lake City, UtahUnited States
University of Vermont Med CtrBurlington, VermontUnited States
University of VirginiaCharlottesville, VirginiaUnited States
Virginia Cwealth Univ RichmondRichmond, VirginiaUnited States
Washington Ctr Bleed DisorderSeattle, WashingtonUnited States
Instituto de Hematologia DR.Ruben DavoliRosario, Santa Fe ProvinceArgentina
Hospital Militar Central Cirujano Mayor Dr. Cosme ArgerichBuenos AiresArgentina
Servicio de Hematologia - Hospital ItalianoBuenos AiresArgentina
Royal Prince Alfred Hospital - Department of HaematologyCamperdown, New South WalesAustralia
Royal Brisbane and Women's Hospital - Integrated Cancer Research (I-CARE)Herston, QueenslandAustralia
The Alfred - Cancer TrialsMelbourne, VictoriaAustralia
Hemocentro UNICAMPDistrito de Barão Geraldo - Campinas, São PauloBrazil
Unidade de Pesquisa Clínica do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São PauloRibeirão Preto, São PauloBrazil
Hospital das Clínicas da Faculdade de Medicina da USPSão Paulo, São PauloBrazil
Hemorio-FundarjRio de JaneiroBrazil
Hospital Samaritano Higienópolis - Instituto de Conhecimento Ensino e Pesquisa (ICEP)São PauloBrazil
St Pauls HospitalVancouver, British ColumbiaCanada
McMaster UniversityHamilton, OntarioCanada
St. Michael's HospitalToronto, OntarioCanada
Skejby Blodsygdomme, blødercentretAarhus NDenmark
HCL - HOPITAL LOUIS PRADEL - Unité d'hémostase CliniqueBronFrance
HOPITAL DE BICETRE_Centre de l'HémophilieLe Kremlin-BicêtreFrance
INSTITUT COEUR POUMON_Service d'hémostase et transfusionLilleFrance
CHU DE NANTES-HOPITAL HOTEL-DIEU_Centre régional de traitement de l'HémophilieNantesFrance
Vivantes Netzwerk für Gesundheit GmbH - Vivantes Klinikum im FriedrichshainBerlinGermany
Universitätsklinikum Bonn - Institut für Experimentelle HämatologieBonnGermany
Medizinische Hochschule Hannover - Hämatologie, Hämostaseologie, OnkologieHanoverGermany
Uniklinik Leipzig - Hämatologie, Zelltherapie, Hämostaseologie, InfektiologieLeipzigGermany
Universitätsklinikum Regensburg - Innere Med. IIIRegensburgGermany
Hippokration Hospital - Department of Hematology, Transfusion and Hemophilia CenterAthensGreece
Laiko General Hospital Of Athens - Blood Transfusion Service and National Reference Centre for Congenital Bleeding DisordersAthensGreece
Ippokratio General Hospital Of Thessaloniki - Hemophilia Centre of Northern GreeceThessalonikiGreece
Gauhati Medical College and HospitalGuwahati, AssamIndia
Government Medical College, KozhikodeKozhikode, KeralaIndia
All India Institute of Medical Sciences (AIIMS)New Delhi, National Capital Territory of DelhiIndia
IMS and SUM HospitalBhubaneswar, OdishaIndia
NIZAM'S Institute of Medical SciencesHyderabad, TelanganaIndia
Victoria Hospital, BangaloreBangaloreIndia
AOU Federico II Di Napoli - Dipartimento di Medicina Clinica e ChirurgiaNaples, CampaniaItaly
Azienda Ospedaliero Universitaria Careggi - Centro malattie emorragiche e della coagulazioneFlorenceItaly
Centro Emofilia E Trombosi Angelo B Bonomi - Dep. Medicina Generale - Emostasi e TrombosiMilanItaly
Azienda Ospedaliera di Padova - UOSD Malattie Trombotiche ed EmorragichePadovaItaly
Kansai Medical University Hospital_Hematology-OncologyHirakata-shi, OsakaJapan
Gunma University Hospital_HematologyMaebashi-shi, GunmaJapan
Nara Medical University Hospital_PediatricsNaraJapan
Niigata Cancer Center Hospital_Department of Internal MedicineNiigata-shi, NiigataJapan
Hyogo Medical University Hospital_HematologyNishinomiya-shi, HyogoJapan
Tokyo Medical Univ. Hospital_Laboratory MedicineTokyoJapan
Hospital Queen Elizabeth 1Kota Kinabalu, SabahMalaysia
Sarawak General HospitalKuching, SarawakMalaysia
Hospital AmpangAmpang, SelangorMalaysia
Uniwersyteckie Centrum KliniczneGdanskPoland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M.Kopernika w LodziLodzPoland
Uniwersytecki Szpital Kliniczny W PoznaniuPoznanPoland
Instytut Hematologii i TransfuzjologiiWarsawPoland
Charlotte Maxeke Johannesburg Academic HospitalParktown, Johannesburg, GautengSouth Africa
Hospital Virgen de la Arrixaca - HematologíaEl Palmar, MurciaSpain
Hospital Vall d'HebronBarcelonaSpain
Hospital Universitario La PazMadridSpain
Hospital Universitario Virgen del RocíoSevilleSpain
Hospital La Fe_Hemostasia y TrombosisValenciaSpain
Ankara Bilkent Şehir HastanesiAnkaraTurkey (Türkiye)
İstanbul Üniversitesi Cerrahpaşa Tıp Fakültesi HastanesiIstanbulTurkey (Türkiye)
Ege Üniversitesi Hastanesi- HematolojiIzmirTurkey (Türkiye)
Queen Elizabeth Hospital, Birmingham - HaemophiliaBirminghamUnited Kingdom
University Hospital of Wales - HaemophiliaCardiffUnited Kingdom
Royal Free Hospital - HaemophiliaLondonUnited Kingdom
St Thomas' Hospital - Haemostasis and Thrombosis CentreLondonUnited Kingdom
Nuffield Orthopaedic Centre - Oxford Haemophilia and Thrombosis CentreOxfordUnited Kingdom
Royal Hallamshire HospitalSheffieldUnited Kingdom

+Investigators

  • Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S