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

RecruitingPhase 3

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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).

About the study

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).

What is being tested

Sponsor: Novo Nordisk A/S · Participants: 84 · Started: Oct 16, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07830732

Locations in the U.S.

IowaUniversity of Iowa_Iowa City, Iowa City (Not yet recruiting)
LouisianaTulane University School of Medicine, Metairie (Not yet recruiting)
MinnesotaUniversity of Minnesota, Minneapolis (Not yet recruiting)
Mayo Clinic, Rochester (Not yet recruiting)
MissouriWashington University, St Louis
North CarolinaUniversity of North Carolina, Chapel Hill (Not yet recruiting)
Duke University_Durham, Durham (Not yet recruiting)
OklahomaUniversity of Oklahoma Health, Oklahoma City (Not yet recruiting)
PennsylvaniaPenn State MS Hershey Med Ctr, Hershey (Not yet recruiting)
Univ of Pennsylvania Hospital, Philadelphia (Not yet recruiting)
TexasUT Southwestern, Dallas (Not yet recruiting)
Univ Texas HSC-Houston, Houston (Not yet recruiting)
UT Health San Antonio, San Antonio (Not yet recruiting)
UtahUniversity of Utah Health, Salt Lake City (Not yet recruiting)
VermontUniversity of Vermont Med Ctr, Burlington (Not yet recruiting)
VirginiaUniversity of Virginia, Charlottesville (Not yet recruiting)
Virginia Cwealth Univ Richmond, Richmond (Not yet recruiting)
WashingtonWashington Ctr Bleed Disorder, Seattle (Not yet recruiting)

Conditions

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.