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NCT Number: NCT07830732

A Research Study Investigating 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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Instituto de Hematologia DR.Ruben Davoli, Rosario, Santa Fe Province, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Denecimig

Drug

Participants will receive subcutaneous (s.c.) injections of denecimig.

Primary outcomes

  1. Number of treated bleeds

    Time frame: From treatment initiation (week 0) until end of main part (week 12)

    Measured as count of treated bleeds.

Secondary outcomes

  1. Number of treated bleeds

    Time frame: From initiation of extension part (week 13) up until end of treatment (week 52)

    Measured as count of treated bleeds.

  2. Number of clinically relevant new bleeds

    Time frame: From treatment initiation (week 0) up until end of treatment (week 52)

    Measured as count of new bleeds.

  3. Days of treatment with bypassing agent (BPAs) or coagulation factor VIII (FVIII) products for management of bleeding episodes

    Time frame: From treatment initiation (week 0) up until end of treatment (week 52)

    Measured as count of bleeds.

  4. Occurrence of infections

    Time frame: From treatment initiation (week 0) up until end of study (week 73)

    Measured as count of infections.

  5. Occurrence of antidrug antibodies

    Time frame: From treatment initiation (week 0) up until end of study (week 73)

    Measured as count of antidrug antibodies.

  6. Denecimig plasma concentration

    Time frame: From treatment initiation (week 0) up until end of treatment (week 52)

    Measured as microgram per milliliter (μg/mL).

Study contacts

Contact information is provided by the study sponsor or research team.

Novo Nordisk

CONTACT

[email protected]

(+1) 866-867-7178

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Acronym: FRONTIERAHA

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Sep 21, 2026
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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