Recruiting
Phase 3

Denecimig

Sponsor:

Novo Nordisk A/S

Code:

NCT07830732

Conditions

Haemophilia A

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Denecimig

Study Details

Brief 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).

Conditions

Haemophilia A

Study ID

NCT07830732

Start date

Oct 16, 2026

Status verified date

Oct, 2026

Completion date

Mar 23, 2029

Anticipated

Primary completion date

Mar 23, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

84 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Denecimig

Denecimig will be administered subcutaneously.

Interventions

Denecimig

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

Primary outcome measure

  • Number of treated bleeds [ Time Frame: From treatment initiation (week 0) until end of main part (week 12) ]

Central Contacts and Locations

Central contacts

Novo Nordisk

(+1) 866-867-7178clinicaltrials@novonordisk.com

Locations

Washington University

Recruiting

St Louis, Missouri, United States, 63110

More Information

Sponsor

Novo Nordisk A/S

Last update posted

Oct 28, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-29. This information was provided to ClinicalTrials.gov by Novo Nordisk A/S on 2026-10-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.