Denecimig (Mim8) for adults with acquired Haemophilia A

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 interventional trial investigates denecimig in adults with acquired Haemophilia A who require treatment for bleeding. Participants will be followed for up to about 73 weeks to assess safety and effectiveness. Eligible adults must have confirmed AHA with FVIII activity below 50% and FVIII inhibitors above 0.6 Bethesda units, and they must have a treatment-requiring bleed at screening. Exclusion criteria include pregnancy or planned pregnancy in females and any current thromboembolic disease. The study is sponsored by Novo Nordisk A/S with sites at University of Iowa, Tulane University, and University of Minnesota.

Why it matters

Who can join: the full rules

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).

Where it's running

• Washington University
  St Louis, Missouri, United States Recruiting
• University of Iowa_Iowa City
  Iowa City, Iowa, United States Not yet recruiting
• Tulane University School of Medicine
  Metairie, Louisiana, United States Not yet recruiting
• University of Minnesota
  Minneapolis, Minnesota, United States Not yet recruiting
• Mayo Clinic
  Rochester, Minnesota, United States Not yet recruiting
• University of North Carolina
  Chapel Hill, North Carolina, United States Not yet recruiting

+33 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Novo Nordisk
• Email: clinicaltrials@novonordisk.com
• Phone: (+1) 866-867-7178

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Surgical Use of Efanoctocog alfa in Hemophilia A Patients

  This observational study looks at how efanesoctocog alfa (Altuvoct) is used around surgery in people with hemophilia A to see if it helps control bleeding.

  Recruiting Hospices Civils de Lyon · Bron · NCT07723560

• SCT800 for preventing and treating bleeds in previously untreated severe hemophilia A patients

  This test tries SCT800, a recombinant factor VIII, as regular prevention and to treat bleeds in male patients with severe hemophilia A who haven't had prior factor VIII treatment.

  Recruiting Phase 3 Sinocelltech Ltd. · Beijing, Beijing Municipality · NCT07437404

• Different doses of Inno8 for adults with haemophilia A.

  This trial will test different doses of the experimental medicine Inno8 in adults with haemophilia A to see if it is safe and how the body handles it.

  Recruiting at 25 sites Phase 1 Novo Nordisk A/S · Aurora, Colorado and 32 other locations · NCT07220564

• Evaluating synovitis in adults with haemophilia A

  This study looks at how often adults with hemophilia A experience joint inflammation caused by bleeding and how it affects their joint health.

  Recruiting University Hospital, Bonn · Bonn, North Rhine-Westphalia · NCT06352216

• Evaluating the effectiveness and safety of FVIII concentrates in young haemophilia A patients

  This study is testing how well and safely a new treatment for hemophilia A works in young children who haven't had much treatment before.

  Recruiting at 33 sites Octapharma · Miami, Florida and 58 other locations · NCT03695978

• Survey on the success of individualized treatment for haemophilia A

  This study is testing whether a personalized high-dose treatment can help people with haemophilia A who have developed inhibitors against factor VIII and if certain lab tests can predict how well this treatment will work.

  Recruiting Haemophilia Centre Rhine Main · Frankfurt am Main, Hesse · NCT02207894

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.