Not yet recruitingPHASE3INTERVENTIONAL

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

This research study is testing a new medicine called denecimig for adults who have a rare bleeding condition known as acquired haemophilia A. This condition causes the body to mistakenly attack its own clotting factors, leading to unexpected bleeding. The main goal of the study is to find out if denecimig is safe to use and if it works well to treat or prevent bleeding in these patients. It's a 'Phase 3' study, which means it's one of the final steps before a medicine might be considered for wider use. Participants will be involved in the study for up to about 1 year and 5 months.

At a glance

Status

Not yet recruiting

Phase

PHASE3

Sponsor

Novo Nordisk A/S

Enrolment target

Start

09 Oct 2026

Estimated completion

23 Mar 2029

Haemophilia A

What is this study about?

Acquired haemophilia A is a rare condition where your body's immune system, which normally fights off infections, mistakenly attacks and destroys an important protein in your blood called factor VIII. This protein is essential for your blood to clot properly. When factor VIII is attacked, it makes it much harder for your blood to stop bleeding, which can lead to unexpected and potentially serious bleeding episodes.

This study is looking into a new medicine called denecimig. It's designed to help blood clot more effectively in people with acquired haemophilia A. The study aims to understand if denecimig is a safe and effective treatment option for this condition. We hope to learn if it can help reduce bleeding and improve the quality of life for those affected.

This is a 'Phase 3' study, which means it's a large-scale study that follows earlier successful research. It's a crucial step in testing new medicines to make sure they are both safe and effective before they can be considered for general use by doctors. By taking part, you could help us find better ways to manage acquired haemophilia A for future patients.

Key takeaways

This study is for adults with recently diagnosed acquired haemophilia A.
It's testing a new medicine called denecimig to see if it's safe and effective for treating bleeding.
Participation would last up to about 1 year and 5 months.
You would receive close medical monitoring and access to a potential new treatment.
You can stop taking part at any time without affecting your normal care.

Who may be eligible?

To join this study, you must be an adult (18 years or older) and have recently been diagnosed with acquired haemophilia A. Your doctor will confirm this diagnosis through special blood tests. You must also have experienced bleeding that required treatment because of your acquired haemophilia A.

There are also some reasons why you might not be able to join. For example, if you are pregnant, breastfeeding, or planning to become pregnant, you cannot take part. Also, if you have a history of blood clots (a condition called thromboembolic disease), or if you are expected to live for less than 3 months, you would not be able to participate.

Certain medications might also affect your eligibility. If you are taking strong medicines to suppress your immune system for acquired haemophilia A, you might not be able to join, unless it's a very short course of a specific steroid. However, if you're on stable immune-suppressing medicines for other conditions that you started at least 6 months ago, you might still be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you recently been diagnosed with acquired haemophilia A?
Have you had bleeding that needed treatment because of your acquired haemophilia A?
Are you *not* pregnant, breastfeeding, or planning to become pregnant?
Do you *not* have a current or past history of blood clots (unless it was a catheter-related clot that's not being treated now)?
Are you able to attend regular appointments and follow study instructions?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have some checks to see if it's right for you. If you qualify, you'll be given the study medicine, denecimig. The study will involve regular visits to the clinic for check-ups, blood tests, and to discuss how you're feeling and any bleeding you might have. You'll be asked to report any new health issues or side effects you experience.

The total time you'd be involved in the study is up to about 1 year and 5 months (around 73 weeks). During this time, the research team will closely monitor your health and how the medicine is working. You'll receive clear instructions on how to take the medicine and what to expect throughout your participation.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as access to a new medicine that isn't widely available and close monitoring of your health by medical professionals. However, there are also potential risks, as with any medicine. Denecimig is a new treatment, and there might be side effects that are not yet fully known. The research team will explain all known risks and closely monitor you throughout the study. You will be given all the information you need to make an informed decision, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (83)

University of Iowa_Iowa City
Verified postcode
Iowa City, United States
Tulane University School of Medicine
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Metairie, United States
University of Minnesota
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Minneapolis, United States
Mayo Clinic
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Rochester, United States
Washington University
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St Louis, United States
University of North Carolina
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Chapel Hill, United States
Duke University_Durham
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Durham, United States
University of Oklahoma Health
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Oklahoma City, United States
Penn State MS Hershey Med Ctr
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Hershey, United States
Univ of Pennsylvania Hospital
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Philadelphia, United States
UT Southwestern
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Dallas, United States
Univ Texas HSC-Houston
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Houston, United States

Common questions

What is acquired haemophilia A?

It's a rare condition where your body's immune system mistakenly attacks a blood clotting protein, leading to unexpected bleeding.

What is denecimig?

It's a new medicine being tested in this study to help blood clot more effectively in people with acquired haemophilia A.

How long will the study last?

If you join, you would be involved in the study for up to about 1 year and 5 months.

What does 'Phase 3' mean?

It means this is one of the final stages of testing a new medicine to check its safety and effectiveness before it might be approved for wider use.

Can I stop participating in the study once I've joined?

Yes, you can leave the study at any time, for any reason, and your regular medical care will not be affected.

How to find out more

Novo Nordisk

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

Always speak to your GP or specialist before deciding to take part in a study.