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Evaluating denecimig as bleeding prophylaxis in adults with acquired haemophilia A

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on adults with acquired haemophilia A, a rare condition in which the immune system creates antibodies that block a protein called factor VIII, which is needed for blood clotting. This can cause spontaneous bleeding or bleeding after minor injuries. The investigational medicine being evaluated is denecimig (code name Mim8), which is supplied as a liquid that is injected just under the skin (subcutaneous injection).

The purpose of the study is to confirm that denecimig can prevent bleeding episodes when used regularly. Participants will start the medication at the beginning of the study and will be followed for about one year. During the first three months, the number of bleeding events that need treatment will be recorded, and the study will continue to monitor bleeding, the need for additional clotting products, infections, and any immune reactions to the drug for up to 12 months. Visits and simple blood tests will be scheduled periodically to check how the drug is working and to ensure safety.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    First Study Visit (Week 0)

    You meet the study team and receive the study medication, denecimig (also called Mim8), which is supplied as a solution for injection to be given under the skin (subcutaneous route).

    A health professional shows you how to prepare and inject the medication, and you are given a diary to record any bleeding events and any additional treatments you may need.

    Baseline measurements are taken, including blood samples to determine your initial health status and to measure denecimig levels.

  2. Step 2

    Weekly Injection Phase (Weeks 0–12)

    You self‑administer one dose of denecimig under the skin each week, following the schedule provided by the study team.

    After each injection you note the date and time in your diary, and you also record any episodes of bleeding, the severity of each bleed, and any rescue medication such as bypassing agents (BPAs) or factor VIII (FVIII) products that you may receive.

    If a bleed occurs, you follow the instructions for treating it and continue to record the details in your diary.

  3. Step 3

    Primary Assessment Visits (Weeks 4, 8, and 12)

    You attend clinic visits at the end of weeks 4, 8 and 12. During each visit a clinician checks your overall health, reviews the diary entries, and collects blood samples.

    The blood samples are used to measure the number of treated bleeds, to assess the concentration of denecimig in your plasma, and to look for any signs of infection or the development of anti‑drug antibodies.

  4. Step 4

    Extension Phase Begins (Week 13)

    You continue the same weekly subcutaneous injection of denecimig for an additional period that extends up to week 52.

    The same diary system is used to record any new bleeds and any additional treatments you receive.

    Blood sampling continues at the scheduled visits to monitor safety and drug levels.

  5. Step 5

    Extension Assessment Visits (Weeks 24, 36, and 52)

    Clinic visits are scheduled at weeks 24, 36 and 52. At each visit the study team reviews your bleeding diary, checks for any infections, and draws blood to measure denecimig concentration and to test for anti‑drug antibodies.

    Any adverse events or concerns you have experienced are discussed and documented.

  6. Step 6

    End of Treatment Visit (Week 52)

    The final dose of denecimig is administered, and a comprehensive set of blood tests is performed to assess the overall safety profile of the medication.

    You receive instructions for the follow‑up period, which does not include further study medication.

  7. Step 7

    Follow‑Up Period (Weeks 53–73)

    Although you no longer receive denecimig, you continue to monitor your health for any late‑onset infections or the appearance of anti‑drug antibodies.

    You may be asked to provide additional blood samples at the end of the follow‑up period.

  8. Step 8

    Final Study Completion Visit (Week 73)

    A final clinic visit is held at week 73. The study team reviews all remaining data, performs a final set of blood tests, and completes the study documentation.

    All information collected during the trial is used to evaluate the effectiveness and safety of denecimig as a bleeding‑prophylaxis treatment.

Who can join the trial?

5 criteria

  • You must sign an informed consent form before any study procedures are done.
  • You must be a male or female who has been newly diagnosed with acquired haemophilia A (a rare bleeding disorder) before signing the consent, and the diagnosis must show a clotting protein level called FVIII activity that is less than 50% of normal and the presence of antibodies called FVIII inhibitors that are higher than 0.6 BU, confirmed during screening.
  • You must have had at least one bleed caused by the disorder that required treatment between the time you were diagnosed and the screening visit.
  • You must be able to follow the study instructions and be able to get medical care if any problem occurs.
  • You must be an adult (generally 18 years old or older).

Who cannot join the trial?

4 criteria

  • Women who are pregnant, are breastfeeding, plan to become pregnant, or could become pregnant and are not using a highly effective birth‑control method (a reliable way to prevent pregnancy, such as an IUD, implant, or sterilization).
  • Anyone who has had or currently has a blood‑clot problem (thromboembolic disease) – except for an old clot caused by a catheter that is not being treated with blood‑thinning medicine – or who is at high risk of developing a clot.
  • People whose doctor believes they have less than three months to live at the time of screening.
  • People who are taking medicines that suppress or change the immune system (immunosuppressive or immune‑modulating drugs) to treat acquired haemophilia A, except for a short course (two days or less) of the steroid prednisolone (or a similar drug) at a dose of 100 mg per day or less. If such immune‑suppressing medicine was started for another condition at least six months ago, has been kept at the same dose, and will stay at that stable dose during the first 12 weeks of the study, it is allowed.
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Investigated drugs

denecimig is an experimental medicine being tested as a preventive treatment for bleeding in adults who have acquired haemophilia A. It is given as a liquid that is injected under the skin (subcutaneous injection). In this study, participants receive denecimig regularly to see if it can keep bleeding episodes low and improve safety compared with not using it. The drug is being evaluated for how well it works to stop bleeding and for any side effects it might cause.

What is already known about the treatment

denecimig - Denecimig is given as a clear liquid that is injected under the skin (subcutaneous injection). It is still an investigational medicine and is being studied in clinical trials, so it is not yet approved for general medical use. The drug is being tested to prevent bleeding in adults with acquired haemophilia A, a rare condition where the blood does not clot properly. It works by a special protein that links two clotting factors together, helping the blood form a clot more effectively, and it is classified as a bispecific monoclonal antibody used for hemostasis.

Investigated diseases

Acquired hemophilia A - Acquired hemophilia A is a rare condition in which the immune system creates antibodies that block a clotting protein called factor VIII. This leads to difficulty forming blood clots, so even minor injuries can cause bleeding that lasts longer than usual. Bleeding may appear under the skin as bruises, in muscles, or inside joints, and can also occur in the digestive or urinary tracts. The amount of bleeding can increase over weeks or months as more antibodies are produced. Symptoms often develop suddenly, and the condition can persist without specific treatment.
Trial detailsLast updated 21 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-525529-19-00Protocol codeNN7769-7602Estimated enrolment54 patientsSponsorNovo Nordisk A/S

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