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New shot Mim8 shows promise for hemophilia a bleed control

NCT ID NCT05878938

Disease control Sponsor: Novo Nordisk A/S Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how safe it is for people with hemophilia A to switch from their current medicine (emicizumab) to a new one called Mim8. Mim8 helps prevent bleeding episodes by doing the job of the missing clotting factor. The study included 61 adults and teens who received Mim8 injections weekly, every two weeks, or monthly for about 6 to 12 months. The goal was to track any side effects and see how easy the pen injector was to use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

61 people

The number who actually took part.

Started

Jun 2023

Finished

Jul 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 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. 2. Male or female with diagnosis of congenital haemophilia A of any severity based on medical records. 3. Age 12 years or above at the time of signing the informed consent. 4. Participants treated with emicizumab once-weekly (QW), once every two weeks (Q2W), or once every four weeks (Q4W) according to the label for at least 8 weeks prior to screening. 5. Participants choosing to discontinue emicizumab treatment and switch to Mim8 QW, Q2W, or once-monthly (QM) treatment for 26 weeks from start of treatment (Visit 2). 6. Participant and/or caregiver willingness and ability to comply with scheduled visits and study procedures, including the completion of an electronic diary and patient-reported outcomes (PRO) questionnaires. Exclusion Criteria: 1. Participation (i.e., signed informed consent) in any interventional, clinical study, with the exception of emicizumab, with receipt of the last dose within 8 weeks (or 5 half-lives of the investigational medicinal product \[IMP\], whichever is longer) before screening. 2. Any disorder, which in the investigator's opinion might jeopardise the participant's compliance with the protocol or safety, including ongoing Adverse Events (AEs) associated with emicizumab. 3. Previous participation in this study. Participation is defined as signed informed consent. 4. Known congenital or acquired coagulation disorders other than haemophilia A. 5. Previous or current thromboembolic disease or events (with the exception of previous catheter associated thrombosis for which anti-thrombotic treatment is not currently ongoing) or risk of thromboembolic disease, as evaluated by investigator. 6. Neutralising antibodies towards emicizumab have been detected or, for patients adherent to emicizumab therapy, are suspected based on clinical and laboratory assessments. 7. Receipt of FVIII gene therapy at any time. 8. Ongoing or planned immune tolerance induction therapy. 9. Minor or major surgery planned to take place after screening and during the 26-week treatment period. 10. Known or suspected hypersensitivity to study intervention, related products, any constituents of the product or to other monoclonal antibodies. 11. Hepatic dysfunction defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) greater than (\>) 3 times the upper limit combined with total bilirubin \>1.5 times the upper limit measured at screening. 12. Renal impairment defined as estimated glomerular filtration rate (eGFR) lesser than or equal to (≤) 30 milliliter per minute per 1.73 square meter (mL/min/1.73 m\^2) for serum creatinine measured at screening. 13. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method. 14. Mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate understanding and cooperation. 15. Other conditions (e.g. autoimmune disease) or laboratory abnormality that may increase risk of bleeding or thrombosis as evaluated by the investigator.

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Conditions

The condition(s) this trial relates to.

hemophilia A

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Haemophilia A Haemophilia A with inhibitors

Contacts and locations

Locations

  • AKH - Klin. Abt. f. Haematologie u. Haemostaseologie

    Vienna, 1090, Austria

  • AOU Careggi Firenze

    Florence, Tuscany, 50134, Italy

  • Arthur Bloom Haemophilia Centre

    Cardiff, CF14 4XW, United Kingdom

  • Augusta Univ/Childrens Hosp-GA

    Augusta, Georgia, 30912, United States

  • Azienda Ospedaliera Santobono Pausilipon - U.S.D. Centro Regionale Pediatrico Malattie della Coagulazione

    Naples, 80122, Italy

  • Azienda Ospedaliera di Rilievo Nazionale Santobono Pausilipon

    Naples, 80122, Italy

  • Belfast City Hospital

    Belfast, BT9 78B, United Kingdom

  • Birmingham Children's Hospital

    Birmingham, United Kingdom

  • Central Michigan University

    Detroit, Michigan, 48201, United States

  • Charlotte Maxeke Johannesburg Academic Hospital

    Parktown, Johannesburg, Gauteng, 2193, South Africa

  • Children's Hospital Los Angeles - Endocrinology

    Los Angeles, California, 90027, United States

  • Cliniques universitaires Saint-Luc - Service Hématologie

    Brussels, 1200, Belgium

  • Fondazione IRCSS Ca' Granda Ospedale Maggiore Policlinico

    Milan, 20122, Italy

  • Hospices Civils de Lyon- Hopital Louis Pradel-1

    Bron, 69500, France

  • Hospital Regional Universitario de Málaga

    Málaga, 29010, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Kyung Hee University Hospital at Gangdong

    Seoul, 05278, South Korea

  • McMaster University

    Hamilton, Ontario, L8N 3Z5, Canada

  • Michigan State University

    East Lansing, Michigan, 48824, United States

  • Nara Medical University Hospital_Pediatrics

    Nara, 634-8522, Japan

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205, United States

  • Penn State MS Hershey Med Ctr

    Hershey, Pennsylvania, 17033-2360, United States

  • Royal Free Haemophilia Comprehensive Care Center

    London, NW3 2QG, United Kingdom

  • Royal Free Haemophilia Comprehensive Care Centre

    London, NW3 2QG, United Kingdom

  • Royal Hallamshire Hospital

    Sheffield, S10 2JF, United Kingdom

  • Rush University Med. Cntr

    Chicago, Illinois, 60612, United States

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722, South Korea

  • St Joseph's Hospital Foundation

    Tampa, Florida, 33607, United States

  • UC Davis Medical Center

    Sacramento, California, 95817, United States

  • UC Denver Hemoph & Thrombo Ctr

    Aurora, Colorado, 80045, United States

  • Univ Hosp Cleveland Med Ctr

    Cleveland, Ohio, 44106, United States

  • University of Iowa_Iowa City

    Iowa City, Iowa, 52242, United States

  • Universitätsklinik für Innere Medizin V

    Innsbruck, 6020, Austria

  • Universitätsklinikum Bonn - Institut für Experimentelle Hämatologie

    Bonn, 53127, Germany

  • Vanderbilt U Med Ctr_Nashville

    Nashville, Tennessee, 37212, United States

  • Vivantes Netzwerk für Gesundheit GmbH - Vivantes Klinikum im Friedrichshain

    Berlin, 10249, Germany

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