Mim8 for Hemophilia A
(FRONTIER4 Trial)

Recruiting in Palo Alto (17 mi)

+238 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Novo Nordisk A/S

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing Mim8, a new medicine to prevent bleeding in people with haemophilia A. It works by replacing the missing part in their blood that helps it clot. The study will last several years and involves frequent injections under the skin.

Research Team

Clinical Transparency dept. 2834

Principal Investigator

Novo Nordisk A/S

Eligibility Criteria

This trial is for males and females with congenital haemophilia A who are already participating in certain ongoing Mim8 studies. They must be able to follow the study schedule and procedures, including diary completion. Pregnant or breastfeeding women, those planning pregnancy, or not using effective contraception are excluded.

Inclusion Criteria

I have been diagnosed with congenital haemophilia A.

Informed consent obtained before any study related activities

- Participant has completed the end of treatment visit for study NN7769-4514, NN7769-4516 or NN7769-4728

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Exclusion Criteria

Any disorder, except for conditions associated with haemophilia, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol

Participant who has discontinued or been withdrawn from studies NN7769-4513, NN7769-4514, NN7769-4516, or NN7769-4728

I have no major surgeries planned during the early phase of the study.

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Treatment Details

Interventions

Mim8 (Replacement Therapy)

Trial OverviewThe trial tests long-term use of Mim8, a new medication designed to prevent bleeding in people with haemophilia A by mimicking clotting factor VIII. Participants will receive up to 262 subcutaneous injections over a maximum of 5.5 years or until Mim8 becomes commercially available.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Arm 2Experimental Treatment1 Intervention

Participants entering from study NN7769-4514 or NN7769-4516. In part 1, participants will receive Mim8 PPX QW or QM with s.c. administration using DV3407 pen-injector for 26 weeks. In part 2, participants will receive Mim8 PPX QW, Q2W or QM with s.c. administration using DV3407 pen-injector.

Group II: Arm 1Experimental Treatment1 Intervention

Participants entering from the multiple ascending dose (MAD) part of study NN7769-4513. In part 1, participants will receive Mim8 prophylaxis (PPX) once every two weeks (Q2W) with subcutaneous (s.c.) administration using enhanced cartridge for 26 weeks. In part 2, participants will receive Mim8 PPX once-weekly (QW), Q2W or once-monthly (QM) with s.c. administration using enhanced cartridge or DV3407 pen-injector once it is approved.