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Replacement Therapy

Mim8 for Hemophilia A (FRONTIER4 Trial)

Phase 3
Recruiting
Research Sponsored by Novo Nordisk A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from visit 8 (week 26) until end of treatment (up to 262 weeks)
Awards & highlights

FRONTIER4 Trial Summary

This trial is testing a new medicine (Mim8) to prevent bleeding episodes in people with haemophilia A who have or don’t have inhibitors. Participants will get up to 262 injections of Mim8 over 5.5 years, with restrictions on other medicines.

Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
While specific side effects for Mim8 aren't listed here, similar treatments may cause injection site reactions, potential development of inhibitors (antibodies against the treatment), allergic reactions, and could potentially affect other medications.

FRONTIER4 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from visit 8 (week 26) until end of treatment (up to 262 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from visit 8 (week 26) until end of treatment (up to 262 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of treatment emergent adverse events
Secondary outcome measures
Device handling using haemophilia device assessment tool (HDAT) (applicable for participants in arm 2 only)
Mim8 plasma concentration
Number of injection site reactions
+6 more

FRONTIER4 Trial Design

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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Hemophilia A involve replacing the missing clotting factor VIII (FVIII) to prevent or control bleeding episodes. Traditional treatments include infusions of plasma-derived or recombinant FVIII concentrates. Newer treatments, like Mim8, are designed to mimic the function of FVIII, enhancing the body's ability to form blood clots. These treatments are crucial for Hemophilia patients as they significantly reduce the frequency and severity of bleeding episodes, improving quality of life and reducing the risk of long-term joint damage and other complications.

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,525 Previous Clinical Trials
2,419,249 Total Patients Enrolled
2 Trials studying Hemophilia
3,100 Patients Enrolled for Hemophilia
Clinical Transparency dept. 2834Study DirectorNovo Nordisk A/S
36 Previous Clinical Trials
522,638 Total Patients Enrolled

Media Library

Mim8 (Replacement Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05685238 — Phase 3
Hemophilia Research Study Groups: Arm 1, Arm 2
Hemophilia Clinical Trial 2023: Mim8 Highlights & Side Effects. Trial Name: NCT05685238 — Phase 3
Mim8 (Replacement Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05685238 — Phase 3
~301 spots leftby Jun 2028