NCT04204408

A Research Study Investigating Mim8 in People With Haemophilia A

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Subcutaneous Doses of NNC0365-3769 (Mim8) in Healthy Subjects and in Subjects With Haemophilia A With or Without Factor VIII Inhibitors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 275 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Male
• Age: 12 Years
• Healthy volunteers: Accepted

Summary

This study is investigating how Mim8 works in people with haemophilia A, who either have inhibitors or do not have inhibitors. Mim8 is a new medication that will be used for prevention of bleeding episodes. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). Mim8 will be injected with a thin needle in the skin of the stomach, using a pen-injector. The study will last for up to 44 months. It consists of a main phase (part 1 and part 2) and an extension phase. In part 1, participants will be injected only once with either Mim8 or a "dummy" medicine (placebo) - which one will be decided by chance. In part 2 and the extension phase participants will get an Mim8 injection weekly or monthly.

Conditions

• Healthy Volunteers
• Haemophilia A With or Without Inhibitors

Interventions

Type	Name	Description
DRUG	NNC0365-3769 (Mim8)	Mim8 administered subcutaneously (s.c., under the skin). The treatment period will consist of 12 once-weekly doses or 3 once-monthly doses
DRUG	Placebo (Mim8)	Mim8 placebo administered subcutaneously (s.c., under the skin)

Timeline

• Start date: 2020-01-10
• Primary completion: 2023-10-06
• Completion: 2023-10-06
• First posted: 2019-12-19
• Last updated: 2025-12-19

Locations

40 sites across 12 countries: United States, Austria, Bulgaria, Germany, Italy, Japan, Poland, South Africa, Spain, Switzerland, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study