NCT05053139

A Research Study Investigating Mim8 in Adults and Adolescents With Haemophilia A With or Without Inhibitors

A Multinational, Open-label, Randomised, Controlled Study to Investigate Efficacy and Safety of NNC0365-3769 (Mim8) in Adults and Adolescents With Haemophilia A With or Without Inhibitors

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 281 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This study is investigating how Mim8 works compared to other medicines in people with haemophilia A, who either have inhibitors or do not have inhibitors. Mim8 is a new medicine that will be used for prevention of bleeding episodes. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). When and how often participants will receive Mim8 is dependent on their previous treatment - but is otherwise decided by chance. Mim8 will be injected into a skinfold on the stomach with a thin needle either once a week or once a month. The study will last 54-124 weeks (12-29 months) depending on how long participants will be followed in run-in before they start treatment and if they continue in the follow period or transfer to an open label extension study. Participants will have 12-17 clinic visits.

Conditions

• Haemophilia A
• Haemophilia A With Inhibitors

Interventions

Type	Name	Description
DRUG	NNC0365-3769 (Mim8)	Mim8 will be injected into a skinfold on the stomach with a thin needle either once a week or once a month.

Timeline

• Start date: 2021-12-02
• Primary completion: 2024-03-11
• Completion: 2024-12-17
• First posted: 2021-09-22
• Last updated: 2025-12-08

Locations

163 sites across 34 countries: United States, Austria, Belgium, Canada, China, Czechia, Denmark, France, Germany, India, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, Netherlands, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Slovakia, South Africa, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study