Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Mim8 · 2 trials · 3 indications
Measured as count of events.
Measured as count of events.
Count of events
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | Participants entering from the multiple ascending dose (MAD) part of study NN7769-4513. In part 1, participants will receive Mim8 prophylaxis (PPX) subcutaneous (s.c.) administration using enhanced cartridge for 26 weeks. In part 2, participants will receive Mim8 PPX s.c. administration using enhanced cartridge or DV3407 pen-injector once it is approved. |
| Arm 2 | EXPERIMENTAL | Participants entering from study NN7769-4514, NN7769-4728 and NN7769-4516. In part 1, participants will receive Mim8 PPX s.c. administration using DV3407 pen-injector for 26 weeks. In part 2, participants will receive Mim8 PPX s.c. administration using DV3407 pen-injector. |
| Arm 3 | EXPERIMENTAL | In part 1 and 2, participants will receive Mim8 PPX s.c. administration using DV3407 pen-injector. |
| Mim8 | EXPERIMENTAL | 52-week treatment period with a part 1 and part 2, where all participants receive Mim8 prophylaxis |
| Name | Type | Description |
|---|---|---|
| Mim8 | DRUG | Participants in arm 1 will administer Mim8 using an enhanced cartridge and switch to the DV3407 pen-injector once it is approved. Participants in arm 2 and 3 will use the DV3407 pen injector. |
Arm 1 \& 2: 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 haemo...
Mim8 is being developed for the treatment of haemophilia A, including haemophilia A with or without inhibitors. It is an investigational therapy studied in adults and children with this bleeding disorder. Novo Nordisk A/S is running Phase 3 clinical trials in these patient populations across multiple countries worldwide.
Mim8 is being developed by Novo Nordisk A/S, which trades under the ticker NVO. The company is running the clinical development program for Mim8 in haemophilia A, including patients with and without inhibitors, across Phase 3 studies conducted in many countries.
Mim8 is in Phase 3 clinical development. It is an investigational therapy and has not been approved by the FDA. Two Phase 3 studies have been conducted, one completed in children and one active but not recruiting in a broader haemophilia A population.
Mim8 has been studied in two Phase 3 trials. NCT05685238 is a long-term treatment study in people with haemophilia A, active but not recruiting, with 451 participants. NCT05306418 studied Mim8 in children with haemophilia A with or without inhibitors, is completed, and enrolled 70 participants.
Across the two Phase 3 trials, 521 participants have been enrolled. The long-term treatment study NCT05685238 enrolled 451 people with haemophilia A, and the pediatric study NCT05306418 enrolled 70 children with haemophilia A with or without inhibitors. Both studies were controlled and conducted internationally.
Mim8 Phase 3 trials have been conducted across many countries, including the United States, Canada, China, Japan, India, and numerous European nations such as Germany, France, Italy, Spain, and the Netherlands. Sites also included Israel, South Korea, Taiwan, Turkey, Mexico, South Africa, and others.