Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05053139 | A Research Study Investigating Mim8 in Adults and Adolescents With Haemophilia A With or Without Inhibitors | PHASE3 | COMPLETED | 281 | — | — | Dec 2, 2021 | Dec 17, 2024 | Dec 8, 2025 | 163 | United States, Austria +32 |
| NCT05681845 | A Study to Compare the Blood Levels of Mim8 in Healthy Men When Administered With the DV3407-C1 Pen Injector or a Syringe and Cartridge | PHASE1 | COMPLETED | 205 | — | — | Jan 2, 2023 | Oct 13, 2023 | Oct 14, 2025 | 1 | Germany |
Count
Measured in micrograms\*day per milliliter (μg\*day/mL).
Measured in μg/mL.
| Arm | Type | Description |
|---|---|---|
| no PPX- no PPX - Mim8 PPXQW/QM | EXPERIMENTAL | Participants not receiving prophylaxis will not enter the run-in period. In arm 1, participants will be randomised to continue no prophylaxis (on-demand treatment with their Standard of Care products) or Mim8 once-weekly or once-monthly prophylaxis in agreement with investigators in the main part of the study (26 weeks). After the main part, participants will continue in the extension part of the study (26 weeks) in agreement with the investigator, either weekly or monthly Mim8 prophylaxis regimen. |
| no PPX - Mim8 PPXQW - Mim8 PPXQW | EXPERIMENTAL | Participants not receiving prophylaxis will not enter the run-in period. In arm 2a, participants will be randomised to Mim8 once-weekly prophylaxis in the main part of the study (26 weeks). After the main part, participants will continue in the extension part of the study (26 weeks) on once-weekly Mim8 prophylaxis regimen. |
| no PPX - Mim8 PPXQM - Mim8 PPXQM | EXPERIMENTAL | Participants not receiving prophylaxis will not enter the run-in period. In arm 2b, participants will be randomised to Mim8 once-monthly prophylaxis in the main part of the study (26 weeks). After the main part, participants will continue in the extension part of the study (26 weeks) on once-monthy Mim8 prophylaxis regimen. |
| PPX - Mim8 PPXQW | EXPERIMENTAL | Participants on coagulation factor prophylaxis prior to enrolment will preferably continue the same product type and dosing frequency in the run-in period for at least 26 weeks before they can be randomised into the main part of the study. These participants will only be allowed to receive coagulation factor prophylaxis. In arm 3, participants will be randomised to once-weekly Mim8 prophylaxis regimen in the main part of the study (26 weeks). After the main part, participants will continue in the extension part of the study (26 weeks) on once-weekly Mim8 prophylaxis regimen. |
| PPX- Mim8 PPXQM | EXPERIMENTAL | Participants on coagulation factor prophylaxis prior to enrolment will preferably continue the same product type and dosing frequency in the run-in period for at least 26 weeks before they can be randomised into the main part of the study. These participants will only be allowed to receive coagulation factor prophylaxis. In arm 4, participants will be randomised to once-monthly Mim8 prophylaxis regimen in the main part of the study (26 weeks). After the main part, participants will continue in the extension part of the study (26 weeks) on once-monthly Mim8 prophylaxis regimen. |
| Arm 1 (Pilot part) | EXPERIMENTAL | Participants will receive a single dose of Mim8 using a 32G, 4 mm pen-needle with the DV3407-C1 pen injector. |
| Arm 2 (Pilot part) | EXPERIMENTAL | Participants will receive a single dose of Mim8 using a 29G, 8 mm needle and syringe with the enhanced cartridge. |
| Arm 3 (Bioequivalence part) | EXPERIMENTAL | Participants will receive a single dose of Mim8 using a 29G, 4 mm pen-needle with the DV3407-C1 pen injector. |
| Arm 4 (Bioequivalence part) | EXPERIMENTAL | Participants will receive a single dose of Mim8 using a 29G, 8 mm needle and syringe with the enhanced cartridge. |
| Name | Type | Description |
|---|---|---|
| NNC0365-3769 (Mim8) | DRUG | Mim8 will be injected into a skinfold on the stomach with a thin needle either once a week or once a month. |
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 participants with diagnosis of congenital haemo...