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Also known as NNC0365-3769 (Mim8)
NNC0365-3769 · 3 trials · 4 indications
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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. |
| Single dose (part 1) Mim8 | EXPERIMENTAL | Blinded. Single doses in healthy volunteers. Dose escalation. In each of the 6 cohorts, 6 participants will receive Mim8. |
| Single dose (part 1) placebo | PLACEBO_COMPARATOR | Blinded. Single doses in healthy volunteers. In each of the 6 cohorts, 2 participants will receive placebo. |
| Multiple dose (part 2) | EXPERIMENTAL | Open-label. There will be 4 cohorts receiving once-weekly doses (part 2 cohorts 1, 2, 3 and 5) and one cohort receiving once-monthly doses (part 2 cohort 4). Participants will continue into the part 2 extension on the same treatment 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. |
| Placebo (Mim8) | DRUG | Mim8 placebo administered subcutaneously (s.c., under the skin) |
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...
NNC0365-3769 is an investigational small molecule developed by Novo Nordisk A/S for haemophilia A, including cases with or without inhibitors. It is also known as Mim8. The drug has completed Phase 3 clinical development, with two completed trials and a total enrollment of 486 participants.
NNC0365-3769 is being developed for the treatment of haemophilia A, both with and without inhibitors. It is intended for use in adults and adolescents aged 12 years and older. The clinical program includes a Phase 3 trial that enrolled 281 participants across multiple countries.
NNC0365-3769 is being developed by Novo Nordisk A/S, which trades under the ticker NVO. The company is responsible for the clinical development of the drug, including the completed Phase 3 trial NCT05053139 and the Phase 1 trial NCT05681845.
NNC0365-3769 has completed Phase 3 clinical development. Two trials are listed as completed: a Phase 3 study (NCT05053139) and a Phase 1 study (NCT05681845). The drug is investigational and has not been approved by the FDA.
NNC0365-3769 has been studied in two completed clinical trials: NCT05053139, a Phase 3 trial in adults and adolescents with haemophilia A with or without inhibitors, and NCT05681845, a Phase 1 trial comparing blood levels in healthy men using a pen injector versus a syringe and cartridge.
Yes, NNC0365-3769 is also known as Mim8. Both names refer to the same investigational small molecule developed by Novo Nordisk A/S for haemophilia A. The alternative name Mim8 is used in the titles of the completed clinical trials NCT05053139 and NCT04204408.