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NCT05053139 (NNC0365-3769 in Haemophilia A): BVCT ex-ante prediction vs. reported outcome

On 24 Mar 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 13 May 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient.

Clinical Trial

NCTID
NCT05053139
Acronym
FRONTIER 2
Drug Name
NNC0365-3769 (Mim8)
Drug MoA
a factor VIIIa-mimetic anti-FIXa/anti-FX bispecific antibody activator
Drug Modality
bispecific antibody
Drug Class
First-In-Class
Therapeutic Area
Hematologic Diseases
Indication
Haemophilia A
Human Patients
267
Sponsor
Novo Nordisk
Phase
Phase 3

Prediction of , index 1530

Prospective Prediction
Prediction Index
1530
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit for patients with and without prophylaxis with and without inhibitors with numerically-superior-to-emicizumab efficacy)
Technical Prediction
SUCCESS (statistically significant clinical benefit for patients with and without prophylaxis with and without inhibitors)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
50 days in advance
Readout Data Interpretation
99% no-prophylaxis-adjusted reduction in treated bleeds for mim8 (vs 96-97% for emicizumab Mahlangu et al. Kruse-Jarres 2018 NEJM).
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
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
Phase
Phase 3
Status
Completed
Enrollment
281
Lead sponsor
Novo Nordisk A/S
Conditions
Haemophilia A; Haemophilia A With Inhibitors
Interventions
DRUG: NNC0365-3769 (Mim8)
Design
Randomized · Parallel · None
Primary purpose
Treatment
Start
2021-12-02
Primary completion
2024-03-11
Completion
2024-12-17
Primary outcomes
  • Number of treated bleeds (No prophylaxis treatment (Arms 1, 2a and 2b): From randomisation (week 0) to end of main (week 26))
  • Number of treated bleeds (Prophylaxis treatment (Arms 3 and 4): From initiation of run-in (26-52 weeks prior to week 0) to week 0 and from randomisation (week 0) to end of main (week 26))

NCT05053139 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials