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NCT05139810 (Donidalorsen in Hereditary Angioedema): BVCT ex-ante prediction vs. reported outcome

On 3 Jan 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 22 Jan 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient (no approved drug for this MoA)..

Clinical Trial

NCTID
NCT05139810
Acronym
OASIS-HAE
Drug Name
Donidalorsen (ISIS 721744 or IONIS-PKK-LRx)
Drug MoA
GalNAc3-conjugated anti-prekallikrein ASO
Drug Modality
small interfering RNA (siRNA) antisense oligonucleotide
Drug Class
First-In-Class
Therapeutic Area
Cardiovascular Diseases
Indication
Hereditary Angioedema
Human Patients
91
Sponsor
Ionis Pharmaceuticals
Phase
Phase 3

Prediction of , index 1400

Prospective Prediction
Prediction Index
1400
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit non-superior non-inferior to deucrictibant)
Technical Prediction
SUCCESS (statistically significant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
19 days in advance
Readout Data Interpretation
primary and secondary endpoints met with 87% lower attack rate vs 85% lower attack rate achieved by deucrictibant.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient (no approved drug for this MoA).
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Phase 3 Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ISIS 721744 in Patients With Hereditary Angioedema (HAE)
Phase
Phase 3
Status
Completed
Enrollment
91
Lead sponsor
Ionis Pharmaceuticals, Inc.
Conditions
Hereditary Angioedema
Interventions
DRUG: Donidalorsen; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2021-12-03
Primary completion
2023-11-09
Completion
2023-11-09
Results first posted
2025-03-06
Primary outcomes
  • Time-Normalized Investigator-Confirmed (IC) HAE Attack Rate (Per Month) From Week 1 to Week 25 (Week 1 to Week 25)

NCT05139810 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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