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NCT05259917 (KVD900 in Hereditary Angioedema): BVCT ex-ante prediction vs. reported outcome

On 25 May 2023, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 13 Feb 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient as a non-inferior oral on-demand treatment.

Clinical Trial

NCTID
NCT05259917
Acronym
KONFIDENT
Drug Name
KVD900
Drug MoA
plasma kallikrein inhibitor
Drug Modality
small molecule
Drug Class
Best-In-Class
Therapeutic Area
Cardiovascular Diseases
Indication
Hereditary Angioedema
Human Patients
136
Sponsor
KalVista Pharmaceuticals
Phase
Phase 3

Prediction of , index 1068

Prospective Prediction
Prediction Index
1068
Prediction Date
Commercial Prediction
SUCCESS (Commercially sufficient clinical benefit non-inferior to lanadelumab)
Technical Prediction
SUCCESS (statistically significant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
264 days in advance
Readout Data Interpretation
met all primary and secondary endpoints.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient as a non-inferior oral on-demand treatment
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Randomized, Double-Blind, Placebo-Controlled, Phase 3, Three-way Crossover Trial to Evaluate the Efficacy and Safety of Two Dose Levels of KVD900, an Oral Plasma Kallikrein Inhibitor, for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema Type I or II
Phase
Phase 3
Status
Completed
Enrollment
136
Lead sponsor
KalVista Pharmaceuticals, Ltd.
Conditions
Hereditary Angioedema
Interventions
DRUG: Placebo; DRUG: KVD900 600 mg; DRUG: KVD900 300 mg
Design
Randomized · Crossover · Double
Primary purpose
Treatment
Start
2022-02-22
Primary completion
2023-12-31
Completion
2023-12-31
Results first posted
2024-07-19
Primary outcomes
  • Time to Beginning of Symptom Relief Patient Global Impression of Change (PGI-C) (Within 12 hours of the first investigational medicinal product (IMP) administration.)

NCT05259917 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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