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

KalVista Pharmaceuticals Ltd0 sites136 target enrollmentSeptember 16, 2022

Overview

2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38819658/ (added 10/06/2024)

Registry

who.int

Start Date

September 16, 2022

End Date

December 31, 2023

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

•Current inclusion criteria as of 26/10/2023:
•1\. Male or female patients 12 years of age and older with a weight of \>30 kg
•2\. Confirmed diagnosis of HAE type I or II at any time in the medical history.
•3\. Patient has access to and ability to use conventional on\-demand treatment for HAE attacks.
•4\. If a patient is receiving long\-term prophylactic treatment with one of the protocol\-allowed therapies, they must be on a stable dose and regimen for at least 3 months prior to the Screening Visit and be willing to remain on a stable dose and regimen for the duration of the trial.
•5\. Patient’s last dose of attenuated androgens was at least 28 days prior to randomization.
•6\. Patient:
•6\.1\. Has had a least two documented HAE attacks within 3 months prior to screening or randomisation; or
•6\.2\. Is a completer of the KVD824\-201 trial within 3 months prior to randomization and meets all other entry criteria to enroll in KVD900\-301\.7\. Patients must meet the contraception requirements.
•8\. Patients must be able to swallow trial tablets whole.

•Current exclusion criteria as of 04/11/2022:
•1\. Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1\-inhibitor deficiency, HAE with normal C1\-INH (previously known as HAE type III), idiopathic angioedema, or angioedema associated with urticaria.
•2\. A clinically significant history of poor response to bradykinin receptor 2 (BR2\) blocker, C1\-INH therapy or plasma kallikrein inhibitor therapy for the management of HAE, in the opinion of the Investigator.
•3\. Use of angiotensin\-converting enzyme (ACE) inhibitors after the Screening Visit or within 7 days prior to randomization.
•4\. Any estrogen\-containing medications with systemic absorption (such as oral contraceptives including ethinylestradiol or hormonal replacement therapy) within 7 days prior to the Screening Visit.
•5\. Patients who require sustained use of strong cytochrome P450 3A4 (CYP3A4\) inhibitors or inducers.
•6\. Inadequate organ function, including but not limited to:
•6\.1\. Alanine aminotransferase (ALT) \>2x upper limit of normal (ULN)
•6\.2\. Aspartate aminotransferase (AST) \>2x ULN
•6\.3\. Bilirubin direct \>1\.25x ULN