1 Study Matches
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Efficacy and Safety of Three Dose Levels of KVD824, an Oral Plasma Kallikrein Inhibitor, for Long-Term Prophylactic Treatment of Hereditary Angioedema Type I or II
This study is being done to study the efficacy of KVD824 as prophylaxis treatment for attacks of HAE (meaning whether or not it works to prevent the occurrence of attacks) in your body. KalVista has designed this study to understand the effect of KVD824 at 3 different dose levels and investigate more about how safe KVD824 is (to find out what effects - good and bad - KVD824 has) when compared with a placebo. Placebo looks like KVD824 but contains no active drug.
18 year(s) or older
Inclusion Criteria:Male of female subjects 18 years of age or older
Confirmed diagnosis of HAE type I or II
Access and ability to use conventional treatment for HAE attacks
Subject is willing to cease any current medications being taken for HAE treatment
Female subjects must agree to use at least one highly effective contraception method from screening visit until end of trial
Exclusion Criteria: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.
Use of ACE inhibitors after the Screening Visit or within 7 days prior to randomization.
History of substance abuse or dependence that would interfere with the completion of the trial, as determined by the Investigator.
Any estrogen containing medications with systemic absorption (such as oral contraceptives including ethinylestradiol or hormonal replacement therapy) after the Screening Visit or within 7 days prior to randomization.
Any pregnant or breastfeeding subject.