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
This research study will test an investigational medication called KVD900, a new oral drug being developed to treat hereditary angioedema, the same condition you have. This study is being done to understand how well one or two doses of KVD900 300mg or KVD900 600mg works against placebo to bring relief from an attack of HAE.
If you decide to take part in the study, you will come to the site for 2 visits, and you will have 4 televisits, which may be done by phone or video. Your participation in the study will be approximately 25 weeks. You will need to complete a study e-diary that will use an app that will be downloaded onto your personal mobile device, or on a mobile device provided to you for the purpose of this study. We will perform vital signs, a physical exam, an electrocardiogram (ECG), pregnancy test, and blood collection. In this study every patient will treat one attack with 300mg of study drug, one attack with 600mg of study drug, and one attack with placebo. If after 3 hours following your first dose of study drug you do not experience the needed relief, your assigned kit includes a second dose of study drug that you may take for the attack. The second dose is the same treatment as the first dose. If after 1 hour of your second dose of study drug you do not experience the needed relief, you may dose with your conventional medication.
Up to $1,050
Confirmed diagnosis of HAE type I or II at any time in the medical history.
Patient has access to and ability to use conventional on-demand treatment for HAE attacks.
Patient provides signed informed consent or assent (when applicable). A parent or legally authorized representative must also provide signed informed consent when required.
Patients must be able to swallow trial tablets whole.
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 angiotensin-converting enzyme (ACE) inhibitors after the Screening Visit or within 7 days prior to randomization.
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.
History of substance abuse or dependence that would interfere with the completion of the trial, as determined by the Investigator.