A recently launched clinical trial aims to determine the long-term safety of KVD900 as a treatment for hereditary angioedema (HAE).
This interventional study is a phase 3, open-label, multicenter extension trial with a single group assignment model of intervention and will include 150 adolescent or adult participants previously diagnosed with HAE type 1 or 2.
The intervention consists of administering 600 mg of KVD900 orally with an on-demand scheme for acute HAE attacks.
The study will measure the proportion of patients who experience at least 1 adverse event after taking at least 1 dose of KVD900 from the first dose to up to 2 years thereafter as the primary outcome.
Read more about HAE therapies
As for the secondary outcomes, measures will include the Patient Global Impression of Change (PGI-C) to determine symptomatic relief of an acute HAE attack in the first 12 hours following the administration of KVD900, the Patient Global Impression of Severity (PGI-S) of HAE attacks within 12 hours of administration, and resolved HAE attacks assessed using PGI-S in the first 24 hours after treatment initiation.
Patients aged 12 or more years who have experienced at least 2 documented HAE attacks during the previous 3 months could be eligible. All participants must receive and appropriately store KVD900, and they must properly fill out an eDiary.
Individuals with other diagnoses, such as acquired C1 inhibitor (C1-INH) deficiency, idiopathic angioedema, and HAE associated with urticaria, among others, cannot participate. Likewise, those that have exhibited suboptimal response to C1-INH therapy, bradykinin receptor 2 blockers, or plasma kallikrein inhibitors cannot take part in the trial. Participants will have to withdraw from angiotensin-converting enzyme (ACE) inhibitors and systemically absorbed medications containing estrogen at least 7 days before enrollment.
This clinical trial, designed to study KVD900, a plasma kallikrein inhibitor, is scheduled to start in August 2022 and is expected to be completed by January 2026.
An open-label extension trial to evaluate the long-term safety of KVD900 for on-demand treatment of angioedema attacks in adolescent and adult patients with hereditary angioedema (HAE). ClinicalTrials.gov. August 18, 2022. Accessed August 22, 2022.