Join the RAPIDe-3 clinical research study for Hereditary Angioedema
This is a sponsored post written by Dr. Raffi Tachdjian in collaboration with Pharvaris
RAPIDe-3
In partnership with about 75 other institutions across the globe, the practice of Dr. Raffi Tachdjian is currently participating in the RAPIDe-3 study on hereditary angioedema (HAE) type 1 and type 2. The purpose of this study is to evaluate the efficacy and safety of an oral investigational drug, deucrictibant, compared to a placebo (sugar pill with no active ingredient) for the on-demand/immediate treatment of angioedema attacks in participants with HAE due to C1 inhibitor (C1-INH) deficiency (type 1 or type 2).
Deucrictibant is an orally bioavailable small-molecule bradykinin B2 receptor antagonist with high therapeutic potential. There are currently two approaches to HAE management: on-demand treatment of attacks and prevention of attacks with prophylactic therapy.
Participation in the RAPIDe-3 study will vary in duration based on how long it takes for a participant to experience and treat two qualifying HAE attacks with deucrictibant and placebo. This includes a screening period, a Day 1 visit/non-attack visit, an attack treatment phase with a follow-up visit for the first qualifying HAE attack, and an end-of-study visit after the second qualifying HAE attack.
Deucrictibant and the placebo are both given in the form of soft capsules, which will be taken orally according to a participant’s assigned order. The participants will be randomly assigned to receive them in one of two orders: deucrictibant first and then the placebo or the placebo first and then deucrictibant, in a double-blinded manner. If the study drug does not provide sufficient symptom relief during an HAE attack, the participant may contact their study doctor to discuss how they feel and determine if they should take a second dose of the study drug. However, if needed following the second dose of study drug, the participant may use their own prescribed HAE medication or study-provided icatibant.
Eligible participants must:
– Be between 12 and 75 years of age (inclusively)
– Have a confirmed diagnosis of HAE type 1 or 2
– Have had at least two HAE attacks within the past three months
– Have experience using standard-of-care treatment to manage on-demand treatment for HAE attacks
– Other eligibility criteria apply
If you are a patient or have any patients, you feel may be interested in and qualify for this clinical research study, click here.
Sincerely,
Raffi Tachdjian, MD, MPH
More Information Regarding Pharvaris:
Pharvaris is a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to treat and prevent hereditary angioedema (HAE) attacks. By directly pursuing this clinically proven therapeutic target with novel small molecules, the Pharvaris team aspires to offer people with all types of HAE effective, well-tolerated, and easy-to-administer alternatives to treat attacks, both on-demand and prophylactically. Deucrictibant is a novel, potent, oral small-molecule bradykinin B2 receptor antagonist. Pharvaris is developing two distinct formulations of deucrictibant to address unmet needs in both the on-demand (via immediate-release capsule) and prophylactic (via extended-release tablet) treatment paradigms.
With positive data in both Phase 2 on-demand and Phase 2 prophylaxis studies in HAE, Pharvaris is encouraged to further develop deucrictibant. Pharvaris is currently enrolling a pivotal Phase 3 study for the on-demand treatment of HAE attacks and a pivotal Phase 3 study of deucrictibant for the prevention of HAE attacks.
