A Phase 3, Randomized, Double-blind, Placebo-controlled, 3-Part Study to Evaluate the Efficacy and Safety of Orally Administered Deucrictibant Extended-release (XR) Tablet for Prophylaxis and Deucrictibant Immediate-release (IR) Capsule for On-demand Treatment of Angioedema Attacks in Adults With Acquired Angioedema Due to C1 Inhibitor Deficiency
Pharvaris Netherlands B.V.
Summary
This is a Phase 3, multicenter, 3-part study, with 2 randomized, double-blind, placebo-controlled parts and an open-label extension part, to evaluate the efficacy and safety of orally administered deucrictibant XR tablet for prophylaxis, and deucrictibant IR capsule for on-demand treatment of angioedema attacks in adult participants aged ≥ 18 years with AAE-C1INH.
Description
The study consists of a Screening Period, during which eligibility is confirmed, a Part 1 Prophylaxis Double-blind Treatment Phase, a Part 2 On-demand, Double-blind Treatment Phase, and a Part 3 On-demand Open-label Extension Phase. Approximately 24 participants will be randomized in Part 1 into 2 parallel arms for a treatment period of 12 weeks. During the prophylaxis treatment period participants will receive blinded study drug (deucrictibant 40 mg XR or placebo randomized in a 1:1 ratio). Upon completion of Part 1, participants will roll-over into Part 2. In addition to rollover participant…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Provision of written informed consent * Male or female (sex at birth) aged ≥18 years * Diagnosis of AAE-C1INH * History of AAE-C1INH attacks prior to the Screening Visit: * Participants enrolling in Part 1 must have stable underlying disease of AAE-C1INH * The underlying condition can reasonably be expected to remain stable for the duration * Reliable access and ability to use available therapy to effectively manage AAE- C1INH attacks. * Female participants of childbearing potential must agree to the protocol-specified pregnancy testing and to be abstinent from hetero…
Interventions
- DrugDeucrictibant
Part 1: Deucrictibant 40 mg extended-release tablet for once daily oral use
- DrugPlacebo
Part 1: Placebo Comparator tablet for once daily oral use
- DrugDeucrictibant
Part 2: Deucrictibant 20 mg soft capsule oral use
- DrugPlacebo
Part 2: Placebo Comparator soft capsule oral use
- DrugDeucrictibant
Part 3: Deucrictibant 20 mg soft capsule oral use
Locations (17)
- Study SiteWalnut Creek, California
- Study SiteWalnut Creek, California
- Study SiteSt Louis, Missouri
- Study SiteSofia
- Study SiteEdmonton
- Study SiteParis