NCT05396105

Extension Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema

A Phase II/III, Extension Study of Orally Administered PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema

• Status: Enrolling By Invitation
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Pharvaris Netherlands B.V. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the safety and efficacy of long-term on-demand treatment with orally administered deucrictibant for acute hereditary angioedema (HAE) attacks, including laryngeal attacks. The study will enroll participants from Study PHA022121-C201 (NCT04618211), Study PHA022121-C306 (NCT06343779) and deucrictibant treatment naïve HAE-nC1INH adult participants who elect to participate in this extension study and meet the eligibility requirements.

Detailed description

Part A of the study will enroll adult participants from Study PHA022121-C201. The double-blind treatment assignment from Study PHA022121-C201 will be maintained. Part B is open-label treatment and will include participants rolling over from Part A. Participants from Study PHA022121-C201 who did not participate in Part A, participants from Study PHA022121-C306, and deucrictibant treatment naïve HAE-nC1INH adult participants who elect to participate in this extension study and meet the eligibility requirements.

Conditions

• Hereditary Angioedema
• Hereditary Angioedema Type I
• Hereditary Angioedema Type II
• Hereditary Angioedema Types I and II
• Hereditary Angioedema Attack
• Hereditary Angioedema With C1 Esterase Inhibitor Deficiency
• Hereditary Angioedema - Type 1
• Hereditary Angioedema - Type 2
• Hereditary Angioedema - Type 3
• C1 Esterase Inhibitor [C1-INH] Deficiency
• C1 Esterase Inhibitor Deficiency
• C1 Esterase Inhibitor, Deficiency of
• C1 Inhibitor Deficiency
• Hereditary Angioedema Type III
• Hereditary Angioedema (HAE)
• Hereditary Angioedema Type I and II

Interventions

Type	Name	Description
DRUG	deucrictibant	3 capsules of deucrictibant or matching placebo will be administered orally for each HAE attack
DRUG	deucrictibant	deucrictibant soft capsules will be administered orally for each HAE attack

Timeline

• Start date: 2022-12-28
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2022-05-31
• Last updated: 2026-03-16

Locations

63 sites across 25 countries: United States, Argentina, Australia, Austria, Brazil, Bulgaria, Canada, Czechia, France, Germany, Hong Kong, Hungary, Israel, Italy, Japan, Netherlands, Poland, Puerto Rico, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study