Extension Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema
NCT05396105 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2026-03-16
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.
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
- 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
Sponsors & Collaborators
-
Pharvaris Netherlands B.V.
lead INDUSTRY
Principal Investigators
-
Study Director · Pharvaris Netherlands B.V.
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-12-28
- Primary Completion
- 2027-06-30
- Completion
- 2027-06-30
- FDA Drug
- Yes
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
Study Locations
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