Dose-ranging Study of Oral PHA-022121 for Prophylaxis Against Angioedema Attacks in Patients With Hereditary Angioedema Type I or Type II

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-19

Study Completion Date

2025-06-30

Brief Summary

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This study evaluates the safety and efficacy of PHA-022121 administered orally for prophylaxis against angioedema attacks in patients with hereditary angioedema (HAE). The study consists of 2 parts, with patients completing participation in Part 1 prior to initiation of treatment in Part 2. Part 1 of the study has 3 parallel arms and approximately 30 patients will be equally randomized to one of two dose regimens of PHA-022121 or matching placebo. Patients will continue to the single open-label arm in Part 2 of the study after completion of Part 1. The screening period is up to 8 weeks and the treatment periods are 12 weeks (Part 1) and 30 months (Part 2) in duration.

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Detailed Description

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Conditions

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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 C1 Esterase Inhibitor Deficiency C1 Inhibitor Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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Deucrictibant low dose

Deucrictibant softgel capsules for oral use (PHVS416)

Intervention Type DRUG

Deucrictibant high dose

Deucrictibant softgel capsules for oral use (PHVS416)

Intervention Type DRUG

Placebo

Matching placebo capsules for oral use

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Signed and dated informed consent form
* Diagnosis of HAE type I or II
* Documented history of at least 3 HAE attacks within the last 3 consecutive months prior to screening, or a minimum of 2 HAE attacks during the screening period
* Reliable access and experience to use standard of care acute attack medications

Exclusion Criteria

* Pregnancy or breast-feeding
* Clinically significant abnormal electrocardiogram
* Any other systemic disease or significant disease or disorder that would interfere with the patient's safety or ability to participate in the study
* Use of C1-esterase inhibitor, oral kallikrein inhibitors, attenuated androgens, anti-fibrinolytics, or monoclonal HAE therapy within a defined period prior to enrolment
* Abnormal hepatic function
* Abnormal renal function
* History of alcohol or drug abuse within defined period, or current evidence of substance dependence or abuse
* Participation in any other investigational drug study within defined period

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No