Phase 3 Extension Study of ADX-324 in Participants With Hereditary Angioedema (HAE)

Phase 3Not Yet RecruitingNCT07428499

ADARx Pharmaceuticals, Inc.90 enrolled

Overview

Study ADX-324-302 is an extension study for participants who complete the Phase 3 ADX-324-301 trial. The extension study will provide information about the safety and efficacy of additional dosing of ADX-324 in participants with Type I and Type II hereditary angioedema (HAE). The study will also include pharmacodynamic (PD), pharmacokinetic (PK), and health-related quality of life (HRQoL) measurements.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hereditary Angioedema (HAE)Hereditary Angioedema - Type 1 Hereditary Angioedema - Type 2 HAE

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Have a documented diagnosis of HAE (Type I or II) * Completed Study ADX-324-301 * Have access to an acute therapy to treat HAE attacks (such as plasma derived or recombinant C1-INH concentrate or a BK2-receptor antagonist) Exclusion Criteria: * A negative reaction to study drug in ADX-324-301

Outcomes

Primary Outcomes

Safety of ADX-324 in Participants with HAE

Incidence and severity of treatment-emergent adverse events

Time frame: Month 36

Secondary Outcomes

Efficacy of ADX-324 in Preventing HAE Attacks

Number of Investigator-confirmed HAE attacks per month