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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorADARx Pharmaceuticals, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

A negative reaction to study drug in ADX-324-301

Trial design

Treatments tested in this trial

  • ADX-324 Dose Level 1
  • ADX-324 Dose Level 2

Treatment groups

90 Participants
are divided into 2 treatment groups

Sponsors and collaborators