RecruitingPhase 3

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

United States90 participantsStarted 2026-04-02

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

Safety of ADX-324 in Participants with HAE

Timeframe: Month 36

Trial details

NCT IDNCT07428499

SponsorADARx Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2030-06-30

Contact for this trial

Lupe Gallegos

877-232-7974 lgallegos@adarx.com

View on ClinicalTrials.gov More Hereditary Angioedema (HAE) trials