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

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

ADX-324 Dose Level 1
Drug
siRNA duplex oligonucleotide
ADX-324 Dose Level 2
Drug
siRNA duplex oligonucleotide

Treatment groups

90 Participants

are divided into 2 treatment groups

Group A: ADX-324 Dose Level 1Experimental treatment 1 intervention

Group B: ADX-324 Dose Level 2Experimental treatment 1 intervention

Trial 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

Time frame

Month 36

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ADARx Pharmaceuticals, Inc.

Lead sponsor

Source ClinicalTrials.gov

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