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

Purpose

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.

Conditions

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
ADX-324 Dose Level 1
  • Drug: ADX-324 Dose Level 1
    siRNA duplex oligonucleotide
Experimental
ADX-324 Dose Level 2
  • Drug: ADX-324 Dose Level 2
    siRNA duplex oligonucleotide

Recruiting Locations

ADARx Clinical Site
Las Vegas, Nevada 89128

More Details

Status
Recruiting
Sponsor
ADARx Pharmaceuticals, Inc.

Study Contact

Lupe Gallegos
877-232-7974
info@adarx.com