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

Part of paid clinical trials in Litchfield Park, Arizona.

Sponsor
ADARx Pharmaceuticals, Inc.
Study ID
NCT07428499
Phase
PHASE3
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ADX-324 Dose Level 1 — DRUG
    siRNA duplex oligonucleotide
  • ADX-324 Dose Level 2 — DRUG
    siRNA duplex oligonucleotide

Study Details

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.

Key Dates

Start date
Apr 2, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2030
Completion
Jun 30, 2030

Study Design

Enrollment
90 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Safety of ADX-324 in Participants with HAE [ Time Frame: Month 36 ]

Central Contacts

Locations (15)

FacilityCityStateZIPSite coordinators
ADARx Clinical SiteLitchfield ParkArizona85340-
ADARx Clinical SiteLittle RockArkansas72205-
ADARx Clinical SiteSan DiegoCalifornia92122-
ADARx Clinical SiteWalnut CreekCalifornia94598-
ADARx Clinical SiteOrlandoFlorida32807-
ADARx Clinical SiteChevy ChaseMaryland20815-
ADARx Clinical SiteWheatonMaryland20902-
ADARx Clinical SiteDetroitMichigan48202-
ADARx Clinical SiteSt LouisMissouri63141-
ADARx Clinical SiteLas VegasNevada89128-
ADARx Clinical SiteNew YorkNew York10029-
ADARx Clinical SiteCincinnatiOhio45236-
ADARx Clinical SiteColumbusOhio43235-
ADARx Clinical SiteToledoOhio43617-
ADARx Clinical SiteHersheyPennsylvania17033-

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