STOP-HAE: A Phase 3 Study of ADX-324 in HAE

Part of paid clinical trials in Litchfield Park, Arizona.

Sponsor
ADARx Pharmaceuticals, Inc.
Study ID
NCT06960213
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • ADX-324 — DRUG
    siRNA duplex oligonucleotide
  • Placebo — DRUG
    saline

Study Details

This study will evaluate the efficacy and safety of ADX-324 in participants with Type 1 or Type 2 hereditary angioedema. The study will also evaluate safety, pharmacokinetics (PK), pharmacodynamics (PD), and health-related quality of life measures.

Key Dates

Start date
Aug 28, 2025
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

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

Arms

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

Primary Outcome Measure

Efficacy of ADX-324 in preventing HAE attacks [ Time Frame: Day 22 to Week 25 ]

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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ADARx Clinical Site· Litchfield Park, AZADARx Clinical Site· Little Rock, ARADARx Clinical Site· San Diego, CAADARx Clinical Site· Walnut Creek, CAADARx Clinical Site· Orlando, FLADARx Clinical Site· Chevy Chase, MD

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