Recruiting
Phase 3

Observational Study

Sponsor:

ADARx Pharmaceuticals, Inc.

Code:

NCT06960213

Conditions

Hereditary Angioedema

HAE

Hereditary Angioedema - Type 1

Hereditary Angioedema - Type 2

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ADX-324

Placebo

Study Details

Brief summary:

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.

Conditions

Hereditary Angioedema

HAE

Hereditary Angioedema - Type 1

Hereditary Angioedema - Type 2

Study ID

NCT06960213

Start date

Aug 28, 2025

Status verified date

Jun, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

  • Age ≥18 years at the time of signing informed consent.
  • Have a documented diagnosis of HAE-1/HAE-2 (Type I or II)
  • Experience ≥1 Investigator-confirmed HAE attack in the first 4 weeks of Screening or ≥2 Investigator-confirmed HAE attacks in 8 weeks of Screening
  • Able to use at least one acute therapy to treat HAE attacks (such as a plasma-derived or recombinant C1-INH concentrate or a BK2-receptor antagonist)

Key Exclusion Criteria:

  • Concurrent diagnosis of another form of recurrent angioedema (such as acquired angioedema, HAE with normal C1-INH (previously known as HAE Type III), idiopathic angioedema, or recurrent angioedema associated with urticaria).
  • Any clinically significant renal disease
  • Any clinically significant hepatic disease
  • Have used any of the following for long-term prevention of HAE attacks:

1. C1-INH agent (CINRYZE, HAEGARDA, RUCONEST) within 2 weeks prior to Screening.
2. Berotralstat (ORLADEYO) within 3 weeks prior to Screening.
3. Lanadelumab (TAKHZYRO) within 8 weeks prior to the Screening.
4. Androgen use within 12 weeks prior to Screening.
  • Received prior treatment with any RNA/DNA-based therapy for HAE or intolerant to any prior RNA/DNA-based therapy for any condition, excluding vaccines.

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ADX-324 Dose Level 1

experimental: ADX-324 Dose Level 2

placebo comparator: Placebo

Interventions

ADX-324

siRNA duplex oligonucleotide

Placebo

saline

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Lupe Gallegos

877-232-7974info@adarx.com

Locations

ADARx Clinical Site

Recruiting

Litchfield Park, Arizona, United States, 85340

ADARx Clinical Site

Recruiting

Little Rock, Arkansas, United States, 72205

ADARx Clinical Site

Recruiting

San Diego, California, United States, 92122

ADARx Clinical Site

Recruiting

Walnut Creek, California, United States, 94598

ADARx Clinical Site

Recruiting

Orlando, Florida, United States, 32807

ADARx Clinical Site

Recruiting

Chevy Chase, Maryland, United States, 20815

ADARx Clinical Site

Recruiting

Wheaton, Maryland, United States, 20902

ADARx Clinical Site

Recruiting

Detroit, Michigan, United States, 48202

ADARx Clinical Site

Recruiting

St Louis, Missouri, United States, 63141

ADARx Clinical Site

Recruiting

Las Vegas, Nevada, United States, 89128

ADARx Clinical Site

Recruiting

New York, New York, United States, 10029

ADARx Clinical Site

Recruiting

Cincinnati, Ohio, United States, 45236

ADARx Clinical Site

Recruiting

Columbus, Ohio, United States, 43235

ADARx Clinical Site

Recruiting

Toledo, Ohio, United States, 43617

ADARx Clinical Site

Recruiting

Hershey, Pennsylvania, United States, 17033

ADARx Clinical Site

Recruiting

Ottawa, Ontario, Canada, K1H 1E4

More Information

Sponsor

ADARx Pharmaceuticals, Inc.

Last update posted

Jun 16, 2026

Last verified

Jun, 2026

Keywords

  • HAE
  • Hereditary angioedema
  • onvuzosiran

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by ADARx Pharmaceuticals, Inc. on 2026-06-16.