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STOP-HAE: A Phase 3 Study of ADX-324 in HAE | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

STOP-HAE: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of siRNA Targeting of Prekallikrein With ADX-324 in Participants With Hereditary Angioedema

NCT06960213•ADARx Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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)

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.

Locations (14)

ADARx Clinical Site

Little Rock, Arkansas, United States

ADARx Clinical Site

Walnut Creek, California, United States

ADARx Clinical Site

Wheaton, Maryland, United States

ADARx Clinical Site

Detroit, Michigan, United States

ADARx Clinical Site

St Louis, Missouri, United States

ADARx Clinical Site

Las Vegas, Nevada, United States

ADARx Clinical Site

New York, New York, United States

ADARx Clinical Site

Cincinnati, Ohio, United States

ADARx Clinical Site

Columbus, Ohio, United States

ADARx Clinical Site

Toledo, Ohio, United States

Key Dates

Start Date

August 28, 2025

Primary Completion Date

June 30, 2027

Completion Date

December 31, 2027

Last Updated

March 2, 2026

Enrollment

ESTIMATED participants

Conditions

Hereditary AngioedemaHAEHereditary Angioedema - Type 1Hereditary Angioedema - Type 2

Interventions

ADX-324

DRUG

Placebo

DRUG

Contacts

Lupe Gallegos

CONTACT

877-232-7974 lgallegos@adarx.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 2, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

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