NCT07428499 Phase 3 Extension Study of ADX-324 in Participants With Hereditary Angioedema (HAE)
| NCT ID | NCT07428499 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | ADARx Pharmaceuticals, Inc. |
| Condition | Hereditary Angioedema (HAE) |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2026-04-02 |
| Primary Completion | 2030-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 90 participants in total. It began in 2026-04-02 with a primary completion date of 2030-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Lauge Farnaes, MD
STUDY DIRECTOR
ADARx Pharmaceuticals
Frequently Asked Questions
Who can join the NCT07428499 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hereditary Angioedema (HAE). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07428499 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 90 participants.
Is NCT07428499 currently recruiting?
Yes, NCT07428499 is actively recruiting participants. Contact the research team at info@adarx.com for enrollment information.
Where is the NCT07428499 trial being conducted?
This trial is being conducted at Litchfield Park, United States, Little Rock, United States, San Diego, United States, Walnut Creek, United States and 11 additional locations.
Who is sponsoring the NCT07428499 clinical trial?
NCT07428499 is sponsored by ADARx Pharmaceuticals, Inc.. The principal investigator is Lauge Farnaes, MD at ADARx Pharmaceuticals. The trial plans to enroll 90 participants.