NCT06960213 STOP-HAE: A Phase 3 Study of ADX-324 in HAE
| NCT ID | NCT06960213 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | ADARx Pharmaceuticals, Inc. |
| Condition | Hereditary Angioedema |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-08-28 |
| Primary Completion | 2027-06-30 |
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 2025-08-28 with a primary completion date of 2027-06-30.
⚠ 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
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 Criteria
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.
Contact & Investigator
Lauge Farnaes, MD
STUDY DIRECTOR
ADARx Pharmaceuticals, Inc.
Frequently Asked Questions
Who can join the NCT06960213 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hereditary Angioedema. 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 NCT06960213 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 NCT06960213 currently recruiting?
Yes, NCT06960213 is actively recruiting participants. Contact the research team at info@adarx.com for enrollment information.
Where is the NCT06960213 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 NCT06960213 clinical trial?
NCT06960213 is sponsored by ADARx Pharmaceuticals, Inc.. The principal investigator is Lauge Farnaes, MD at ADARx Pharmaceuticals, Inc.. The trial plans to enroll 90 participants.