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New treatment option for Hereditary Angioedema
Official title STOP-HAE: A Phase 3 Study of ADX-324 in HAE
ClinicalTrials.gov ID: NCT06960213
What this study is testing
What is ADX-324?
ADX-324 is an investigational medicine, being studied as a potential treatment for hereditary angioedema.
Also referred to as siRNA.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)...
You likely can't join if
- Concurrent diagnosis of another form of recurrent angioedema (such as acquired angioedema, HAE with normal C1-INH (previously known as HAE Type III)...
- Any clinically significant renal disease
- Any clinically significant hepatic disease
- Have used any of the following for long-term prevention of HAE attacks:
- C1-INH agent (CINRYZE, HAEGARDA, RUCONEST) within 2 weeks prior to Screening.
- Berotralstat (ORLADEYO) within 3 weeks prior to Screening.
See the full eligibility 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
- 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...
- Any clinically significant renal disease
- Any clinically significant hepatic disease
- Have used any of the following for long-term prevention of HAE attacks:
- C1-INH agent (CINRYZE, HAEGARDA, RUCONEST) within 2 weeks prior to Screening.
- Berotralstat (ORLADEYO) within 3 weeks prior to Screening.
- Lanadelumab (TAKHZYRO) within 8 weeks prior to the Screening.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Litchfield Park, Arizona, United States
- Little Rock, Arkansas, United States
- San Diego, California, United States
- Walnut Creek, California, United States
- Orlando, Florida, United States
- Chevy Chase, Maryland, United States
- Wheaton, Maryland, United States
- Detroit, Michigan, United States
- St Louis, Missouri, United States
- Las Vegas, Nevada, United States
- New York, New York, United States
- Cincinnati, Ohio, United States
- Columbus, Ohio, United States
- Toledo, Ohio, United States
- Hershey, Pennsylvania, United States
- Capital Federal, Buenos Aires, Argentina
- Buenos Aires, Buenos Aires F.D., Argentina
- Adelaide, South Australia, Australia
- Vienna, Austria
- Edegem, Antwerpen, Belgium
+ 31 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Litchfield Park, Arizona, United States; Little Rock, Arkansas, United States; San Diego, California, United States; Walnut Creek, California, United States; Orlando, Florida, United States; Chevy Chase, Maryland, United States and 45 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.