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Extension Study of ADX-324 in Hereditary angioedema
EU CTIS ID: 2025-521353-16-00
What this study is testing
To evaluate the long-term safety of repeat dosing of ADX-324 in participants with HAE
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Received 2 doses of study drug (ADX-324 and/or placebo) in Study ADX-324-301 and completed the study (follow up through Week 25).
- 2. Provided written informed consent and any authorizations required by local law and be willing to comply with all study requirements for the duration of the study.
- 3. Have access to, and the ability to use, at least one acute HAE therapy to treat HAE attacks (eg, plasma-derived or recombinant C1-INH concentrate or a BK2-receptor antagonist) that has previously been shown to be effective for the participant.
- 4. Women of childbearing potential must have a negative urine pregnancy test on Day 1 before study drug administration and must agree to use acceptable contraceptive methods if engaged in sexual activity of childbearing potential (refer to Section 13.2.2) from the time of signing the informed consent form (ICF) until the EOS Visit or 3 months after the last study drug administration, whichever is longer. Fertile male participants with female partners of childbearing potential should agree to use acceptable contraceptive methods from the time of signing the ICF until the EOS Visit or 3 months after the last study drug administration, whichever is longer.
You likely can't join if
- 1. Had unacceptable toxicity in Study ADX-324-301, as determined by the Investigator. This includes, but is not limited to, the following: a. Met Hy’s law criteria (ALT or AST ≥3 × ULN AND total bilirubin ≥2 × ULN AND ALP <2 × ULN and no other reason could be found to explain the findings). b. Grade ≥3 hypersensitivity reaction to study drug.
- 2. Has any condition or abnormal laboratory value, ECG finding, vital signs, or physical examination finding that, in the Investigator’s opinion, would pose an unacceptable risk to the participant if they participate in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Israel
- Hong Kong
- United States
- Australia
- Serbia
- Turkey
- Argentina
- United Kingdom
- Canada
- Taiwan
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Israel; Hong Kong; United States; Australia; Serbia; Turkey and 4 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 EU CTIS; the study team decides eligibility.