Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
90 participants
INTERVENTIONAL
2025-08-28
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ADX-324 Dose Level 1
ADX-324
siRNA duplex oligonucleotide
ADX-324 Dose Level 2
ADX-324
siRNA duplex oligonucleotide
Placebo
Placebo
saline
Interventions
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ADX-324
siRNA duplex oligonucleotide
Placebo
saline
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
* Participants must be deemed medically appropriate for on-demand treatment as the sole medicinal management for their HAE during the study, per Investigator.
* Women of childbearing potential must have a negative serum pregnancy test during Screening and a negative urine pregnancy test on Study 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 1 month after study drug administration, whichever is longer.
Exclusion Criteria
* Any clinically significant medical history including, but not limited to, uncontrolled hypertension (defined as systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥ 100 mmHg despite therapy), uncontrolled diabetes mellitus (HbA1c \>9.0%), or current cardiovascular disease, including recent acute coronary syndrome (within the past 6 months), congestive heart failure (NYHA Class III or IV), and significant arrhythmias.
* Any clinically significant renal disease
* Any clinically significant hepatic disease
* Exposure to any of the following LTP for HAE:
1. Chronic prophylaxis with C1-INH (CINRYZE, HAEGARDA, RUCONEST) within 2 weeks prior to Screening.
2. Chronic prophylaxis with berotralstat (ORLADEYO) within 3 weeks prior to Screening.
3. Chronic prophylaxis with 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 (including ADX-324) or is intolerant of any prior RNA/DNA-based therapy for any condition, excluding vaccines.
18 Years
ALL
No
Sponsors
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ADARx Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Masako Murai, MD
Role: STUDY_DIRECTOR
ADARx Pharmaceuticals, Inc.
Locations
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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
ADARx Clinical Site
Ottawa, Ontario, Canada
ADARx Clinical Site
Hradec Králové, , Czechia
ADARx Clinical Site
Budapest, , Hungary
ADARx Clinical Site
Madrid, , Spain
Countries
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Central Contacts
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Other Identifiers
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ADX-324-301
Identifier Type: -
Identifier Source: org_study_id
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