Actively Recruiting
STOP-HAE: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of siRNA Targeting of Prekallikrein With ADX-324 in Participants With Hereditary Angioedema
Led by ADARx Pharmaceuticals, Inc. · Updated on 2026-05-18
90
Participants Needed
51
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of ADX-324 in adults with Type 1 or Type 2 hereditary angioedema (HAE). This Phase 3 study aims to assess not only how well ADX-324 prevents HAE attacks but also its safety, how the body processes the drug (pharmacokinetics), its effects on the body (pharmacodynamics), and impacts on participants' quality of life. The study is sponsored by ADARx Pharmaceuticals, Inc. Participants will be randomly assigned to receive one of two dose levels of ADX-324, a small interfering RNA (siRNA) duplex oligonucleotide drug, or a placebo (saline). The study uses a double-blind design, meaning neither participants nor researchers know who receives the active drug or placebo. The treatment period focuses on evaluating outcomes from Day 22 through Week 25. During the trial, participants will be monitored for the number and quality of HAE attacks, along with assessments of drug safety and effects on quality of life. Researchers will track pharmacokinetics and pharmacodynamics to understand how the drug behaves in the body. Participation involves regular visits and evaluations throughout the study period, which lasts until the end of 2027. The main measurement is the efficacy of ADX-324 in preventing HAE attacks during the treatment window.
CONDITIONS
Brief Title
STOP-HAE: A Phase 3 Study of ADX-324 in HAE
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of signing informed consent
- Documented diagnosis of Type 1 or Type 2 hereditary angioedema (HAE-1/HAE-2)
- At least 1 investigator-confirmed HAE attack in the first 4 weeks of screening or at least 2 investigator-confirmed HAE attacks in 8 weeks of screening
- Ability to use at least one acute therapy for HAE attacks, such as plasma-derived or recombinant C1-INH concentrate or BK2-receptor antagonist
You will not qualify if you...
- Diagnosis of other recurrent angioedema types, including acquired angioedema, HAE with normal C1-INH, idiopathic angioedema, or recurrent angioedema with urticaria
- Any clinically significant kidney (renal) disease
- Any clinically significant liver (hepatic) disease
- Use of C1-INH agents within 2 weeks prior to screening
- Use of Berotralstat within 3 weeks prior to screening
- Use of Lanadelumab within 8 weeks prior to screening
- Use of androgens within 12 weeks prior to screening
- Prior treatment with any RNA/DNA-based therapy for HAE or intolerance to such therapies (excluding vaccines)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From Day 1 to Week 25
Participants receive ADX-324 or placebo to evaluate the efficacy in preventing hereditary angioedema (HAE) attacks.
Weekly visits for up to 25 weeks
Trial Site Locations
Total: 51 locations
1
ADARx Clinical Site
Litchfield Park, Arizona, United States, 85340
Actively Recruiting
2
ADARx Clinical Site
Little Rock, Arkansas, United States, 72205
Actively Recruiting
3
ADARx Clinical Site
San Diego, California, United States, 92122
Actively Recruiting
4
ADARx Clinical Site
Walnut Creek, California, United States, 94598
Actively Recruiting
5
ADARx Clinical Site
Orlando, Florida, United States, 32807
Actively Recruiting
6
ADARx Clinical Site
Chevy Chase, Maryland, United States, 20815
Actively Recruiting
7
ADARx Clinical Site
Wheaton, Maryland, United States, 20902
Actively Recruiting
8
ADARx Clinical Site
Detroit, Michigan, United States, 48202
Actively Recruiting
9
ADARx Clinical Site
St Louis, Missouri, United States, 63141
Actively Recruiting
10
ADARx Clinical Site
Las Vegas, Nevada, United States, 89128
Actively Recruiting
11
ADARx Clinical Site
New York, New York, United States, 10029
Actively Recruiting
12
ADARx Clinical Site
Cincinnati, Ohio, United States, 45236
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13
ADARx Clinical Site
Columbus, Ohio, United States, 43235
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14
ADARx Clinical Site
Toledo, Ohio, United States, 43617
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15
ADARx Clinical Site
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
16
ADARx Clinical Site
Capital Federal, Buenos Aires, Argentina, C1425BEN
Not Yet Recruiting
17
ADARx Clinical Site
Buenos Aires, Buenos Aires F.D., Argentina, C1035AAT
Actively Recruiting
18
ADARx Clinical Site
Adelaide, South Australia, Australia, 5000
Actively Recruiting
19
ADARx Clinical Site
Vienna, Austria, 1090
Actively Recruiting
20
ADARx Clinical Site
Edegem, Antwerpen, Belgium, 2650
Not Yet Recruiting
21
ADARx Clinical Site
Sofia, Bulgaria, 1000
Actively Recruiting
22
ADARx Clinical Site
Edmonton, Alberta, Canada, T6G 2R3
Not Yet Recruiting
23
ADARx Clinical Site
Ottawa, Ontario, Canada, K1H 1E4
Actively Recruiting
24
ADARx Clinical Site
Montreal, Quebec, Canada, H2W 1R7
Not Yet Recruiting
25
ADARx Clinical Site
Beijing, China, 100730
Actively Recruiting
26
ADARx Clinical Site
Harbin, China, 150001
Not Yet Recruiting
27
ADARx Clinical Site
Zhengzhou, China, 450003
Not Yet Recruiting
28
ADARx Clinical Site
Split, Croatia, 21000
Actively Recruiting
29
ADARx Clinical Site
Zagreb, Croatia, 10000
Actively Recruiting
30
ADARx Clinical Site
Hradec Králové, Czechia, 500 05
Actively Recruiting
31
ADARx Clinical Site
Prague, Czechia, 15000
Actively Recruiting
32
ADARx Clinical Site
Nice, Alpes-Maritimes, France, 06300
Not Yet Recruiting
33
ADARx Clinical Site
Tours, Indre-et-Loire, France, 37000
Actively Recruiting
34
ADARx Clinical Site
Montpellier, France, 34295
Not Yet Recruiting
35
ADARx Clinical Site
Paris, France, 75012
Actively Recruiting
36
ADARx Clinical Site
Tübingen, Baden-Wurttemberg, Germany, 72076
Actively Recruiting
37
ADARx Clinical Site
Hong Kong, Hong Kong, 111
Not Yet Recruiting
38
ADARx Clinical Site
Budapest, Hungary, 1088
Actively Recruiting
39
ADARx Clinical Site
Ramat Gan, Tel Aviv, Israel, 5262100
Not Yet Recruiting
40
ADARx Clinical Site
Ashkelon, Israel, 7830604
Not Yet Recruiting
41
ADARx Clinical Site
Tel Aviv, Israel, 64239
Not Yet Recruiting
42
ADARx Clinical Site
Krakow, Poland
Actively Recruiting
43
ADARx Clinical Site
Lodz, Poland, 92-213
Actively Recruiting
44
ADARx Clinical Site
Wroclaw, Poland, 50-556
Actively Recruiting
45
ADARx Clinical Site
Barcelona, Spain, 08907
Actively Recruiting
46
ADARx Clinical Site
Madrid, Spain, 28007
Actively Recruiting
47
ADARx Clinical Site
Taichung, Taiwan, 40705
Actively Recruiting
48
ADARx Clinical Site
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
49
ADARx Clinical Site
Cardiff, United Kingdom, CF14 4YS
Actively Recruiting
50
ADARx Clinical Site
London, United Kingdom, E1 1BB
Actively Recruiting
51
ADARx Clinical Site
Southampton, United Kingdom, SO16 6YD
Actively Recruiting
Research Team
L
Lupe Gallegos
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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