Actively Recruiting
STOP-HAE: A Phase 3 Study of ADX-324 in HAE
Led by ADARx Pharmaceuticals, Inc. · Updated on 2026-04-22
90
Participants Needed
50
Research Sites
122 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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)
- Experienced at least 1 investigator-confirmed HAE attack in the first 4 weeks of screening or at least 2 confirmed attacks in 8 weeks of screening
- Able to use at least one acute therapy to treat HAE attacks (such as plasma-derived or recombinant C1-INH concentrate or BK2-receptor antagonist)
You will not qualify if you...
- Diagnosis of another form of recurrent angioedema (such as acquired angioedema, HAE with normal C1-INH, idiopathic angioedema, or angioedema with urticaria)
- Any clinically significant kidney disease
- Any clinically significant liver disease
- Use of C1-INH agent 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 therapy for any condition (excluding vaccines)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 50 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
Actively Recruiting
14
ADARx Clinical Site
Toledo, Ohio, United States, 43617
Actively Recruiting
15
ADARx Clinical Site
Hershey, Pennsylvania, United States, 17033
Not Yet 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
Not Yet Recruiting
18
ADARx Clinical Site
Adelaide, South Australia, Australia, 5000
Not Yet 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
Not Yet 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
Not Yet Recruiting
34
ADARx Clinical Site
Montpellier, France, 34295
Not Yet Recruiting
35
ADARx Clinical Site
Paris, France, 75012
Not Yet Recruiting
36
ADARx Clinical Site
Tübingen, Baden-Wurttemberg, Germany, 72076
Not Yet 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
Lodz, Poland, 92-213
Actively Recruiting
43
ADARx Clinical Site
Wroclaw, Poland, 50-556
Actively Recruiting
44
ADARx Clinical Site
Barcelona, Spain, 08907
Actively Recruiting
45
ADARx Clinical Site
Madrid, Spain, 28007
Actively Recruiting
46
ADARx Clinical Site
Taichung, Taiwan, 40705
Actively Recruiting
47
ADARx Clinical Site
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
48
ADARx Clinical Site
Cardiff, United Kingdom, CF14 4YS
Actively Recruiting
49
ADARx Clinical Site
London, United Kingdom, E1 1BB
Actively Recruiting
50
ADARx Clinical Site
Southampton, United Kingdom, SO16 6YD
Actively Recruiting
Research Team
L
Lupe Gallegos
CONTACT
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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