Actively Recruiting
Long-Term, Open-label Study of Oral Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults With HAE
Led by Pharvaris Netherlands B.V. · Updated on 2026-05-07
170
Participants Needed
62
Research Sites
199 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase 3, multicenter, long-term, open-label study to evaluate the safety and efficacy of once-daily orally administered deucrictibant extended-release tablet for prophylaxis to prevent angioedema attacks in participants aged ≥12 years with Hereditary Angioedema
CONDITIONS
Official Title
Long-Term, Open-label Study of Oral Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults With HAE
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form by the participant or legally authorized representative
- Male or female aged 12 years or older at consent
- Diagnosis of hereditary angioedema (HAE)
- For new participants, at least one angioedema attack in the last three consecutive months before screening
- Reliable access and ability to use standard on-demand treatments for acute HAE attacks
- Willingness and ability to follow all study requirements, including electronic diary and questionnaire completion
- Female participants of childbearing potential must agree to pregnancy testing and use contraception as per protocol
You will not qualify if you...
- Any type of angioedema other than HAE
- Participation in another clinical study with investigational drugs within 30 days or 5 half-lives before consent
- Prior gene therapy for any condition
- Discontinuation from previous deucrictibant studies due to safety or compliance issues that affect participation
- Use of ACE inhibitors or estrogen-containing medications with systemic absorption within 4 weeks before screening
- Use of prophylactic HAE treatments within specified timeframes before screening: 2 weeks for C1INH, oral kallikrein inhibitors, or anti-fibrinolytics; 4 weeks for attenuated androgens; 5 half-lives for monoclonal antibodies; 7 days for short-term prophylaxis
- Females who are pregnant, planning pregnancy, or breastfeeding
- Abnormal liver function
- Moderate or severe kidney impairment
- Any significant medical condition or systemic dysfunction that may affect safety or participation
- History of alcohol or drug abuse within the past year or current substance dependence
- Use of moderate or strong CYP3A4 inhibitors or inducers within 30 days or 5 half-lives prior to randomization
- Known allergy to deucrictibant or any ingredients of the study drug
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 62 locations
1
Study Site
Birmingham, Alabama, United States, 35209
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2
Study Site
Scottsdale, Arizona, United States, 85251
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3
Study Site
Little Rock, Arkansas, United States, 72205
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4
Study Site
San Diego, California, United States, 92122
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5
Study Site
Santa Monica, California, United States, 90404
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6
Study Site
Walnut Creek, California, United States, 94598
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7
Study Site
Wheaton, Maryland, United States, 20902
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8
Study Site
St Louis, Missouri, United States, 63141
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9
Study Site
Las Vegas, Nevada, United States, 89128-0450
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10
Study Site
Hershey, Pennsylvania, United States, 17033
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11
Study Site
Dallas, Texas, United States, 75231
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12
Study Site
Milwaukee, Wisconsin, United States, 53226-3067
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13
Study Site
Corrientes, Argentina
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14
Study Site
Pilar, Argentina
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15
Study Site
Salta, Argentina
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16
Study Site
Melbourne, Australia, 3052
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17
Study Site
Melbourne, Australia
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18
Study Site
Perth, Australia
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19
Study Site
Sydney, Australia
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20
Study Site
Vienna, Austria
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21
Study Site
Ribeirão Preto, Brazil
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22
Study Site
Salvador, Brazil
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23
Study Site
Santo André, Brazil
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24
Study Site
São Paulo, Brazil, 01454010
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25
Study Site
São Paulo, Brazil, 14051-140
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26
Study Site
Sofia, Bulgaria
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27
Study Site
Edmonton, Canada
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28
Study Site
Montreal, Canada
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29
Study Site
Beijing, China
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30
Study Site
Grenoble, France
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31
Study Site
Berlin, Germany
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32
Study Site
Frankfurt, Germany
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33
Study Site
Munich, Germany
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34
Study Site
Hong Kong, Hong Kong
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35
Study Site
Budapest, Hungary
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36
Study Site
Dublin, Ireland
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37
Study Site
Padova, Italy
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38
Study Site
Palermo, Italy
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39
Study Site
Roma, Italy
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40
Study Site
Hiroshima, Japan
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41
Study Site
Kanagawa, Japan
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42
Study Site
Osaka, Japan
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43
Study Site
Tokyo, Japan
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44
Study Site
Krakow, Poland
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45
Study Site
Martin, Slovakia
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46
Study Site
Cape Town, South Africa
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47
Study Site
Daegu, South Korea
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48
Study Site
Seoul, South Korea
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49
Study Site
Barcelona, Spain, 08907
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50
Study Site
Ankara, Turkey (Türkiye)
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51
Study Site
Istanbul, Turkey (Türkiye)
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52
Study Site
Izmir, Turkey (Türkiye)
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53
Study Site
Birmingham, United Kingdom, B18 7QH
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54
Study Site
Birmingham, United Kingdom, B9 5SS
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55
Study Site
Brighton, United Kingdom
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56
Study Site
Bristol, United Kingdom
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57
Study Site
Cambridge, United Kingdom
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58
Study Site
London, United Kingdom, E1 1FR
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59
Study Site
London, United Kingdom
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60
Study Site
Oxford, United Kingdom
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61
Study Site
Plymouth, United Kingdom
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62
Study Site
Southampton, United Kingdom
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Research Team
P
Pharvaris Clinical Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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