Actively Recruiting
Study of Oral Deucrictibant XR Tablet for Prophylaxis and Deucrictibant IR Capsule for On-Demand Treatment of Angioedema Attacks in Adults With Acquired Angioedema Due to C1 Inhibitor Deficiency
Led by Pharvaris Netherlands B.V. · Updated on 2026-05-07
32
Participants Needed
17
Research Sites
84 weeks
Total Duration
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AI-Summary
What this Trial Is About
This is a Phase 3, multicenter, 3-part study, with 2 randomized, double-blind, placebo-controlled parts and an open-label extension part, to evaluate the efficacy and safety of orally administered deucrictibant XR tablet for prophylaxis, and deucrictibant IR capsule for on-demand treatment of angioedema attacks in adult participants aged ≥ 18 years with AAE-C1INH.
CONDITIONS
Official Title
Study of Oral Deucrictibant XR Tablet for Prophylaxis and Deucrictibant IR Capsule for On-Demand Treatment of Angioedema Attacks in Adults With Acquired Angioedema Due to C1 Inhibitor Deficiency
Who Can Participate
Eligibility Criteria
You may qualify if you...
-
Provision of written informed consent
-
Male or female (sex at birth) aged ≥18 years
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Diagnosis of AAE-C1INH
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History of AAE-C1INH attacks prior to the Screening Visit:
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Participants enrolling in Part 1 must have stable underlying disease of AAE-C1INH
- The underlying condition can reasonably be expected to remain stable for the duration
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Reliable access and ability to use available therapy to effectively manage AAE- C1INH attacks.
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Female participants of childbearing potential must agree to the protocol-specified pregnancy testing and to be abstinent from heterosexual intercourse or to use an acceptable contraception method.
Females of non-childbearing potential (prepubertal, surgically sterile, or postmenopausal with ≥ 12 months amenorrhea and postmenopausal FSH confirmation) are not required to use contraception during the study.
• Capable of recording, without assistance, eDiary and ePRO data using an electronic device, as evidenced by the eDiary and ePRO training.
You will not qualify if you...
- Participation in a clinical study with any other investigational drug within the last 30 days or within 5 half-lives of the investigational drug at the Screening Visit (whichever is longer).
- Participants who have previously received prophylactic therapy but have stopped can participate in this study provided the last dose of the treatment was received prior to the timepoint before the Screening Visit
- Any females who are pregnant, plan to become pregnant, or are currently breast-feeding
- Abnormal hepatic function
- Moderate or severe renal impairment
- Any clinically significant comorbidity or systemic dysfunction that would interfere with the participant's safety or ability to participate in the study.
- History of epilepsy and/or other significant neurological diseases
- Any clinically significant and uncontrolled gastrointestinal dysfunction that may impact study drug absorption
- Evidence of current alcohol or drug abuse
- Use of medications that are moderate and strong inhibitors of cytochrome P450 (CYP) 3A4, or strong inducers of CYP3A4 within the last 30 days or within 5 half-lives (whichever is longer) at the time of the Screening Visit
- Known hypersensitivity to deucrictibant or any of the excipients of the study drug
- Use of angiotensin-converting enzyme inhibitors or any estrogen-containing medications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
Study Site
Walnut Creek, California, United States, 94598,
Actively Recruiting
2
Study Site
Walnut Creek, California, United States, 94598
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3
Study Site
St Louis, Missouri, United States, 63130
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4
Study Site
Sofia, Bulgaria
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5
Study Site
Edmonton, Canada
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6
Study Site
Paris, France
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7
Study Site
Berlin, Germany
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8
Study Site
Frankfurt am Main, Germany
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9
Study Site
Munich, Germany
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10
Study Site
Budapest, Hungary
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11
Study List
Milan, Italy
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12
Study Site
Basel, Switzerland
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13
Study Site
Cambridge, United Kingdom
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14
Study Site
Leicester, United Kingdom
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15
Study Site
London, United Kingdom
Actively Recruiting
16
Study Site
Newcastle upon Tyne, United Kingdom
Actively Recruiting
17
Study Site
Plymouth, United Kingdom
Actively Recruiting
Research Team
P
Pharvaris Clinical Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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