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Clinical Trials in the USA / NCT07266805
Recruiting Phase 3

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

NCT07266805 · tracked via the Priya Life Science USA tracker
Sponsor
Pharvaris Netherlands B.V.
Phase
Phase 3
Started
2025-10-16
Last updated
2026-06-29

Condition(s) studied

Acquired Angioedema Due to C1-Inhibitor Deficiency (AAE-C1-INH)

Investigational drug(s) / intervention(s)

DeucrictibantPlaceboDeucrictibantPlaceboDeucrictibant

Deucrictibant: Part 1: Deucrictibant 40 mg extended-release tablet for once daily oral use

Placebo: Part 1: Placebo Comparator tablet for once daily oral use

Deucrictibant: Part 2: Deucrictibant 20 mg soft capsule oral use

Placebo: Part 2: Placebo Comparator soft capsule oral use

Deucrictibant: Part 3: Deucrictibant 20 mg soft capsule oral use

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Provision of written informed consent * Male or female (sex at birth) aged ≥18 years * Diagnosis of AAE-C1INH * History of AAE-C1INH attacks prior to the Screening Visit: * 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 * Reliable access and ability to use available therapy to effectively manage AAE- C1INH attacks. * 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. Exclusion Criteria: * 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

Primary outcome measure(s)

Trial sites (32)

FacilityCityRegionStatus
Study Site San Diego California Recruiting
Study Site Walnut Creek California Recruiting
Study Site St Louis Missouri Recruiting
Study Site Hershey Pennsylvania Recruiting
Study Site Clayton Australia Recruiting
Study Site Vienna Austria Recruiting
Study Site Sofia Bulgaria Recruiting
Study Site Edmonton Canada Recruiting
Study Site Grenoble France Recruiting
Study Site Lille France Recruiting
Study Site Paris France Recruiting
Study Site Berlin Germany Recruiting
Study Site Frankfurt am Main Germany Recruiting
Study Site Munich Germany Recruiting
Study Site Budapest Hungary Recruiting
Study Site 1 Milan Italy Recruiting
Study Site 2 Milan Italy Recruiting
Study Site 3 Milan Italy Recruiting
Study Site Padova Italy Recruiting
Study Site Roma Italy Recruiting
Study Site Amsterdam Netherlands Recruiting
Study Site Auckland New Zealand Recruiting
Study Site Krakow Poland Recruiting
Study Site Madrid Spain Recruiting
Study Site Basel Switzerland Recruiting
Study Site Ankara Turkey (Türkiye) Recruiting
Study Site Bristol United Kingdom Recruiting
Study Site Cambridge United Kingdom Recruiting
Study Site Leicester United Kingdom Recruiting
Study Site London United Kingdom Recruiting
Study Site Newcastle upon Tyne United Kingdom Recruiting
Study Site Plymouth United Kingdom Recruiting

More Pharvaris Netherlands B.V. trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07266805 on ClinicalTrials.gov ↗ ← All trials in the USA