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RECRUITING Phase 3 ClinicalTrials.gov

Study of Oral Deucrictibant XR Tablet for Prophylaxis and Deucrictibant Soft Capsule for On-Demand Treatment of Angioedema Attacks in Adults With Acquired Angioedema Due to C1 Inhibitor Deficiency

Sponsor: Pharvaris Netherlands B.V. • ClinicalTrials.gov ID: NCT07266805

Registry updated: 2026-09-21
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Description

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 soft capsule for on-demand treatment of angioedema attacks in adult participants aged ≥ 18 years with AAE-C1INH.

Interventions

  • Deucrictibant (Drug)
    Part 1: Deucrictibant 40 mg extended-release tablet for once daily oral use
  • Placebo (Drug)
    Part 1: Placebo Comparator tablet for once daily oral use
  • Deucrictibant (Drug)
    Part 2: Deucrictibant 20 mg soft capsule oral use
  • Placebo (Drug)
    Part 2: Placebo Comparator soft capsule oral use
  • Deucrictibant (Drug)
    Part 3: Deucrictibant 20 mg soft capsule oral use

Eligibility criteria

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. * If underlying disease associated with AAE is present, the underlying disease must be stable throughout the duration of part 1. * 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 (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). * Receiving long-term prophylaxis (LTP) treatment for AAE-C1INH and satisfied with this treatment. Participants who are not satisfied (eg, tolerability issues, lack of efficacy) and have previously stopped LTP treatment for AAE-C1INH, for reasons other than participation in this study, can sign the ICF and begin the Screening Period only if their 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 (ACE) inhibitors or any estrogen-containing medications with systemic absorption within 5 half-lives before the Screening Visit

Conditions

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

Locations

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

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record