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 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: PHA022121-C308
• Study Type: interventional
• Target: 32
• Locations: 9 countries
• Sites: 17

Brief 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.

Conditions

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

Keywords

Acquired Angioedema-C1-INH; AAE-C1-INH; Oral Treatment; deucrictibant; Prophylaxis; On-demand; C1-Inhibitor Deficiency; PHA121; Pharvaris; Bradykinin B2 Receptor Antagonists; Angioedema; Acquired; Acquired angioedema

Outcome Measures

Primary Outcomes (3)

• Part 1 (Prophylaxis, Double-blind Treatment Phase)

  Time-normalized number of Investigator-confirmed AAE attacks during Treatment Phase

  12 weeks

• Part 2 (On-demand, Double-blind Treatment Phase)

  Time to symptom relief, Patient Global Impression of Change (PGI-C) rating of at least "better"

  12 hours post-treatment

• Part 3 (On-demand, Open-label Extension Treatment Phase)

  Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), and TEAEs leading to study drug discontinuation

  Through study completion, an average of 36 weeks

Secondary Outcomes (13)

• Part 1 (Prophylaxis, Double-blind Treatment Phase)

  12 weeks

• Part 1 (Prophylaxis, Double-blind Treatment Phase)

  12 weeks

• Part 1 (Prophylaxis, Double-blind Treatment Phase)

  12 weeks

• Part 1 (Prophylaxis, Double-blind Treatment Phase)

  12 weeks

• Part 1 (Prophylaxis, Double-blind Treatment Phase)

  12 weeks

Other Outcomes (1)

• Part 3 (On-demand, Open-label Extension Treatment Phase)

  12 hours post-treatment

Study Arms (5)

Part 1 - Arm 1 - Active

EXPERIMENTAL

Drug: Deucrictibant

Part 1 - Arm 2 - Placebo

PLACEBO COMPARATOR

Drug: Placebo

Part 2 - Arm 1

EXPERIMENTAL

Drug: Deucrictibant; Drug: Placebo

Part 2 - Arm 2

EXPERIMENTAL

Drug: Deucrictibant; Drug: Placebo

Part 3 - Open-label

EXPERIMENTAL

Drug: Deucrictibant

Interventions

Placebo DRUG

Part 1: Placebo Comparator tablet for once daily oral use

Part 1 - Arm 2 - Placebo

Deucrictibant DRUG

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

Part 1 - Arm 1 - Active

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pharvaris Netherlands B.V.: lead

Study Sites (17)

Study Site

Walnut Creek, California, 94598,, United States

RECRUITING

Study Site

Walnut Creek, California, 94598, United States

RECRUITING

Study Site

St Louis, Missouri, 63130, United States

RECRUITING

Study Site

Sofia, Bulgaria

RECRUITING

Study Site

Edmonton, Canada

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 List

Milan, Italy

RECRUITING

Study Site

Basel, Switzerland

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

MeSH Terms

Conditions

Angioedemas, Hereditary; Angioedema; Acquired angioedema

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hereditary Complement Deficiency Diseases; Primary Immunodeficiency Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Immunologic Deficiency Syndromes

Study Officials

• Study Director, Pharvaris

  Pharvaris Netherlands B.V.

  STUDY DIRECTOR

Central Study Contacts

Pharvaris Clinical Team

CONTACT

0031-712-036-410; clinicaltrials@pharvaris.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part 1 is parallel Part 2 is crossover Part 3 is single group

Study Record Dates

• First Submitted: October 20, 2025
• First Posted: December 5, 2025
• Study Start: October 16, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 7, 2026

Record last verified: 2026-05

Locations

US (3); GB (5); CA (1); FR (1); CH (1); IT (1); DE (3); BU (1); HU (1)