EAP for Deucrictibant Immediate-release

NCT07759141 | Unknown

• 1 other identifier: EAP-01
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is an expanded access program (EAP) designed to allow access to deucrictibant immediate-release (IR) capsule for eligible participants with hereditary angioedema (HAE) in the United States (US) and US territories who lack satisfactory alternative treatment options for on-demand treatment of HAE attacks, as determined by their treating physician.

Conditions

Hereditary Angioedema

Keywords

Angioedema; Hereditary Angioedema; HAE; Deucrictibant; Deucrictibant immediate-release; Bradykinin; Bradykinin B2 receptor; Hereditary angioedema with C1 inhibitor deficiency/dysfunction; HAE-C1INH; Hereditary angioedema with normal C1 inhibitor; HAE-nC1INH

Interventions

Deucrictibant IR DRUG

Deucrictibant IR capsule administered orally.

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of informed consent: Participants must provide written informed consent. Adolescents (≥12 to \<18 years old, or as per local law) require consent of parent or legally designated representative/guardian and must assent. If an adolescent reaches adulthood during the EAP, they must sign the adult informed consent form (ICF) to remain in the EAP.
• Male or female, aged ≥12 to ≤75 years at the time of providing written informed consent/assent.
• Confirmed diagnosis of HAE.
• for participants with hereditary angioedema with normal C1 inhibitor (HAE-nC1INH): documented genetic mutation associated with HAE-nC1INH
• if no documented mutation:
• clinical diagnosis with family history of HAE-nC1INH,
• attacks not responding to treatment with high-dose antihistamine (cetirizine 40 milligrams \[mg\]/day or equivalent high-dose second-generation antihistamine medication) and no clinical attack symptom relief if treated with corticosteroid, montelukast, and/or omalizumab.
• documented effective attack symptom relief with on-demand icatibant treatment
• No satisfactory treatment options are available among currently approved HAE therapies for treatment of acute attacks ((i.e. Berinert (C1 esterase inhibitor \[human\]), Ekterly (sebetralstat), Firazyr (icatibant), Kalbitor (ecallantide), Ruconest (C1 esterase inhibitor \[recombinant\])) based on inadequate response, contraindication, safety/tolerability concerns, and/or other reasons, as documented by the treating physician in the participant's medical records and maintained as part of the EAP enrollment documentation.
• Not eligible for an ongoing clinical study or for whom participation in a clinical study is not possible or feasible for other reasons, including but not limited to clinical study eligibility criteria, geographic accessibility, study availability, timing considerations, participant decision to participate, or other participant-specific factors, as documented by the treating physician in the participant's medical records and maintained as part of the EAP enrollment documentation.
• Residence in the US or US territories.

You may not qualify if:

• Pregnancy or nursing: any female participant who is pregnant, planning to become pregnant during the EAP, or currently breastfeeding.
• Any diagnosis of angioedema other than HAE.
• Significant comorbidity: any clinically significant comorbidity or systemic dysfunction (e.g., cardiovascular, gastrointestinal, renal, neurologic, respiratory) that, in the opinion of the treating physician, would interfere with the participant's safety or ability to participate in this EAP.
• Severe hepatic impairment (Child-Pugh Class C).
• Substance abuse: history of alcohol or drug abuse within the past year, or current evidence of substance dependence or abuse.
• Prior treatment with deucrictibant IR resulting in discontinuation due to lack of efficacy, safety concerns, or tolerability issues.
• Participation in another investigational drug study, or treatment with any investigational drug within 30 days or 5 half-lives (whichever is longer) prior to enrolment.
• Prior gene therapy use for any indication at any time.
• Current use of medications with systemic absorption that are strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, ketoconazole, ritonavir) or strong CYP3A4 inducers (e.g., carbamazepine, phenytoin) within 30 days (or 5 half-lives, whichever longer) prior to enrolment.

Sponsors & Collaborators

• Pharvaris Netherlands B.V.: lead

MeSH Terms

Conditions

Angioedemas, Hereditary; 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

Central Study Contacts

Pharvaris Medical Affairs

CONTACT

+1 267 841 5106; expandedaccess@pharvaris.com

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 12, 2026
• Last Updated: August 12, 2026

Record last verified: 2026-08