Recruiting
Phase 3

Deucrictibant

Sponsor:

Pharvaris Netherlands B.V.

Code:

NCT07266805

Conditions

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

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Deucrictibant

Placebo

Deucrictibant

Placebo

Deucrictibant

Study Details

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)

Study ID

NCT07266805

Start date

Oct 16, 2025

Status verified date

Jun, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1 - Arm 1 - Active

placebo comparator: Part 1 - Arm 2 - Placebo

experimental: Part 2 - Arm 1

experimental: Part 2 - Arm 2

experimental: Part 3 - Open-label

Interventions

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

Primary outcome measure

  • Part 1 (Prophylaxis, Double-blind Treatment Phase) [ Time Frame: 12 weeks ]
  • Part 2 (On-demand, Double-blind Treatment Phase) [ Time Frame: 12 hours post-treatment ]
  • Part 3 (On-demand, Open-label Extension Treatment Phase) [ Time Frame: Through study completion, an average of 36 weeks ]

Central Contacts and Locations

Central contacts

Locations

Study Site

Recruiting

San Diego, California, United States, 92093

Study Site

Recruiting

Walnut Creek, California, United States, 94598,

Study Site

Recruiting

St Louis, Missouri, United States, 63130

Study Site

Recruiting

Hershey, Pennsylvania, United States, 17033

Study Site

Recruiting

Edmonton, Canada

More Information

Sponsor

Pharvaris Netherlands B.V.

Last update posted

Jun 29, 2026

Last verified

Jun, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Pharvaris Netherlands B.V. on 2026-06-29.