Study of Oral Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults With HAE (CHAPTER-3)

February 12, 2026 updated by: Pharvaris Netherlands B.V.

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Orally Administered Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of once-daily orally administered deucrictibant extended-release tablet compared to placebo for prophylaxis to prevent angioedema attacks in participants aged ≥ 12 years with hereditary angioedema.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study consists of a Screening Period during which eligibility is confirmed, a Treatment Period of 24 weeks, and a Follow-up Period of maximum 4 weeks or subjects may roll over into the open-label study PHA022121-C307 (CHAPTER-4). During the Treatment period participants will receive blinded study drug (deucrictibant or placebo randomized in a 2:1 ratio). Participants will undergo regular efficacy and safety assessments, complete an electronic diary daily, and also complete questionnaires at predefined timepoints during the study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
81

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Argentina
      • Corrientes, Argentina
        • Study Site
      • San Martín, Argentina
        • Study Site
  • Brazil
      • Santo André, Brazil
        • Study Site
  • Bulgaria
      • Sofia, Bulgaria, 1431
        • Study Site
      • Sofia, Bulgaria, 1680
        • Study Site
  • Canada
      • Edmonton, Canada
        • Study Site
      • Ottawa, Canada
        • Study Site
  • France
      • Grenoble, France
        • Study Site
      • Lille, France, 59037
        • Study Site
  • Germany
      • Berlin, Germany
        • Study Site
      • Frankfurt, Germany
        • Study Site
      • Hanover, Germany
        • Study Site
  • Hong Kong
      • Hong Kong, Hong Kong
        • Study Site
  • Hungary
      • Budapest, Hungary
        • Study Site
  • Ireland
      • Dublin, Ireland
        • Study Site
  • Italy
      • Milan, Italy, 20062
        • Study Site
      • Padua, Italy
        • Study Site
  • Japan
      • Kawasaki, Japan
        • Study Site
      • Tokyo, Japan, 113-0033
        • Study Site
      • Tokyo, Japan, 1130033
        • Study Site
  • New Zealand
      • Auckland, New Zealand
        • Study Site
  • Poland
      • Krakow, Poland
        • Study Site
  • Puerto Rico
      • San Juan, Puerto Rico
        • Study Site
  • Romania
      • Sângeorgiu de Mureş, Romania
        • Study Site
  • Singapore
      • Singapore, Singapore
        • Study Site
  • Slovakia
      • Martin, Slovakia
        • Study Site
  • South Africa
      • Cape Town, South Africa
        • Study Site
  • South Korea
      • Daegu, South Korea
        • Study Site
      • Seoul, South Korea, 06351
        • Study Site
      • Seoul, South Korea
        • Study Site
      • Suwon, South Korea
        • Study Site
  • Spain
      • Barcelona, Spain, 08907
        • Study Site
      • Barcelona, Spain, 08013
        • Study Site
      • Seville, Spain
        • Study Site
  • Switzerland
      • Basel, Switzerland
        • Study Site
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye)
        • Study Site
      • Istanbul, Turkey (Türkiye)
        • Study Site
      • Izmir, Turkey (Türkiye)
        • Study Site
  • United Kingdom
      • Birmingham, United Kingdom, B18 7QH
        • Study Site
      • Birmingham, United Kingdom, B9 5SS
        • Study Site
      • Bristol, United Kingdom, BS10 5NB
        • Study Site
      • Cambridge, United Kingdom, CB2 0QQ
        • Study Site
      • Frimley, United Kingdom, GU16 7UJ
        • Study Site
      • Leeds, United Kingdom, LS9 7TF
        • Study Site
      • London, United Kingdom, NW3 2QG
        • Study Site
      • Oxford, United Kingdom
        • Study Site
      • Plymouth, United Kingdom, PL6 5FP
        • Study Site
      • Southampton, United Kingdom
        • Study Site
      • Stoke, United Kingdom
        • Study Site
    • England
      • London, England, United Kingdom, E1 1FR
        • Study Site
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Study Site
    • California
      • San Diego, California, United States, 92122
        • Study Site
      • Santa Monica, California, United States, 90404
        • Study Site
      • Walnut Creek, California, United States, 94598
        • Study Site
    • Maryland
      • Chevy Chase, Maryland, United States, 20915
        • Study Site
    • Missouri
      • St Louis, Missouri, United States, 63141
        • Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Provision of written informed consent/assent.
  2. Male or female, aged ≥12 years at the time of providing written informed consent/assent.
  3. Diagnosis of hereditary angioedema (HAE)
  4. History of at least 3 HAE attacks within the 3 consecutive months prior to Screening Visit
  5. Predefined number of attacks during the Screening Period
  6. Reliable access and ability to use standard of care on-demand treatments to effectively manage acute HAE attacks.
  7. Willing and able to adhere to all protocol requirements, including eDiary and ePRO data recording.
  8. Female participants of childbearing potential must agree to the protocol specified pregnancy testing and contraception methods.

Exclusion Criteria:

  1. Any diagnosis of angioedema other than HAE
  2. 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 Screening (whichever is longer)
  3. Has received prior prophylactic treatment with deucrictibant
  4. Exposure to ACE inhibitors or any estrogen-containing medications with systemic absorption within 4 weeks of Screening
  5. Prior gene therapy for any indication at any time
  6. Use of prophylactic treatment for HAE within 2 weeks of Screening for C1INH, oral kallikrein inhibitors, or anti-fibrinolytics; within 4 weeks of Screening for attenuated androgens; within 5 half-lives of Screening for monoclonal antibodies, or within 7 days of Screening for short-term prophylaxis
  7. Any females who are pregnant, plan to become pregnant, or are currently breast-feeding
  8. Abnormal hepatic function
  9. Moderate or severe renal impairment
  10. Any clinically significant comorbidity or systemic dysfunction that would interfere with the participant's safety or ability to participate in the study.
  11. History of alcohol or drug abuse within the previous year, or current evidence of substance dependence or abuse
  12. Use of medications that are moderate and strong inhibitors or strong inducers of CYP3A4 within the last 30 days or within 5 half-lives (whichever is longer) of the time of randomization
  13. Known hypersensitivity to deucrictibant or any of the excipients of the study drug

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Active
Deucrictibant 40mg extended-release tablet by mouth once daily
Drug: Deucrictibant
Deucrictibant 40mg extended-release tablet for once daily oral use
Experimental: Placebo
Placebo 1 tablet by mouth once daily
Drug: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Time-normalized (per 4 weeks) number of Investigator-confirmed HAE attacks during the 24-week Treatment Period
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time-normalized number of Investigator-confirmed HAE attacks treated with on-demand medication during the 24-week Treatment Period
Time Frame: 24 weeks
24 weeks
Time-normalized number of Investigator-confirmed moderate or severe HAE attacks during the 24-week Treatment Period
Time Frame: 24 weeks
24 weeks
Time-normalized number of Investigator-confirmed severe HAE attacks during the 24-week Treatment Period
Time Frame: 24 weeks
24 weeks
Proportion of participants achieving ≥50% reduction in HAE attack rate relative to baseline during the 24-week Treatment Period
Time Frame: 24 weeks
24 weeks
Proportion of participants achieving ≥70% reduction in HAE attack rate relative to baseline during the 24-week Treatment Period
Time Frame: 24 weeks
24 weeks
Proportion of participants achieving ≥90% reduction in HAE attack rate relative to baseline during the 24-week Treatment Period
Time Frame: 24 weeks
24 weeks
Proportion of participants that are HAE attack-free during the 24-week Treatment Period
Time Frame: 24 weeks
24 weeks
Proportion of time without angioedema symptoms during the 24-week Treatment Period
Time Frame: 24 weeks
24 weeks
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), and TEAEs leading to study drug discontinuation
Time Frame: Up to 38 weeks
Up to 38 weeks
Pharmacokinetics [PK]: Deucrictibant plasma concentration time profiles
Time Frame: 24 weeks
24 weeks
Patient reported outcome: Angioedema Quality of Life (AE-QoL) questionnaire
Time Frame: 24 weeks
The AE-QoL is a short 17-item questionnaire designed to retrospectively assess HRQoL, with a recall period of 4 weeks. Its results can be displayed as a total score or as 4 domain scores. The scores range from 0 to 100, after linear transformation of raw values, with higher scores indicating higher HRQoL impairment.
24 weeks
Patient reported outcome: Patient Global Assessment of Change (PGA-Change)
Time Frame: 24 weeks
PGA-Change assesses on a 5-point scale how the participant's QoL has been impacted by HAE since start taking the study drug
24 weeks
Patient reported outcome: Angioedema Control Test 4-week version (AECT-4wk)
Time Frame: 24 weeks
AECT-4wk measures disease control retrospectively, it comprises 4 questions over a 4-week recall period. Scores for the responses in the AECT range from 0 to 16, with higher scores indicating better disease control (≤ 9 poorly controlled; ≥ 10 well controlled)
24 weeks
Patient reported outcome: Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP)
Time Frame: Up to 34 weeks
WPAI-SHP is a questionnaire assessing how a health condition impacts a person's ability to work and do regular activities and it includes 4 domains. Scores indicate the percentage of time the patient missed work or was less productive owing to HAE-related complications.
Up to 34 weeks
Patient reported outcome: Abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9)
Time Frame: Up to 34 weeks
TSQM-9 is a 9-item questionnaire evaluating patient treatment satisfaction and it includes 3 domains. Scoring is by domain and each domain score is computed by summing the individual TSQM items in each domain and then transforming the composite score into a value ranging from 0 to 100, with higher scores indicating higher satisfaction.
Up to 34 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pharvaris Netherlands B.V.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Study Director, Pharvaris, Pharvaris Netherlands B.V.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 24, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 1, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PHA022121-C305

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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