Study of Oral Deucrictibant Soft Capsule for On-Demand Treatment of Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema (RAPIDe-3)

November 20, 2025 updated by: Pharvaris Netherlands B.V.

A Phase 3, Randomized, Double-blind, Placebo-controlled, Cross-over Study of Oral Deucrictibant Soft Capsule for On-Demand Treatment of Attacks in Adolescents and Adults With Hereditary Angioedema

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, 2-period, 2-treatment cross-over study to evaluate the efficacy and safety of orally administered deucrictibant compared to placebo for the on-demand treatment of HAE attacks, including non-severe laryngeal attacks, in participants ≥12 to ≤75 years of age with HAE type 1, type 2, or type 3, a proportion of whom are using long-term prophylactic medication for HAE.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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 Phase during which eligibility is confirmed, a Treatment Phase in which participants will be randomized and receive double blinded study drug to treat 2 qualifying HAE attacks (i.e., 2 Treatment Periods within the Treatment Phase), and an End-of-Study Follow-up Phase after the second attack treated with study drug. In addition, for adolescent participants (age ≥12 to <18 years), PK samples are collected after administration of deucrictibant at Day 1 in a non-attack state.

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 (Actual)

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.
134

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
      • Buenos Aires, Argentina, B1629AHJ
        • Study Site
      • Salta, Argentina, 4400
        • Study Site
  • Australia
      • Box Hill, Australia, 3128
        • Study Site
    • New South Wales
      • Campbelltown, New South Wales, Australia, 2560
        • Study Site
  • Austria
      • Graz, Austria, 8036
        • Study Site
      • Linz, Austria, 4021
        • Study Site
      • Vienna, Austria, 1090
        • Study Site
  • Brazil
      • Paraná, Brazil, 80810-100
        • Study Site
      • Ribeirão Preto, Brazil, 14048-900
        • Study Site
      • Salvador, Brazil, 41950-640
        • Study Site
      • Santo André, Brazil, 09060-870
        • Study Site
      • São Paulo, Brazil, 05403-000
        • Study Site
  • Bulgaria
      • Sofia, Bulgaria, 1431
        • Study Site
      • Sofia, Bulgaria, 1680
        • Study Site
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z1
        • Study Site
  • Colombia
      • Bogotá, Colombia, 00
        • Study Site
      • Bogotá, Colombia, 111221
        • Study Site
      • Bogotá, Colombia, 111711
        • Study Site
      • Medellín, Colombia, 050021
        • Study Site
  • Czechia
      • Brno, Czechia, 602 00
        • Study Site
  • France
      • Lille, France, 59037
        • Study Site
      • Paris, France, 75571
        • Study Site
  • Germany
      • Berlin, Germany, 12203
        • Study Site
      • Frankfurt am Main, Germany, 60596
        • Study Site
      • Frankfurt am Main, Germany, 60590
        • Study Site
      • Lübeck, Germany, 23538
        • Study Site
  • Hong Kong
      • Hong Kong, Hong Kong
        • Study Site
  • Hungary
      • Budapest, Hungary, 1088
        • Study Site
  • Ireland
      • Dublin, Ireland, D08 A978
        • Study Site
  • Italy
      • Catania, Italy, 95124
        • Study Site
      • Milan, Italy, 20097
        • Study Site
      • Milan, Italy, 20138
        • Study Site
      • Padua, Italy, 35128
        • Study Site
      • Palermo, Italy, 90146
        • Study Site
      • Roma, Italy, 00133
        • Study Site
  • Japan
      • Chiba, Japan, 260-8677
        • Study Site
      • Hiroshima, Japan, 730-8518
        • Study Site
      • Kanagawa, Japan, 216-8511
        • Study Site
      • Osaka, Japan, 569-8686
        • Study Site
      • Tokyo, Japan, 113-8431
        • Study Site
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Study Site
  • North Macedonia
      • Skopje, North Macedonia, 1000
        • Study Site
  • Poland
      • Krakow, Poland, 31-503
        • Study Site
  • Puerto Rico
      • San Juan, Puerto Rico, 00918
        • Study Site
      • San Juan, Puerto Rico, 00927
        • Study Site
  • Romania
      • Sângeorgiu de Mureş, Romania, 547530
        • Study Site
  • Saudi Arabia
      • Riyadh, Saudi Arabia, 11471
        • Study Site
  • Singapore
      • Singapore, Singapore, 308433
        • Study Site
  • South Africa
      • Cape Town, South Africa, 7700
        • Study Site
  • South Korea
      • Daegu, South Korea, 41944
        • Study Site
      • Seoul, South Korea, 03080
        • Study Site
  • Spain
      • Barcelona, Spain, 08035
        • Study Site
      • Barcelona, Spain, 08907
        • Study Site
  • Sweden
      • Lund, Sweden, 22185
        • Study Site
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06203
        • Study Site
      • Istanbul, Turkey (Türkiye), 34093
        • Study Site
      • Izmir, Turkey (Türkiye), 35100
        • Study Site
  • United Kingdom
      • Bristol, United Kingdom, BS10 5NB
        • Study Site
      • Camberley, United Kingdom, GU16 7UJ
        • Study Site
      • Cambridge, United Kingdom, CB2 0QQ
        • Study Site
      • Leeds, United Kingdom, LS9 7TF
        • Study Site
      • London, United Kingdom, E1 2ES
        • Study Site
      • Plymouth, United Kingdom, PL6 8DH
        • Study Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Study Site
    • Arizona
      • Paradise Valley, Arizona, United States, 85258
        • Study Site
    • 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
    • Colorado
      • Colorado Springs, Colorado, United States, 80907-6231
        • Study Site
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Study Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Study Site
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Study Site
    • Missouri
      • St Louis, Missouri, United States, 63141
        • Study Site
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Study Site
    • Texas
      • Dallas, Texas, United States, 75231
        • 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 to ≤75 years at the time of providing written informed consent/assent.
  3. Diagnosis of HAE-1/2/3.
  4. History of at least 2 HAE attacks in the last 3 months before screening.
  5. Experience with using standard-of-care treatment to effectively manage on-demand treatment for HAE attacks.
  6. Participants on long-term prophylactic therapy with plasma-derived C1-INH (danazol, anti-fibrinolytics, berotralstat, or lanadelumab) must be on a stable dose and regimen and intend to remain on the same dose for 6 months before screening and the duration of the study. OR, Participant has stopped using plasma-derived C1-INH (danazol, anti-fibrinolytics, berotralstat) at least 2 weeks or lanadelumab at least 10 weeks before screening.
  7. Capable of recording, without assistance, electronic HAE diary and ePRO data using an electronic device.
  8. For adolescent participants aged ≥12 and <18 years of age: body weight ≥40 kg.
  9. Female participants of childbearing potential must agree to the protocol specified pregnancy testing and contraception methods.

Exclusion Criteria:

  1. Any female who is pregnant, plans to become pregnant, or is breastfeeding.
  2. Any diagnosis of angioedema other than HAE.
  3. Any clinically significant comorbidity or systemic dysfunction that would interfere with the participant's safety or ability to participate in the study.
  4. Use of attenuated androgens for short-term prophylaxis within 2 weeks before screening.
  5. Abnormal hepatic function.
  6. Abnormal renal function (eGFR <60 ml/min/1.73 m2).
  7. History of alcohol or drug abuse within the previous year, or current evidence of substance dependence or abuse.
  8. Has received prior on-demand HAE treatment with deucrictibant.
  9. Currently participating in any other investigational drug study or receiving other investigational treatment within the last 30 days, or within 5 half-lives (whichever is longer) of the time of randomization.
  10. Prior gene therapy for any indication at any time.
  11. Use of concomitant medications with systemic absorption that are strong inhibitors of CYP3A4 or strong inducers of CYP3A4 within the last 30 days, or within 5 half-lives (whichever is longer) of the time of randomization.
  12. Known hypersensitivity to study drug or any of the excipients of 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: Crossover 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: Arm 1
Deucrictibant administered for first HAE attack, placebo administered for second HAE attack.
Drug: Deucrictibant, Placebo
Deucrictibant Soft Capsules for Oral Use
Experimental: Arm 2
Placebo administered for first HAE attack, deucrictibant administered for second HAE attack.
Drug: Deucrictibant, Placebo
Deucrictibant Soft Capsules for Oral Use

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
Measure Description
Time Frame
Time to onset of symptom relief, defined as Patient Global Impression of Change (PGI-C) rating of at least "a little better" for 2 consecutive timepoints within 12 hours post-treatment.
Time Frame: Pre-treatment to 12 hours post-treatment.
The PGI-C (7-point scale) is used to evaluate the change in the HAE attack symptoms as compared to pre-treatment.
Pre-treatment to 12 hours post-treatment.

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
Proportion of study drug-treated attacks achieving PGI-C rating of at least "a little better" at 4 hours post-treatment.
Time Frame: Pre-treatment to 4 hours post-treatment.
The PGI-C (7-point scale) is used to evaluate the change in the HAE attack symptoms as compared to pre-treatment.
Pre-treatment to 4 hours post-treatment.
Time to substantial symptom relief, defined as achieving PGI-C rating of at least "better" for 2 consecutive timepoints within 12 hours post-treatment.
Time Frame: Pre-treatment to 12 hours post-treatment.
The PGI-C (7-point scale) is used to evaluate the change in the HAE attack symptoms as compared to pre-treatment.
Pre-treatment to 12 hours post-treatment.
Time to substantial symptom relief by Patient Global Impression of Severity (PGI-S).
Time Frame: Pre-treatment to 12 hours post-treatment.
Defined as achieving ≥1 point reduction in PGI-S (5-point scale) from pre-treatment for 2 consecutive timepoints within 12 hours post-treatment.
Pre-treatment to 12 hours post-treatment.
Time to complete symptom resolution, defined as achieving PGI-S rating of "none" within 48 hours post-treatment.
Time Frame: Pre-treatment to 48 hours post-treatment.
The PGI-S (5-point scale) is used to evaluate the severity of HAE attack symptoms.
Pre-treatment to 48 hours post-treatment.
Time to End of Progression (EoP) in attack symptoms within 12 hours.
Time Frame: Pre-treatment to 12 hours post-treatment.
EoP time defined as the earliest post-treatment timepoint after which all subsequent PGI-C ratings are stable or improved.
Pre-treatment to 12 hours post-treatment.
Proportion of study drug-treated attacks requiring rescue medication within 24 hours post-treatment.
Time Frame: Pre-treatment to 24 hours post-treatment.
Rescue medication is defined as the participant's usual acute on-demand HAE treatment taken if symptoms persist or progress after study drug administration.
Pre-treatment to 24 hours post-treatment.
Proportion of attacks achieving symptom resolution.
Time Frame: Pre-treatment to 24 hours post-treatment.
Defined as achieving PGI-S rating of "none" with one dose of study drug at 24 hours post-treatment.
Pre-treatment to 24 hours post-treatment.
Time to substantial symptom relief by Angioedema Symptom Rating Scale (AMRA).
Time Frame: Pre-treatment to 12 hours post-treatment.
Defined as a ≥50% reduction in AMRA composite score from pre-treatment for 2 consecutive timepoints within 12 hours post-treatment.
Pre-treatment to 12 hours post-treatment.
Time to almost complete or complete symptom relief by AMRA.
Time Frame: Pre-treatment to 24 hours post-treatment.
Defined as all item scores in AMRA having a value ≤10 for 2 consecutive timepoints within 24 hours post-treatment.
Pre-treatment to 24 hours post-treatment.
Proportion of study drug-treated attacks reaching almost complete or complete symptom relief by AMRA.
Time Frame: Pre-treatment to 24 hours post-treatment.
Defined as all item scores in AMRA having a value ≤10 at 24 hours post-treatment.
Pre-treatment to 24 hours post-treatment.
Time to EoP in attack symptoms within 12 hours.
Time Frame: Pre-treatment to 12 hours post-treatment.
Defined as the earliest post-treatment timepoint after which every individual AMRA item is stable or improved at all subsequent timepoints.
Pre-treatment to 12 hours post-treatment.

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.
February 26, 2024

Primary Completion (Actual)

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.
October 17, 2025

Study Completion (Actual)

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.
October 17, 2025

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).
March 18, 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.
March 26, 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.
April 3, 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.
November 21, 2025

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.
November 20, 2025

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.
November 1, 2025

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-C306

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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