Study of Oral Deucrictibant XR Tablet for Prophylaxis and Deucrictibant Soft Capsule for On-Demand Treatment of Angioedema Attacks in Adults With Acquired Angioedema Due to C1 Inhibitor Deficiency (CREAATE)

September 16, 2026 updated by: Pharvaris Netherlands B.V.

A Phase 3, Randomized, Double-blind, Placebo-controlled, 3-Part Study to Evaluate the Efficacy and Safety of Orally Administered Deucrictibant XR Tablet for Prophylaxis and Deucrictibant Soft Capsule for On-demand Treatment of Angioedema Attacks in Adults With Acquired Angioedema Due to C1 Inhibitor Deficiency

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 soft capsule for on-demand treatment of angioedema attacks in adult participants aged ≥ 18 years with AAE-C1INH.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
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 Part 1 Prophylaxis Double-blind Treatment Phase, a Part 2 On-demand, Double-blind Treatment Phase, and a Part 3 On-demand Open-label Extension Phase. Approximately 24 participants will be randomized in Part 1 into 2 parallel arms for a treatment period of 12 weeks. During the prophylaxis treatment period participants will receive blinded study drug (deucrictibant 40 mg XR or placebo randomized in a 1:1 ratio). Upon completion of Part 1, participants will roll-over into Part 2. In addition to rollover participants completing Part 1, new deucrictibant treatment-naïve participants will be enrolled directly into Part 2 and this may occur while Part 1 is ongoing. During the on-demand period participants will receive blinded study drug (deucrictibant 20 mg soft capsule or matching placebo randomized in a 1:1 ratio, 2-period, 2-treatment crossover design) for 2 qualifying AAE-C1INH attacks. Participants completing Part 2 may roll over into Part 3 where all AAE-C1INH attacks will be treated with open-label deucrictibant 20 mg soft capsule.

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.
48

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

  • Australia
      • Clayton, Australia
        • Recruiting
        • Study Site
  • Austria
      • Vienna, Austria
        • Recruiting
        • Study Site
  • Bulgaria
      • Sofia, Bulgaria
        • Recruiting
        • Study Site
  • Canada
      • Edmonton, Canada
        • Recruiting
        • Study Site
  • France
      • Grenoble, France
        • Recruiting
        • Study Site
      • Lille, France
        • Recruiting
        • Study Site
      • Paris, France
        • Recruiting
        • Study Site
  • Germany
      • Berlin, Germany
        • Recruiting
        • Study Site
      • Frankfurt am Main, Germany
        • Recruiting
        • Study Site
      • Munich, Germany
        • Recruiting
        • Study Site
  • Hungary
      • Budapest, Hungary
        • Recruiting
        • Study Site
  • Italy
      • Milan, Italy
        • Recruiting
        • Study Site 1
      • Milan, Italy
        • Recruiting
        • Study Site 2
      • Milan, Italy
        • Recruiting
        • Study Site 3
      • Padova, Italy
        • Recruiting
        • Study Site
      • Roma, Italy
        • Recruiting
        • Study Site
  • Netherlands
      • Amsterdam, Netherlands
        • Recruiting
        • Study Site
  • New Zealand
      • Auckland, New Zealand
        • Recruiting
        • Study Site
  • Poland
      • Krakow, Poland
        • Recruiting
        • Study Site
  • Spain
      • Madrid, Spain
        • Recruiting
        • Study Site
  • Switzerland
      • Basel, Switzerland
        • Recruiting
        • Study Site
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye)
        • Recruiting
        • Study Site
  • United Kingdom
      • Bristol, United Kingdom
        • 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
        • Study Site
  • United States
    • California
      • San Diego, California, United States, 92093
        • Recruiting
        • Study Site
      • Walnut Creek, California, United States, 94598,
        • Recruiting
        • Study Site
    • Missouri
      • St Louis, Missouri, United States, 63130
        • Recruiting
        • Study Site
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Recruiting
        • 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.
  • If underlying disease associated with AAE is present, the underlying disease must be stable throughout the duration of part 1.
  • 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 (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).
  • Receiving long-term prophylaxis (LTP) treatment for AAE-C1INH and satisfied with this treatment. Participants who are not satisfied (eg, tolerability issues, lack of efficacy) and have previously stopped LTP treatment for AAE-C1INH, for reasons other than participation in this study, can sign the ICF and begin the Screening Period only if their 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 (ACE) inhibitors or any estrogen-containing medications with systemic absorption within 5 half-lives before the Screening Visit

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: Part 1 - Arm 1 - Active
Drug: Deucrictibant

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

Drug: Deucrictibant

Part 2: Deucrictibant 20 mg soft capsule oral use

Drug: Deucrictibant

Part 3: Deucrictibant 20 mg soft capsule oral use
Placebo Comparator: Part 1 - Arm 2 - Placebo
Drug: Placebo

Part 1: Placebo Comparator tablet for once daily oral use

Drug: Placebo

Part 2: Placebo Comparator soft capsule oral use
Experimental: Part 2 - Arm 1
Drug: Deucrictibant

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

Drug: Deucrictibant

Part 2: Deucrictibant 20 mg soft capsule oral use

Drug: Deucrictibant

Part 3: Deucrictibant 20 mg soft capsule oral use

Drug: Placebo

Part 1: Placebo Comparator tablet for once daily oral use

Drug: Placebo

Part 2: Placebo Comparator soft capsule oral use
Experimental: Part 2 - Arm 2
Drug: Deucrictibant

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

Drug: Deucrictibant

Part 2: Deucrictibant 20 mg soft capsule oral use

Drug: Deucrictibant

Part 3: Deucrictibant 20 mg soft capsule oral use

Drug: Placebo

Part 1: Placebo Comparator tablet for once daily oral use

Drug: Placebo

Part 2: Placebo Comparator soft capsule oral use
Experimental: Part 3 - Open-label
Drug: Deucrictibant

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

Drug: Deucrictibant

Part 2: Deucrictibant 20 mg soft capsule oral use

Drug: Deucrictibant

Part 3: Deucrictibant 20 mg soft capsule 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
Time Frame
Part 1: Time-normalized number of Investigator-confirmed AAE-C1INH attacks during Treatment Phase
Time Frame: 12 weeks
12 weeks
Part 2: Time to symptom relief, Patient Global Impression of Change (PGI-C) rating of at least "better"
Time Frame: 12 hours post-treatment
12 hours post-treatment
Part 3: Incidence of treatment-emergent adverse events (TEAEs), treatment-emergent adverse events of special interest (AESIs), and serious adverse events (SAEs)
Time Frame: Through study termination, an average of 36 weeks
Through study termination, an average of 36 weeks
Part 3: Number of participants with clinically significant changes from baseline in Hematology parameters
Time Frame: Through study termination, an average of 36 weeks
Through study termination, an average of 36 weeks
Part 3: Number of participants with clinically significant changes from baseline in Urinalysis parameters
Time Frame: Through study termination, an average of 36 weeks
Through study termination, an average of 36 weeks
Part 3: Number of participants with clinically significant changes from baseline in Biochemistry parameters
Time Frame: Through study termination, an average of 36 weeks
Through study termination, an average of 36 weeks
Part 3: Number of participants with clinically significant changes from baseline in vital signs
Time Frame: Through study termination, an average of 36 weeks
Through study termination, an average of 36 weeks
Part 3: Number of participants with clinically significant changes from baseline in physical examinations
Time Frame: Through study termination, an average of 36 weeks
Through study termination, an average of 36 weeks
Part 3: Number of participants with clinically significant changes in electrocardiogram (ECG)
Time Frame: Through study termination, an average of 36 weeks
Through study termination, an average of 36 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
Part 1: Proportion of participants who are AAE-C1INH attack-free during Treatment Phase
Time Frame: 12 weeks
12 weeks
Part 1: Time-normalized number of Investigator-confirmed AAE-C1INH attacks treated with on-demand medication during Treatment Phase
Time Frame: 12 weeks
12 weeks
Part 1: Time-normalized number of Investigator-confirmed moderate or severe AAE-C1INH attacks during Treatment Phase
Time Frame: 12 weeks
12 weeks
Part 1: Time-normalized number of Investigator-confirmed severe AAE-C1INH attacks during Treatment Phase
Time Frame: 12 weeks
12 weeks
Part 1: Proportion of participants achieving ≥50%, ≥70% and ≥90% reduction in AAE-C1NH attack rate relative to baseline during Treatment Phase
Time Frame: 12 weeks
12 weeks
Part 1: Incidence of TEAEs, treatment-emergent AESIs, and SAEs
Time Frame: 12 weeks
12 weeks
Part 1: Number of participants with clinically significant changes from baseline in Hematology parameters
Time Frame: 12 weeks
12 weeks
Part 1: Number of participants with clinically significant changes from baseline in Urinalysis parameters
Time Frame: 12 weeks
12 weeks
Part 1: Number of participants with clinically significant changes from baseline in Biochemistry parameters
Time Frame: 12 weeks
12 weeks
Part 1: Number of participants with clinically significant changes from baseline in Vital signs
Time Frame: 12 weeks
12 weeks
Part 1: Number of participants with clinically significant changes from baseline in physical examination
Time Frame: 12 weeks
12 weeks
Part 1: Number of participants with clinically significant changes from baseline in ECG parameters
Time Frame: 12 weeks
12 weeks
Part 1: Pre-dose plasma concentrations of Deucrictibant
Time Frame: At Weeks 6 and 12

Deucrictibant plasma concentrations will be analyzed using liquid chromatography-mass spectrometry/mass spectrometry methods
At Weeks 6 and 12
Part 1: Pre-dose plasma concentrations of deucrictibant metabolites
Time Frame: At Weeks 6 and 12

Deucrictibant metabolites plasma concentrations will be analyzed using liquid chromatography-mass spectrometry/mass spectrometry methods
At Weeks 6 and 12
Part 1: Pharmacokinetics [PK]: Urine concentrations of Deucrictibant and deucrictibant metabolites
Time Frame: At Week 12
At Week 12
Part 1: Change from baseline in Angioedema Quality of Life (AE-QoL) questionnaire total score, functioning domain score, and fears/shame domain score
Time Frame: Baseline (Day 1) and at Weeks 4, 8 and 12

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.
Baseline (Day 1) and at Weeks 4, 8 and 12
Part 1: Change from baseline in Angioedema Control Test 4-week version (AECT-4wk)
Time Frame: Baseline (Day 1) and at Week 12

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)
Baseline (Day 1) and at Week 12
Part 1: Patient Global Assessment-Status (PGA-S) at baseline
Time Frame: At Baseline (Day 1)

PGA-Status assesses on a 5-point scale how the participant's QoL has been impacted by AAE-C1INH since start taking the study drug
At Baseline (Day 1)
Part 1: Patient Global Assessment of Change (PGA-Change) at Week 12
Time Frame: At Week 12

PGA-Change assesses on a 5-point scale how the participant's QoL has been impacted by AAE-C1INH since start taking the study drug
At Week 12
Part 1: Change from baseline in EuroQol 5 Dimension 5 level (EQ 5D 5L)
Time Frame: Baseline (Day 1) and at Week 12

EQ 5D 5L is a brief, multiattribute, generic, health status measure composed of 5 questions with Likert response options (descriptive system) and a visual analog scale (EQ-VAS). The latter asks patients to rate their own health from 0 to 100 (the worst and best imaginable health, respectively)
Baseline (Day 1) and at Week 12
Part 2: Time to complete symptom resolution, Patient Global Impression of Severity (PGI-S) rating of "no symptoms
Time Frame: sustained within 24 hours post-treatment
sustained within 24 hours post-treatment
Part 2: Time to symptom relief defined as PGI-S rating of at least 1 point reduction
Time Frame: 12 hours post-treatment
12 hours post-treatment
Part 2: Proportion of study drug-treated attacks achieving complete symptom resolution defined as achieving PGI- S rating of "no symptoms"
Time Frame: At 24 hours post-treatment
At 24 hours post-treatment
Part 2: Time to onset of symptom relief, defined as PGI-C rating of at least "a little better"
Time Frame: Within 12 hours post-treatment
Within 12 hours post-treatment
Part 2: Time to End of Progression (EoP) in attack symptoms
Time Frame: Within 12 hours post-treatment

EOP is defined as the earliest post-treatment timepoint after which all subsequent PGI-C ratings are stable or improved
Within 12 hours post-treatment
Part 2: Incidence of TEAEs, treatment-emergent AESIs, and SAEs
Time Frame: Up to 24 weeks
Up to 24 weeks
Part 2: Number of participants with clinically significant changes from baseline in Hematology parameters
Time Frame: 24 weeks
24 weeks
Part 2: Number of participants with clinically significant changes from baseline in Urinalysis parameters
Time Frame: 24 weeks
24 weeks
Part 2: Number of participants with clinically significant changes from baseline in Biochemistry parameters
Time Frame: 24 weeks
24 weeks
Part 2: Number of participants with clinically significant changes from baseline in Vital signs
Time Frame: 24 weeks
24 weeks
Part 2: Number of participants with clinically significant changes from baseline in physical examination
Time Frame: 24 weeks
24 weeks
Part 2: Number of participants with clinically significant changes from baseline in ECG parameters
Time Frame: 24 weeks
24 weeks
Part 2: Pharmacokinetics [PK]: Deucrictibant and deucrictibant metabolites plasma concentration-time profiles
Time Frame: Day 1
Day 1
Part 3: Time to symptom relief, as PGI-C rating of at least "better"
Time Frame: 12 hours post-treatment
12 hours post-treatment
Part 3: Time to symptom relief, as PGI-S rating of at least 1 point reduction
Time Frame: 12 hours post-treatment
12 hours post-treatment
Part 3: Proportion of study drug-treated attacks achieving complete symptom resolution, defined as achieving PGI-S rating of "no symptoms"
Time Frame: 24 hours post-treatment
24 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.
October 16, 2025

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.
June 1, 2027

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.
June 1, 2027

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 20, 2025

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.
November 25, 2025

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.
December 5, 2025

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.
September 21, 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.
September 16, 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.
September 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-C308

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

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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