Acquired Angioedema Due to C1-Inhibitor Deficiency (AAE-C1-INH)Phase 3CREAATENCT07266805
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
A Phase 3 study testing Deucrictibant in people with Acquired Angioedema Due to C1-Inhibitor Deficiency (AAE-C1-INH), run by Pharvaris Netherlands B.V. at 32 sites in 16 countries.
Trial 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 soft capsule for on-demand treatment of angioedema attacks in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acquired Angioedema Due to C1-Inhibitor Deficiency (AAE-C1-INH)
- What is being tested?
- Deucrictibant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 32 sitesin 16 countries
- Study dates
- 16 Oct 2025to Jun 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
32 sites in 16 countries. Contact the study team or a site near you to ask about taking part.
32 sites in 16 countries
United Kingdom6 sites, 6 recruiting
- Recruiting
Study Site
Bristol
- Recruiting
Study Site
Cambridge
- Recruiting
Study Site
Leicester
- Recruiting
Study Site
London
- Recruiting
Study Site
Newcastle upon Tyne
- Recruiting
Study Site
Plymouth
Italy5 sites, 5 recruiting
- Recruiting
Study Site 1
Milan
- Recruiting
Study Site 2
Milan
- Recruiting
Study Site 3
Milan
- Recruiting
Study Site
Padova
- Recruiting
Study Site
Roma
United States4 sites, 4 recruiting
- Recruiting
Study Site
Hershey, Pennsylvania, 17033
- Recruiting
Study Site
San Diego, California, 92093
- Recruiting
Study Site
St Louis, Missouri, 63130
- Recruiting
Study Site
Walnut Creek, California, 94598,
France3 sites, 3 recruiting
- Recruiting
Study Site
Grenoble
- Recruiting
Study Site
Lille
- Recruiting
Study Site
Paris
Germany3 sites, 3 recruiting
- Recruiting
Study Site
Berlin
- Recruiting
Study Site
Frankfurt am Main
- Recruiting
Study Site
Munich
About this study
Official title: 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.
Read the 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.
- Being tested
- Deucrictibant, Placebo
- 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
- Medical subject headings
- Angioedemas, Hereditary, Angioedema, Acquired angioedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeucrictibantDrug
Part 1: Deucrictibant 40 mg extended-release tablet for once daily oral use
PlaceboDrug
Part 1: Placebo Comparator tablet for once daily oral use
DeucrictibantDrug
Part 2: Deucrictibant 20 mg soft capsule oral use
PlaceboDrug
Part 2: Placebo Comparator soft capsule oral use
DeucrictibantDrug
Part 3: Deucrictibant 20 mg soft capsule oral use
| Study group | Role | What they receive |
|---|---|---|
| Part 1 - Arm 1 - Active | Experimental | Not described Receives: Drug: Deucrictibant |
| Part 1 - Arm 2 - Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Part 2 - Arm 1 | Experimental | Not described Receives: Drug: Deucrictibant; Drug: Placebo |
| Part 2 - Arm 2 | Experimental | Not described Receives: Drug: Deucrictibant; Drug: Placebo |
| Part 3 - Open-label | Experimental | Not described Receives: Drug: Deucrictibant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Time-normalized number of Investigator-confirmed AAE-C1INH attacks during Treatment Phase
Measured: 12 weeks
Part 2: Time to symptom relief, Patient Global Impression of Change (PGI-C) rating of at least "better"
Measured: 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)
Measured: Through study termination, an average of 36 weeks
Part 3: Number of participants with clinically significant changes from baseline in Hematology parameters
Measured: Through study termination, an average of 36 weeks
Part 3: Number of participants with clinically significant changes from baseline in Urinalysis parameters
Measured: Through study termination, an average of 36 weeks
Part 3: Number of participants with clinically significant changes from baseline in Biochemistry parameters
Measured: Through study termination, an average of 36 weeks
Part 3: Number of participants with clinically significant changes from baseline in vital signs
Measured: Through study termination, an average of 36 weeks
Part 3: Number of participants with clinically significant changes from baseline in physical examinations
Measured: Through study termination, an average of 36 weeks
Part 3: Number of participants with clinically significant changes in electrocardiogram (ECG)
Measured: Through study termination, an average of 36 weeks
Secondary outcomes (36)
Part 1: Proportion of participants who are AAE-C1INH attack-free during Treatment Phase
Measured: 12 weeks
Part 1: Time-normalized number of Investigator-confirmed AAE-C1INH attacks treated with on-demand medication during Treatment Phase
Measured: 12 weeks
Part 1: Time-normalized number of Investigator-confirmed moderate or severe AAE-C1INH attacks during Treatment Phase
Measured: 12 weeks
Part 1: Time-normalized number of Investigator-confirmed severe AAE-C1INH attacks during Treatment Phase
Measured: 12 weeks
Part 1: Proportion of participants achieving ≥50%, ≥70% and ≥90% reduction in AAE-C1NH attack rate relative to baseline during Treatment Phase
Measured: 12 weeks
Part 1: Incidence of TEAEs, treatment-emergent AESIs, and SAEs
Measured: 12 weeks
Part 1: Number of participants with clinically significant changes from baseline in Hematology parameters
Measured: 12 weeks
Part 1: Number of participants with clinically significant changes from baseline in Urinalysis parameters
Measured: 12 weeks
Part 1: Number of participants with clinically significant changes from baseline in Biochemistry parameters
Measured: 12 weeks
Part 1: Number of participants with clinically significant changes from baseline in Vital signs
Measured: 12 weeks
Part 1: Number of participants with clinically significant changes from baseline in physical examination
Measured: 12 weeks
Part 1: Number of participants with clinically significant changes from baseline in ECG parameters
Measured: 12 weeks
Part 1: Pre-dose plasma concentrations of Deucrictibant
Deucrictibant plasma concentrations will be analyzed using liquid chromatography-mass spectrometry/mass spectrometry methods
Measured: At Weeks 6 and 12
Part 1: Pre-dose plasma concentrations of deucrictibant metabolites
Deucrictibant metabolites plasma concentrations will be analyzed using liquid chromatography-mass spectrometry/mass spectrometry methods
Measured: At Weeks 6 and 12
Part 1: Pharmacokinetics [PK]: Urine concentrations of Deucrictibant and deucrictibant metabolites
Measured: 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
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.
Measured: Baseline (Day 1) and at Weeks 4, 8 and 12
Part 1: Change from baseline in Angioedema Control Test 4-week version (AECT-4wk)
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)
Measured: Baseline (Day 1) and at Week 12
Part 1: Patient Global Assessment-Status (PGA-S) at baseline
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
Measured: At Baseline (Day 1)
Part 1: Patient Global Assessment of Change (PGA-Change) 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
Measured: At Week 12
Part 1: Change from baseline in EuroQol 5 Dimension 5 level (EQ 5D 5L)
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)
Measured: 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
Measured: sustained within 24 hours post-treatment
Part 2: Time to symptom relief defined as PGI-S rating of at least 1 point reduction
Measured: 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"
Measured: At 24 hours post-treatment
Part 2: Time to onset of symptom relief, defined as PGI-C rating of at least "a little better"
Measured: Within 12 hours post-treatment
Part 2: Time to End of Progression (EoP) in attack symptoms
EOP is defined as the earliest post-treatment timepoint after which all subsequent PGI-C ratings are stable or improved
Measured: Within 12 hours post-treatment
Part 2: Incidence of TEAEs, treatment-emergent AESIs, and SAEs
Measured: Up to 24 weeks
Part 2: Number of participants with clinically significant changes from baseline in Hematology parameters
Measured: 24 weeks
Part 2: Number of participants with clinically significant changes from baseline in Urinalysis parameters
Measured: 24 weeks
Part 2: Number of participants with clinically significant changes from baseline in Biochemistry parameters
Measured: 24 weeks
Part 2: Number of participants with clinically significant changes from baseline in Vital signs
Measured: 24 weeks
Part 2: Number of participants with clinically significant changes from baseline in physical examination
Measured: 24 weeks
Part 2: Number of participants with clinically significant changes from baseline in ECG parameters
Measured: 24 weeks
Part 2: Pharmacokinetics [PK]: Deucrictibant and deucrictibant metabolites plasma concentration-time profiles
Measured: Day 1
Part 3: Time to symptom relief, as PGI-C rating of at least "better"
Measured: 12 hours post-treatment
Part 3: Time to symptom relief, as PGI-S rating of at least 1 point reduction
Measured: 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"
Measured: 24 hours post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start16 Oct 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Angioedema Due to C1-Inhibitor Deficiency (AAE-C1-INH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Part 1 is parallel Part 2 is crossover Part 3 is single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharvaris Netherlands B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Pharvaris, Study director, Pharvaris Netherlands B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07266805
- Sponsor's protocol ID
- PHA022121-C308
- Acronym
- CREAATE
- Status last verified
- Sep 2026
- First submitted
- 20 Oct 2025
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07266805
- Acronym / sponsor ID
- CREAATE / PHA022121-C308
- Keywords
- Acquired Angioedema-C1-INH, AAE-C1-INH, Oral Treatment, deucrictibant, Prophylaxis, On-demand, C1-Inhibitor Deficiency, PHA121
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Pharvaris Netherlands B.V.Industry (pharma, biotech, devices)
- Study start
- 16 Oct 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- Part 1 is parallel Part 2 is crossover Part 3 is single group
| Arm | Type | Receives |
|---|---|---|
| Part 1 - Arm 1 - Active | Experimental | Drug: Deucrictibant |
| Part 1 - Arm 2 - Placebo | Placebo comparator | Drug: Placebo |
| Part 2 - Arm 1 | Experimental | Drug: Deucrictibant, Drug: Placebo |
| Part 2 - Arm 2 | Experimental | Drug: Deucrictibant, Drug: Placebo |
| Part 3 - Open-label | Experimental | Drug: Deucrictibant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DeucrictibantPart 1: Deucrictibant 40 mg extended-release tablet for once daily oral use | Drug | Part 1 - Arm 1 - Active |
| PlaceboPart 1: Placebo Comparator tablet for once daily oral use | Drug | Part 1 - Arm 2 - Placebo |
| DeucrictibantPart 2: Deucrictibant 20 mg soft capsule oral use | Drug | Part 2 - Arm 1, Part 2 - Arm 2 |
| PlaceboPart 2: Placebo Comparator soft capsule oral use | Drug | Part 2 - Arm 1, Part 2 - Arm 2 |
| DeucrictibantPart 3: Deucrictibant 20 mg soft capsule oral use | Drug | Part 3 - Open-label |
Primary outcome
Part 1: Time-normalized number of Investigator-confirmed AAE-C1INH attacks during Treatment Phase
Time frame: 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
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
Part 3: Number of participants with clinically significant changes from baseline in Hematology parameters
Time frame: 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
Part 3: Number of participants with clinically significant changes from baseline in Biochemistry parameters
Time frame: 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
Part 3: Number of participants with clinically significant changes from baseline in physical examinations
Time frame: 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
36 secondary outcomes
Part 1: Proportion of participants who are AAE-C1INH attack-free during Treatment Phase
Time frame: 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
Part 1: Time-normalized number of Investigator-confirmed moderate or severe AAE-C1INH attacks during Treatment Phase
Time frame: 12 weeks
Part 1: Time-normalized number of Investigator-confirmed severe AAE-C1INH attacks during Treatment Phase
Time frame: 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
Part 1: Incidence of TEAEs, treatment-emergent AESIs, and SAEs
Time frame: 12 weeks
Part 1: Number of participants with clinically significant changes from baseline in Hematology parameters
Time frame: 12 weeks
Part 1: Number of participants with clinically significant changes from baseline in Urinalysis parameters
Time frame: 12 weeks
Part 1: Number of participants with clinically significant changes from baseline in Biochemistry parameters
Time frame: 12 weeks
Part 1: Number of participants with clinically significant changes from baseline in Vital signs
Time frame: 12 weeks
Part 1: Number of participants with clinically significant changes from baseline in physical examination
Time frame: 12 weeks
Part 1: Number of participants with clinically significant changes from baseline in ECG parameters
Time frame: 12 weeks
Part 1: Pre-dose plasma concentrations of Deucrictibant
Time frame: At Weeks 6 and 12
Part 1: Pre-dose plasma concentrations of deucrictibant metabolites
Time frame: At Weeks 6 and 12
Part 1: Pharmacokinetics [PK]: Urine concentrations of Deucrictibant and deucrictibant metabolites
Time frame: 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
Part 1: Change from baseline in Angioedema Control Test 4-week version (AECT-4wk)
Time frame: Baseline (Day 1) and at Week 12
Part 1: Patient Global Assessment-Status (PGA-S) at baseline
Time frame: At Baseline (Day 1)
Part 1: Patient Global Assessment of Change (PGA-Change) at Week 12
Time frame: 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
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
Part 2: Time to symptom relief defined as PGI-S rating of at least 1 point reduction
Time frame: 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
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
Part 2: Time to End of Progression (EoP) in attack symptoms
Time frame: Within 12 hours post-treatment
Part 2: Incidence of TEAEs, treatment-emergent AESIs, and SAEs
Time frame: Up to 24 weeks
Part 2: Number of participants with clinically significant changes from baseline in Hematology parameters
Time frame: 24 weeks
Part 2: Number of participants with clinically significant changes from baseline in Urinalysis parameters
Time frame: 24 weeks
Part 2: Number of participants with clinically significant changes from baseline in Biochemistry parameters
Time frame: 24 weeks
Part 2: Number of participants with clinically significant changes from baseline in Vital signs
Time frame: 24 weeks
Part 2: Number of participants with clinically significant changes from baseline in physical examination
Time frame: 24 weeks
Part 2: Number of participants with clinically significant changes from baseline in ECG parameters
Time frame: 24 weeks
Part 2: Pharmacokinetics [PK]: Deucrictibant and deucrictibant metabolites plasma concentration-time profiles
Time frame: Day 1
Part 3: Time to symptom relief, as PGI-C rating of at least "better"
Time frame: 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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Study Director, Pharvaris study director
Pharvaris Netherlands B.V.
32 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Deucrictibant in people with Acquired Angioedema Due to C1-Inhibitor Deficiency (AAE-C1-INH), run by Pharvaris Netherlands B.V. at 32 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United Kingdom, Italy, United States, France, Germany and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pharvaris Clinical Team (0031-712-036-410, clinicaltrials@pharvaris.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Time-normalized number of Investigator-confirmed AAE-C1INH attacks during Treatment Phase (time frame: 12 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.