A Phase 3 interventional study of Deucrictibant and Placebo in Acquired Angioedema Due to C1-Inhibitor Deficiency (AAE-C1-INH), sponsored by Pharvaris Netherlands B.V.. Recruiting at 32 sites in 16 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Pharvaris Netherlands B.V. · Phase 3, Interventional, and Treatment
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.
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.
171 studies on the registry are indexed under Angioedemas, Hereditary; 24 are open to participants now.
This study's planned enrollment of 48 is close to the median of 48 across 116 interventional studies indexed under Angioedemas, Hereditary.
Browse Angioedemas, Hereditary studies →Pharvaris Netherlands B.V. is the lead sponsor of 8 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Females of non-childbearing potential (surgically sterile, or with ≥ 12 months amenorrhea and postmenopausal FSH confirmation) are not required to use contraception during the study.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Deucrictibant
Drug: Placebo
Drug: Deucrictibant · Drug: Placebo
Drug: Deucrictibant · Drug: Placebo
Drug: Deucrictibant
Part 1: Deucrictibant 40 mg extended-release tablet for once daily oral use
Part 1: Placebo Comparator tablet for once daily oral use
Part 2: Deucrictibant 20 mg soft capsule oral use
Part 2: Placebo Comparator soft capsule oral use
Part 3: Deucrictibant 20 mg soft capsule oral use
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
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
Deucrictibant plasma concentrations will be analyzed using liquid chromatography-mass spectrometry/mass spectrometry methods
Time frame: 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
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
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.
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)
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)
Time frame: 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
Time frame: 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
Time frame: 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)
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
EOP is defined as the earliest post-treatment timepoint after which all subsequent PGI-C ratings are stable or improved
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
Started Oct 2025 (actual). Primary completion is estimated for Jun 2027, 20 months after the start.
Of 46 industry-sponsored phase 3 interventional studies under Angioedemas, Hereditary, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 33. This study's planned 20 months is close to that.
Counting every sponsor, half of 46 studies reached it within 22 months; a quarter within 16 and three quarters within 33.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Deucrictibant
Pharvaris Netherlands B.V.