Hereditary Angioedema (HAE)Phase 3CHAPTER-3NCT06669754
Study of Oral Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults With HAE
A Phase 3 study testing Deucrictibant in people with Hereditary Angioedema (HAE), run by Pharvaris Netherlands B.V. at 56 sites in 24 countries.
Trial summary
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of once-daily orally administered deucrictibant extended-release tablet compared to placebo for prophylaxis to prevent angioedema attacks in participants aged ≥ 12 years with hereditary angioedema. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Hereditary Angioedema (HAE)
- 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
- 85 participants
- Where
- 56 sitesin 24 countries
- Study dates
- 1 Dec 2024to 21 Jul 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Provision of written informed consent/assent.
- Male or female, aged ≥12 years at the time of providing written informed consent/assent.
- Diagnosis of hereditary angioedema (HAE)
- History of at least 3 HAE attacks within the 3 consecutive months prior to Screening Visit
- Predefined number of attacks during the Screening Period
- Reliable access and ability to use standard of care on-demand treatments to effectively manage acute HAE attacks.
- Willing and able to adhere to all protocol requirements, including eDiary and ePRO data recording.
- Female participants of childbearing potential must agree to the protocol specified pregnancy testing and contraception methods.
Who cannot join
- Any diagnosis of angioedema other than HAE
- Participation in a clinical study with any other investigational drug within the last 30 days or within 5 half-lives of the investigational drug at Screening (whichever is longer)
- Has received prior prophylactic treatment with deucrictibant
- Exposure to ACE inhibitors or any estrogen-containing medications with systemic absorption within 4 weeks of Screening
- Prior gene therapy for any indication at any time
- Use of prophylactic treatment for HAE within 2 weeks of Screening for C1INH, oral kallikrein inhibitors, or anti-fibrinolytics; within 4 weeks of Screening for attenuated androgens; within 5 half-lives of Screening for monoclonal antibodies, or within 7 days of Screening for short-term prophylaxis
Show all 13Show fewer
- 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 alcohol or drug abuse within the previous year, or current evidence of substance dependence or abuse
- Use of medications that are moderate and strong inhibitors or strong inducers of CYP3A4 within the last 30 days or within 5 half-lives (whichever is longer) of the time of randomization
- Known hypersensitivity to deucrictibant or any of the excipients of the study drug
Trial locations and contacts
56 sites in 24 countries.
56 sites in 24 countries
United Kingdom12 sites
Study Site
Birmingham, B18 7QH
Study Site
Birmingham, B9 5SS
Study Site
Bristol, BS10 5NB
Study Site
Cambridge, CB2 0QQ
Study Site
Frimley, GU16 7UJ
Study Site
Leeds, LS9 7TF
Study site
London, England, E1 1FR
Study Site
London, NW3 2QG
Study Site
Oxford
Study site
Plymouth, PL6 5FP
Study Site
Southampton
Study Site
Stoke
United States6 sites
Study Site
Chevy Chase, Maryland, 20915
Study Site
Little Rock, Arkansas, 72205
Study Site
San Diego, California, 92122
Study site
Santa Monica, California, 90404
Study Site
St Louis, Missouri, 63141
Study site
Walnut Creek, California, 94598
South Korea4 sites
Study Site
Daegu
Study Site
Seoul, 06351
Study Site
Seoul
Study Site
Suwon
Japan3 sites
Study Site
Kawasaki
Study Site
Tokyo, 113-0033
Study Site
Tokyo, 1130033
Spain3 sites
Study Site
Barcelona, 08013
Study Site
Barcelona, 08907
Study Site
Seville
Turkey (Türkiye)3 sites
Study Site
Ankara
Study Site
Istanbul
Study Site
Izmir
About this study
Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Orally Administered Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of once-daily orally administered deucrictibant extended-release tablet compared to placebo for prophylaxis to prevent angioedema attacks in participants aged ≥ 12 years with hereditary angioedema.
Read the detailed description
The study consists of a Screening Period during which eligibility is confirmed, a Treatment Period of 24 weeks, and a Follow-up Period of maximum 4 weeks or subjects may roll over into the open-label study PHA022121-C307 (CHAPTER-4). During the Treatment period participants will receive blinded study drug (deucrictibant or placebo randomized in a 2:1 ratio). Participants will undergo regular efficacy and safety assessments, complete an electronic diary daily, and also complete questionnaires at predefined timepoints during the study.
- Conditions
- Hereditary Angioedema (HAE)
- Being tested
- Deucrictibant, Placebo
- Keywords
- HAE, Oral Treatment, Bradykinin B2 Receptor Antagonists, PHVS719, PHA121, Deucrictibant, Prophylaxis
- Medical subject headings
- Angioedemas, Hereditary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeucrictibantDrug
Deucrictibant 40mg extended-release tablet for once daily oral use
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Deucrictibant 40mg extended-release tablet by mouth once daily Receives: Drug: Deucrictibant |
| Placebo | Experimental | Placebo 1 tablet by mouth once daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-normalized (per 4 weeks) number of Investigator-confirmed HAE attacks during the 24-week Treatment Period
Measured: 24 weeks
Secondary outcomes (15)
Time-normalized number of Investigator-confirmed HAE attacks treated with on-demand medication during the 24-week Treatment Period
Measured: 24 weeks
Time-normalized number of Investigator-confirmed moderate or severe HAE attacks during the 24-week Treatment Period
Measured: 24 weeks
Time-normalized number of Investigator-confirmed severe HAE attacks during the 24-week Treatment Period
Measured: 24 weeks
Proportion of participants achieving ≥50% reduction in HAE attack rate relative to baseline during the 24-week Treatment Period
Measured: 24 weeks
Proportion of participants achieving ≥70% reduction in HAE attack rate relative to baseline during the 24-week Treatment Period
Measured: 24 weeks
Proportion of participants achieving ≥90% reduction in HAE attack rate relative to baseline during the 24-week Treatment Period
Measured: 24 weeks
Proportion of participants that are HAE attack-free during the 24-week Treatment Period
Measured: 24 weeks
Proportion of time without angioedema symptoms during the 24-week Treatment Period
Measured: 24 weeks
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), and TEAEs leading to study drug discontinuation
Measured: Up to 38 weeks
Pharmacokinetics [PK]: Deucrictibant plasma concentration time profiles
Measured: 24 weeks
Patient reported outcome: Angioedema Quality of Life (AE-QoL) questionnaire
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: 24 weeks
Patient reported outcome: Patient Global Assessment of Change (PGA-Change)
PGA-Change assesses on a 5-point scale how the participant's QoL has been impacted by HAE since start taking the study drug
Measured: 24 weeks
Patient reported outcome: 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: 24 weeks
Patient reported outcome: Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP)
WPAI-SHP is a questionnaire assessing how a health condition impacts a person's ability to work and do regular activities and it includes 4 domains. Scores indicate the percentage of time the patient missed work or was less productive owing to HAE-related complications.
Measured: Up to 34 weeks
Patient reported outcome: Abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9)
TSQM-9 is a 9-item questionnaire evaluating patient treatment satisfaction and it includes 3 domains. Scoring is by domain and each domain score is computed by summing the individual TSQM items in each domain and then transforming the composite score into a value ranging from 0 to 100, with higher scores indicating higher satisfaction.
Measured: Up to 34 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start1 Dec 2024
- Primary completion21 Jul 2026
- Study completion21 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hereditary Angioedema (HAE)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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 85 participants (actual)
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
- NCT06669754
- Sponsor's protocol ID
- PHA022121-C305
- Acronym
- CHAPTER-3
- Status last verified
- Nov 2026
- First submitted
- 24 Oct 2024
- Last updated
- 6 Nov 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 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Orally Administered Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema
- ClinicalTrials.gov ID
- NCT06669754
- Acronym / sponsor ID
- CHAPTER-3 / PHA022121-C305
- Conditions
- Hereditary Angioedema (HAE)
- Keywords
- HAE, Oral Treatment, Bradykinin B2 Receptor Antagonists, PHVS719, PHA121, Deucrictibant, Prophylaxis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Pharvaris Netherlands B.V.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 21 Jul 2026 (actual)
- Study completion
- 21 Jul 2026 (actual)
- First posted
- 1 Nov 2024 (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, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of once-daily orally administered deucrictibant extended-release tablet compared to placebo for prophylaxis to prevent angioedema attacks in participants aged ≥ 12 years with hereditary angioedema.
Detailed description
The study consists of a Screening Period during which eligibility is confirmed, a Treatment Period of 24 weeks, and a Follow-up Period of maximum 4 weeks or subjects may roll over into the open-label study PHA022121-C307 (CHAPTER-4). During the Treatment period participants will receive blinded study drug (deucrictibant or placebo randomized in a 2:1 ratio). Participants will undergo regular efficacy and safety assessments, complete an electronic diary daily, and also complete questionnaires at predefined timepoints during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: DeucrictibantDeucrictibant 40mg extended-release tablet by mouth once daily |
| Placebo | Experimental | Drug: PlaceboPlacebo 1 tablet by mouth once daily |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Provision of written informed consent/assent.
- Male or female, aged ≥12 years at the time of providing written informed consent/assent.
- Diagnosis of hereditary angioedema (HAE)
- History of at least 3 HAE attacks within the 3 consecutive months prior to Screening Visit
- Predefined number of attacks during the Screening Period
Key exclusion criteria (13 listed)
- Any diagnosis of angioedema other than HAE
- Participation in a clinical study with any other investigational drug within the last 30 days or within 5 half-lives of the investigational drug at Screening (whichever is longer)
- Has received prior prophylactic treatment with deucrictibant
- Exposure to ACE inhibitors or any estrogen-containing medications with systemic absorption within 4 weeks of Screening
- Prior gene therapy for any indication at any time
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 |
|---|---|---|
| DeucrictibantDeucrictibant 40mg extended-release tablet for once daily oral use | Drug | Active |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Time-normalized (per 4 weeks) number of Investigator-confirmed HAE attacks during the 24-week Treatment Period
Time frame: 24 weeks
15 secondary outcomes
Time-normalized number of Investigator-confirmed HAE attacks treated with on-demand medication during the 24-week Treatment Period
Time frame: 24 weeks
Time-normalized number of Investigator-confirmed moderate or severe HAE attacks during the 24-week Treatment Period
Time frame: 24 weeks
Time-normalized number of Investigator-confirmed severe HAE attacks during the 24-week Treatment Period
Time frame: 24 weeks
Proportion of participants achieving ≥50% reduction in HAE attack rate relative to baseline during the 24-week Treatment Period
Time frame: 24 weeks
Proportion of participants achieving ≥70% reduction in HAE attack rate relative to baseline during the 24-week Treatment Period
Time frame: 24 weeks
Proportion of participants achieving ≥90% reduction in HAE attack rate relative to baseline during the 24-week Treatment Period
Time frame: 24 weeks
Proportion of participants that are HAE attack-free during the 24-week Treatment Period
Time frame: 24 weeks
Proportion of time without angioedema symptoms during the 24-week Treatment Period
Time frame: 24 weeks
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), and TEAEs leading to study drug discontinuation
Time frame: Up to 38 weeks
Pharmacokinetics [PK]: Deucrictibant plasma concentration time profiles
Time frame: 24 weeks
Patient reported outcome: Angioedema Quality of Life (AE-QoL) questionnaire
Time frame: 24 weeks
Patient reported outcome: Patient Global Assessment of Change (PGA-Change)
Time frame: 24 weeks
Patient reported outcome: Angioedema Control Test 4-week version (AECT-4wk)
Time frame: 24 weeks
Patient reported outcome: Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP)
Time frame: Up to 34 weeks
Patient reported outcome: Abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9)
Time frame: Up to 34 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
Related trials for Hereditary Angioedema (HAE)
RecruitingPhase 3
Donidalorsen Treatment in Children With Hereditary Angioedema
Hereditary Angioedema (HAE)
RecruitingObservational study
A Study of Takhzyro in Teenagers and Adults With Hereditary Angioedema (HAE) in South Korea
Hereditary Angioedema (HAE)
Active, not recruitingPhase 3
HAELO: A Phase 3 Study to Evaluate NTLA-2002 in Participants With Hereditary Angioedema (HAE)
Hereditary Angioedema
RecruitingPhase 3
Study of IV Human Plasma-derived C1 Esterase Inhibitor Concentrate in Patients With Congenital C1-INH Deficiency for Treatment and Pre-procedure Preventing of Acute Hereditary Angioedema Attacks
Acute Hereditary Angio Edema
Active, not recruitingPhase 1/2
NTLA-2002 in Adults With Hereditary Angioedema (HAE)
Hereditary Angioedema
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. This study is not recruiting at the moment.
Study Director, Pharvaris study director
Pharvaris Netherlands B.V.
56 sites in 24 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 Hereditary Angioedema (HAE), run by Pharvaris Netherlands B.V. at 56 sites in 24 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 8 inclusion and 13 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: finished, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in United Kingdom, United States, South Korea, Germany, Japan and 19 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-normalized (per 4 weeks) number of Investigator-confirmed HAE attacks during the 24-week Treatment Period (time frame: 24 weeks). 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 6 Nov 2026.