Hereditary AngioedemaNCT07759141
EAP for Deucrictibant Immediate-release
A study testing Deucrictibant IR in people with Hereditary Angioedema, run by Pharvaris Netherlands B.V..
Trial summary
This is an expanded access program (EAP) designed to allow access to deucrictibant immediate-release (IR) capsule for eligible participants with hereditary angioedema (HAE) in the United States (US) and US territories who lack satisfactory alternative treatment options for on-demand treatment of HAE attacks, as… Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Hereditary Angioedema
- What is being tested?
- Deucrictibant IR
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 to 75 years
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Provision of informed consent: Participants must provide written informed consent. Adolescents (≥12 to <18 years old, or as per local law) require consent of parent or legally designated representative/guardian and must assent. If an adolescent reaches adulthood during the EAP, they must sign the adult informed consent form (ICF) to remain in the EAP.
- Male or female, aged ≥12 to ≤75 years at the time of providing written informed consent/assent.
- Confirmed diagnosis of HAE.
- for participants with hereditary angioedema with normal C1 inhibitor (HAE-nC1INH): documented genetic mutation associated with HAE-nC1INH
- OR
- if no documented mutation:
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- clinical diagnosis with family history of HAE-nC1INH,
- attacks not responding to treatment with high-dose antihistamine (cetirizine 40 milligrams [mg]/day or equivalent high-dose second-generation antihistamine medication) and no clinical attack symptom relief if treated with corticosteroid, montelukast, and/or omalizumab.
- documented effective attack symptom relief with on-demand icatibant treatment
- No satisfactory treatment options are available among currently approved HAE therapies for treatment of acute attacks ((i.e. Berinert (C1 esterase inhibitor [human]), Ekterly (sebetralstat), Firazyr (icatibant), Kalbitor (ecallantide), Ruconest (C1 esterase inhibitor [recombinant])) based on inadequate response, contraindication, safety/tolerability concerns, and/or other reasons, as documented by the treating physician in the participant's medical records and maintained as part of the EAP enrollment documentation.
- Not eligible for an ongoing clinical study or for whom participation in a clinical study is not possible or feasible for other reasons, including but not limited to clinical study eligibility criteria, geographic accessibility, study availability, timing considerations, participant decision to participate, or other participant-specific factors, as documented by the treating physician in the participant's medical records and maintained as part of the EAP enrollment documentation.
- Residence in the US or US territories.
Who cannot join
- Pregnancy or nursing: any female participant who is pregnant, planning to become pregnant during the EAP, or currently breastfeeding.
- Any diagnosis of angioedema other than HAE.
- Significant comorbidity: any clinically significant comorbidity or systemic dysfunction (e.g., cardiovascular, gastrointestinal, renal, neurologic, respiratory) that, in the opinion of the treating physician, would interfere with the participant's safety or ability to participate in this EAP.
- Severe hepatic impairment (Child-Pugh Class C).
- Substance abuse: history of alcohol or drug abuse within the past year, or current evidence of substance dependence or abuse.
- Prior treatment with deucrictibant IR resulting in discontinuation due to lack of efficacy, safety concerns, or tolerability issues.
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- Participation in another investigational drug study, or treatment with any investigational drug within 30 days or 5 half-lives (whichever is longer) prior to enrolment.
- Prior gene therapy use for any indication at any time.
- Current use of medications with systemic absorption that are strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, ketoconazole, ritonavir) or strong CYP3A4 inducers (e.g., carbamazepine, phenytoin) within 30 days (or 5 half-lives, whichever longer) prior to enrolment.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Expanded Access for Deucrictibant IR Capsule
This is an expanded access program (EAP) designed to allow access to deucrictibant immediate-release (IR) capsule for eligible participants with hereditary angioedema (HAE) in the United States (US) and US territories who lack satisfactory alternative treatment options for on-demand treatment of HAE attacks, as determined by their treating physician.
Read the detailed description
The EAP is intended to address unmet medical needs not adequately addressed by currently available therapies and is not designed to replace clinical trials conducted to support regulatory assessment and approval of the investigational product. The program will continue beyond the commercial availability of deucrictibant IR, upon regulatory approval, for up to approximately 6 months to ensure continuity of treatment for participants for whom ongoing therapy is considered appropriate. Participants will self-administer 1 capsule orally at the onset of an HAE attack. If response is inadequate or symptoms worsen or recur, a second capsule may be taken at least 4 hours after the initial dose. Capsule(s) may be taken with or without food.
- Conditions
- Hereditary Angioedema
- Being tested
- Deucrictibant IR
- Keywords
- Angioedema, Hereditary Angioedema, HAE, Deucrictibant, Deucrictibant immediate-release, Bradykinin, Bradykinin B2 receptor, Hereditary angioedema with C1 inhibitor deficiency/dysfunction, HAE-C1INH, Hereditary angioedema with normal C1 inhibitor, HAE-nC1INH
- Medical subject headings
- Angioedemas, Hereditary, Angioedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deucrictibant IRDrug
Deucrictibant IR capsule administered orally.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hereditary AngioedemaStudies 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Pharvaris Netherlands B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07759141
- Sponsor's protocol ID
- EAP-01
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access for Deucrictibant IR Capsule
- ClinicalTrials.gov ID
- NCT07759141
- Acronym / sponsor ID
- EAP-01
- Conditions
- Hereditary Angioedema
- Keywords
- Angioedema, Hereditary Angioedema, HAE, Deucrictibant, Deucrictibant immediate-release, Bradykinin, Bradykinin B2 receptor, Hereditary angioedema with C1 inhibitor deficiency/dysfunction
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Pharvaris Netherlands B.V.Industry (pharma, biotech, devices)
- First posted
- 12 Aug 2026 (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 an expanded access program (EAP) designed to allow access to deucrictibant immediate-release (IR) capsule for eligible participants with hereditary angioedema (HAE) in the United States (US) and US territories who lack satisfactory alternative treatment options for on-demand treatment of HAE attacks, as determined by their treating physician.
Detailed description
The EAP is intended to address unmet medical needs not adequately addressed by currently available therapies and is not designed to replace clinical trials conducted to support regulatory assessment and approval of the investigational product. The program will continue beyond the commercial availability of deucrictibant IR, upon regulatory approval, for up to approximately 6 months to ensure continuity of treatment for participants for whom ongoing therapy is considered appropriate. Participants will self-administer 1 capsule orally at the onset of an HAE attack. If response is inadequate or symptoms worsen or recur, a second capsule may be taken at least 4 hours after the initial dose. Capsule(s) may be taken with or without food.
Study design
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Provision of informed consent: Participants must provide written informed consent. Adolescents (≥12 to <18 years old, or as per local law) require consent of parent or legally designated representative/guardian and must assent. If an adolescent reaches adulthood during the EAP, they must sign the adult informed consent form (ICF) to remain in the EAP.
- Male or female, aged ≥12 to ≤75 years at the time of providing written informed consent/assent.
- Confirmed diagnosis of HAE.
- OR
- No satisfactory treatment options are available among currently approved HAE therapies for treatment of acute attacks ((i.e. Berinert (C1 esterase inhibitor [human]), Ekterly (sebetralstat), Firazyr (icatibant), Kalbitor (ecallantide), Ruconest (C1 esterase inhibitor [recombinant])) based on inadequate response, contraindication, safety/tolerability concerns, and/or other reasons, as documented by the treating physician in the participant's medical records and maintained as part of the EAP enrollment documentation.
Key exclusion criteria (9 listed)
- Pregnancy or nursing: any female participant who is pregnant, planning to become pregnant during the EAP, or currently breastfeeding.
- Any diagnosis of angioedema other than HAE.
- Significant comorbidity: any clinically significant comorbidity or systemic dysfunction (e.g., cardiovascular, gastrointestinal, renal, neurologic, respiratory) that, in the opinion of the treating physician, would interfere with the participant's safety or ability to participate in this EAP.
- Severe hepatic impairment (Child-Pugh Class C).
- Substance abuse: history of alcohol or drug abuse within the past year, or current evidence of substance dependence or abuse.
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 |
|---|---|---|
| Deucrictibant IRDeucrictibant IR capsule administered orally. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Deucrictibant IR in people with Hereditary Angioedema, run by Pharvaris Netherlands B.V..
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 12 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pharvaris Medical Affairs (+1 267 841 5106, expandedaccess@pharvaris.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 12 Aug 2026.