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ENROLLING BY INVITATIONPhase3

Long-Term, Open-label Study of Oral Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults With HAE

Sponsor: Pharvaris Netherlands B.V.

NCT ID: NCT06679881

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Deucrictibant (drug)
How long the study runs
Study runs about 46 months (dates as stated)
About the drug or intervention
Deucrictibant — drug: Deucrictibant extended-release tablet for once daily oral use
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
12 Years and over
Who
All
Number of participants
170
Started
2025-02-01
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for hereditary angioedema (hae)
  • • Phase3 - 170 participants
  • • This is a Phase 3, multicenter, long-term, open-label study to evaluate the safety and efficacy of once-daily orally administered deucrictibant extended-release tablet for prophylaxis to prevent angioedema attacks in participants aged ≥12 years with Hereditary Angioedema

Who can take part?

  • • Ages 12 Years and over
  • • Diagnosed with hereditary angioedema (hae)

Where?

  • • Birmingham - Study Site
  • • Birmingham - Study Site
  • • Brighton - Study Site
  • • Bristol - Study Site
  • • +7 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

This is a Phase 3, multicenter, long-term, open-label study to evaluate the safety and efficacy of once-daily orally administered deucrictibant extended-release tablet for prophylaxis to prevent angioedema attacks in participants aged ≥12 years with Hereditary Angioedema

More detail

The study consists of a Screening Period during which eligibility is confirmed (only for participants not rolling over within 28 days from a previous deucrictibant prophylactic study), a Treatment Period in which participants will receive open-label deucrictibant extended-release tablet once daily for approximately 240 weeks, followed by an End of Study visit after maximum 4 weeks. Participants will undergo regular safety (e.g. lab draws) and efficacy assessments, will complete an electronic diary, and also complete questionnaires at predefined timepoints during the study.

Hereditary Angioedema (HAE)

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 12 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Provision of the signed ICF by the participant and/or legally designated representative.
  • ✓Male or female, aged ≥12 years at the time of providing written agreement to take part/assent.
  • ✓Diagnosis of hereditary angioedema (HAE)
  • ✓For participants that did not participate in a previous deucrictibant prophylactic study: history of at least 1...
  • ✓Reliable access and ability to use the usual treatment on-demand treatments to effectively manage acute HAE attacks.

Who cannot take part

  • ✗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...
  • ✗Prior gene therapy for any indication at any time
  • ✗Any females who are pregnant, plan to become pregnant, or are currently breast-feeding
  • ✗Abnormal liver function
See the full criteria
Inclusion Criteria: 1. Provision of the signed ICF by the participant and/or legally designated representative. 2. Male or female, aged ≥12 years at the time of providing written informed consent/assent. 3. Diagnosis of hereditary angioedema (HAE) 4. For participants that did not participate in a previous deucrictibant prophylactic study: history of at least 1 attack in the last 3 consecutive months prior to Screening 5. Reliable access and ability to use standard of care on-demand treatments to effectively manage acute HAE attacks. 6. Willing and able to adhere to all protocol requirements, including the participant being capable of and compliant with data recording into an eDiary. 7. Female participants of childbearing age must agree to the protocol specified pregnancy testing and contraception methods. Exclusion Criteria: 1. Any diagnosis of angioedema other than HAE 2. 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 ICF signature (whichever is longer) 3. Prior gene therapy for any indication at any time 4. Participants who discontinued from previous studies with deucrictibant prophylactic and/or on-demand treatment due to safety reasons or compliance issues that, in the opinion of the Investigator, would interfere with the participant's safety or compliance to participate in the study 5. Exposure to angiotensin-converting enzyme (ACE) inhibitors or any estrogen-containing medications with systemic absorption (such as oral contraceptives or hormonal replacement therapy) within 4 weeks of Screening 6. 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 7. Any females who are pregnant, plan to become pregnant, or are currently breast-feeding 8. Abnormal hepatic function 9. Moderate or severe renal impairment 10. Any clinically significant comorbidity or systemic dysfunction that would interfere with the participant's safety or ability to participate in the study. 11. History of alcohol or drug abuse within the previous year, or current evidence of substance dependence or abuse 12. 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 enrollment. 13. Known hypersensitivity to deucrictibant or any of the excipients of the study drug

Where Is This Study? (11 UK sites)

Study Site

Birmingham B18 7QH, United Kingdom

Study Site

Birmingham B9 5SS, United Kingdom

Study Site

Brighton, United Kingdom

Study Site

Bristol, United Kingdom

Study Site

Cambridge, United Kingdom

Study Site

Frimley, United Kingdom

Study Site

London E1 1FR, United Kingdom

Study Site

London, United Kingdom

Study Site

Oxford, United Kingdom

Study Site

Plymouth, United Kingdom

Study Site

Southampton, United Kingdom

Data sourced from ClinicalTrials.gov · Last verified: 2026-09