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New daily pill could stop debilitating swelling attacks in HAE patients

NCT ID NCT06679881

Disease control Sponsor: Pharvaris Netherlands B.V. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 02, 2026 · Updated 2 times

Summary

This Phase 3 study tests a once-daily pill called deucrictibant to prevent swelling attacks in people aged 12 and older with hereditary angioedema (HAE). The trial will enroll 170 participants and monitor safety and attack rates over a long period. Unlike a cure, patients would need to keep taking the medication to control their condition.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Deucrictibant extended-release tablet
What this could lead to
If successful, this once-daily pill could help prevent painful swelling attacks in people with hereditary angioedema, reducing the need for emergency treatments.
What could go wrong
This is an open-label study (everyone knows they're getting the drug), which can bias results. Long-term safety and effectiveness are still being evaluated, and the drug may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 170 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 eDiary and ePRO data recording. 7. Female participants of childbearing 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 ACE inhibitors or any estrogen-containing medications with systemic absorption 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 randomization 13. Known hypersensitivity to deucrictibant or any of the excipients of the study drug

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Conditions

The condition(s) this trial relates to.

hereditary angioedema angioedema prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hereditary angioedema (HAE)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    67 sites in 23 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Study Site

    RECRUITING

    Birmingham, Alabama, 35209, United States

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    Scottsdale, Arizona, 85251, United States

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    Little Rock, Arkansas, 72205, United States

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    San Diego, California, 92122, United States

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    Santa Monica, California, 90404, United States

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    Walnut Creek, California, 94598, United States

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    Colorado Springs, Colorado, 80907, United States

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    Wheaton, Illinois, 20902, United States

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    St Louis, Missouri, 63141, United States

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    Las Vegas, Nevada, 89128-0450, United States

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    Hershey, Pennsylvania, 17033, United States

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    Dallas, Texas, 75231, United States

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    Milwaukee, Wisconsin, 53226-3067, United States

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    Corrientes, Argentina

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    Pilar, Argentina

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    Salta, Argentina

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    Box Hill, 3128, Australia

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    Parkville, Australia

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    Perth, Australia

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    Sydney, Australia

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    Vienna, Austria

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    Ribeirão Preto, Brazil

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    Salvador, Brazil

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    Santo André, Brazil

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    São Paulo, 01454010, Brazil

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    São Paulo, 14051-140, Brazil

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    Sofia, Bulgaria

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    Edmonton, Canada

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    Montreal, Canada

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    Beijing, China

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    Grenoble, France

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    Berlin, Germany

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    Frankfurt, Germany

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    Munich, Germany

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    Hong Kong, Hong Kong

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    Budapest, Hungary

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    Dublin, Ireland

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    Milan, Italy

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    Padova, Italy

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    Palermo, Italy

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    Roma, Italy

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    Fukuoka, Japan

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    Hiroshima, Japan

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    Kanagawa, Japan

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    Osaka, Japan

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    Tokyo, Japan

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    Auckland, New Zealand

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    Krakow, Poland

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    Martin, Slovakia

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    Cape Town, South Africa

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    Daegu, South Korea

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    Seoul, South Korea

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    Barcelona, 08907, Spain

  • Study Site

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    Ankara, Turkey (Türkiye)

  • Study Site

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    Istanbul, Turkey (Türkiye)

  • Study Site

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    Izmir, Turkey (Türkiye)

  • Study Site

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    Birmingham, B18 7QH, United Kingdom

  • Study Site

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    Birmingham, B9 5SS, United Kingdom

  • Study Site

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    Brighton, United Kingdom

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    Bristol, United Kingdom

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    Cambridge, United Kingdom

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    Frimley, United Kingdom

  • Study Site

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    London, E1 1FR, United Kingdom

  • Study Site

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    London, United Kingdom

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    Oxford, United Kingdom

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    Plymouth, United Kingdom

  • Study Site

    RECRUITING

    Southampton, United Kingdom

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