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New daily pill could stop painful swelling attacks for HAE patients

NCT ID NCT06669754

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tests whether a once-daily pill called deucrictibant can prevent sudden swelling attacks in people aged 12 and older with hereditary angioedema (HAE). Participants receive either the drug or a placebo for 24 weeks, and researchers count how many attacks occur. The goal is to see if the pill safely reduces attack frequency.

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 a relatively small Phase 3 trial (81 participants), and results may not apply to all patients. The drug may not significantly reduce attacks compared to placebo, and side effects are still being evaluated.

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 81 people

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

Started

Dec 2024

Expected to finish

Aug 2026

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 written informed consent/assent. 2. Male or female, aged ≥12 years at the time of providing written informed consent/assent. 3. Diagnosis of hereditary angioedema (HAE) 4. History of at least 3 HAE attacks within the 3 consecutive months prior to Screening Visit 5. Predefined number of attacks during the Screening Period 6. Reliable access and ability to use standard of care on-demand treatments to effectively manage acute HAE attacks. 7. Willing and able to adhere to all protocol requirements, including eDiary and ePRO data recording. 8. Female participants of childbearing potential 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 Screening (whichever is longer) 3. Has received prior prophylactic treatment with deucrictibant 4. Exposure to ACE inhibitors or any estrogen-containing medications with systemic absorption within 4 weeks of Screening 5. Prior gene therapy for any indication at any time 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.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Study Site

    Little Rock, Arkansas, 72205, United States

  • Study Site

    San Diego, California, 92122, United States

  • Study Site

    Chevy Chase, Maryland, 20915, United States

  • Study Site

    St Louis, Missouri, 63141, United States

  • Study Site

    Corrientes, Argentina

  • Study Site

    San Martin, Argentina

  • Study Site

    Santo André, Brazil

  • Study Site

    Sofia, 1431, Bulgaria

  • Study Site

    Sofia, 1680, Bulgaria

  • Study Site

    Edmonton, Canada

  • Study Site

    Ottawa, Canada

  • Study Site

    Grenoble, France

  • Study Site

    Lille, 59037, France

  • Study Site

    Berlin, Germany

  • Study Site

    Frankfurt, Germany

  • Study Site

    Hanover, Germany

  • Study Site

    Hong Kong, Hong Kong

  • Study Site

    Budapest, Hungary

  • Study Site

    Dublin, Ireland

  • Study Site

    Milan, 20062, Italy

  • Study Site

    Padova, Italy

  • Study Site

    Kawasaki, Japan

  • Study Site

    Tokyo, 113-0033, Japan

  • Study Site

    Tokyo, 1130033, Japan

  • Study Site

    Auckland, New Zealand

  • Study Site

    Krakow, Poland

  • Study Site

    San Juan, Puerto Rico

  • Study Site

    Sângeorgiu de Mureş, Romania

  • Study Site

    Singapore, Singapore

  • Study Site

    Martin, Slovakia

  • Study Site

    Cape Town, South Africa

  • Study Site

    Daegu, South Korea

  • Study Site

    Seoul, 06351, South Korea

  • Study Site

    Seoul, South Korea

  • Study Site

    Suwon, South Korea

  • Study Site

    Barcelona, 08013, Spain

  • Study Site

    Barcelona, 08907, Spain

  • Study Site

    Seville, Spain

  • Study Site

    Basel, Switzerland

  • Study Site

    Ankara, Turkey (Türkiye)

  • Study Site

    Istanbul, Turkey (Türkiye)

  • Study Site

    Izmir, Turkey (Türkiye)

  • Study Site

    Birmingham, B18 7QH, United Kingdom

  • Study Site

    Birmingham, B9 5SS, United Kingdom

  • Study Site

    Bristol, BS10 5NB, United Kingdom

  • Study Site

    Cambridge, CB2 0QQ, United Kingdom

  • Study Site

    Frimley, GU16 7UJ, United Kingdom

  • Study Site

    Leeds, LS9 7TF, United Kingdom

  • Study Site

    London, NW3 2QG, United Kingdom

  • Study Site

    Oxford, United Kingdom

  • Study Site

    Southampton, United Kingdom

  • Study Site

    Stoke, United Kingdom

  • Study site

    Santa Monica, California, 90404, United States

  • Study site

    Walnut Creek, California, 94598, United States

  • Study site

    London, England, E1 1FR, United Kingdom

  • Study site

    Plymouth, PL6 5FP, United Kingdom

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Other studies related to the condition(s) this trial covers.