New daily pill could stop painful swelling attacks for HAE patients
NCT ID NCT06669754
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 81 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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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
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12 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Study Site
Little Rock, Arkansas, 72205, United States
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Study Site
San Diego, California, 92122, United States
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Study Site
Chevy Chase, Maryland, 20915, United States
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Study Site
St Louis, Missouri, 63141, United States
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Study Site
Corrientes, Argentina
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Study Site
San Martin, Argentina
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Study Site
Santo André, Brazil
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Study Site
Sofia, 1431, Bulgaria
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Sofia, 1680, Bulgaria
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Study Site
Edmonton, Canada
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Ottawa, Canada
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Study Site
Grenoble, France
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Study Site
Lille, 59037, France
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Study Site
Berlin, Germany
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Frankfurt, Germany
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Hanover, Germany
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Hong Kong, Hong Kong
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Study Site
Budapest, Hungary
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Dublin, Ireland
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Study Site
Milan, 20062, Italy
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Padova, Italy
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Study Site
Kawasaki, Japan
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Study Site
Tokyo, 113-0033, Japan
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Study Site
Tokyo, 1130033, Japan
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Auckland, New Zealand
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Study Site
Krakow, Poland
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Study Site
San Juan, Puerto Rico
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Study Site
Sângeorgiu de Mureş, Romania
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Study Site
Singapore, Singapore
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Martin, Slovakia
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Study Site
Cape Town, South Africa
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Study Site
Daegu, South Korea
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Study Site
Seoul, 06351, South Korea
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Study Site
Seoul, South Korea
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Study Site
Suwon, South Korea
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Study Site
Barcelona, 08013, Spain
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Study Site
Barcelona, 08907, Spain
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Study Site
Seville, Spain
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Study Site
Basel, Switzerland
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Study Site
Ankara, Turkey (Türkiye)
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Study Site
Istanbul, Turkey (Türkiye)
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Study Site
Izmir, Turkey (Türkiye)
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Study Site
Birmingham, B18 7QH, United Kingdom
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Study Site
Birmingham, B9 5SS, United Kingdom
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Study Site
Bristol, BS10 5NB, United Kingdom
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Study Site
Cambridge, CB2 0QQ, United Kingdom
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Study Site
Frimley, GU16 7UJ, United Kingdom
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Study Site
Leeds, LS9 7TF, United Kingdom
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Study Site
London, NW3 2QG, United Kingdom
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Study Site
Oxford, United Kingdom
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Study Site
Southampton, United Kingdom
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Study Site
Stoke, United Kingdom
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Study site
Santa Monica, California, 90404, United States
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Study site
Walnut Creek, California, 94598, United States
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Study site
London, England, E1 1FR, United Kingdom
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Study site
Plymouth, PL6 5FP, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- HAE patients and caregivers speak out: the hidden costs of On-Demand treatment
- Real-world study shows lanadelumab keeps HAE attacks at bay for many patients
- Takhzyro under the microscope: Real-World safety check for rare swelling disease
- New hope for HAE patients: experimental drug aims to slash attack rate
- New RNA drug shows promise in preventing HAE attacks in ongoing study
- New drug TAKHZYRO tracked for Long-Term safety in rare swelling disorder