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New daily pill could stop painful swelling attacks in rare disease

NCT ID NCT02303626

Disease control Sponsor: BioCryst Pharmaceuticals Source: ClinicalTrials.gov ↗

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tested an oral drug called BCX4161 to prevent attacks of hereditary angioedema (HAE), a condition that causes sudden, painful swelling. Over 12 weeks, 110 adults with HAE took either a low dose, high dose, or placebo pill. Researchers tracked how many swelling attacks each person had to see if the drug worked better than a dummy pill.

What this could mean

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

Active substance
BCX4161 (an oral drug that blocks a protein involved in swelling attacks)
What this could lead to
If successful, BCX4161 could offer a convenient daily pill to prevent painful swelling attacks in people with hereditary angioedema.
What could go wrong
This is a mid-stage trial with only 110 participants, so results may not apply to everyone. The drug may not work better than placebo or could have side effects.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

110 people

The number who actually took part.

Started

Dec 2014

Finished

Jan 2016

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

18 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.

Key Inclusion Criteria: 1. A clinical diagnosis of HAE type I or II 2. Documented HAE attacks within a defined calendar period; in the absence of documented HAE attacks, participants will be required to enter a run-in period to document attacks 3. Access to acute attack medications 4. Sexually active women of child-bearing potential and sexually active men must utilize highly effective contraception Key Exclusion Criteria: 1. Women who are pregnant or breast-feeding 2. Any clinical condition or medical history that would interfere with the subject's safety or ability to participate in the study 3. Use of C1INH or tranexamic acid for prophylaxis of HAE attacks 4. Current participation in any other investigational drug study or within the last 30 days 5. History of or current alcohol or drug abuse 6. Infection with hepatitis B, hepatitis C or HIV

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Conditions

The condition(s) this trial relates to.

hereditary angioedema type 1 hereditary angioedema type 2 hereditary angioedema prevention target

As listed by the trial registrant

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

HAE Hereditary angioedema

Contacts and locations

Locations

  • Study site

    Birmingham, Alabama, 35209, United States

  • Study site

    Scottsdale, Arizona, 85251, United States

  • Study site

    Granada Hills, California, 91344, United States

  • Study site

    San Diego, California, 92093, United States

  • Study site

    San Diego, California, 92112, United States

  • Study site

    Walnut Creek, California, 94598, United States

  • Study site

    Colorado Springs, Colorado, 80907, United States

  • Study site

    Shreveport, Louisiana, 71106, United States

  • Study site

    Chevy Chase, Maryland, 20815, United States

  • Study site

    Boston, Massachusetts, 02114, United States

  • Study site

    Plymouth, Minnesota, 55446, United States

  • Study site

    St Louis, Missouri, 63141, United States

  • Study site

    New York, New York, 10029, United States

  • Study site

    Charlotte, North Carolina, 28277, United States

  • Study site

    Cincinnati, Ohio, 45267, United States

  • Study site

    Oklahoma City, Oklahoma, 73131, United States

  • Study site

    Tulsa, Oklahoma, 74133, United States

  • Study site

    Lake Oswego, Oregon, 97035, United States

  • Study site

    Hershey, Pennsylvania, 17033, United States

  • Study site

    Pittsburgh, Pennsylvania, 15241, United States

  • Study site

    Dallas, Texas, 75231, United States

  • Study site

    Galveston, Texas, 77555, United States

  • Study site

    Fairfax, Virginia, 63141, United States

  • Study site

    Spokane, Washington, 99204, United States

  • Study site

    Tacoma, Washington, 98405, United States

  • Study site

    Leuven, Belgium

  • Study site

    Ottawa, Canada

  • Study site

    Grenoble, France

  • Study site

    Lille, France

  • Study site

    Paris, France

  • Study site

    Berlin, Germany

  • Study site

    Frankfurt, Germany

  • Study site

    Mörfelden-Walldorf, Germany

  • Study site

    Budapest, Hungary

  • Study site

    Milan, Italy

  • Study site

    Birmingham, United Kingdom

  • Study site

    Bristol, United Kingdom

  • Study site

    Cardiff, United Kingdom

  • Study site

    London, United Kingdom

  • Study site

    Manchester, United Kingdom

More trials for these conditions

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