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New RNA drug aims to stop debilitating swelling attacks in rare genetic condition

NCT ID NCT06960213

Disease control Sponsor: ADARx Pharmaceuticals, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 11, 2026 · Updated 2 times

Summary

This phase 3 trial is testing an experimental drug called ADX-324 in 90 adults with hereditary angioedema (HAE) types 1 or 2. HAE causes sudden, painful swelling in the body. ADX-324 uses a technology called siRNA to lower levels of a protein involved in triggering these attacks. The study compares two doses of ADX-324 against a placebo to see if it can reduce the number of swelling attacks over time.

What this could mean

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

Active substance
ADX-324 (a type of RNA drug called siRNA that targets a protein involved in swelling attacks)
What this could lead to
If successful, ADX-324 could offer a new way to prevent painful and dangerous swelling attacks in people with hereditary angioedema, reducing attack frequency and improving quality of life.
What could go wrong
This is a phase 3 trial, but it's still relatively small (90 participants). The drug may not work better than placebo, or side effects could emerge. Long-term safety and effectiveness are not yet known.

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 90 people

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

Started

Aug 2025

Expected to finish

Dec 2027

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

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: * Age ≥18 years at the time of signing informed consent. * Have a documented diagnosis of HAE-1/HAE-2 (Type I or II) * Experience ≥1 Investigator-confirmed HAE attack in the first 4 weeks of Screening or ≥2 Investigator-confirmed HAE attacks in 8 weeks of Screening * Able to use at least one acute therapy to treat HAE attacks (such as a plasma-derived or recombinant C1-INH concentrate or a BK2-receptor antagonist) Key Exclusion Criteria: * Concurrent diagnosis of another form of recurrent angioedema (such as acquired angioedema, HAE with normal C1-INH (previously known as HAE Type III), idiopathic angioedema, or recurrent angioedema associated with urticaria). * Any clinically significant renal disease * Any clinically significant hepatic disease * Have used any of the following for long-term prevention of HAE attacks: 1. C1-INH agent (CINRYZE, HAEGARDA, RUCONEST) within 2 weeks prior to Screening. 2. Berotralstat (ORLADEYO) within 3 weeks prior to Screening. 3. Lanadelumab (TAKHZYRO) within 8 weeks prior to the Screening. 4. Androgen use within 12 weeks prior to Screening. * Received prior treatment with any RNA/DNA-based therapy for HAE or intolerant to any prior RNA/DNA-based therapy for any condition, excluding vaccines.

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Conditions

The condition(s) this trial relates to.

hereditary angioedema hereditary angioedema type 1 hereditary angioedema type 2

As listed by the trial registrant

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

HAE Hereditary angioedema Hereditary angioedema - type 1 Hereditary angioedema - type 2

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    66 sites in 24 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • ADARx Clinical Site

    RECRUITING

    Litchfield Park, Arizona, 85340, United States

  • ADARx Clinical Site

    RECRUITING

    Scottsdale, Arizona, 85251, United States

  • ADARx Clinical Site

    RECRUITING

    Little Rock, Arkansas, 72205, United States

  • ADARx Clinical Site

    RECRUITING

    San Diego, California, 92122, United States

  • ADARx Clinical Site

    NOT_YET_RECRUITING

    Santa Monica, California, 90404, United States

  • ADARx Clinical Site

    RECRUITING

    Walnut Creek, California, 94598, United States

  • ADARx Clinical Site

    RECRUITING

    Centennial, Colorado, 80112, United States

  • ADARx Clinical Site

    RECRUITING

    Orlando, Florida, 32807, United States

  • ADARx Clinical Site

    RECRUITING

    Chevy Chase, Maryland, 20815, United States

  • ADARx Clinical Site

    WITHDRAWN

    Wheaton, Maryland, 20902, United States

  • ADARx Clinical Site

    RECRUITING

    Detroit, Michigan, 48202, United States

  • ADARx Clinical Site

    RECRUITING

    St Louis, Missouri, 63141, United States

  • ADARx Clinical Site

    RECRUITING

    Las Vegas, Nevada, 89128, United States

  • ADARx Clinical Site

    RECRUITING

    New York, New York, 10029, United States

  • ADARx Clinical Site

    RECRUITING

    Cincinnati, Ohio, 45236, United States

  • ADARx Clinical Site

    NOT_YET_RECRUITING

    Cleveland, Ohio, 44195, United States

  • ADARx Clinical Site

    WITHDRAWN

    Columbus, Ohio, 43235, United States

  • ADARx Clinical Site

    RECRUITING

    Toledo, Ohio, 43617, United States

  • ADARx Clinical Site

    RECRUITING

    Hershey, Pennsylvania, 17033, United States

  • ADARx Clinical Site

    RECRUITING

    Capital Federal, Buenos Aires, C1425BEN, Argentina

  • ADARx Clinical Site

    RECRUITING

    Buenos Aires, Buenos Aires F.D., C1035AAT, Argentina

  • ADARx Clinical Site

    RECRUITING

    Pilar, 1629, Argentina

  • ADARx Clinical Site

    RECRUITING

    Rosario, 2000, Argentina

  • ADARx Clinical Site

    NOT_YET_RECRUITING

    Campbelltown, New South Wales, 2560, Australia

  • ADARx Clinical Site

    RECRUITING

    Adelaide, South Australia, 5000, Australia

  • ADARx Clinical Site

    RECRUITING

    Vienna, 1090, Austria

  • ADARx Clinical Site

    RECRUITING

    Edegem, Antwerpen, 2650, Belgium

  • ADARx Clinical Site

    NOT_YET_RECRUITING

    Campinas, 13073-002, Brazil

  • ADARx Clinical Site

    NOT_YET_RECRUITING

    São Paulo, 01246-903, Brazil

  • ADARx Clinical Site

    RECRUITING

    Sofia, 1000, Bulgaria

  • ADARx Clinical Site

    WITHDRAWN

    Edmonton, Alberta, T6G 2R3, Canada

  • ADARx Clinical Site

    NOT_YET_RECRUITING

    Edmonton, Alberta, T6G 2R3, Canada

  • ADARx Clinical Site

    WITHDRAWN

    Ottawa, Ontario, K1H 1E4, Canada

  • ADARx Clinical Site

    RECRUITING

    Montreal, Quebec, H2W 1R7, Canada

  • ADARx Clinical Site

    RECRUITING

    Beijing, 100730, China

  • ADARx Clinical Site

    NOT_YET_RECRUITING

    Harbin, 150001, China

  • ADARx Clinical Site

    NOT_YET_RECRUITING

    Zhengzhou, 450003, China

  • ADARx Clinical Site

    RECRUITING

    Split, 21000, Croatia

  • ADARx Clinical Site

    RECRUITING

    Zagreb, 10000, Croatia

  • ADARx Clinical Site

    RECRUITING

    Hradec Králové, 500 05, Czechia

  • ADARx Clinical Site

    RECRUITING

    Prague, 15000, Czechia

  • ADARx Clinical Site

    RECRUITING

    Nice, Alpes-Maritimes, 06300, France

  • ADARx Clinical Site

    RECRUITING

    Tours, Indre-et-Loire, 37000, France

  • ADARx Clinical Site

    RECRUITING

    Grenoble, 38043, France

  • ADARx Clinical Site

    RECRUITING

    Montpellier, 34295, France

  • ADARx Clinical Site

    RECRUITING

    Paris, 75012, France

  • ADARx Clinical Site

    RECRUITING

    Tübingen, Baden-Wurttemberg, 72076, Germany

  • ADARx Clinical Site

    RECRUITING

    Hong Kong, 111, Hong Kong

  • ADARx Clinical Site

    RECRUITING

    Budapest, 1088, Hungary

  • ADARx Clinical Site

    RECRUITING

    Ramat Gan, Tel Aviv, 5262100, Israel

  • ADARx Clinical Site

    RECRUITING

    Ashkelon, 7830604, Israel

  • ADARx Clinical Site

    RECRUITING

    Tel Aviv, 64239, Israel

  • ADARx Clinical Site

    RECRUITING

    Palermo, 90100, Italy

  • ADARx Clinical Site

    RECRUITING

    Krakow, Poland

  • ADARx Clinical Site

    RECRUITING

    Lodz, 92-213, Poland

  • ADARx Clinical Site

    RECRUITING

    Wroclaw, 50-556, Poland

  • ADARx Clinical Site

    RECRUITING

    Belgrade, 11000, Serbia

  • ADARx Clinical Site

    NOT_YET_RECRUITING

    Mowbray, Capetown, 7700, South Africa

  • ADARx Clinical Site

    RECRUITING

    Barcelona, 08907, Spain

  • ADARx Clinical Site

    RECRUITING

    Madrid, 28007, Spain

  • ADARx Clinical Site

    RECRUITING

    Taichung, 40705, Taiwan

  • ADARx Clinical Site

    NOT_YET_RECRUITING

    Ankara, 06100, Turkey (Türkiye)

  • ADARx Clinical Site

    NOT_YET_RECRUITING

    Bornova, 35100, Turkey (Türkiye)

  • ADARx Clinical Site

    NOT_YET_RECRUITING

    Istanbul, 34093, Turkey (Türkiye)

  • ADARx Clinical Site

    NOT_YET_RECRUITING

    Kayseri, 38039, Turkey (Türkiye)

  • ADARx Clinical Site

    NOT_YET_RECRUITING

    Guildford, Surrey, GU2 7XX, United Kingdom

  • ADARx Clinical Site

    RECRUITING

    Cambridge, CB2 0QQ, United Kingdom

  • ADARx Clinical Site

    RECRUITING

    Cardiff, CF14 4YS, United Kingdom

  • ADARx Clinical Site

    RECRUITING

    London, E1 1BB, United Kingdom

  • ADARx Clinical Site

    RECRUITING

    Southampton, SO16 6YD, United Kingdom

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