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New drug navenibart aims to tame hereditary swelling attacks

NCT ID NCT05695248

Disease control Sponsor: Astria Therapeutics, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early trial tested a new drug called navenibart in 29 people with hereditary angioedema (HAE), a condition that causes sudden, painful swelling attacks. Participants received one or two doses of the drug to check its safety and how well it might reduce attacks. The study is a first step to see if navenibart could become a new treatment for HAE.

What this could mean

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

Active substance
navenibart (also called STAR-0215)
What this could lead to
If it works, this could lead to a new treatment option that reduces swelling attacks in people with hereditary angioedema.
What could go wrong
This is an early, small trial (29 people) testing the drug for the first time in this condition. It may not prove effective or safe enough for wider use.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

29 people

The number who actually took part.

Started

Feb 2023

Finished

Mar 2025

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.

Inclusion Criteria: 1. Documented diagnosis of HAE (type I or II). The following must be met: a. Documented clinical history consistent with HAE (for example, subcutaneous or mucosal, nonpruritic swelling episodes without accompanying urticaria). 2. Experienced at least 2 HAE attacks during the Run-In period, as confirmed by an investigator based on meeting the protocol-specified definition of an HAE attack. Exclusion Criteria: 1. Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1 inhibitor deficiency, HAE with normal C1-INH (also known as HAE type III), idiopathic angioedema, or angioedema associated with urticaria. 2. Use of therapies prescribed for the prevention of HAE attacks prior to Screening: 1. lanadelumab within 90 days 2. berotralstat within 21 days 3. all other prophylactic therapies, within 7 days 3. Any exposure to angiotensin-converting enzyme inhibitors or any estrogen containing medications with systemic absorption (such as hormonal contraceptives or hormone replacement therapy) within 28 days prior to Screening. 4. Any exposure to androgens (for example, stanozolol, danazol, oxandrolone, methyltestosterone, testosterone) within 7 days prior to Screening.

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Conditions

The condition(s) this trial relates to.

angioedema 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.

Hereditary angioedema

Contacts and locations

Locations

  • AARA Research Center

    Dallas, Texas, 75231, United States

  • Acuro Research, Inc.

    Little Rock, Arkansas, 72205, United States

  • Addenbrooke's Hospital

    Cambridge, CB2 0QQ, United Kingdom

  • Allergy & Asthma Clinic of Northwest Arkansas

    Bentonville, Arkansas, 72712, United States

  • Allergy & Asthma Clinical Research

    Walnut Creek, California, 94598, United States

  • Allervie Clinical Research

    Birmingham, Alabama, 35209, United States

  • Charité Universitätsmedizin Berlin

    Berlin, 12203, Germany

  • Diagnostical Consultative Center Convex Ltd.

    Sofia, 1680, Bulgaria

  • Institute for Asthma and Allergy, PC

    Chevy Chase, Maryland, 20815, United States

  • Institute of Clinical Immunology/Allergology, Faculty Hospital

    Hradec Králové, 500 05, Czechia

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Medical Research of Arizona a Division of Allergy, Asthma & Immunology Associates, LTD.

    Scottsdale, Arizona, 85251, United States

  • Optimed Research

    Columbus, Ohio, 43235, United States

  • Ottawa Allergy Research Corporation

    Ottawa, Ontario, K1H 1E4, Canada

  • Penn State Health Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033, United States

  • Raffi Tachdjian MD, Inc

    Santa Monica, California, 90404, United States

  • St. James's Hospital

    Leeds, LS9 7TF, United Kingdom

  • UC San Diego US HAEA Angioedema Center

    San Diego, California, 92122, United States

  • University of Alberta

    Edmonton, Alberta, T6G 2R3, Canada

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

More trials for these conditions

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