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New hope for HAE: Long-Term trial of navenibart launches

NCT ID NCT07204938

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 31, 2026 · Updated 3 times

Summary

This Phase 3 trial tests the long-term safety and effectiveness of navenibart, an injectable drug, in 145 adults and teens with hereditary angioedema (HAE) who were in a previous study. The trial has two parts: first, everyone gets a fixed dose; then, some may switch to a personalized dose based on their needs. Researchers will track side effects and how well the drug prevents swelling attacks.

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), given as a shot under the skin
What this could lead to
If successful, this could provide a long-term treatment option to prevent swelling attacks in people with hereditary angioedema, potentially improving quality of life.
What could go wrong
This is an extension study, so participants already know the drug is safe enough to continue. However, long-term side effects are still being tracked, and the personalized dosing part is new, so its benefits are not yet proven.

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 145 people

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

Started

Oct 2025

Expected to finish

Dec 2031

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\. Participants from STAR-0215-301 who met one of the following conditions: 1. Completed STAR-0215-301 through the Day 181 visit 2. Withdrew from STAR-0215-301 but met the following criteria: i. Received 2 doses of IP ii. completed ≥ 2 months of trial follow-up after the second dose of IP iii. Met other eligibility criteria as assessed by Investigator Exclusion Criteria: 1. Participation in an investigational clinical trial other than STAR-0215- 301 in the 30 days or any exposure to an investigational drug (other than navenibart in STAR-0215-301) within 5 half-lives before informed consent/assent 2. Any exposure to angiotensin-converting enzyme (ACE) inhibitors or any estrogen containing medications with systemic absorption (such as hormonal contraceptives or hormone replacement therapy) within 30 days before Screening. 3. Known sensitivity to the ingredients in the formulation of IP

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Conditions

The condition(s) this trial relates to.

angioedema hereditary angioedema

As listed by the trial registrant

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

Hereditary angioedema (HAE)

How to take part

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

  1. The places running it

    40 sites in 18 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. 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

Locations

  • Site 1

    Walnut Creek, California, 94598, United States

  • Site 10

    Hong Kong, Hong Kong

  • Site 11

    Cape Town, South Africa

  • Site 12

    Bristol, BS10 5N, United Kingdom

  • Site 13

    London, E1 2ES, United Kingdom

  • Site 14

    Plymouth, PL6 8HD, United Kingdom

  • Site 15

    Hampstead, NW3 2QG, United Kingdom

  • Site 16

    Rzeszów, 35-051, Poland

  • Site 17

    Amsterdam, Netherlands

  • Site 18

    Skopje, 1000, North Macedonia

  • Site 19

    Colorado Springs, Colorado, 80907, United States

  • Site 2

    Scottsdale, Arizona, 85251, United States

  • Site 20

    Sofia, 1680, Bulgaria

  • Site 21

    Wheaton, Maryland, 20902, United States

  • Site 22

    Santo André, 09060870, Brazil

  • Site 23

    Edmonton, AB T6G 2B7, Canada

  • Site 24

    Petah Tikva, 4920235, Israel

  • Site 25

    Frankfurt, D-60590, Germany

  • Site 26

    Valencia, 46026, Spain

  • Site 27

    Fukuoka, 830-0011, Japan

  • Site 28

    Frimley, GU16 7UJ, United Kingdom

  • Site 29

    Ashkelon, 783604, Israel

  • Site 3

    Little Rock, Arkansas, 72205, United States

  • Site 30

    Haifa, 3104802, Israel

  • Site 31

    Petah Tikva, 49100, Israel

  • Site 32

    San Juan, 00918, Puerto Rico

  • Site 33

    Kawasaki, 216-8511, Japan

  • Site 34

    Madrid, 28007, Spain

  • Site 35

    Krakow, 31-503, Poland

  • Site 36

    Prague, 150 06, Czechia

  • Site 37

    Milan, 20157, Italy

  • Site 38

    Monserrato, 09042, Italy

  • Site 39

    Paris, 75012, France

  • Site 4

    Santa Monica, California, 90404, United States

  • Site 40

    Kawagoe, Saitama, 350-0844, Japan

  • Site 5

    Centennial, Colorado, 80112, United States

  • Site 6

    Cincinnati, Ohio, 45236, United States

  • Site 7

    San Diego, California, 92122, United States

  • Site 8

    Cambridge, CB2 0QQ, United Kingdom

  • Site 9

    Hershey, Pennsylvania, 17033, United States

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