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New shot could stop dangerous swelling attacks in HAE

NCT ID NCT06842823

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 01, 2026 · Updated 2 times

Summary

This Phase 3 trial tests whether navenibart, a drug given as a shot under the skin, can prevent attacks in people with hereditary angioedema (HAE). About 145 adults and teens with HAE type 1 or 2 will receive either navenibart or a placebo for 6 months. The main goal is to see if the drug reduces the number of confirmed HAE 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 it works, this could give people with HAE a new option to prevent painful and dangerous swelling attacks.
What could go wrong
This is still a controlled trial, so we don't know yet if navenibart works better than placebo. It may not prevent attacks for everyone, and side effects are possible.

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

157 people

The number who actually took part.

Started

Mar 2025

Expected to finish

Jun 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

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: * Documented diagnosis of HAE (Type 1 or 2). The following must be met: 1. Documented clinical history consistent with HAE 2. Lab findings consistent with HAE Type 1 or 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: * 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 3), idiopathic angioedema, or angioedema associated with urticaria. * Use of therapies prescribed for the prevention of HAE attacks may not be used during the trial or within the below time frames prior to the Run-In Period (adult participants may be on these medications at the time of the Screening Visit, but will need to washout prior to entering the Run-In Period). 1. Tranexamic acid, oral danazol, oral stanazolol, and oral oxandrolone within 3 days prior to Run-In 2. Plasma-derived C1INH for LTP within 14 days prior to Run-In 3. Berotralstat within 21 days prior to Run-In 4. Lanadelumab within 70 days prior to Run-In 5. Garadacimab within 90 days prior to Run-In

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Conditions

The condition(s) this trial relates to.

angioedema 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.

Hereditary angioedema (HAE)

Contacts and locations

Locations

  • Site 1

    Walnut Creek, California, 94598, United States

  • Site 10

    St Louis, Missouri, 63141, United States

  • Site 11

    Colorado Springs, Colorado, 80907, United States

  • Site 12

    Toledo, Ohio, 43617, United States

  • Site 13

    Detroit, Michigan, 48202, United States

  • Site 14

    San Diego, California, 92123,, United States

  • Site 15

    Hummelstown, Pennsylvania, 17036, United States

  • Site 16

    Cambridge, CB2 0QQ, United Kingdom

  • Site 17

    London, E1 2ES, United Kingdom

  • Site 18

    Plymouth, Devon, PL6 8HD, United Kingdom

  • Site 19

    Bristol, BS10 5N, United Kingdom

  • Site 2

    Scottsdale, Arizona, 85251, United States

  • Site 20

    Hong Kong, Hong Kong

  • Site 21

    Cape Town, 7700, South Africa

  • Site 22

    Frimley, GU16 7UJ, United Kingdom

  • Site 23

    Edmonton, AB T6G 2B7, Canada

  • Site 24

    Hampstead, London, NW3 2QG, United Kingdom

  • Site 25

    Tampa, Florida, 33613, United States

  • Site 26

    San Diego, California, 92122, United States

  • Site 27

    Amsterdam, Netherlands

  • Site 28

    Sofia, 1680, Bulgaria

  • Site 29

    Rzeszów, 35-051, Poland

  • Site 3

    Little Rock, Arkansas, 72205, United States

  • Site 30

    Fukuoka, Kurume-shi, 830-0011, Japan

  • Site 31

    Saitama, Soka-shi, 340-0041, Japan

  • Site 32

    Barcelona, Spain

  • Site 33

    Skopje, 1000, North Macedonia

  • Site 34

    Petah Tikva, 4920235, Israel

  • Site 35

    Petah Tikva, 49100, Israel

  • Site 36

    Valencia, 46026, Spain

  • Site 37

    Hradec Králové, 500 05, Czechia

  • Site 38

    Berlin, 12203, Germany

  • Site 39

    Prague, 150 06, Czechia

  • Site 4

    Santa Monica, California, 90404, United States

  • Site 40

    San Donato Milanese, 20097, Italy

  • Site 41

    Torino, 10128, Italy

  • Site 42

    Milan, 20138, Italy

  • Site 44

    Frankfurt, D-60590, Germany

  • Site 45

    Santo André, 09060870, Brazil

  • Site 46

    La Tronche, 38700, France

  • Site 47

    Saga, 849-8501, Japan

  • Site 48

    Seville, 41013, Spain

  • Site 49

    Haifa, 3104802, Israel

  • Site 5

    Ottawa, Ontario, K1H 1E4, Canada

  • Site 50

    Hiroshima, 734-8551, Japan

  • Site 51

    Monserrato, 09042, Italy

  • Site 51

    Monserrato, CA 09042, Italy

  • Site 52

    Paris, 75012, France

  • Site 53

    Tel Aviv, 6423906, Israel

  • Site 54

    Lille, 59037, France

  • Site 55

    Ashkelon, 7830604, Israel

  • Site 56

    Tsu, Mei, 514-8507, Japan

  • Site 57

    Hiroshima, 730-8518, Japan

  • Site 58

    Kawasaki, 216-8511, Japan

  • Site 59

    San Juan, 00918, Puerto Rico

  • Site 6

    Wheaton, Maryland, 20902, United States

  • Site 60

    Yangcheon, Seoul, South Korea

  • Site 61

    Kawagoe, Saitama, 350-8550, Japan

  • Site 62

    Seoul, Jongno, South Korea

  • Site 63

    Madrid, 28007, Spain

  • Site 64

    Budapest, 1088, Hungary

  • Site 65

    Marseille, 13005, France

  • Site 66

    Padova, 35128, Italy

  • Site 67

    Boston, Massachusetts, 02114, United States

  • Site 68

    Campbelltown, New South Wales, 2560, Australia

  • Site 69

    Weston, Florida, 33331, United States

  • Site 7

    Cincinnati, Ohio, 45236, United States

  • Site 70

    Hanover, 30625, Germany

  • Site 71

    Krakow, 31-503, Poland

  • Site 72

    Nice, 06202, France

  • Site 73

    Tokyo, 173-0032, Japan

  • Site 74

    Murdoch, WA 6150, Australia

  • Site 75

    Auckland, New Zealand

  • Site 76

    Melbourne, Victoria, Australia

  • Site 77

    Seongnam-si, South Korea

  • Site 78

    Lodz, 92-213, Poland

  • Site 79

    Warsaw, 04-141, Poland

  • Site 8

    Centennial, Colorado, 80112, United States

  • Site 80

    Nagasaki, 852-8501, Japan

  • Site 81

    Coimbra, 3004-561, Portugal

  • Site 82

    Lisbon, 1649-028, Portugal

  • Site 83

    Vienna, 1090, Austria

  • Site 84

    Santa Cruz de Tenerife, 38010, Spain

  • Site 85

    Milan, 20157, Italy

  • Site 86

    Dallas, Texas, 75231, United States

  • Site 9

    Birmingham, Alabama, 35209, United States

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