A Study of Navenibart in Participants With Hereditary Angioedema

Last updated: June 29, 2026
Sponsor: Astria Therapeutics, Inc.
Overall Status: Active - Not Recruiting

Phase

3

Condition

Allergy

Urticaria

Hives (Urticaria)

Treatment

navenibart

Placebo

Clinical Study ID

NCT06842823
STAR-0215-301
  • Ages > 12
  • All Genders

Study Summary

This is a Phase 3 multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating the safety and efficacy of subcutaneous administration of navenibart in adult and adolescent participants with type 1 or type 2 hereditary angioedema (HAE). The goal of this clinical trial is to evaluate the efficacy and safety of navenibart compared to placebo in preventing HAE attacks in participants with HAE.

Eligibility Criteria

Inclusion

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 aninvestigator based on meeting the protocol-specified definition of an HAE attack.

Exclusion

Exclusion Criteria:

  • Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1inhibitor deficiency, HAE with normal C1-INH (also known as HAE type 3), idiopathicangioedema, or angioedema associated with urticaria.

  • Use of therapies prescribed for the prevention of HAE attacks may not be used duringthe trial or within the below time frames prior to the Run-In Period (adultparticipants may be on these medications at the time of the Screening Visit, butwill need to washout prior to entering the Run-In Period).

  1. Tranexamic acid, oral danazol, oral stanazolol, and oral oxandrolone within 3days 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

Study Design

Total Participants: 157
Treatment Group(s): 2
Primary Treatment: navenibart
Phase: 3
Study Start date:
March 20, 2025
Estimated Completion Date:
June 30, 2027

Connect with a study center

  • Site 68

    Campbelltown, New South Wales 2560
    Australia

    Site Not Available

  • Site 76

    Melbourne, Victoria
    Australia

    Site Not Available

  • Site 74

    Murdoch, WA 6150
    Australia

    Site Not Available

  • Site 83

    Vienna, 1090
    Austria

    Site Not Available

  • Site 45

    Santo André, 09060870
    Brazil

    Site Not Available

  • Site 28

    Sofia, 1680
    Bulgaria

    Site Not Available

  • Site 5

    Ottawa, Ontario K1H 1E4
    Canada

    Site Not Available

  • Site 23

    Edmonton, AB T6G 2B7
    Canada

    Site Not Available

  • Site 37

    Hradec Králové, 500 05
    Czechia

    Site Not Available

  • Site 39

    Prague, 150 06
    Czechia

    Site Not Available

  • Site 46

    La Tronche, 38700
    France

    Site Not Available

  • Site 54

    Lille, 59037
    France

    Site Not Available

  • Site 65

    Marseille, 13005
    France

    Site Not Available

  • Site 72

    Nice, 06202
    France

    Site Not Available

  • Site 52

    Paris, 75012
    France

    Site Not Available

  • Site 38

    Berlin, 12203
    Germany

    Site Not Available

  • Site 44

    Frankfurt, D-60590
    Germany

    Site Not Available

  • Site 70

    Hanover, 30625
    Germany

    Site Not Available

  • Site 20

    Hong Kong,
    Hong Kong

    Site Not Available

  • Site 64

    Budapest, 1088
    Hungary

    Site Not Available

  • Site 55

    Ashkelon, 7830604
    Israel

    Site Not Available

  • Site 49

    Haifa, 3104802
    Israel

    Site Not Available

  • Site 34

    Petah Tikva, 4920235
    Israel

    Site Not Available

  • Site 35

    Petah Tikva, 49100
    Israel

    Site Not Available

  • Site 35

    Petah Tikva 293918, 49100
    Israel

    Active - Recruiting

  • Site 53

    Tel Aviv, 6423906
    Israel

    Site Not Available

  • Site 42

    Milan, 20138
    Italy

    Site Not Available

  • Site 85

    Milan, 20157
    Italy

    Site Not Available

  • Sie 51

    Monserrato, 09042
    Italy

    Site Not Available

  • Site 51

    Monserrato, CA 09042
    Italy

    Site Not Available

  • Site 51

    Monserrato 2524084, CA 09042
    Italy

    Active - Recruiting

  • Site 66

    Padova, 35128
    Italy

    Site Not Available

  • Site 40

    San Donato Milanese, 20097
    Italy

    Site Not Available

  • Site 41

    Torino, 10128
    Italy

    Site Not Available

  • Site 30

    Fukuoka, Kurume-shi 830-0011
    Japan

    Site Not Available

  • Site 56

    Tsu, Mei 514-8507
    Japan

    Site Not Available

  • Site 61

    Kawagoe, Saitama 350-8550
    Japan

    Site Not Available

  • Site 31

    Saitama, Soka-shi 340-0041
    Japan

    Site Not Available

  • Site 50

    Hiroshima, 734-8551
    Japan

    Site Not Available

  • Site 57

    Hiroshima, 730-8518
    Japan

    Site Not Available

  • Site 50

    Hiroshima 1862415, 734-8551
    Japan

    Active - Recruiting

  • Site 58

    Kawasaki, 216-8511
    Japan

    Site Not Available

  • Site 80

    Nagasaki, 852-8501
    Japan

    Site Not Available

  • Site 47

    Saga, 849-8501
    Japan

    Site Not Available

  • Site 73

    Tokyo, 173-0032
    Japan

    Site Not Available

  • Site 27

    Amsterdam,
    Netherlands

    Site Not Available

  • Site 75

    Auckland,
    New Zealand

    Site Not Available

  • Site 33

    Skopje, 1000
    North Macedonia

    Site Not Available

  • Site 71

    Krakow, 31-503
    Poland

    Site Not Available

  • Site 78

    Lodz, 92-213
    Poland

    Site Not Available

  • Site 29

    Rzeszów, 35-051
    Poland

    Site Not Available

  • Site 79

    Warsaw, 04-141
    Poland

    Site Not Available

  • Site 81

    Coimbra, 3004-561
    Portugal

    Site Not Available

  • Site 82

    Lisbon, 1649-028
    Portugal

    Site Not Available

  • Site 59

    San Juan, 00918
    Puerto Rico

    Site Not Available

  • Site 21

    Cape Town, 7700
    South Africa

    Site Not Available

  • Site 62

    Seoul, Jongno
    South Korea

    Site Not Available

  • Site 60

    Yangcheon, Seoul
    South Korea

    Site Not Available

  • Site 77

    Seongnam-si,
    South Korea

    Site Not Available

  • Site 32

    Barcelona,
    Spain

    Site Not Available

  • Site 63

    Madrid, 28007
    Spain

    Site Not Available

  • Site 84

    Santa Cruz de Tenerife, 38010
    Spain

    Site Not Available

  • Site 48

    Seville, 41013
    Spain

    Site Not Available

  • Site 36

    Valencia, 46026
    Spain

    Site Not Available

  • Site 18

    Plymouth, Devon PL6 8HD
    United Kingdom

    Site Not Available

  • Site 24

    Hampstead, London NW3 2QG
    United Kingdom

    Site Not Available

  • Site 19

    Bristol, BS10 5N
    United Kingdom

    Site Not Available

  • Site 16

    Cambridge, CB2 0QQ
    United Kingdom

    Site Not Available

  • Site 22

    Frimley, GU16 7UJ
    United Kingdom

    Site Not Available

  • Site 17

    London, E1 2ES
    United Kingdom

    Site Not Available

  • Site 9

    Birmingham, Alabama 35209
    United States

    Site Not Available

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

    Scottsdale, Arizona 85251
    United States

    Active - Recruiting

  • Site 2

    Scottsdale, Arizona 85251
    United States

    Site Not Available

  • Acuro Research, Inc.

    Little Rock, Arkansas 72205
    United States

    Active - Recruiting

  • Little Rock Allergy & Asthma Clinical Research Center

    Little Rock, Arkansas 72205
    United States

    Active - Recruiting

  • Site 3

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Site 14

    San Diego, California 92123,
    United States

    Site Not Available

  • Site 26

    San Diego, California 92122
    United States

    Site Not Available

  • Raffi Tachdjian MD, Inc

    Santa Monica, California 90404
    United States

    Active - Recruiting

  • Site 4

    Santa Monica, California 90404
    United States

    Site Not Available

  • Allergy & Asthma Clinical Research

    Walnut Creek, California 94598
    United States

    Active - Recruiting

  • Site 1

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Site 14

    San Diego 5391811, California 5332921 92123,
    United States

    Active - Recruiting

  • Site 8

    Centennial, Colorado 80112
    United States

    Site Not Available

  • Site 11

    Colorado Springs, Colorado 80907
    United States

    Site Not Available

  • Site 25

    Tampa, Florida 33613
    United States

    Site Not Available

  • Site 69

    Weston, Florida 33331
    United States

    Site Not Available

  • Site 6

    Wheaton, Maryland 20902
    United States

    Site Not Available

  • Site 67

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Site 13

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Site 10

    St Louis, Missouri 63141
    United States

    Site Not Available

  • Site 7

    Cincinnati, Ohio 45236
    United States

    Site Not Available

  • Site 12

    Toledo, Ohio 43617
    United States

    Site Not Available

  • Site 15

    Hummelstown, Pennsylvania 17036
    United States

    Site Not Available

  • Site 86

    Dallas, Texas 75231
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.