A Study of Navenibart in Participants With Hereditary Angioedema

Last updated: February 9, 2026
Sponsor: Astria Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Hives (Urticaria)

Allergy

Urticaria

Treatment

Placebo

navenibart

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: 145
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
March 20, 2025
Estimated Completion Date:
September 30, 2027

Connect with a study center

  • Site 68

    Campbelltown 2172586, New South Wales 2155400 2560
    Australia

    Active - Recruiting

  • Site 76

    Melbourne 2158177, Victoria 2145234
    Australia

    Active - Recruiting

  • Site 74

    Murdoch 8349091, WA 6150
    Australia

    Active - Recruiting

  • Site 45

    Santo André 3449701, 09060870
    Brazil

    Active - Recruiting

  • Site 28

    Sofia 727011, 1680
    Bulgaria

    Active - Recruiting

  • Site 5

    Ottawa, Ontario K1H 1E4
    Canada

    Site Not Available

  • Site 5

    Ottawa 6094817, Ontario 6093943 K1H 1E4
    Canada

    Active - Recruiting

  • Site 23

    Edmonton 5946768, AB T6G 2B7
    Canada

    Active - Recruiting

  • Site 37

    Hradec Králové 3074967, 500 05
    Czechia

    Active - Recruiting

  • Site 39

    Prague 3067696, 150 06
    Czechia

    Active - Recruiting

  • Site 46

    La Tronche 3006131, 38700
    France

    Active - Recruiting

  • Site 54

    Lille 2998324, 59037
    France

    Active - Recruiting

  • Site 65

    Marseille 2995469, 13005
    France

    Active - Recruiting

  • Site 72

    Nice 2990440, 06202
    France

    Active - Recruiting

  • Site 52

    Paris 2988507, 75012
    France

    Active - Recruiting

  • Site 38

    Berlin 2950159, 12203
    Germany

    Active - Recruiting

  • Site 44

    Frankfurt 2925536, D-60590
    Germany

    Active - Recruiting

  • Site 70

    Hanover 2910831, 30625
    Germany

    Active - Recruiting

  • Site 20

    Hong Kong 1819729,
    Hong Kong

    Active - Recruiting

  • Site 64

    Budapest 3054643, 1088
    Hungary

    Active - Recruiting

  • Site 55

    Ashkelon 295620, 7830604
    Israel

    Active - Recruiting

  • Site 49

    Haifa 294801, 3104802
    Israel

    Active - Recruiting

  • Site 34

    Petah Tikva 293918, 4920235
    Israel

    Active - Recruiting

  • Site 35

    Petah Tikva 293918, 49100
    Israel

    Active - Recruiting

  • Site 53

    Tel Aviv 293397, 6423906
    Israel

    Active - Recruiting

  • Site 42

    Milan 3173435, 20138
    Italy

    Active - Recruiting

  • Sie 51

    Monserrato 2524084, 09042
    Italy

    Active - Recruiting

  • Site 51

    Monserrato 2524084, CA 09042
    Italy

    Active - Recruiting

  • Site 66

    Padua 3171728, 35128
    Italy

    Active - Recruiting

  • Site 40

    San Donato Milanese 3168414, 20097
    Italy

    Active - Recruiting

  • Site 41

    Torino 8980539, 10128
    Italy

    Active - Recruiting

  • Site 30

    Fukuoka 1863967, Kurume-shi 830-0011
    Japan

    Active - Recruiting

  • Site 56

    Tsu 1849796, Mei 514-8507
    Japan

    Active - Recruiting

  • Site 61

    Kawagoe 1859740, Saitama 1853226 350-8550
    Japan

    Active - Recruiting

  • Site 31

    Saitama 6940394, Soka-shi 340-0041
    Japan

    Active - Recruiting

  • Site 50

    Hiroshima 1862415, 734-8551
    Japan

    Active - Recruiting

  • Site 57

    Hiroshima 1862415, 730-8518
    Japan

    Active - Recruiting

  • Site 58

    Kawasaki 1859642, 216-8511
    Japan

    Active - Recruiting

  • Site 47

    Saga 1853303, 849-8501
    Japan

    Active - Recruiting

  • Site 73

    Tokyo 1850147, 173-0032
    Japan

    Active - Recruiting

  • Site 27

    Amsterdam 2759794,
    Netherlands

    Active - Recruiting

  • Site 75

    Auckland 2193733,
    New Zealand

    Active - Recruiting

  • Site 33

    Skopje 785842, 1000
    North Macedonia

    Active - Recruiting

  • Site 71

    Krakow 3094802, 31-503
    Poland

    Active - Recruiting

  • Site 78

    Lodz 3093133, 92-213
    Poland

    Active - Recruiting

  • Site 29

    Rzeszów 759734, 35-051
    Poland

    Active - Recruiting

  • Site 59

    San Juan 4568127, 00918
    Puerto Rico

    Active - Recruiting

  • Site 21

    Cape Town 3369157, 7700
    South Africa

    Active - Recruiting

  • Site 62

    Seoul 1835848, Jongno
    South Korea

    Active - Recruiting

  • Site 60

    Yangcheon, Seoul 1835847
    South Korea

    Active - Recruiting

  • Site 77

    Seongnam-si 1897000,
    South Korea

    Active - Recruiting

  • Site 32

    Barcelona 3128760,
    Spain

    Active - Recruiting

  • Site 63

    Madrid 3117735, 28007
    Spain

    Active - Recruiting

  • Site 48

    Seville 2510911, 41013
    Spain

    Active - Recruiting

  • Site 36

    Valencia 2509954, 46026
    Spain

    Active - Recruiting

  • Site 18

    Plymouth 2640194, Devon PL6 8HD
    United Kingdom

    Active - Recruiting

  • Site 24

    Hampstead 2647553, London NW3 2QG
    United Kingdom

    Active - Recruiting

  • Site 19

    Bristol 2654675, BS10 5N
    United Kingdom

    Active - Recruiting

  • Site 16

    Cambridge 2653941, CB2 0QQ
    United Kingdom

    Active - Recruiting

  • Site 22

    Frimley 2649052, GU16 7UJ
    United Kingdom

    Active - Recruiting

  • Site 17

    London 2643743, E1 2ES
    United Kingdom

    Active - Recruiting

  • Site 9

    Birmingham, Alabama 35209
    United States

    Site Not Available

  • Site 9

    Birmingham 4049979, Alabama 4829764 35209
    United States

    Active - Recruiting

  • 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

  • Site 2

    Scottsdale 5313457, Arizona 5551752 85251
    United States

    Active - Recruiting

  • 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 3

    Little Rock 4119403, Arkansas 4099753 72205
    United States

    Active - Recruiting

  • Site 14

    San Diego, California 92123,
    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 26

    San Diego 5391811, California 5332921 92122
    United States

    Active - Recruiting

  • Site 4

    Santa Monica 5393212, California 5332921 90404
    United States

    Active - Recruiting

  • Site 1

    Walnut Creek 5406990, California 5332921 94598
    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 8

    Centennial 5416541, Colorado 5417618 80112
    United States

    Active - Recruiting

  • Site 11

    Colorado Springs 5417598, Colorado 5417618 80907
    United States

    Active - Recruiting

  • Site 25

    Tampa 4174757, Florida 4155751 33613
    United States

    Active - Recruiting

  • Site 69

    Weston 4178003, Florida 4155751 33331
    United States

    Active - Recruiting

  • Site 43

    Overland Park 4276873, Kansas 4273857 66211-1318
    United States

    Site Not Available

  • Site 6

    Wheaton, Maryland 20902
    United States

    Site Not Available

  • Site 6

    Wheaton 4373349, Maryland 4361885 20902
    United States

    Active - Recruiting

  • Site 67

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Active - Recruiting

  • Site 13

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Site 13

    Detroit 4990729, Michigan 5001836 48202
    United States

    Active - Recruiting

  • Site 10

    St. Louis, Missouri 63141
    United States

    Site Not Available

  • Site 10

    St Louis 4407066, Missouri 4398678 63141
    United States

    Active - Recruiting

  • Site 7

    Cincinnati, Ohio 45236
    United States

    Site Not Available

  • Site 12

    Toledo, Ohio 43617
    United States

    Site Not Available

  • Site 7

    Cincinnati 4508722, Ohio 5165418 45236
    United States

    Active - Recruiting

  • Site 12

    Toledo 5174035, Ohio 5165418 43617
    United States

    Active - Recruiting

  • Site 15

    Hummelstown 5194513, Pennsylvania 6254927 17036
    United States

    Active - Recruiting

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