A Study of Navenibart in Participants With Hereditary Angioedema

NCT06842823 | Active Not Recruiting Phase 3 FDA Drug

• 1 other identifier: STAR-0215-301
• Study Type: interventional
• Target: 157
• Locations: 23 countries
• Sites: 85

Brief 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.

Conditions

Hereditary Angioedema (HAE)

Keywords

HAE; Angioedema

Outcome Measures

Primary Outcomes (1)

• Number of time-normalized investigator-confirmed HAE attacks during the 6-month Treatment Period.

  Day 1 through Day 181

Secondary Outcomes (7)

• Number of moderate or severe investigator-confirmed HAE attacks during the 6-month Treatment Period.

  Day 1 through Day 181

• Number of investigator-confirmed HAE attacks that require on-demand treatment during the 6-month Treatment Period.

  Day 1 through Day 181

• Percent reduction in monthly investigator-confirmed HAE attacks in the 6-month Treatment Period versus the Run-In Period.

  Baseline through Day 181

• Time to first investigator-confirmed HAE attack after first and second dose.

  Day 1 through Day 181

• The number of participants responding to treatment, defined as a ≥ 50%, ≥ 70%, or ≥ 90% reduction from the Run-In Period in investigator-confirmed HAE attack rate (for adult participants: compared to placebo during the 6-month Treatment Period).

  Baseline through Day 181

Other Outcomes (1)

• Incidence of treatment-emergent adverse events.

  Day 1 through Day 361

Study Arms (5)

Adult Navenibart Dosing Regimen 1

EXPERIMENTAL

Participants will receive 600 mg of navenibart every 3 months.

Drug: navenibart

Adult Navenibart Dosing Regimen 2

EXPERIMENTAL

Participants will receive 600 mg of navenibart on Day 1 and 300 mg every 3 months starting at month 3.

Drug: navenibart

Adult Navenibart Dosing Regimen 3

EXPERIMENTAL

Participants will receive 600 mg of navenibart every 6 months.

Drug: navenibart

Placebo (adult)

PLACEBO COMPARATOR

Participants will receive placebo every 3 months.

Drug: Placebo

Adolescent Navenibart Dosing Regimen 1

EXPERIMENTAL

Participants will receive 600 mg of navenibart on Day 1 and 300 mg every 3 months starting at month 3.

Drug: navenibart

Interventions

navenibart DRUG

Navenibart will be administered as a subcutaneous injection.

Also known as: STAR-0215

Adolescent Navenibart Dosing Regimen 1; Adult Navenibart Dosing Regimen 1; Adult Navenibart Dosing Regimen 2; Adult Navenibart Dosing Regimen 3

Placebo DRUG

Placebo will be administered as a subcutaneous injection.

Placebo (adult)

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented diagnosis of HAE (Type 1 or 2). The following must be met:
• Documented clinical history consistent with HAE
• 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.

You may not qualify if:

• 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).
• Tranexamic acid, oral danazol, oral stanazolol, and oral oxandrolone within 3 days prior to Run-In
• Plasma-derived C1INH for LTP within 14 days prior to Run-In
• Berotralstat within 21 days prior to Run-In
• Lanadelumab within 70 days prior to Run-In
• Garadacimab within 90 days prior to Run-In

Sponsors & Collaborators

• Astria Therapeutics, Inc.: lead

Study Sites (86)

Site 9

Birmingham, Alabama, 35209, United States

Location

Site 2

Scottsdale, Arizona, 85251, United States

Location

Site 3

Little Rock, Arkansas, 72205, United States

Location

Site 26

San Diego, California, 92122, United States

Location

Site 14

San Diego, California, 92123,, United States

Location

Site 4

Santa Monica, California, 90404, United States

Location

Site 1

Walnut Creek, California, 94598, United States

Location

Site 8

Centennial, Colorado, 80112, United States

Location

Site 11

Colorado Springs, Colorado, 80907, United States

Location

Site 25

Tampa, Florida, 33613, United States

Location

Site 69

Weston, Florida, 33331, United States

Location

Site 6

Wheaton, Maryland, 20902, United States

Location

Site 67

Boston, Massachusetts, 02114, United States

Location

Site 13

Detroit, Michigan, 48202, United States

Location

Site 10

St Louis, Missouri, 63141, United States

Location

Site 7

Cincinnati, Ohio, 45236, United States

Location

Site 12

Toledo, Ohio, 43617, United States

Location

Site 15

Hummelstown, Pennsylvania, 17036, United States

Location

Site 86

Dallas, Texas, 75231, United States

Location

Site 68

Campbelltown, New South Wales, 2560, Australia

Location

Site 76

Melbourne, Victoria, Australia

Location

Site 74

Murdoch, WA 6150, Australia

Location

Site 83

Vienna, 1090, Austria

Location

Site 45

Santo André, 09060870, Brazil

Location

Site 28

Sofia, 1680, Bulgaria

Location

Site 5

Ottawa, Ontario, K1H 1E4, Canada

Location

Site 23

Edmonton, AB T6G 2B7, Canada

Location

Site 37

Hradec Králové, 500 05, Czechia

Location

Site 39

Prague, 150 06, Czechia

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Site 46

La Tronche, 38700, France

Location

Site 54

Lille, 59037, France

Location

Site 65

Marseille, 13005, France

Location

Site 72

Nice, 06202, France

Location

Site 52

Paris, 75012, France

Location

Site 38

Berlin, 12203, Germany

Location

Site 44

Frankfurt, D-60590, Germany

Location

Site 70

Hanover, 30625, Germany

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Site 20

Hong Kong, Hong Kong

Location

Site 64

Budapest, 1088, Hungary

Location

Site 55

Ashkelon, 7830604, Israel

Location

Site 49

Haifa, 3104802, Israel

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Site 35

Petah Tikva, 49100, Israel

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Site 34

Petah Tikva, 4920235, Israel

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Site 53

Tel Aviv, 6423906, Israel

Location

Site 42

Milan, 20138, Italy

Location

Site 85

Milan, 20157, Italy

Location

Site 51

Monserrato, 09042, Italy

Location

Site 51

Monserrato, CA 09042, Italy

Location

Site 66

Padova, 35128, Italy

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Site 40

San Donato Milanese, 20097, Italy

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Site 41

Torino, 10128, Italy

Location

Site 30

Fukuoka, Kurume-shi, 830-0011, Japan

Location

Site 56

Tsu, Mei, 514-8507, Japan

Location

Site 61

Kawagoe, Saitama, 350-8550, Japan

Location

Site 31

Saitama, Soka-shi, 340-0041, Japan

Location

Site 57

Hiroshima, 730-8518, Japan

Location

Site 50

Hiroshima, 734-8551, Japan

Location

Site 58

Kawasaki, 216-8511, Japan

Location

Site 80

Nagasaki, 852-8501, Japan

Location

Site 47

Saga, 849-8501, Japan

Location

Site 73

Tokyo, 173-0032, Japan

Location

Site 27

Amsterdam, Netherlands

Location

Site 75

Auckland, New Zealand

Location

Site 33

Skopje, 1000, North Macedonia

Location

Site 71

Krakow, 31-503, Poland

Location

Site 78

Lodz, 92-213, Poland

Location

Site 29

Rzeszów, 35-051, Poland

Location

Site 79

Warsaw, 04-141, Poland

Location

Site 81

Coimbra, 3004-561, Portugal

Location

Site 82

Lisbon, 1649-028, Portugal

Location

Site 59

San Juan, 00918, Puerto Rico

Location

Site 21

Cape Town, 7700, South Africa

Location

Site 62

Seoul, Jongno, South Korea

Location

Site 60

Yangcheon, Seoul, South Korea

Location

Site 77

Seongnam-si, South Korea

Location

Site 32

Barcelona, Spain

Location

Site 63

Madrid, 28007, Spain

Location

Site 84

Santa Cruz de Tenerife, 38010, Spain

Location

Site 48

Seville, 41013, Spain

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Site 36

Valencia, 46026, Spain

Location

Site 18

Plymouth, Devon, PL6 8HD, United Kingdom

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Site 24

Hampstead, London, NW3 2QG, United Kingdom

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Site 19

Bristol, BS10 5N, United Kingdom

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Site 16

Cambridge, CB2 0QQ, United Kingdom

Location

Site 22

Frimley, GU16 7UJ, United Kingdom

Location

Site 17

London, E1 2ES, United Kingdom

Location

MeSH Terms

Conditions

Angioedemas, Hereditary; Angioedema

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hereditary Complement Deficiency Diseases; Primary Immunodeficiency Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Immunologic Deficiency Syndromes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Adult participants will be randomly assigned to one of 4 arms. Adolescent participants will be assigned to a single experimental group.

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: February 24, 2025
• Study Start: March 20, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2); CZ (2); BR (1); GB (6); NZ (1); PR (1); HU (1); FR (5); IT (7); ZA (1); HK (1); NO (1); ES (5); AU (3); US (19); KR (3); JP (10); IL (5); BU (1); DE (3); PL (4); NL (1); PT (2)