A Long-Term Study of Navenibart in Participants With Hereditary Angioedema

NCT07204938 | Enrolling By Invitation Phase 3 FDA Drug

• 1 other identifier: STAR-0215-302
• Study Type: interventional
• Target: 145
• Locations: 18 countries
• Sites: 40

Brief Summary

This is a Phase 3 multicenter trial in 2 parts to evaluate the long-term safety and efficacy of navenibart in adult and adolescent participants with hereditary angioedema (HAE) who participated in STAR-0215-301 (NCT06842823; ALPHA-ORBIT). Part 1 provides all participants with navenibart in a dose-controlled fashion; Part 2 introduces a personalized dosing option (PDO) for participants based on individual needs.

Conditions

Hereditary Angioedema (HAE)

Keywords

HAE; Angioedema; Long-Term; Safety

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment-emergent adverse events (TEAEs)

  Day 1 through Month 48

Secondary Outcomes (8)

• Number of time-normalized investigator-confirmed HAE attacks

  Day 1 through Month 48

• Number of moderate or severe investigator-confirmed HAE attacks

  Day 1 through Month 48

• Number of investigator-confirmed HAE attacks that require on-demand treatment

  Day 1 through Month 48

• Percent reduction in monthly investigator-confirmed HAE attacks

  Day 1 through Month 48

• Time to first investigator-confirmed HAE attack after first dose

  Day 1 through Month 48

Study Arms (4)

Adult Dosing Regimen 1

EXPERIMENTAL

Participants will receive 600 mg of navenibart every 3 months.

Drug: navenibart

Adult Dosing Regimen 2

EXPERIMENTAL

Participants will receive 300 mg of navenibart every 3 months.

Drug: navenibart

Adult Dosing Regimen 3

EXPERIMENTAL

Participants will receive 600 mg of navenibart every 6 months.

Drug: navenibart

Adolescent Dosing Regimen 1

EXPERIMENTAL

Participants will receive 300 mg of navenibart every 3 months.

Drug: navenibart

Interventions

navenibart DRUG

Navenibart will be administered as a subcutaneous injection.

Also known as: STAR-0215

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

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:

• \. Participants from STAR-0215-301 who met one of the following conditions:
• Completed STAR-0215-301 through the Day 181 visit
• 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

You may not qualify if:

• 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
• 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.
• Known sensitivity to the ingredients in the formulation of IP

Sponsors & Collaborators

• Astria Therapeutics, Inc.: lead

Study Sites (40)

Site 2

Scottsdale, Arizona, 85251, United States

Location

Site 3

Little Rock, Arkansas, 72205, United States

Location

Site 7

San Diego, California, 92122, United States

Location

Site 4

Santa Monica, California, 90404, United States

Location

Site 1

Walnut Creek, California, 94598, United States

Location

Site 5

Centennial, Colorado, 80112, United States

Location

Site 19

Colorado Springs, Colorado, 80907, United States

Location

Site 21

Wheaton, Maryland, 20902, United States

Location

Site 6

Cincinnati, Ohio, 45236, United States

Location

Site 9

Hershey, Pennsylvania, 17033, United States

Location

Site 22

Santo André, 09060870, Brazil

Location

Site 20

Sofia, 1680, Bulgaria

Location

Site 23

Edmonton, AB T6G 2B7, Canada

Location

Site 36

Prague, 150 06, Czechia

Location

Site 39

Paris, 75012, France

Location

Site 25

Frankfurt, D-60590, Germany

Location

Site 10

Hong Kong, Hong Kong

Location

Site 29

Ashkelon, 783604, Israel

Location

Site 30

Haifa, 3104802, Israel

Location

Site 31

Petah Tikva, 49100, Israel

Location

Site 24

Petah Tikva, 4920235, Israel

Location

Site 37

Milan, 20157, Italy

Location

Site 38

Monserrato, 09042, Italy

Location

Site 40

Kawagoe, Saitama, 350-0844, Japan

Location

Site 27

Fukuoka, 830-0011, Japan

Location

Site 33

Kawasaki, 216-8511, Japan

Location

Site 17

Amsterdam, Netherlands

Location

Site 18

Skopje, 1000, North Macedonia

Location

Site 35

Krakow, 31-503, Poland

Location

Site 16

Rzeszów, 35-051, Poland

Location

Site 32

San Juan, 00918, Puerto Rico

Location

Site 11

Cape Town, South Africa

Location

Site 34

Madrid, 28007, Spain

Location

Site 26

Valencia, 46026, Spain

Location

Site 12

Bristol, BS10 5N, United Kingdom

Location

Site 8

Cambridge, CB2 0QQ, United Kingdom

Location

Site 28

Frimley, GU16 7UJ, United Kingdom

Location

Site 15

Hampstead, NW3 2QG, United Kingdom

Location

Site 13

London, E1 2ES, United Kingdom

Location

Site 14

Plymouth, PL6 8HD, 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: NON RANDOMIZED
• Masking: NONE
• Masking Details: All participants will knowingly receive navenibart, however participants, care providers, investigators, and outcome assessors will be blinded to their treatment arm for a duration specific to the individual.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: In Part 1, adult participants who completed STAR-0215-301 and received navenibart will maintain their fixed dosing regimen from STAR-0215-301, whereas those who were randomized to placebo in STAR-0215-301 will receive navenibart 600 mg Q3M. In Part 2, adult participants may move among dosing regimens via the personalized dosing option (PDO) based on their individual needs. Adult participants who did not complete STAR-0215-301 may be eligible to enroll in Part 2 of STAR-0215-302 if they meet certain criteria. Adolescent participants will continue to receive their fixed dosing regimen from STAR-0215-301 until they turn 18 years of age.

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: October 3, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): June 1, 2031
• Study Completion (Estimated): December 1, 2031
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (10); CZ (1); FR (1); IT (2); PR (1); NL (1); JP (3); DE (1); ZA (1); BR (1); ES (2); PL (2); BU (1); IL (4); CA (1); NO (1); GB (6); HK (1)