A Study of Navenibart (STAR-0215) in Participants With Hereditary Angioedema

NCT05695248 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: STAR-0215-2012022-502953-32
• Study Type: interventional
• Target: 29
• Locations: 6 countries
• Sites: 20

Brief Summary

The goal of this clinical trial is to test the drug navenibart in participants with hereditary angioedema (HAE). One group of participants will get 1 dose of navenibart, and 2 other groups will get 2 doses of navenibart. Researchers will study the effects of navenibart in participants with HAE as this is the first time that the drug has been given to participants with HAE.

Conditions

Hereditary Angioedema

Keywords

HAE; Angioedema

Outcome Measures

Primary Outcomes (1)

• Number of Participants Experiencing Treatment-emergent Adverse Events

  An adverse event was any untoward medical occurrence in a clinical investigation participant who was administered a pharmaceutical product that did not necessarily have a causal relationship with the treatment. A treatment-emergent adverse event was defined as any adverse event with an onset at the time of or following the start of treatment with study drug, or medical conditions present before the start of treatment that increased in severity or relationship at the time of or following the start of treatment. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' section.

  Day 1 through Day 448 (Cohort 1), Day 531 (Cohort 2), Day 475 (Cohort 3)

Secondary Outcomes (10)

• Percent Change From Baseline in Monthly Hereditary Angioedema (HAE) Attack Rate

  Baseline, Day 168 (Cohort 1), Day 251 (Cohort 2), Day 195 (Cohort 3)

• Number of Participants Who Were HAE Attack Free

  Baseline through Day 168 (Cohort 1), Day 251 (Cohort 2), Day 195 (Cohort 3)

• Severity of HAE Attacks Experienced by Participants

  Day 1 through Day 168 (Cohort 1), Day 251 (Cohort 2), and Day 195 (Cohort 3)

• Duration of HAE Attacks

  Day 1 through Day 168 (Cohort 1), Day 251 (Cohort 2), and Day 195 (Cohort 3)

• Number of HAE Attacks Requiring On-demand Therapy

  Day 1 through Day 168 (Cohort 1), Day 251 (Cohort 2), and Day 195 (Cohort 3)

Study Arms (3)

Cohort 1 - Single Dose

EXPERIMENTAL

Participants received 1 dose (450 milligrams \[mg\]) of navenibart.

Drug: Navenibart

Cohort 2 - Multiple Dose

EXPERIMENTAL

Participants received 2 doses (600 mg, 300 mg) of navenibart administered 3 months apart.

Drug: Navenibart

Cohort 3 - Multiple Dose

EXPERIMENTAL

Participants received 2 doses (600 mg) of navenibart administered 1 month apart.

Drug: Navenibart

Interventions

Navenibart DRUG

Navenibart will be administered as a subcutaneous bolus injection.

Also known as: STAR-0215

Cohort 1 - Single Dose; Cohort 2 - Multiple Dose; Cohort 3 - Multiple Dose

Eligibility Criteria

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

You may qualify if:

• Documented diagnosis of HAE (type I or II). The following must be met:
• a. Documented clinical history consistent with HAE (for example, subcutaneous or mucosal, nonpruritic swelling episodes without accompanying urticaria).
• 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 III), idiopathic angioedema, or angioedema associated with urticaria.
• Use of therapies prescribed for the prevention of HAE attacks prior to Screening:
• lanadelumab within 90 days
• berotralstat within 21 days
• all other prophylactic therapies, within 7 days
• Any exposure to angiotensin-converting enzyme inhibitors or any estrogen containing medications with systemic absorption (such as hormonal contraceptives or hormone replacement therapy) within 28 days prior to Screening.
• Any exposure to androgens (for example, stanozolol, danazol, oxandrolone, methyltestosterone, testosterone) within 7 days prior to Screening.

Sponsors & Collaborators

• Astria Therapeutics, Inc.: lead

Study Sites (20)

Allervie Clinical Research

Birmingham, Alabama, 35209, United States

Location

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

Scottsdale, Arizona, 85251, United States

Location

Allergy & Asthma Clinic of Northwest Arkansas

Bentonville, Arkansas, 72712, United States

Location

Acuro Research, Inc.

Little Rock, Arkansas, 72205, United States

Location

UC San Diego US HAEA Angioedema Center

San Diego, California, 92122, United States

Location

Raffi Tachdjian MD, Inc

Santa Monica, California, 90404, United States

Location

Allergy & Asthma Clinical Research

Walnut Creek, California, 94598, United States

Location

Institute for Asthma and Allergy, PC

Chevy Chase, Maryland, 20815, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Optimed Research

Columbus, Ohio, 43235, United States

Location

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

AARA Research Center

Dallas, Texas, 75231, United States

Location

Diagnostical Consultative Center Convex Ltd.

Sofia, 1680, Bulgaria

Location

University of Alberta

Edmonton, Alberta, T6G 2R3, Canada

Location

Ottawa Allergy Research Corporation

Ottawa, Ontario, K1H 1E4, Canada

Location

Institute of Clinical Immunology/Allergology, Faculty Hospital

Hradec Králové, 500 05, Czechia

Location

Charité Universitätsmedizin Berlin

Berlin, 12203, Germany

Location

Addenbrooke's Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

St. James's Hospital

Leeds, LS9 7TF, United Kingdom

Location

Related Publications (1)

• Banerji A, Craig T, Sitz K, Li HH, Lumry W, Adatia A, Yang W, Jacobs JS, Tachdjian R, Soong W, Manning M, Wedner J, Savic S, Manson A, Valerieva A, Gunsior M, Mugundu G, Cohen T, Bernard K, VanEenwyk C, Joseph K, Best JM, Morabito C, Riedl MA. Open-label phase 1b/2 trial of navenibart, a long-acting plasma kallikrein inhibitor for hereditary angioedema. J Allergy Clin Immunol. 2026 Mar 5:S0091-6749(26)00171-5. doi: 10.1016/j.jaci.2026.02.034. Online ahead of print.

  PMID: 41794053 RESULT

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

Results Point of Contact

• Title: Astria Therapeutics Medical Affairs
• Organization: Astria Therapeutics, Inc.

201study_general@astriatx.com

1-617-349-1971

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2023
• First Posted: January 23, 2023
• Study Start: February 21, 2023
• Primary Completion: March 13, 2025
• Study Completion: March 13, 2025
• Last Updated: May 8, 2026
• Results First Posted: May 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (13); BU (1); CZ (1); CA (2); GB (2); DE (1)