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A Study of Navenibart in Participants With Hereditary Angioedema | Clinical Trials | Clareo Health

RECRUITINGPHASE3

A Study of Navenibart in Participants With Hereditary Angioedema

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Navenibart in Participants With Hereditary Angioedema (HAE)

NCT06842823•Astria Therapeutics, Inc.

View on ClinicalTrials.gov

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

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

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

Exclusion Criteria

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

Locations (79)

Site 9

Birmingham, Alabama, United States

Site 2

Scottsdale, Arizona, United States

Site 3

Little Rock, Arkansas, United States

Site 26

San Diego, California, United States

Site 14

San Diego, California, United States

Site 4

Santa Monica, California, United States

Site 1

Walnut Creek, California, United States

Site 8

Centennial, Colorado, United States

Site 11

Colorado Springs, Colorado, United States

Site 25

Tampa, Florida, United States

Key Dates

Start Date

March 20, 2025

Primary Completion Date

March 1, 2027

Completion Date

September 1, 2027

Last Updated

February 11, 2026

Enrollment

145

ESTIMATED participants

Conditions

Hereditary Angioedema (HAE)

Interventions

navenibart

DRUG

Placebo

DRUG

Contacts

Claire VanEenwyk, MD

CONTACT

1-617-349-1971 alphaorbit_general@astriatx.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 11, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Navenibart in Participants With Hereditary Angioedema

Inclusion Criteria

Exclusion Criteria

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