A Study of Navenibart in Participants With Hereditary Angioedema

Purpose

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.

Condition

  • Hereditary Angioedema (HAE)

Eligibility

Eligible Ages
Over 12 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Adult participants will be randomly assigned to one of 4 arms. Adolescent participants will be assigned to a single experimental group.
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Adult Navenibart Dosing Regimen 1 		Participants will receive 600 mg of navenibart every 3 months.
  • Drug: navenibart
    Navenibart will be administered as a subcutaneous injection.
    Other names:
    • STAR-0215
Experimental
Adult Navenibart Dosing Regimen 2 		Participants will receive 600 mg of navenibart on Day 1 and 300 mg every 3 months starting at month 3.
  • Drug: navenibart
    Navenibart will be administered as a subcutaneous injection.
    Other names:
    • STAR-0215
Experimental
Adult Navenibart Dosing Regimen 3 		Participants will receive 600 mg of navenibart every 6 months.
  • Drug: navenibart
    Navenibart will be administered as a subcutaneous injection.
    Other names:
    • STAR-0215
Placebo Comparator
Placebo (adult) 		Participants will receive placebo every 3 months.
  • Drug: Placebo
    Placebo will be administered as a subcutaneous injection.
Experimental
Adolescent Navenibart Dosing Regimen 1 		Participants will receive 600 mg of navenibart on Day 1 and 300 mg every 3 months starting at month 3.
  • Drug: navenibart
    Navenibart will be administered as a subcutaneous injection.
    Other names:
    • STAR-0215

Recruiting Locations

Site 9
Birmingham, Alabama 35209

Site 2
Scottsdale, Arizona 85251

Site 3
Little Rock, Arkansas 72205

Site 26
San Diego, California 92122

Site 14
San Diego, California 92123,

Site 4
Santa Monica, California 90404

Site 1
Walnut Creek, California 94598

Site 8
Centennial, Colorado 80112

Site 11
Colorado Springs, Colorado 80907

Site 25
Tampa, Florida 33613

Site 69
Weston, Florida 33331

Site 6
Wheaton, Maryland 20902

Site 67
Boston, Massachusetts 02114

Site 13
Detroit, Michigan 48202

Site 10
St Louis, Missouri 63141

Site 7
Cincinnati, Ohio 45236

Site 12
Toledo, Ohio 43617

Site 15
Hummelstown, Pennsylvania 17036

Site 59
San Juan, Puerto Rico 00918

More Details

Status
Recruiting
Sponsor
Astria Therapeutics, Inc.

Study Contact

Claire VanEenwyk, MD
1-617-349-1971
alphaorbit_general@astriatx.com