A Study of Navenibart in Participants With Hereditary Angioedema

Last updated: April 24, 2025
Sponsor: Astria Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Hives (Urticaria)

Allergy

Urticaria

Treatment

navenibart

Placebo

Clinical Study ID

NCT06842823
STAR-0215-301
  • Ages > 12
  • All Genders

Study 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 Criteria

Inclusion

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

Exclusion

Exclusion Criteria:

  • Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1inhibitor deficiency, HAE with normal C1-INH (also known as HAE type 3), idiopathicangioedema, or angioedema associated with urticaria.

  • Use of therapies prescribed for the prevention of HAE attacks may not be used duringthe trial or within the below time frames prior to the Run-In Period (adultparticipants may be on these medications at the time of the Screening Visit, butwill need to washout prior to entering the Run-In Period):

  1. Lanadelumab within 90 days prior to Run-In

  2. Berotralstat within 21 days prior to Run-In

  3. Plasma-derived C1INH for LTP within 14 days prior to Run-In

  4. Tranexamic acid, oral danazol, oral stanazolol, and oral oxandrolone within 3days prior to Run-In

  5. All other prophylactic therapies, including investigational drugs, requireconsultation with the Medical Monitor

Study Design

Total Participants: 145
Treatment Group(s): 2
Primary Treatment: navenibart
Phase: 3
Study Start date:
March 20, 2025
Estimated Completion Date:
September 30, 2027

Connect with a study center

  • Site 5

    Ottawa, Ontario K1H 1E4
    Canada

    Active - Recruiting

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

    Scottsdale, Arizona 85251
    United States

    Active - Recruiting

  • Site 2

    Scottsdale, Arizona 85251
    United States

    Active - Recruiting

  • Acuro Research, Inc.

    Little Rock, Arkansas 72205
    United States

    Active - Recruiting

  • Little Rock Allergy & Asthma Clinical Research Center

    Little Rock, Arkansas 72205
    United States

    Active - Recruiting

  • Site 3

    Little Rock, Arkansas 72205
    United States

    Active - Recruiting

  • Raffi Tachdjian MD, Inc

    Santa Monica, California 90404
    United States

    Active - Recruiting

  • Site 4

    Santa Monica, California 90404
    United States

    Active - Recruiting

  • Allergy & Asthma Clinical Research

    Walnut Creek, California 94598
    United States

    Active - Recruiting

  • Site 1

    Walnut Creek, California 94598
    United States

    Active - Recruiting

  • Site 6

    Wheaton, Maryland 20902
    United States

    Active - Recruiting

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