A Study of STAR-0215 in Participants With Hereditary Angioedema

Last updated: April 9, 2025
Sponsor: Astria Therapeutics, Inc.
Overall Status: Completed

Phase

1/2

Condition

Allergy

Hereditary Angioedema

Urticaria

Treatment

STAR-0215

Clinical Study ID

NCT05695248
STAR-0215-201
2022-502953-32
  • Ages > 18
  • All Genders

Study Summary

The goal of this clinical trial is to test the drug STAR-0215 in participants with hereditary angioedema (HAE). One group of participants will get 1 dose of STAR-0215, and two other groups will get 2 doses of STAR-0215. Researchers will study the effects of STAR-0215 in participants with HAE as this is the first time that the drug has been given to participants with HAE.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Documented diagnosis of HAE (type I or II). The following must be met: a. Documented clinical history consistent with HAE (for example, subcutaneous ormucosal, nonpruritic swelling episodes without accompanying urticaria).

  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:

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

  2. Use of therapies prescribed for the prevention of HAE attacks prior to Screening:

  3. lanadelumab within 90 days

  4. berotralstat within 21 days

  5. all other prophylactic therapies, within 7 days

  6. Any exposure to angiotensin-converting enzyme inhibitors or any estrogen containingmedications with systemic absorption (such as hormonal contraceptives or hormonereplacement therapy) within 28 days prior to Screening.

  7. Any exposure to androgens (for example, stanozolol, danazol, oxandrolone,methyltestosterone, testosterone) within 7 days prior to Screening.

Study Design

Total Participants: 29
Treatment Group(s): 1
Primary Treatment: STAR-0215
Phase: 1/2
Study Start date:
February 21, 2023
Estimated Completion Date:
March 13, 2025

Study Description

This is a Phase 1b/2 single and multiple dose trial evaluating the safety, tolerability, clinical activity, pharmacokinetics, pharmacodynamics, and immunogenicity of subcutaneous administration of STAR-0215 in participants with type I or type II HAE in 3 dose cohorts. The first cohort will receive 1 dose of STAR-0215; the second and third cohorts will receive 2 sequential doses. This is the first trial of STAR-0215 in participants with HAE and the first evaluation of a multiple-dose regimen. After the required follow up period, participants who are willing and eligible to consent can begin participation in the long-term open label extension study (STAR-0215-202, ALPHA-SOLAR).

Connect with a study center

  • Diagnostical Consultative Center Convex Ltd.

    Sofia, 1680
    Bulgaria

    Site Not Available

  • University of Alberta

    Edmonton, Alberta T6G 2R3
    Canada

    Site Not Available

  • Ottawa Allergy Research Corporation

    Ottawa, Ontario K1H 1E4
    Canada

    Site Not Available

  • Institute of Clinical Immunology/Allergology, Faculty Hospital

    Hradec Králové, 500 05
    Czechia

    Site Not Available

  • Charité Universitätsmedizin Berlin

    Berlin, 12203
    Germany

    Site Not Available

  • Addenbrooke's Hospital

    Cambridge, CB2 0QQ
    United Kingdom

    Site Not Available

  • St. James's Hospital

    Leeds, LS9 7TF
    United Kingdom

    Site Not Available

  • Allervie Clinical Research

    Birmingham, Alabama 35209
    United States

    Site Not Available

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

    Scottsdale, Arizona 85251
    United States

    Site Not Available

  • Allergy & Asthma Clinic of Northwest Arkansas

    Bentonville, Arkansas 72712
    United States

    Site Not Available

  • Acuro Research, Inc.

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Little Rock Allergy & Asthma Clinical Research Center

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • UC San Diego US HAEA Angioedema Center

    San Diego, California 92122
    United States

    Site Not Available

  • Raffi Tachdjian MD, Inc

    Santa Monica, California 90404
    United States

    Site Not Available

  • Allergy & Asthma Clinical Research

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Institute for Asthma and Allergy, PC

    Chevy Chase, Maryland 20815
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Optimed Research

    Columbus, Ohio 43235
    United States

    Site Not Available

  • Penn State Health Milton S. Hershey Medical Center

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • AARA Research Center

    Dallas, Texas 75231
    United States

    Site Not Available

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