A Long-term Study of STAR-0215 in Participants With Hereditary Angioedema

Last updated: March 13, 2025
Sponsor: Astria Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Allergies & Asthma

Allergy

Urticaria

Treatment

STAR-0215

Clinical Study ID

NCT06007677
STAR-0215-202
2023-506540-16
  • Ages > 18
  • All Genders

Study Summary

The goal of this trial is to enable the collection of information about long-term safety and clinical activity of STAR-0215 in participants with hereditary angioedema (HAE). Participants will receive repeat doses of STAR-0215 for up to 5 years.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Open to participants from STAR-0215-201 (NCT05695248) who have met one of thefollowing conditions:

  • Completed STAR-0215-201 (follow up through 6 months after their last dose);

  • Eligible for STAR-0215-201 and entered the Run-In period but did not qualifyfor the Treatment Period because they did not meet the criterion for theminimum number of HAE attacks;

  • Eligible for STAR-0215-201 and entered the Run-In period but did not completeit for reasons other than not meeting the criterion for the minimum number ofHAE attacks (eligibility requires consultation with the Medical Monitor); or

  • Discontinued STAR-0215-201 (for reasons other than safety) after havingcompleted at least 84 days of trial follow-up since their last dose ofSTAR-0215 (eligibility requires consultation with the Medical Monitor).

  • Open to participants who are STAR-0215 naïve and were not enrolled in STAR-0215-201 (NCT05695248), have a documented diagnosis of HAE (Type 1 or Type 2).

Exclusion

Exclusion Criteria:

  • Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1inhibitor deficiency, HAE with normal C1-esterase inhibitor protein (also known asHAE Type III), idiopathic angioedema, or angioedema associated with urticaria.

  • 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

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

  • 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, discuss with the Medical Monitor

Note: Other inclusion and exclusion criteria may apply.

Study Design

Total Participants: 56
Treatment Group(s): 1
Primary Treatment: STAR-0215
Phase: 2
Study Start date:
September 26, 2023
Estimated Completion Date:
March 31, 2031

Connect with a study center

  • Diagnostic Consultative Center Convex Ltd.

    Sofia, 1680
    Bulgaria

    Active - Recruiting

  • 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 Kralove

    Hradec Králové, 550 05
    Czechia

    Active - Recruiting

  • Charité Universitätsmedizin Berlin

    Berlin, 12203
    Germany

    Active - Recruiting

  • Universitätsklinikum Frankfurt

    Frankfurt, 60596
    Germany

    Active - Recruiting

  • Addenbrooke's Hospital

    Cambridge, CB2 0QQ
    United Kingdom

    Active - Recruiting

  • St. James's Hospital

    Leeds, LS9 7TF
    United Kingdom

    Active - Recruiting

  • Alabama 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

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

    Scottsdale, Arizona 85251
    United States

    Site Not Available

  • Little Rock Allergy & Asthma Clinical Research Center

    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

    Active - Recruiting

  • 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

  • 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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