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

Description

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.

Conditions

Hereditary Angioedema

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Study Overview

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Study Details

Study overview

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.

A Phase 2 Long-Term Open-Label Trial to Assess the Safety and Efficacy of Repeat Dosing of STAR-0215 in Adult Patients With Hereditary Angioedema (The ALPHA-SOLAR Trial)

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

Condition
Hereditary Angioedema
Intervention / Treatment

-

Contacts and Locations

Birmingham

Alabama Allervie Clinical Research, Birmingham, Alabama, United States, 35209

Scottsdale

Medical Research of Arizona a Division of Allergy, Asthma & Immunology Associates, LTD, Scottsdale, Arizona, United States, 85251

Little Rock

Little Rock Allergy & Asthma Clinical Research Center, Little Rock, Arkansas, United States, 72205

San Diego

UC San Diego US HAEA Angioedema Center, San Diego, California, United States, 92122

Santa Monica

Raffi Tachdjian MD, Inc, Santa Monica, California, United States, 90404

Walnut Creek

Allergy & Asthma Clinical Research, Walnut Creek, California, United States, 94598

Chevy Chase

Institute for Asthma and Allergy, PC, Chevy Chase, Maryland, United States, 20815

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Saint Louis

Washington University School of Medicine, Saint Louis, Missouri, United States, 63110

Columbus

Optimed Research, Columbus, Ohio, United States, 43235

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Open to participants from STAR-0215-201 (NCT05695248) who have met one of the following 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 qualify for the Treatment Period because they did not meet the criterion for the minimum number of HAE attacks;
  • * Eligible for STAR-0215-201 and entered the Run-In period but did not complete it for reasons other than not meeting the criterion for the minimum number of HAE attacks (eligibility requires consultation with the Medical Monitor); or
  • * Discontinued STAR-0215-201 (for reasons other than safety) after having completed at least 84 days of trial follow-up since their last dose of STAR-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).
  • * Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1 inhibitor deficiency, HAE with normal C1-esterase inhibitor protein (also known as HAE Type III), idiopathic angioedema, or angioedema associated with urticaria.
  • * Any exposure to angiotensin-converting enzyme inhibitors or any estrogen-containing medications with systemic absorption (such as hormonal contraceptives or hormone replacement 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Astria Therapeutics, Inc.,

Study Record Dates

2031-03