A trial to learn about a study drug (STAR-0215) in adults with hereditary angioedema

Phase 1

Recruiting

• Conditions: Hereditary Angioedema (HAE); MedDRA version: 21.0Level: LLTClassification code: 10080960Term: Hereditary angioedema type II Class: 10010331; MedDRA version: 20.0Level: PTClassification code: 10019860Term: Hereditary angioedema Class: 100000004850; MedDRA version: 20.0Level: LLTClassification code: 10075280Term: Hereditary angioedema attack Class: 10010331; MedDRA version: 21.0Level: LLTClassification code: 10080956Term: Hereditary angioedema type I Class: 10010331; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: CTIS2022-502953-32-01
• Lead Sponsor: Astria Therapeutics Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-06
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

At least 18 years of age at the time of Screening., Willing and able to read, understand, and sign the IRB/IEC/REC approved informed consent form (ICF)., Documented diagnosis of HAE (Type I or II). All of the following must be met: a. Documented clinical history consistent with HAE (e.g. SC or mucosal, nonpruritic swelling episodes without accompanying urticaria); c. Age at reported onset of first angioedema symptoms 30 years of age or younger, or a family history consistent with HAE Type I or II., 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 C1inhibitor deficiency, HAE with normal C1-INH (also known as HAE Type III), idiopathic angioedema, or angioedema associated with urticaria., Use of therapies prescribed for the prevention of HAE attacks prior to Screening: a.lanadelumab within 90 days; b.berotralstat within 21 days; c.all other prophylactic therapies, within 7 days., Any exposure to angiotensin-converting enzyme (ACE) inhibitors or any estrogen-containing medications with systemic absorption (such as hormonal contraceptives or hormone replacement therapy [HRT]) within 28 days prior to Screening., Any exposure to androgens (e.g. stanozolol, danazol, oxandrolone, methyltestosterone, testosterone) within 7 days prior to Screening.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified