A trial to learn about the long-term safety and efficacy of a study drug (STAR-0215) in adult patients with hereditary angioedema

Phase 2

• Conditions: Hereditary angioedema (HAE); Circulatory System

• Registration Number: ISRCTN17914189
• Lead Sponsor: Astria Therapeutics, Inc. (USA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-18
• Last Update Posted: 12 August 2024
• Study Completion: 2029-09-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Open to participants from STAR-0215-201 (NCT05695248) who have met one of the following conditions:
1. Completed STAR-0215-201 (follow up through 6 months after their last dose)
2. 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
3. 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)
4. 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)

Exclusion Criteria

1. 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.
2. 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
3. Any exposure to androgens (for example, stanozolol, danazol, oxandrolone, methyltestosterone, testosterone) within 7 days prior to Screening.
4. Use of therapies prescribed for the prevention of HAE attacks prior to Screening:
4.1. Lanadelumab within 90 days
4.2. Berotralstat within 21 days
4.3. All other prophylactic therapies, discuss with the Medical Monitor
Note: Other inclusion and exclusion criteria may apply.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of participants experiencing treatment-emergent adverse events [time frame: day 1 through up to 6 years and 4 months]