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

Launched by ASTRIA THERAPEUTICS, INC. · Aug 17, 2023

Keywords

ClinConnect Summary

This clinical trial, called STAR-0215, is looking at a new treatment for people with hereditary angioedema (HAE), a condition that causes painful swelling in different parts of the body. The main goal of the trial is to gather information about how safe and effective STAR-0215 is when given over a long period, with participants receiving the treatment for up to five years. The trial is currently recruiting participants, and it is open to anyone aged 18 and older who has been diagnosed with HAE, either Type 1 or Type 2, and meets specific criteria.

To be eligible for this study, participants must either have previously taken part in another STAR-0215 trial or be new to the treatment. Some important points to note are that individuals with other types of chronic angioedema or certain recent medication use may not qualify. If you join the trial, you can expect regular check-ins to monitor your health and the effects of the treatment. This study aims to provide valuable insights that could help improve care for those living with HAE.

Gender

ALL

Eligibility criteria

• Inclusion 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).
• Exclusion Criteria:
• • 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
• • Note: Other inclusion and exclusion criteria may apply.