CompletedPhase 1/2

A Study of Navenibart (STAR-0215) in Participants With Hereditary Angioedema

United States29 participantsStarted 2023-02-21

Plain-language summary

The goal of this clinical trial is to test the drug navenibart in participants with hereditary angioedema (HAE). One group of participants will get 1 dose of navenibart, and 2 other groups will get 2 doses of navenibart. Researchers will study the effects of navenibart in participants with HAE as this is the first time that the drug has been given to participants with HAE.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Documented diagnosis of HAE (type I or II). The following must be met:
✓. 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 C1 inhibitor 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:
✕. lanadelumab within 90 days
✕. berotralstat within 21 days
✕. all other prophylactic therapies, within 7 days
✕. 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.

What they're measuring

Number of Participants Experiencing Treatment-emergent Adverse Events

Timeframe: Day 1 through Day 448 (Cohort 1), Day 531 (Cohort 2), Day 475 (Cohort 3)

Trial details

NCT IDNCT05695248

SponsorAstria Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-03-13

Results submitted2026-03-12

View on ClinicalTrials.gov More Hereditary Angioedema trials