At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 29 enrolled
Drug / intervention
Navenibartdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1b/2 Single and Multiple Dose Study to Assess the Safety, Tolerability, Clinical Activity, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of STAR-0215 in Participants With Hereditary Angioedema (The ALPHA-STAR Trial)
In Brief
A Phase 2 clinical trial evaluating Navenibart for Hereditary Angioedema. Completed, enrolled 29 participants across 20 sites in 6 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHereditary Angioedema
CountriesBulgaria, Canada, Czechia, Germany, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2023202420252026
First PostedJan 2023
Enrollment StartFeb 2023
Primary CompletionMar 2025
TodayJul 2026
First PostedJan 23, 2023
Enrollment StartFeb 21, 2023
Primary CompletionMar 13, 2025
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 3.4 years ago
Interventions
Navenibartdrug
Navenibart will be administered as a subcutaneous bolus injection.