At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 44 enrolled
Drug / intervention
Factor XIIa antagonist monoclonal antibody +1 morebiological
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 Multicenter, Randomized, Placebo-controlled, Parallel-arm Study to Investigate the Efficacy, Pharmacokinetics, and Safety of CSL312 in Subjects With Hereditary Angioedema
In Brief
A Phase 2 clinical trial evaluating Factor XIIa antagonist monoclonal antibody and Placebo for Hereditary Angioedema. Completed, enrolled 44 participants across 16 sites in 5 countries.
Detailed Summary
This is a multicenter, randomized, placebo-controlled, parallel-arm, phase 2 study to investigate the clinical efficacy, pharmacokinetics, and safety of CSL312 as prophylaxis to prevent attacks in subjects with HAE.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHereditary Angioedema
CountriesAustralia, Canada, Germany, Israel, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedOct 2018
Enrollment StartOct 2018
Primary CompletionOct 2021
TodayJul 2026
First PostedOct 19, 2018
Enrollment StartOct 29, 2018
Primary CompletionOct 15, 2021
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 7.7 years ago
Interventions
Factor XIIa antagonist monoclonal antibodybiological
Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use
Placebodrug
Buffer without active ingredient