At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 64 enrolled
Drug / intervention
CSL312 +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, Double-blind, Randomized, Placebo-controlled, Parallel-arm Study to Investigate the Efficacy and Safety of Subcutaneous Administration of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema
In Brief
A Phase 3 clinical trial evaluating CSL312 and Placebo for Hereditary Angioedema. Completed, enrolled 64 participants across 28 sites in 7 countries.
Detailed Summary
This is a multicenter, double-blind, randomized, placebo-controlled, parallel-arm study to investigate the efficacy and safety of subcutaneous administration of CSL312 (garadacimab) in the prophylactic treatment of hereditary angioedema.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHereditary Angioedema
CountriesCanada, Germany, Hungary, Israel, Japan, Netherlands, United States
Collaborators--
Timeline
Phase 3CompletedFinished
202120222023202420252026
First PostedDec 2020
Enrollment StartJan 2021
Primary CompletionJun 2022
TodayJul 2026
First PostedDec 7, 2020
Enrollment StartJan 27, 2021
Primary CompletionJun 7, 2022
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 5.6 years ago
Interventions
CSL312biological
Fully human immunoglobulin G subclass 4/lambda recombinant monoclonal antibody
Placebodrug
Buffer without active ingredient