CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 171 enrolled / 171 target
Drug / intervention
CSL312biological
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.

Search/NCT04739059
NCT04739059Phase 3CompletedMonitor (2.7/mo)Completion was 7mo ago
CompareCT.gov

An Open-label Study to Evaluate the Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema

CSL Behring·interventional·Posted Feb 4, 2021·Updated Jun 2, 2026

In Brief

A Phase 3 clinical trial evaluating CSL312 for Hereditary Angioedema. Completed, enrolled 171 participants across 44 sites in 14 countries.

Signals

Enrolling slower than its timeline implies

Detailed Summary

This phase 3b study will evaluate long-term safety and efficacy of CSL312 (also known as garadacimab) when administered subcutaneously (SC)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHereditary Angioedema
CountriesAustralia, Canada, Czechia, Germany, Hong Kong, Hungary, Israel, Japan, Netherlands, New Zealand, Russia, Spain, Taiwan, United States
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedFeb 4, 2021
Enrollment StartMar 29, 2021
Primary CompletionNov 21, 2025
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 5.4 years ago

Arms & Interventions

CSL312experimental

Fully human immunoglobulin G subclass 4/lambda recombinant inhibitor monoclonal antibody administered subcutaneously

Biological: CSL312

Interventions

CSL312biological

Fully human immunoglobulin G subclass 4/lambda recombinant inhibitor monoclonal antibody