CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 22 enrolled / 22 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/NCT05819775
NCT05819775Phase 3CompletedMonitor (0.6/mo)Completion was 7mo ago
CompareCT.gov

A Phase 3 Open-label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema in Pediatric Subjects 2 to 11 Years of Age

CSL Behring·interventional·Posted Apr 19, 2023·Updated Jun 2, 2026

In Brief

A Phase 3 clinical trial evaluating CSL312 for Hereditary Angioedema (HAE). Completed, enrolled 22 participants across 13 sites in 5 countries.

Signals

Enrolling slower than its timeline implies

Detailed Summary

The purpose of this study is to investigate the safety, PK / PD, and efficacy of SC CSL312 for prophylactic treatment of pediatric subjects with HAE.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHereditary Angioedema (HAE)
CountriesAustralia, Canada, Germany, Israel, United States
Collaborators--

Timeline

Phase 3CompletedFinished
202420252026
First PostedApr 19, 2023
Enrollment StartMay 30, 2023
Primary CompletionNov 19, 2025
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 3.2 years ago

Arms & Interventions

CSL312experimental

Ages 2-5 years and 6-11 years will have specific subcutaneous dosing schedules

Biological: CSL312

Interventions

CSL312biological

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