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A Study to Investigate CSL312 in Subjects With Hereditary Angioedema (HAE)

NCT03712228 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2022-11-08

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

Factor XIIa antagonist monoclonal antibody

Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use

DRUG

Placebo

Buffer without active ingredient

Sponsors & Collaborators

  • CSL Behring

    lead INDUSTRY

Principal Investigators

  • Study Director · CSL Behring LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-29
Primary Completion
2021-10-15
Completion
2021-10-15
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Germany
  • Israel

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03712228 on ClinicalTrials.gov