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
Phase 3
Completed
- Conditions
- HAEHereditary angioedema10027664
- Registration Number
- NL-OMON50841
- Lead Sponsor
- CSL Behring LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 8
Inclusion Criteria
Male or female * 12 years of age; diagnosed with clinically confirmed C1-INH
hereditry angioedema; experience * 3 attacks during the 3 months before
Screening
Exclusion Criteria
Concomitant diagnosis of another form of angioedema such as idiopathic or
acquired angioedema, recurrent angioedema associated with urticarial or
hereditary angioedema type 3
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is the time-normalized number of HAE attacks during<br /><br>treatment from Day 1 through Day 182.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary endpoints of the study are:<br /><br>* The reduction in the attack rate during the Treatment Period compared to the<br /><br>Run-in Period.<br /><br>* The time-normalized number of HAE attacks requiring on-demand treatment.<br /><br>* The time-normalized number of moderate and / or severe HAE attacks.<br /><br>* The time-normalized number of HAE attacks at various time points during the<br /><br>treatment period.<br /><br>* Subject Global Assessment of Response to Treatment (SGART).<br /><br>* Adverse events (AEs).<br /><br>* Adverse events of special interest (AESIs).<br /><br>* Serious adverse events (SAEs).<br /><br>* CSL312 induced anti-CSL312 antibodies.<br /><br>* Clinically significant abnormalities in laboratory assessments (ie,<br /><br>laboratory abnormalities reported as AEs).</p><br>