CSL312 (garadacimab) in the prevention of hereditary angioedema attacks

JRCT ID: jRCT2031210056

Registered date:26/04/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Hereditary angioedema
• Date of first enrollment: 16/08/2021
• Target sample size: 60
• Countries of recruitment: Canada,Japan,Israel,Japan,Germany,Japan,Spain,Japan,Hungary,Japan,Netherland,Japan,USA,Japan,Italy,Japan
• Study type: Interventional
• Intervention(s): Subcutaneous injection of Factor XIIa antagonist monoclonal antibody (CSL312) 200 mg

Outcome(s)

• Primary Outcome: Time-normalized number of HAE attacks during treatment period (up to 6 months)

Secondary Outcome

1. Reduction in the HAE attack rate during the treatment period compared to the run-in period (up to 6 months)
2. Time-normalized number of attacks requiring on-demand treatment (6 months, and first 3 months and second 3 months)
3. Time-normalized number of moderate and/or severe HAE attacks (6 months, and first 3 months and second 3 months)
4. Time-normalized number of HAE attacks at various timepoints during the treatment period (first 3 months and second 3 months and 6 months)
5. Percent reduction in the time-normalized number of HAE attacks between CSL312 and Placebo (6 months, and first 3 months and second 3 months)
6. Subject's Global Assessment of Response to Therapy (SGART) (up to 6 months)
7. Number and percent of subjects with adverse events, adverse events of special interest, serious adverse events, CSL312-induced anti-CSL312 antibodies, clinically significant abnormalities in laboratory assessments (up to 8 months)

Key inclusion & exclusion criteria

• Age minimum: >= 12age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Male or female >= 12 years of age; diagnosed with clinically confirmed C1-INH hereditary angioedema; experience >= 3 attacks during the 3 months before screening
• Exclude criteria: Concomitant diagnosis of another form of angioedema such as idiopathic or acquired angioedema, recurrent angioedema associated with urticarial or hereditary angioedema type 3

Related Information

• Primary Sponsor: Akama Hideto
• Secondary ID(s): 2020-000570-25