| Primary | Time-Normalized Number of Hereditary Angioedema (HAE) Attacks Per Month During Treatment Period | Time-normalized number of HAE attacks per month during treatment was calculated per participant as: [number of HAE attacks / length of participant treatment in days] * 30.4375. | ITT analysis set included all the randomized participants who provided written informed consent and underwent study screening procedures. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. | Posted | | Mean | Standard Deviation | number of HAE attacks per month | | First injection up to 6 months | | | | ID | Title | Description |
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| OG000 | CSL312 | Participants received a CSL312 loading dose of 400 mg as two 200 mg SC injections in Month 1 along with CSL312 of 200 mg SC injections, once monthly from Months 2 to 6. | | OG001 | Placebo | Participants received a CSL312 matched loading dose of placebo as two SC injections in Month 1 along with CSL312 matched placebo SC injections, once monthly from Months 2 to 6. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0000.27± 0.683
- OG0012.01± 1.341
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Two-sided Wilcoxon test | | <0.001 | Compared the time-normalized number of HAE attacks in the active and placebo arms by using a two-sided Wilcoxon test (Hierarchical Testing H01) at alpha = 5%. | | | | | | | | | | | | | Other | | |
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| Secondary | Percentage Change in the Time-normalized Number of HAE Attacks Per Month During the Treatment Period Compared to the Run-in Period | Percentage change in the time-normalized number of HAE attacks was calculated within a participant as: 100 * [1 - (time-normalized number of HAE attacks per month during treatment period / time-normalized number of HAE attacks per month during run-in period)]. Time-normalized number of HAE attacks per month during treatment period was calculated per participant as: [number of HAE attacks / length of participant treatment in days] * 30.4375. | ITT analysis set included all the randomized participants who provided written informed consent and underwent study screening procedures. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis at the specified time point. | Posted | | Mean | Standard Deviation | percentage change in HAE attacks/month | | 6 months, first 3-months and second 3-months of treatment period | | | | ID | Title | Description |
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| OG000 | CSL312 | Participants received a CSL312 loading dose of 400 mg as two 200 mg SC injections in Month 1 along with CSL312 of 200 mg SC injections, once monthly from Months 2 to 6. | | OG001 | Placebo | Participants received a CSL312 matched loading dose of placebo as two SC injections in Month 1 along with CSL312 matched placebo SC injections, once monthly from Months 2 to 6. |
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| Secondary | Time-Normalized Number of HAE Attacks Per Month Requiring On-Demand Treatment | Time-normalized number of HAE attacks per month requiring on-demand treatment was calculated per participant as: [number of HAE attacks requiring on-demand treatment / length of participant in days] * 30.4375. | ITT analysis set included all the randomized participants who provided written informed consent and underwent study screening procedures. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis at the specified time point. | Posted | | Mean | Standard Deviation | number of HAE attacks per month | | 6 months, first 3-months and second 3-months of treatment period | Total number of HAE attacks | Total number of HAE attacks | | ID | Title | Description |
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| OG000 | CSL312 | Participants received a CSL312 loading dose of 400 mg as two 200 mg SC injections in Month 1 along with CSL312 of 200 mg SC injections, once monthly from Months 2 to 6. | | OG001 | Placebo | Participants received a CSL312 matched loading dose of placebo as two SC injections in Month 1 along with CSL312 matched placebo SC injections, once monthly from Months 2 to 6. |
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| Secondary | Time-Normalized Number of Moderate or Severe HAE Attacks Per Month | Time-normalized number of moderate or severe HAE attacks per month during treatment period was calculated per participant as: [number of moderate or severe HAE attacks / length of participant treatment in days] * 30.4375. | ITT analysis set included all the randomized participants who provided written informed consent and underwent study screening procedures. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis at the specified time point. | Posted | | Mean | Standard Deviation | number of HAE attacks per month | | 6 months, first 3-months and second 3-months of treatment period | Total number of HAE attacks | Total number of HAE attacks | | ID | Title | Description |
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| OG000 | CSL312 | Participants received a CSL312 loading dose of 400 mg as two 200 mg SC injections in Month 1 along with CSL312 of 200 mg SC injections, once monthly from Months 2 to 6. | | OG001 | Placebo | Participants received a CSL312 matched loading dose of placebo as two SC injections in Month 1 along with CSL312 matched placebo SC injections, once monthly from Months 2 to 6. |
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| Secondary | Time-normalized Number of HAE Attacks Per Month in the First 3-months and Second 3-months of Treatment Period | Time-normalized number of HAE attacks per month during treatment was calculated per participant as: [number of HAE attacks / length of participant treatment in days] * 30.4375. | ITT analysis set included all the randomized participants who provided written informed consent and underwent study screening procedures. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis at the specified time point. | Posted | | Mean | Standard Deviation | number of HAE attacks per month | | First 3-months and second 3-months of treatment period | | | | ID | Title | Description |
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| OG000 | CSL312 | Participants received a CSL312 loading dose of 400 mg as two 200 mg SC injections in Month 1 along with CSL312 of 200 mg SC injections, once monthly from Months 2 to 6. | | OG001 | Placebo | Participants received a CSL312 matched loading dose of placebo as two SC injections in Month 1 along with CSL312 matched placebo SC injections, once monthly from Months 2 to 6. |
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| Secondary | Relative Difference in Means in the Time-Normalized Number of HAE Attacks Per Month Between CSL312 to Placebo | Relative difference in means in the time-normalized number of HAE attacks per month CSL312 to Placebo was calculated as: 100 * [(mean time-normalized number of HAE attacks for CSL312 - mean time-normalized number of HAE attacks for placebo) / mean time-normalized number of HAE attacks for placebo]. Time-normalized number of HAE attacks per month during treatment was calculated per participant as: [number of HAE attacks / length of participant treatment in days] * 30.4375. | ITT analysis set included all randomized participants who provided written informed consent and underwent study screening procedures. 'Overall number of participants analyzed' indicates number of participants with data available for outcome measure (OM) analysis. 'Number analyzed' indicates number of participants with data available for analysis at specified time point. As pre-specified in protocol and SAP, data for this OM was reported for participants of CSL312 and Placebo Comparison group. | Posted | | Mean | 95% Confidence Interval | number of HAE attacks per month | | 6 months, first 3-months and second 3-months of treatment period | | | | ID | Title | Description |
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| OG000 | CSL312 and Placebo Comparison Group | CSL312: Participants received a CSL312 loading dose of 400 mg as two 200 mg SC injections in Month 1 along with CSL312 of 200 mg SC injections, once monthly from Months 2 to 6. Placebo: Participants received a CSL312 matched loading dose of placebo as two SC injections in Month 1 along with CSL312 matched placebo SC injections, once monthly from Months 2 to 6. |
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| Secondary | Percentage of Participants With a Response to Subject's Global Assessment of Response to Therapy (SGART) | SGART is a self-assessment by the participant and measures the subject's overall treatment response to the investigational product using the following ratings: 0 (none: worse or no response at all, not acceptable), 1 (poor: very little response, not acceptable), 2 (fair: some response, acceptable but could be better), 3 (good: good response, acceptable), and 4 (excellent: excellent response, as good as can be imagined). | ITT analysis set included all the randomized participants who provided written informed consent and underwent study screening procedures. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. | Posted | | Number | | percentage of participants | | Up to 6 months | | | | ID | Title | Description |
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| OG000 | CSL312 | Participants received a CSL312 loading dose of 400 mg as two 200 mg SC injections in Month 1 along with CSL312 of 200 mg SC injections, once monthly from Months 2 to 6. | | OG001 | Placebo | Participants received a CSL312 matched loading dose of placebo as two SC injections in Month 1 along with CSL312 matched placebo SC injections, once monthly from Months 2 to 6. |
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| Secondary | Number of Participants With at Least One Adverse Event (AE), Serious Adverse Event (SAE), and AEs of Special Interest (AESI) | AE is any untoward medical occurrence in a participant administered with an investigational product which does not necessarily have a causal relationship with treatment, can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of an investigational product, whether or not considered related to product. SAE is any untoward medical occurrence that results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, is a congenital anomaly or birth defect, or is a medically significant event. An AESI is an AE of scientific and medical concern specific to sponsor's product or program, for which ongoing monitoring and rapid communication by investigator to sponsor is appropriate. | Safety analysis set included all the randomized participants who provided written informed consent, underwent study screening procedures and received at least 1 dose of the investigational product. | Posted | | Count of Participants | | Participants | | From first dose of study drug up to 3 months after the last injection (approximately 8 months) | | | | ID | Title | Description |
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| OG000 | CSL312 | Participants received a CSL312 loading dose of 400 mg as two 200 mg SC injections in Month 1 along with CSL312 of 200 mg SC injections, once monthly from Months 2 to 6. | | OG001 | Placebo | |
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| Secondary | Number of Participants With CSL312-induced Anti-CSL312 Antibodies | | Safety analysis set included all the randomized participants who provided written informed consent, underwent study screening procedures and received at least 1 dose of the investigational product. | Posted | | Count of Participants | | Participants | | Up to 8 months | | | | ID | Title | Description |
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| OG000 | CSL312 | Participants received a CSL312 loading dose of 400 mg as two 200 mg SC injections in Month 1 along with CSL312 of 200 mg SC injections, once monthly from Months 2 to 6. | | OG001 | Placebo | Participants received a CSL312 matched loading dose of placebo as two SC injections in Month 1 along with CSL312 matched placebo SC injections, once monthly from Months 2 to 6. |
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| Secondary | Number of Participants With Clinically Significant Abnormalities in Laboratory Assessments Reported as Treatment Emergent Adverse Events (TEAEs) | Laboratory assessments included: Hematology, biochemistry, urinalysis, and coagulation parameters. | Safety analysis set included all the randomized participants who provided written informed consent, underwent study screening procedures and received at least 1 dose of the investigational product. | Posted | | Count of Participants | | Participants | | From first dose of study drug up to 3 months after the last injection (approximately 8 months) | | | | ID | Title | Description |
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| OG000 | CSL312 | Participants received a CSL312 loading dose of 400 mg as two 200 mg SC injections in Month 1 along with CSL312 of 200 mg SC injections, once monthly from Months 2 to 6. | | OG001 | Placebo | Participants received a CSL312 matched loading dose of placebo as two SC injections in Month 1 along with CSL312 matched placebo SC injections, once monthly from Months 2 to 6. |
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| Secondary | Percentage of Participants With at Least One AE, SAE, and AESI | AE is any untoward medical occurrence in a participant administered with an investigational product which does not necessarily have a causal relationship with treatment, can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of an investigational product, whether or not considered related to product. SAE is any untoward medical occurrence that results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, is a congenital anomaly or birth defect, or is a medically significant event. An AESI is an AE of scientific and medical concern specific to sponsor's product or program, for which ongoing monitoring and rapid communication by investigator to sponsor is appropriate. | Safety analysis set included all the randomized participants who provided written informed consent, underwent study screening procedures and received at least 1 dose of the investigational product. The percentage of participants are rounded off to the single decimal point. | Posted | | Number | | percentage of participants | | From first dose of study drug up to 3 months after the last injection (approximately 8 months) | | | | ID | Title | Description |
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| OG000 | CSL312 | Participants received a CSL312 loading dose of 400 mg as two 200 mg SC injections in Month 1 along with CSL312 of 200 mg SC injections, once monthly from Months 2 to 6. | | OG001 | Placebo | |
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| Secondary | Percentage of Participants With CSL312-induced Anti-CSL312 Antibodies | | Safety analysis set included all the randomized participants who provided written informed consent, underwent study screening procedures and received at least 1 dose of the investigational product. The percentage of participants are rounded off to the single decimal point. | Posted | | Number | | percentage of participants | | Up to 6 months | | | | ID | Title | Description |
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| OG000 | CSL312 | Participants received a CSL312 loading dose of 400 mg as two 200 mg SC injections in Month 1 along with CSL312 of 200 mg SC injections, once monthly from Months 2 to 6. | | OG001 | Placebo | Participants received a CSL312 matched loading dose of placebo as two SC injections in Month 1 along with CSL312 matched placebo SC injections, once monthly from Months 2 to 6. |
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| Secondary | Percentage of Participants With Clinically Significant Abnormalities in Laboratory Assessments Reported as TEAEs | Laboratory assessments included: Hematology, biochemistry, urinalysis, and coagulation parameters. | Safety analysis set included all the randomized participants who provided written informed consent, underwent study screening procedures and received at least 1 dose of the investigational product. The percentage of participants are rounded off to the single decimal point. | Posted | | Number | | percentage of participants | | From first dose of study drug up to 3 months after the last injection (approximately 8 months) | | | | ID | Title | Description |
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| OG000 | CSL312 | Participants received a CSL312 loading dose of 400 mg as two 200 mg SC injections in Month 1 along with CSL312 of 200 mg SC injections, once monthly from Months 2 to 6. | | OG001 | Placebo | Participants received a CSL312 matched loading dose of placebo as two SC injections in Month 1 along with CSL312 matched placebo SC injections, once monthly from Months 2 to 6. |
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