The purpose of this study is to evaluate the effectiveness, safety and tolerability of zilucoplan auto-injector (ZLP-AI) self-administration.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Zilucoplan will be self-administered subcutaneously by study participants at pre-specified time points.
Dv0013 50628
New Haven, Connecticut, United States
Dv0013 50634
Tampa, Florida, United States
Dv0013 50648
Columbia, Missouri, United States
Dv0013 50556
Chapel Hill, North Carolina, United States
Percentage of Effective Self-administrations (SA) of Zilucoplan (ZLP) Using the Zilucoplan-auto-injector (ZLP-AI) From Visit 1 to Visit 8
Effective SA of ZLP was defined as completeness of the delivery as confirmed by the Investigator. The entire dose of investigational medicinal product (IMP) was completely delivered (ie, the yellow plunger that was seen through the device window was completely depressed). The percentage of effective SA overall was summarized based on the number of ZLP-AIs used and returned, within participants in the Safety Set (SS). Complete Dose Delivery = Total number (no.) of ZLP-AIs with complete dose delivery/Total no. of ZLP-AIs used and returned.
Time frame: From Visit 1 (Day 1) to Visit 8 (Day 14)
Percentage of Effective Self-administration of Zilucoplan Using ZLP-AI at Visit 1
Effective SA of ZLP was defined as completeness of the delivery as confirmed by the Investigator. The entire dose of IMP was completely delivered (ie, the yellow plunger that was seen through the device window was completely depressed). The percentage of effective SA overall was summarized based on the number of ZLP-AIs used and returned, within participants in the SS. Complete Dose Delivery = Total number (no.) of ZLP-AIs with complete dose delivery/Total no. of ZLP-AIs used and returned.
Time frame: Visit 1 (Day 1)
Percentage of Effective Self-administrations of Zilucoplan Using ZLP-AI at Visit 8
Effective SA of ZLP was defined as completeness of the delivery as confirmed by the Investigator. The entire dose of IMP was completely delivered (ie, the yellow plunger that was seen through the device window was completely depressed). The percentage of effective SA overall was summarized based on the number of ZLP-AIs used and returned, within participants in the SS. Complete Dose Delivery = Total number (no.) of ZLP-AIs with complete dose delivery/Total no. of ZLP-AIs used and returned.
Time frame: Visit 8 (Day 14)
Percentage of Participants With Serious Adverse Events (SAEs) During the Course of the Study
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Dv0013 50635
Columbus, Ohio, United States
Dv0013 50555
Austin, Texas, United States
Dv0013 50636
Greenfield, Wisconsin, United States
Dv0013 40609
Katowice, Poland
Dv0013 40759
Krakow, Poland
Dv0013 40605
Poznan, Poland
...and 1 more locations
An SAE was defined as any untoward medical occurrence that, at any dose, met 1 or more of the criteria listed: Led to death; Led to a life-threatening illness or injury; Led to a permanent impairment of a body structure or a body function; Led to a inpatient or prolonged hospitalization; Led to a medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function; Led to fetal distress, fetal death, or a congenital abnormality or birth defect.
Time frame: From Visit 1 (Day 1) up to 40 days after last administration of self-injection of ZLP-AI (up to 54 days after Visit 1)
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the Course of the Study
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory finding) in study participants, users, or other persons, whether or not related to the investigational medical device. A TEAE was defined as an AE starting on or after the date/time of the first self-injection of ZLP-AI and up to and including 40 days after the final self-injection of ZLP-AI (or last contact depending on which occurs first).
Time frame: From Visit 1 (Day 1) up to 40 days after last administration of self-injection of ZLP-AI (up to 54 days after Visit 1)
Percentage of Participants With Non-serious Adverse Device Effects (ADE) During the Course of the Study
An ADE was defined as an AE related to the use of an investigational medical device included any AEs resulting from insufficient or inadequate instructions for use, deployment, implantation, installation, or operation, or any malfunction of the investigational medical device as well as any event resulting from use error or from intentional misuse of the investigational medical device.
Time frame: From Visit 1 (Day 1) up to 40 days after last administration of self-injection of ZLP-AI (up to 54 days after Visit 1)
Percentage of Participants With Serious Adverse Device Effects (SADE) During the Course of the Study
An SAE was defined as any untoward medical occurrence that, at any dose, met 1 or more of the criteria listed: Led to death; Led to a life-threatening illness or injury; Led to a permanent impairment of a body structure or a body function; Led to a inpatient or prolonged hospitalization; Led to a medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function; Led to fetal distress, fetal death, or a congenital abnormality or birth defect. A SADE was defined as an adverse device effect that had resulted in any of the consequences characteristic of a SAE.
Time frame: From Visit 1 (Day 1) up to 40 days after last administration of self-injection of ZLP-AI (up to 54 days after Visit 1)