Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06450886
Status:
RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-06-04
Brief Title:
Long-term Extension Study of Ulviprubart ABC008 in Subjects with Inclusion Body Myositis
Sponsor:
Abcuro Inc
Organization:
Abcuro Inc
Study Overview
Official Title:
An Open-label Multicenter Study to Evaluate the Long-term Safety and Efficacy of Ulviprubart ABC008 in Subjects Who Have Completed a Trial of Ulviprubart for the Treatment of Inclusion Body Myositis
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
ABC008-IBM-202 is an open-label multicenter study to evaluate the safety and efficacy of long-term administration of ulviprubart ABC008 in subjects with IBM who have completed either Study ABC008-IBM-101 or Study ABC008-IBM-201 Subjects may be enrolled in this study if they meet study eligibility criteria and
Have completed the Part 2 Multiple Ascending Dose MAD End of-Treatment EOT Visit in Study ABC008-IBM-101 subjects who continued further on into Part 3 of the study MAD Extension prior to enrolling in this study are also eligible OR
Have completed the Week 80 Follow-up Visit in Study ABC008-IBM-201
Have completed the Part 2 Multiple Ascending Dose MAD End of-Treatment EOT Visit in Study ABC008-IBM-101 subjects who continued further on into Part 3 of the study MAD Extension prior to enrolling in this study are also eligible OR
Have completed the Week 80 Follow-up Visit in Study ABC008-IBM-201
Detailed Description:
ABC008-IBM-202 is an open-label multicenter study to evaluate the safety and efficacy of long-term administration of ulviprubart ABC008 in subjects with IBM who have completed either Study ABC008-IBM-101 or Study ABC008-IBM-201 Subjects may be enrolled in this study if they meet study eligibility criteria and
Have completed the Part 2 Multiple Ascending Dose MAD End of-Treatment EOT Visit in Study ABC008-IBM-101 subjects who continued further on into Part 3 of the study MAD Extension prior to enrolling in this study are also eligible OR
Have completed the Week 80 Follow-up Visit in Study ABC008-IBM-201 Subjects will enter this study following their initial study such that dosing continues every eight weeks Q8W between the last dose in the initial study and the first dose in this long-term extension LTE Study IBM-202 Study subjects will continue to receive any ongoing concomitant medications from the initial study
Subjects will be required to sign an informed consent form before undertaking any study-specific procedures or assessments Screening is intended to be done at the final visit of the initial study which will coincide with the Baseline Day 1 Visit for this study if this is not possible the Baseline Day 1 Visit for this study including screening may be conducted at a separate visit provided it occurs within the visit window defined in Appendix 1 of the protocol Subsequent study visits will occur every eight weeks until EOT at Week 156 or withdrawal from the study
Have completed the Part 2 Multiple Ascending Dose MAD End of-Treatment EOT Visit in Study ABC008-IBM-101 subjects who continued further on into Part 3 of the study MAD Extension prior to enrolling in this study are also eligible OR
Have completed the Week 80 Follow-up Visit in Study ABC008-IBM-201 Subjects will enter this study following their initial study such that dosing continues every eight weeks Q8W between the last dose in the initial study and the first dose in this long-term extension LTE Study IBM-202 Study subjects will continue to receive any ongoing concomitant medications from the initial study
Subjects will be required to sign an informed consent form before undertaking any study-specific procedures or assessments Screening is intended to be done at the final visit of the initial study which will coincide with the Baseline Day 1 Visit for this study if this is not possible the Baseline Day 1 Visit for this study including screening may be conducted at a separate visit provided it occurs within the visit window defined in Appendix 1 of the protocol Subsequent study visits will occur every eight weeks until EOT at Week 156 or withdrawal from the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None