Ignite Creation Date:
2024-07-17 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06479863
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-05-24
Brief Title:
Efficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Patients With Sporadic Inclusion Body Myositis
Sponsor:
Austin Neuromuscular Center
Organization:
Austin Neuromuscular Center
Study Overview
Official Title:
Efficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Patients With Sporadic Inclusion Body Myositis
Status:
RECRUITING
Status Verified Date:
2024-09
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:
To evaluate the efficacy of PozelimabCemdisiran combination therapy in patients with sIBM
Detailed Description:
This is a pilot study of 10 patients to receive Pozelimab 200mgCemdisiran 200 mg SC injections every 4 weeks for 104 weeks SC injections will be administered by the study staff and the patient will be monitored for 30 minutes after the initial first injection During the remainder of the study injections can be administered at home by the patient or caregiver after injection training provided by the study staff Designated persons will be observed to confirm their ability to perform the injections
The dosing window of the study treatment is within 7 days from the scheduled dose date
The dosing window of the study treatment is within 7 days from the scheduled dose date
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