Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:48 PM
Study NCT ID:
NCT04931667
Status:
TERMINATED
Last Update Posted:
2022-01-10
First Post:
2021-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
3-year, Open-Label Study Evaluating Safety, Tolerability, and Efficacy of Lorecivivint in Subjects With Osteoarthritis of the Knee
Sponsor:
Biosplice Therapeutics, Inc.
Organization:
Study Overview
Official Title:
A 3-Year, Multicenter, Open-Label Study Evaluating the Safety, Tolerability, and Efficacy of Intra-articular Lorecivivint in Subjects With Osteoarthritis of the Knee in a Real-World Setting (STRIDES-EXTRA)
Status:
TERMINATED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was terminated due to business reasons by Sponsor.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is designed as a 3-year, multicenter, open-label study evaluating the safety, tolerability, and efficacy of intra-articular (IA) Lorecivivint (LOR) in subjects with osteoarthritis of the knee in a real-world setting.
Detailed Description:
At Day 1, after a screening period of up to 14 days, subjects will receive an IA injection of 0.07 mg LOR into one or both knees, followed by a 36-month evaluation period. Clinic visits will be scheduled at Day 1, and Months 3, 12, 24, and 36 \[End of study (EOS)\] or Early Termination (ET) for completion of all Patient Reported Outcome (PRO) measurements Western Ontario and McMaster University Arthritis Index (WOMAC), Knee Injury and Ostheoarthritis Outcome Score (KOOS), pain Numeric Rating Scale (NRS), Study Form (SF)-12, Patient Acceptable Symptom State Questionnaire (PASS), Work Productivity and Activity Impairment Questionnaire (WPAI)\], functional tests \[40-meter walk test and Time Up and Go (TUG) test at a subset of sites\], and safety evaluations. On Day 1, the Charlson Comorbidity Index and Widespread Pain Index and Symptom Severity \[WPI\&SS\] assessments will also be completed. A phone visit for safety follow-up will occur 4 weeks after the injection on Day 1. Subjects may also have Unscheduled Injection Visits for additional injections of LOR, glucocorticoid, or hyaluronic acid (HA). Following each injection, subjects will return to the clinic for 3-Month Post-Injection Follow-Up Visits, unless another visit has occurred between the injection and the 3-month post injection date. At these injection visits and 3-Month Post-Injection Follow-Up Visits, subjects will complete PRO measurements and functional tests (at a subset of sites).
Study Oversight
Has Oversight DMC:
False
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?: