3-year, Open-Label Study Evaluating Safety, Tolerability, and Efficacy of Lorecivivint in Subjects With Osteoarthritis of the Knee
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|ClinicalTrials.gov Identifier: NCT04931667|
Recruitment Status : Recruiting
First Posted : June 18, 2021
Last Update Posted : July 29, 2021
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis of the Knee||Drug: Lorecivivint||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Actual Study Start Date :||July 22, 2021|
|Estimated Primary Completion Date :||July 1, 2026|
|Estimated Study Completion Date :||July 1, 2026|
Experimental: 0.07 mg Lorecivivint
One intra-articular injection of 0.07 mg Lorecivivint in 2 ml vehicle in one or both knees as clinically indicated. Bilateral injection of 0.07 mg LOR are allowed.
Healthcare professional-administered intra-articular (IA) injection into one or both knees as clinically indicated. Bilateral injections of 0.07 mg of LOR are allowed. IA injection performed on Day 1. Additional IA injections of LOR to same knee (with at least a 6 month separation) between Day 1 and Month 33.
Other Name: SM04690
- Number of participants with adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: From Study Day 1 through Subject's last visit, Early Termination (ET) or End of Study (EOS), up to 36 months. ]AEs that occur during the study will be recorded. All AEs will be evaluated for severity, seriousness and causal relationship to study medication.
- Change from baseline in pain numeric rating scale (NRS) score for the knee [ Time Frame: 3 months after each injection (planned and unscheduled) monitored throughout the study for up to 36 months ]Change from baseline in pain numeric rating scale (NRS) score for the knee. The pain NRS is an 11-point scale [0-10] for subject self-reporting of average knee pain in the last 24 hours; 0 indicates no pain, and 10 represents the worst possible pain.
- Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical function subscore (WOMAC Function) [ Time Frame: 3 months after each injection (planned and unscheduled) monitored throughout the study for up to 36 months ]Change from baseline OA function in the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical function subscore (WOMAC Function). The WOMAC is a widely-used, proprietary outcome measurement tool used to evaluate the condition of subjects with OA of the knee and hip, including pain, stiffness, and physical functioning of a target joint. Each question is measured on a scale from 0 (lowest pain/lowest stiffness/highest function) to 4 (highest pain/highest stiffness/lowest function). The WOMAC Function subscore ranges from 0 to 68 (raw) and will be scaled 0 to 100 for reporting.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04931667
|Contact: Biosplice Clinical Trialsfirstname.lastname@example.org|
|United States, Arizona|
|Tucson, Arizona, United States, 85712|
|United States, Florida|
|Winter Park, Florida, United States, 32789|
|United States, Illinois|
|Research Site||Not yet recruiting|
|Oak Brook, Illinois, United States, 60523|
|Study Director:||Yusuf Yazici, MD||Biosplice Therapeutics, Inc.|