NCT04931667

3-year, Open-Label Study Evaluating Safety, Tolerability, and Efficacy of Lorecivivint in Knee Osteoarthritis

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Biosplice Therapeutics, Inc. · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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). All Patient Reported Outcome (PRO) measurements, including Western Ontario and McMaster University Osteoarthritis Index (WOMAC), and Pain Numeric Rating Scale (NRS), as well as safety evaluations will be conducted at each clinic visit. An additional phone follow-up visit for safety will occur 4 weeks after the injection on Day 1. Study was terminated by Sponsor based on a business decision not due to safety. The study report was finalized without any statistical analysis.

Conditions

• Osteoarthritis of the Knee

Interventions

Type	Name	Description
DRUG	Lorecivivint	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.

Timeline

• Start date: 2021-07-15
• Primary completion: 2021-12-13
• Completion: 2021-12-13
• First posted: 2021-06-18
• Last updated: 2026-03-31
• Results posted: 2026-03-31

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study