NCT05603754

A Study Utilizing Patient-Reported Outcomes to Evaluate the Safety and Efficacy of Lorecivivint (SM04690) for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis (STRIDES)

A Phase 3, 16-Week, Multicenter, Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a Single Injection of Lorecivivint 0.07 mg Dose in the Target Knee Joint of Subjects With Moderate to Severe Osteoarthritis Pain of the Knee

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 496 (actual)
• Sponsor: Biosplice Therapeutics, Inc. · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This phase 3 study is a multicenter, randomized, double-blind, placebo-controlled study of lorecivivint injected intra-articularly (IA) into the target (most painful) knee joint of moderately to severely symptomatic osteoarthritis (OA) subjects at a single dose of 0.07 mg lorecivivint per 2 mL injection. This study will utilize standard outcomes to evaluate the safety and efficacy of lorecivivint.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DRUG	Lorecivivint	One intra-articular injection of 0.07 mg lorecivivint in 2 mL vehicle
DRUG	Placebo	One intra-articular injection of 0 mg lorecivivint in 2 mL vehicle

Timeline

• Start date: 2022-11-18
• Primary completion: 2024-02-20
• Completion: 2024-02-20
• First posted: 2022-11-03
• Last updated: 2024-07-25

Locations

44 sites across 1 country: United States

Regulatory

• FDA-regulated drug study