NCT04385303

Patient-Reported Outcomes in Evaluating Lorecivivint (SM04690) for Moderate to Severe Knee Osteoarthritis (STRIDES-1)

A 28-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate a Single Injection of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects

• 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 intraarticularly (IA) into the target knee (most painful) 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 patient reported outcomes (PROs) to evaluate the safety and efficacy of lorecivivint.

Detailed description

SM04690-OA-10 was a phase 3, 28-week multicenter, randomized, double-blind, placebo-controlled, parallel group study investigating the safety, tolerability and efficacy of lorecivivint 0.07 mg (compared with placebo) injected into the target knee joint of moderately to severely symptomatic knee OA subjects. Patient-reported outcomes included Pain Numeric Rating Scale (NRS) \[0-10\], Western Ontario and McMaster Universities Arthritis Index (WOMAC), and Patient Global Assessment (PGA) of knee osteoarthritis. The primary efficacy endpoint was change from baseline in target knee Pain NRS at Week 12. Secondary endpoints included change at Week 12 in WOMAC Function and PGA.

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: 2020-05-26
• Primary completion: 2021-09-08
• Completion: 2021-09-08
• First posted: 2020-05-12
• Last updated: 2026-02-04
• Results posted: 2026-02-04

Locations

76 sites across 1 country: United States

Regulatory

• FDA-regulated drug study