NCT03706521

MRI Study to Evaluate the Safety and Efficacy of SM04690 for Knee Osteoarthritis

A Phase 2, 52 Week, Single Center, Open-Label Study Utilizing Imaging Techniques and Evaluating the Safety and Efficacy of SM04690 Injectable Suspension for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Biosplice Therapeutics, Inc. · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to evaluate the safety and efficacy of lorecivivint (LOR) injected in the target knee joint of moderately to severely symptomatic osteoarthritis (OA) subjects. Efficacy was primarily evaluated via magnetic resonance imaging (MRI).

Detailed description

This phase 2 study was a single center, open-label study of lorecivivint (LOR) (internal identification SM04690) 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 LOR per 2 mL injection. The primary objective was to evaluate the efficacy of LOR for the treatment of knee OA via magnetic resonance imaging (MRI) by assessing various cartilage health biomarkers, including cartilage thickness, cartilage volume, and cartilage quality and hydration markers. The study was terminated early due to COVID-19-related issues (e.g., temporary site closures impacting data collection).

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DRUG	lorecivivint	Healthcare professional-administered intra-articular injection performed once on Day 1 of the study.

Timeline

• Start date: 2019-03-11
• Primary completion: 2020-07-22
• Completion: 2020-12-21
• First posted: 2018-10-16
• Last updated: 2026-03-04
• Results posted: 2026-03-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study