Overview

A Study Utilizing Imaging Techniques and Evaluating the Safety and Efficacy of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis

Status:
Completed

Trial end date:
2020-12-21

Target enrollment:

Participant gender:

Summary

This phase 2 study is a single center, open-label study of 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 SM04690 per 2 mL injection. This study will utilize magnetic resonance imaging (MRI) (including T1rho and T2 mapping pulse sequence MRI, three-dimensional spoiled gradient recalled [3D-SPGR] pulse sequence MRI, and whole organ MRI scoring [WORMS]), radiographic imaging, Western Ontario and McMaster Universities Arthritis Index (WOMAC) and patient reported outcomes (PROs) for data collection to assess efficacy outcome measures.

Phase:

Phase 2

Details

Lead Sponsor:

Biosplice Therapeutics, Inc.
Samumed LLC

Treatments:

Lorecivivint