NCT02536833

A Study Evaluating the Safety, Tolerability, and Efficacy of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 455 (actual)
• Sponsor: Biosplice Therapeutics, Inc. · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy, safety, and tolerability of three different strengths of SM04690 injected in the target knee joint of moderately to severely symptomatic osteoarthritis (OA) subjects.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DRUG	SM04690
DRUG	Placebo

Timeline

• Start date: 2015-09-09
• Primary completion: 2017-04-20
• Completion: 2017-04-20
• First posted: 2015-09-01
• Last updated: 2021-03-17
• Results posted: 2020-09-16

Locations

36 sites across 1 country: United States

Regulatory

• FDA-regulated drug study