drugset / Trial / NCT03727022

Safety and Bone Health Study of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis

NCT03727022

Phase 2 Completed 101 enrolled Biosplice Therapeutics, Inc.
RandomizedParallel-groupTriple-blindTreatment

Summary

The primary purpose of this phase 2, placebo-controlled, double-blind, parallel group study was to provide an initial safety evaluation of two intra-articular (IA) injections of SM04690 (each at the dose of 0.07mg per 2mL injection) approximately six months apart into the target knee of moderately to severely symptomatic osteoarthritis (OA) subjects. Subjects who completed this 52-week long study were invited to enter the extension phase for an additional 52 weeks of treatment.

Timeline

Start
2018-11-28
Primary completion
2020-09-18
Completion
2021-08-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Lorecivivint Small molecule 0.07 mg Other

Indications