drugset / Trial / NCT03928184

Patient-Reported and Radiographic Outcomes in Evaluating Lorecivivint (SM04690) for the Treatment of Knee Osteoarthritis

NCT03928184

Phase 3 Completed 501 enrolled Biosplice Therapeutics, Inc.
RandomizedParallel-groupTriple-blindTreatment

Summary

This phase 3 study is a multicenter, randomized, double-blind, placebo-controlled study of lorecivivint injected intra-articularly (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 radiographs and patient reported outcomes (PROs) to evaluate the safety and efficacy of lorecivivint.

Timeline

Start
2019-05-17
Primary completion
2021-08-20
Completion
2021-08-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Lorecivivint Small molecule 0.07 mg Other

Indications