Patient-Reported Outcomes in Evaluating Lorecivivint (SM04690) for Moderate to Severe Knee Osteoarthritis (STRIDES-1)

Phase 3 Completed 496 enrolled Biosplice Therapeutics, Inc.

RandomizedParallel-groupTriple-blindTreatment

Summary

This phase 3 study is a multicenter, randomized, double-blind, placebo-controlled study of lorecivivint 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 lorecivivint per 2 mL injection. This study will utilize patient reported outcomes (PROs) to evaluate the safety and efficacy of lorecivivint.

Timeline

Start: 2020-05-26
Primary completion: 2021-09-08
Completion: 2021-09-08

Outcome

Missed primary endpoint

registry analysis (superiority test); Vehicle vs Lorecivivint; p = 0.703; Mean Difference (Final Values) -0.07 (95% CI -0.46 to 0.31); Mixed Models Analysis NCT04385303 ↗

Publications

Tambiah J, Kennedy S, Swearingen C, McAlindon T, Yazici Y. Impact of structural severity on outcomes in knee osteoarthritis: an analysis of data from phase 2 and phase 3 lorecivivint clinical trials. Rheumatology (Oxford). 2025 May 1;64(5):2583-2590. doi: 10.1093/rheumatology/keae610.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lorecivivint	Small molecule	0.07 mg	Other