CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 501 enrolled
Drug / intervention
Lorecivivint +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03928184
NCT03928184Phase 3Completed
CompareCT.gov

A 56-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a Single Injection of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects

Biosplice Therapeutics, Inc.·interventional·Posted Apr 26, 2019·Updated Feb 13, 2026

In Brief

A Phase 3 clinical trial evaluating Lorecivivint and Placebo for Knee Osteoarthritis. Completed, enrolled 501 participants across 99 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKnee Osteoarthritis
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedApr 26, 2019
Enrollment StartMay 17, 2019
Primary CompletionAug 20, 2021
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 7.2 years ago

Interventions

Lorecivivintdrug

Healthcare professional-administered intra-articular injection; performed on Day 1

Placebodrug

Healthcare professional-administered intra-articular injection; performed on Day 1