CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 496 enrolled
Drug / intervention
Lorecivivint +1 moredrug
Likely dose
Lorecivivint 0.07 mgfrom 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/NCT04385303
NCT04385303Phase 3Completed
CompareCT.gov

A 28-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate a Single Injection of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects

Biosplice Therapeutics, Inc.·interventional·Posted May 12, 2020·Updated Feb 4, 2026

In Brief

A Phase 3 clinical trial evaluating Lorecivivint and Placebo for Knee Osteoarthritis. Completed, enrolled 496 participants across 76 sites.

Detailed 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.

Study Details

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

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedMay 12, 2020
Enrollment StartMay 26, 2020
Primary CompletionSep 8, 2021
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 6.1 years ago

Interventions

Lorecivivintdrug

One intra-articular injection of 0.07 mg lorecivivint in 2 mL vehicle

Placebodrug

One intra-articular injection of 0 mg lorecivivint in 2 mL vehicle