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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT04385303

Public ClinicalTrials.gov record NCT04385303. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 18, 2026, 3:26 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT04385303
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Biosplice Therapeutics, Inc.
Industry
Enrollment
496 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
40 Years to 80 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 26, 2020 (Actual)
Primary completion
Sep 8, 2021 (Actual)
Completion
Sep 8, 2021 (Actual)
Last update posted
Feb 4, 2026

2020 – 2021

United States locations

U.S. sites
76
U.S. states
30
U.S. cities
72
Facility City State ZIP Site status
Research Site Birmingham Alabama 35205 —
Research Site Birmingham Alabama 35215 —
Research Site Mobile Alabama 36608 —
Research Site Phoenix Arizona 85018 —
Research Site Phoenix Arizona 85053 —
Research Site Tucson Arizona 85712 —
Research Site Little Rock Arkansas 72205 —
Research Site Anaheim California 92805 —
Research Site Beverly Hills California 90211 —
Research Site Canoga Park California 91303 —
Research Site Garden Grove California 92840 —
Research Site La Mesa California 91942 —
Research Site Norco California 92860 —
Research Site Pomona California 91767 —
Research Site San Diego California 92103 —
Research Site Santa Monica California 90404 —
Research Site Thousand Oaks California 91360 —
Research Site Westminster California 92683 —
Research Site Boulder Colorado 80301 —
Research Site Hamden Connecticut 06517 —
Reserach Site Clearwater Florida 33761 —
Research Site Edgewater Florida 32132 —
Research Site Gulf Breeze Florida 32561 —
Research Site Miami Florida 33125 —
Research Site Miami Florida 33173 —
Research Site Miami Lakes Florida 33014 —
Research Site Sunrise Florida 33351 —
Research Site Sweetwater Florida 33172 —
Research Site West Palm Beach Florida 33409 —
Research Site Winter Haven Florida 33880 —
Research Site 1 Winter Park Florida 32789 —
Research Site Marietta Georgia 30060 —
Research Site Newnan Georgia 30265 —
Research Site Woodstock Georgia 30189 —
Research Site Boise Idaho 83713 —
Research Site Chicago Illinois 60607 —
Research Site Gurnee Illinois 60031 —
Research Site Oak Brook Illinois 60523 —
Research Site Evansville Indiana 47714 —
Research Site Greenwood Indiana 46143 —
Research Site Valparaiso Indiana 46383 —
Research Site New Orleans Louisiana 70124 —
Research Site Wheaton Maryland 20902 —
Research Site Boston Massachusetts 02111 —
Research Site Troy Michigan 48085 —
Research Site Hazelwood Missouri 63042 —
Research Site Kansas City Missouri 64114 —
Research Site 1 St Louis Missouri 63141 —
Research Site 2 St Louis Missouri 63141 —
Research Site Omaha Nebraska 68114 —
Research Site Las Vegas Nevada 89119 —
Research Site Reno Nevada 89519 —
Research Site Freehold New Jersey 07728 —
Research Site Albuquerque New Mexico 87102 —
Research Site Hartsdale New York 10530 —
Research Site Rochester New York 14642 —
Research Site Greensboro North Carolina 27408 —
Research Site Salisbury North Carolina 28144 —
Research Site Winston-Salem North Carolina 27103 —
Research Site Cincinnati Ohio 45224 —
Research Site Edmond Oklahoma 73013 —
Research Site Duncansville Pennsylvania 16635 —
Research Site Charleston South Carolina 29406 —
Research Site Fort Mill South Carolina 29707 —
Research Site Mt. Pleasant South Carolina 29464 —
Research Site Rapid City South Dakota 57702 —
Research Site Bellaire Texas 77401 —
Research Site Carrollton Texas 75007 —
Research Site Dallas Texas 75231 —
Research Site Houston Texas 77029 —
Research Site Plano Texas 75075 —
Research Site Draper Utah 84020 —
Research Site Ogden Utah 84405 —
Research Site Salt Lake City Utah 84107 —
Research Site Charlottesville Virginia 22911 —
Research Site Richmond Virginia 23219 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04385303, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 4, 2026 · Synced Oct 18, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04385303 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →