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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT03928184

Public ClinicalTrials.gov record NCT03928184. 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 19, 2026, 10:28 PM 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 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

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 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 identification

NCT ID
NCT03928184
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Biosplice Therapeutics, Inc.
Industry
Enrollment
501 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 17, 2019 (Actual)
Primary completion
Aug 20, 2021 (Actual)
Completion
Aug 20, 2021 (Actual)
Last update posted
Feb 13, 2026

2019 – 2021

United States locations

U.S. sites
99
U.S. states
30
U.S. cities
88
Facility City State ZIP Site status
Research Site Birmingham Alabama 35205 —
Research Site Birmingham Alabama 35215 —
Research Site Birmingham Alabama 35216 —
Research Site Peoria Arizona 85381 —
Research Site Phoenix Arizona 85037 —
Research Site Tucson Arizona 85712 —
Research Site Little Rock Arkansas 72205 —
Research Site Anaheim California 92805 —
Research Site Garden Grove California 92840 —
Research Site Norco California 92860 —
Research Site Pomona California 91767 —
Research Site San Diego California 92103 —
Research Site San Marcos California 92078 —
Research Site Spring Valley California 91978 —
Research Site Westminster California 92683 —
Research Site Boulder Colorado 80301 —
Research Site Colorado Springs Colorado 80918 —
Research Site Denver Colorado 80209 —
Research Site Waterbury Connecticut 06708 —
Research Site Clearwater Florida 33761 —
Research Site Coral Gables Florida 33134 —
Research Site Hialeah Florida 33016 —
Research Site Miami Florida 33143 —
Research Site Miami Lakes Florida 33014 —
Research Site Orlando Florida 32806 —
Research Site Oviedo Florida 32765 —
Research Site Port Orange Florida 32127 —
Research Site Sunrise Florida 33351 —
Research Site West Palm Beach Florida 33409 —
Research Site Winter Haven Florida 33880 —
Research Site #1 Winter Park Florida 32789 —
Research Site #2 Winter Park Florida 32789 —
Research Site Marietta Georgia 30060 —
Research Site Newnan Georgia 30265 —
Research Site Stockbridge Georgia 30281 —
Research Site Woodstock Georgia 30189 —
Research Site Boise Idaho 83713 —
Research Site Meridian Idaho 83642 —
Research Site Bloomington Illinois 61704 —
Research Site Gurnee Illinois 60031 —
Research Site Oak Brook Illinois 60523 —
Research Site Rockford Illinois 61114 —
Research Site Anderson Indiana 46011 —
Research Site Evansville Indiana 47714 —
Research Site Valparaiso Indiana 46383 —
Research Site Kansas City Kansas 66160 —
Research Site Wichita Kansas 67205 —
Research Site Monroe Louisiana 71203 —
Research Site New Orleans Louisiana 70124 —
Research Site Wheaton Maryland 20902 —
Research Site Boston Massachusetts 02111 —
Research Site Bay City Michigan 48706 —
Research Site Troy Michigan 48085 —
Research Site Hazelwood Missouri 63042 —
Research Site St Louis Missouri 63141 —
Research Site La Vista Nebraska 68128 —
Research Site Lincoln Nebraska 68516 —
Research Site Omaha Nebraska 68114 —
Research Site Albuquerque New Mexico 87108 —
Research Site Great Neck New York 11021 —
Research Site Hartsdale New York 10530 —
Research Site New York New York 10016 —
Research Site 1 New York New York 10021 —
Research Site 2 New York New York 10021 —
Research Site Rochester New York 14609 —
Research Site Williamsville New York 14221 —
Research Site Charlotte North Carolina 28209 —
Research Site Leland North Carolina 28451 —
Research Site Salisbury North Carolina 28144 —
Research Site Winston-Salem North Carolina 27103 —
Research Site Fargo North Dakota 58104 —
Research Site Cincinnati Ohio 45219 —
Research Site Cincinnati Ohio 45224 —
Research Site Cincinnati Ohio 45242 —
Research Site Columbus Ohio 43235 —
Research Site Oklahoma City Oklahoma 73103 —
Research Site Oklahoma City Oklahoma 73112 —
Research Site Duncansville Pennsylvania 16635 —
Research Site Fort Mill South Carolina 29707 —
Research Site Greenville South Carolina 29607 —
Research Site Greer South Carolina 29651 —
Research Site Mt. Pleasant South Carolina 29464 —
Research Site Rapid City South Dakota 57702 —
Research Site Austin Texas 78745 —
Research Site Bedford Texas 76021 —
Research Site Carrollton Texas 75007 —
Research Site Dallas Texas 75231 —
Research Site Edinburg Texas 78539 —
Research Site Houston Texas 77029 —
Research Site Houston Texas 77055 —
Research Site Plano Texas 75075 —
Research Site San Antonio Texas 78215 —
Research Site San Antonio Texas 78229 —
Research Site San Antonio Texas 78258 —
Research Site Draper Utah 84020 —
Research Site Murray Utah 84123 —
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 NCT03928184, 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 13, 2026 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03928184 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →