Patient-Reported Outcomes in Evaluating Lorecivivint (SM04690) for Moderate to Severe Knee Osteoarthritis (STRIDES-1)
NCT ID: NCT04385303
Last Updated: 2026-02-04
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
496 participants
INTERVENTIONAL
2020-05-26
2021-09-08
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study Utilizing Patient-Reported and Radiographic Outcomes and Evaluating the Safety and Efficacy of Lorecivivint (SM04690) for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis
NCT03928184
A Study Utilizing Patient-Reported Outcomes to Evaluate the Safety and Efficacy of Lorecivivint (SM04690) for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis (STRIDES)
NCT05603754
A Long-Term Safety and Efficacy Study of Lorecivivint in Subjects With Osteoarthritis of the Knee
NCT04520607
3-year, Open-Label Study Evaluating Safety, Tolerability, and Efficacy of Lorecivivint in Subjects With Osteoarthritis of the Knee
NCT04931667
A Study Evaluating the Safety, Tolerability, and Efficacy of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects
NCT02536833
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Patient-reported outcomes included Pain Numeric Rating Scale (NRS) \[0-10\], Western Ontario and McMaster Universities Arthritis Index (WOMAC), and Patient Global Assessment (PGA) of knee osteoarthritis.
The primary efficacy endpoint was change from baseline in target knee Pain NRS at Week 12. Secondary endpoints included change at Week 12 in WOMAC Function and PGA.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Vehicle
Healthcare professional-administered intra-articular injection; performed on Day 1.
Placebo
One intra-articular injection of 0 mg lorecivivint in 2 mL vehicle
Lorecivivint
Healthcare professional-administered intra-articular injection; performed on Day 1.
Lorecivivint
One intra-articular injection of 0.07 mg lorecivivint in 2 mL vehicle
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Lorecivivint
One intra-articular injection of 0.07 mg lorecivivint in 2 mL vehicle
Placebo
One intra-articular injection of 0 mg lorecivivint in 2 mL vehicle
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Ambulatory (single assistive devices such as canes allowed if needed less than 50% of the time, subjects requiring a walker are excluded)
* Diagnosis of femorotibial OA in the target knee by standard American College of Rheumatology (ACR) criteria at the Screening Visit (clinical AND radiographic criteria); OA of the knee is not to be secondary to any rheumatologic conditions (e.g., rheumatoid arthritis)
* Radiographic disease Stage 2 or 3 in target knee within 24 weeks of the Screening Visit according to the Kellgren-Lawrence (KL) grading of knee OA as assessed by independent central readers
* Qualifying mean score on the 24-h average pain score (0-10 numeric rating scale)
* Pain compatible with OA of the knee(s) for at least 26 weeks prior to the Screening Visit
* Primary source of pain throughout the body is due to OA in the target knee
* Body mass index (BMI) ≤ 35 kg/m2 at the Screening Visit
* Negative drug test for amphetamine, buprenorphine, cocaine, methadone, opiates, phencyclidine (PCP), propoxyphene, barbiturates, benzodiazepine, methaqualone, and tricyclic antidepressants, unless any of these drugs are allowed per protocol and prescribed by a physician to treat a specific condition
Exclusion Criteria
* Significant malalignment of anatomical axis (medial angle formed by the femur and tibia) of the target knee (varus \> 10°, valgus \> 10°) by radiograph within 24 weeks of the Screening Visit as assessed by independent central readers
* Partial or complete joint replacement in either knee
* Currently requires use of a lower extremity prosthesis, and/or a structural knee brace (i.e., a knee brace that contains hardware)
* Any surgery (e.g., arthroscopy) in either knee within 26 weeks prior to Day 1
* Intra-articular (IA) injection into the target knee with a therapeutic aim including, but not limited to hyaluronic acid, platelet-rich plasma (PRP), and stem cell therapies within 26 weeks prior to Day 1; or IA glucocorticoids within 12 weeks prior to Day 1 allowed
* Previous treatment with lorecivivint (SM04690)
* Subjects who have previously failed screening on this protocol and fail to meet re-screening criteria
* Participation in a clinical research trial that included the receipt of an investigational product or any experimental therapeutic procedure within 26 weeks prior to the Screening Visit, or planned participation in any such trial
* Subjects requiring the use of opioids \> 1x per week within 12 weeks prior to Day 1
* History of malignancy within the last 5 years; not including subjects with prior history of adequately treated in situ cervical cancer or basal or squamous cell skin cancer
* Clinically significant abnormal screening hematology values, blood chemistry values, or urinalysis values as determined by the Investigator
* Any known active infections, including urinary tract infection, upper respiratory tract infection, sinusitis, suspicion of IA infection, hepatitis B or hepatitis C infection, and/or infections that may compromise the immune system such as human immunodeficiency virus (HIV) at Day 1
40 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Biosplice Therapeutics, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yusuf Yazici, M.D.
Role: STUDY_DIRECTOR
Biosplice Therapeutics, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Birmingham, Alabama, United States
Research Site
Birmingham, Alabama, United States
Research Site
Mobile, Alabama, United States
Research Site
Phoenix, Arizona, United States
Research Site
Phoenix, Arizona, United States
Research Site
Tucson, Arizona, United States
Research Site
Little Rock, Arkansas, United States
Research Site
Anaheim, California, United States
Research Site
Beverly Hills, California, United States
Research Site
Canoga Park, California, United States
Research Site
Garden Grove, California, United States
Research Site
La Mesa, California, United States
Research Site
Norco, California, United States
Research Site
Pomona, California, United States
Research Site
San Diego, California, United States
Research Site
Santa Monica, California, United States
Research Site
Thousand Oaks, California, United States
Research Site
Westminster, California, United States
Research Site
Boulder, Colorado, United States
Research Site
Hamden, Connecticut, United States
Reserach Site
Clearwater, Florida, United States
Research Site
Edgewater, Florida, United States
Research Site
Gulf Breeze, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Miami Lakes, Florida, United States
Research Site
Sunrise, Florida, United States
Research Site
Sweetwater, Florida, United States
Research Site
West Palm Beach, Florida, United States
Research Site
Winter Haven, Florida, United States
Research Site 1
Winter Park, Florida, United States
Research Site
Marietta, Georgia, United States
Research Site
Newnan, Georgia, United States
Research Site
Woodstock, Georgia, United States
Research Site
Boise, Idaho, United States
Research Site
Chicago, Illinois, United States
Research Site
Gurnee, Illinois, United States
Research Site
Oak Brook, Illinois, United States
Research Site
Evansville, Indiana, United States
Research Site
Greenwood, Indiana, United States
Research Site
Valparaiso, Indiana, United States
Research Site
New Orleans, Louisiana, United States
Research Site
Wheaton, Maryland, United States
Research Site
Boston, Massachusetts, United States
Research Site
Troy, Michigan, United States
Research Site
Hazelwood, Missouri, United States
Research Site
Kansas City, Missouri, United States
Research Site 1
St Louis, Missouri, United States
Research Site 2
St Louis, Missouri, United States
Research Site
Omaha, Nebraska, United States
Research Site
Las Vegas, Nevada, United States
Research Site
Reno, Nevada, United States
Research Site
Freehold, New Jersey, United States
Research Site
Albuquerque, New Mexico, United States
Research Site
Hartsdale, New York, United States
Research Site
Rochester, New York, United States
Research Site
Greensboro, North Carolina, United States
Research Site
Salisbury, North Carolina, United States
Research Site
Winston-Salem, North Carolina, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Edmond, Oklahoma, United States
Research Site
Duncansville, Pennsylvania, United States
Research Site
Charleston, South Carolina, United States
Research Site
Fort Mill, South Carolina, United States
Research Site
Mt. Pleasant, South Carolina, United States
Research Site
Rapid City, South Dakota, United States
Research Site
Bellaire, Texas, United States
Research Site
Carrollton, Texas, United States
Research Site
Dallas, Texas, United States
Research Site
Houston, Texas, United States
Research Site
Plano, Texas, United States
Research Site
Draper, Utah, United States
Research Site
Ogden, Utah, United States
Research Site
Salt Lake City, Utah, United States
Research Site
Charlottesville, Virginia, United States
Research Site
Richmond, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SM04690-OA-10
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.