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)

Completed · Phase 3 · Has a placebo group

Conditions studied: Knee Osteoarthritis

In brief

This phase 3 study is a multicenter, randomized, double-blind, placebo-controlled study of lorecivivint injected intra-articularly (IA) into the target (most painful) knee 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 standard outcomes to evaluate the safety and efficacy of lorecivivint.

Key facts

Study ID

NCT05603754

Run by

Biosplice Therapeutics, Inc.

People needed

496

Starts

2022-11-18

Expected to finish

2024-02-20

Last updated by the study team

2024-07-25

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females between 40 and 80 years of age, inclusive, in general good health apart from their knee OA
• 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

You may not qualify if…

• Pregnant women, breastfeeding women, and women who are not post-menopausal (defined as 12 months with no menses without an alternative medical cause) or permanently surgically sterile (includes hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) who have a positive or indeterminate pregnancy test result at the Screening Visit or Day 1
• 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)
• 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
• Use of APAP or NSAIDs during washout period (between Screening Visit 2 and Day 1). Use of aspirin (up to 325 mg/day) for thrombosis prophylaxis is permitted.

Where it is running

• Tucson Orthopaedic Institute — Tucson, Arizona, United States
• Core Healthcare Research — Cerritos, California, United States
• BioSolutions Clinical Research Center — La Mesa, California, United States
• Infinity Clinical Research — Norco, California, United States
• Dream Team Clinical Research — Pomona, California, United States
• Artemis Institute for Clinical Research — San Diego, California, United States
• Encompass Clinical Research — Spring Valley, California, United States
• Millennium Clinical Trials, LLC — Thousand Oaks, California, United States
• Unique Clinical Trials — Doral, Florida, United States
• Eastern Research, Inc. — Hialeah, Florida, United States
• TecTum Research — Hollywood, Florida, United States
• Columbus Clinical Services, LLC — Miami, Florida, United States
• AppleMed Research Group, LLC — Miami, Florida, United States
• Advance Medical Research Center — Miami, Florida, United States
• Health and Life Research Institute, LLC — Miami, Florida, United States
• BioMed Research and Medical Center — Miami, Florida, United States
• Well Pharma Medical Research, Corp — Miami, Florida, United States
• South Florida Research Phase I-IV, Inc. — Miami Springs, Florida, United States
• Tampa Pain Relief Center — Tampa, Florida, United States
• Premier Medical Associates — The Villages, Florida, United States
• Conquest Research, LLC — Winter Park, Florida, United States
• Pinnacle Trials, Inc. — Stockbridge, Georgia, United States
• Chicago Clinical Research Institute — Chicago, Illinois, United States
• MediSphere Medical Research Center, LLC — Evansville, Indiana, United States
• DelRicht Research - Mandeville — Mandeville, Louisiana, United States

Full record on ClinicalTrials.gov

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