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)
- Registration Number
- NCT05603754
- Lead Sponsor
- Biosplice Therapeutics, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 496
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lorecivivint Lorecivivint Healthcare professional-administered intra-articular injection; performed on Day 1. Vehicle Placebo Healthcare professional-administered intra-articular injection; performed on Day 1.
- Primary Outcome Measures
Name Time Method Change from baseline OA pain in the target knee as assessed by weekly average of daily pain numeric rating scale (NRS) at Week 12 Baseline and Week 12 Evaluate change from baseline OA pain in the target knee as assessed by weekly average of daily pain NRS at Week 12. The pain NRS is an 11-point scale \[0-10\] for subject self-reporting of average knee pain in the last 24 hours; 0 indicates no pain, and 10 indicates pain as bad as you can imagine.
- Secondary Outcome Measures
Name Time Method Change from baseline OA disease activity as assessed by Patient Global Assessment at Week 12 Baseline and Week 12 Evaluate change from baseline OA disease activity as assessed by Patient Global Assessment at Week 12. The Patient Global Assessment is an 11-point NRS \[0-10\] for subject self-reporting of how they feel their target knee is impacting them; 0 indicates very good, and 10 indicates very bad.
Change from baseline OA function as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical function subscore (WOMAC Function) at Week 12 Baseline and Week 12 Evaluate change from baseline OA function as assessed by WOMAC Function at Week 12. The WOMAC is a widely-used, proprietary outcome measurement tool used to evaluate the condition of subjects with OA of the knee and hip, including pain (5 questions), stiffness (2 questions) and physical functioning (17 questions) of the joints. Each question is measured on an 11-point NRS scale \[0-10\]; 0 indicates no pain / no stiffness / no difficulty, and 10 indicates extreme pain / extreme stiffness / extreme difficulty. The WOMAC Function subscore is scaled to range from 0 to 100.
Trial Locations
- Locations (43)
Eastern Research, Inc.
🇺🇸Hialeah, Florida, United States
TecTum Research
🇺🇸Hollywood, Florida, United States
Conquest Research, LLC
🇺🇸Winter Park, Florida, United States
Chicago Clinical Research Institute
🇺🇸Chicago, Illinois, United States
Columbus Clinical Services, LLC
🇺🇸Miami, Florida, United States
Advance Medical Research Center
🇺🇸Miami, Florida, United States
Health and Life Research Institute, LLC
🇺🇸Miami, Florida, United States
BioSolutions Clinical Research Center
🇺🇸La Mesa, California, United States
Artemis Institute for Clinical Research
🇺🇸San Diego, California, United States
Dream Team Clinical Research
🇺🇸Pomona, California, United States
Infinity Clinical Research
🇺🇸Norco, 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
AppleMed Research Group, LLC
🇺🇸Miami, Florida, United States
South Florida Research Phase I-IV, Inc.
🇺🇸Miami Springs, Florida, United States
Well Pharma Medical Research, Corp
🇺🇸Miami, Florida, United States
Premier Medical Associates
🇺🇸The Villages, Florida, United States
Pinnacle Trials, Inc.
🇺🇸Stockbridge, Georgia, United States
MediSphere Medical Research Center, LLC
🇺🇸Evansville, Indiana, United States
Skylight Health Research
🇺🇸Burlington, Massachusetts, United States
DelRicht Research - Rockville
🇺🇸Rockville, Maryland, United States
Oakland Medical Research
🇺🇸Troy, Michigan, United States
Healthcare Research Network
🇺🇸Hazelwood, Missouri, United States
Hightop Medical Research Center
🇺🇸Cincinnati, Ohio, United States
DelRicht Research - Tulsa
🇺🇸Tulsa, Oklahoma, United States
Conrad Clinical Research
🇺🇸Edmond, Oklahoma, United States
Health Concepts
🇺🇸Rapid City, South Dakota, United States
Zenos Clinical Research
🇺🇸Dallas, Texas, United States
Synergy Groups Medical, LLC
🇺🇸Houston, Texas, United States
Clinical Investigations of Texas
🇺🇸Plano, Texas, United States
Diagnostic Research Group
🇺🇸San Antonio, Texas, United States
Piedmont Research Partners, LLC
🇺🇸Fort Mill, South Carolina, United States
DelRicht Research - Mandeville
🇺🇸Mandeville, Louisiana, United States
Core Healthcare Research
🇺🇸Cerritos, California, United States
BioMed Research and Medical Center
🇺🇸Miami, Florida, United States
Tampa Pain Relief Center
🇺🇸Tampa, Florida, United States
Clinical Trials of South Carolina
🇺🇸Charleston, South Carolina, United States
Wasatch Clinical Research, LLC
🇺🇸Salt Lake City, Utah, United States
DelRicht Research
🇺🇸New Orleans, Louisiana, United States
Albuquerque Clinical Trials
🇺🇸Albuquerque, New Mexico, United States
Tucson Orthopaedic Institute
🇺🇸Tucson, Arizona, United States
DelRicht Research - Prairieville
🇺🇸Prairieville, Louisiana, United States