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)
NCT ID: NCT05603754
Last Updated: 2024-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
496 participants
INTERVENTIONAL
2022-11-18
2024-02-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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
Vehicle
Healthcare professional-administered intra-articular injection; performed on Day 1.
Placebo
One intra-articular injection of 0 mg lorecivivint in 2 mL vehicle
Interventions
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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
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Eligibility Criteria
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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
Exclusion Criteria
* 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.
40 Years
80 Years
ALL
No
Sponsors
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NBCD A/S
INDUSTRY
Biosplice Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Yusuf Yazici, MD
Role: STUDY_DIRECTOR
Biosplice Therapeutics, Inc.
Locations
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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
DelRicht Research
New Orleans, Louisiana, United States
DelRicht Research - Prairieville
Prairieville, Louisiana, United States
DelRicht Research - Rockville
Rockville, Maryland, United States
Skylight Health Research
Burlington, Massachusetts, United States
Oakland Medical Research
Troy, Michigan, United States
Healthcare Research Network
Hazelwood, Missouri, United States
Albuquerque Clinical Trials
Albuquerque, New Mexico, United States
Hightop Medical Research Center
Cincinnati, Ohio, United States
Conrad Clinical Research
Edmond, Oklahoma, United States
DelRicht Research - Tulsa
Tulsa, Oklahoma, United States
Clinical Trials of South Carolina
Charleston, South Carolina, United States
Piedmont Research Partners, LLC
Fort Mill, South Carolina, 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
Synergy Groups Medical, LLC
Houston, Texas, United States
Clinical Investigations of Texas
Plano, Texas, United States
Diagnostic Research Group
San Antonio, Texas, United States
Wasatch Clinical Research, LLC
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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SM04690-OA-21
Identifier Type: -
Identifier Source: org_study_id
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