A Long-Term Safety and Efficacy Study of Lorecivivint in Subjects With Osteoarthritis of the Knee
NCT ID: NCT04520607
Last Updated: 2023-12-20
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
276 participants
INTERVENTIONAL
2020-08-25
2023-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Arm 1
Subjects assigned to this arm will receive one intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle (same treatment as in the parent-study) into their target knee (the same target knee injected in the parent study); performed on Day 1, at Week 48 and every 52 weeks thereafter.
Lorecivivint
Healthcare professional-administered intra-articular injections of lorecivivint.
Arm 2
Subjects assigned to this arm will receive one intra-articular injection of 0 mg lorecivivint in 2 ml vehicle (same treatment as in the parent-study) into their target knee (the same target knee injected in the parent study) on Day 1, followed by one intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle at Week 48 and every 52 weeks thereafter.
Placebo
Healthcare professional-administered intra-articular injection of vehicle.
Lorecivivint
Healthcare professional-administered intra-articular injections of lorecivivint.
Interventions
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Placebo
Healthcare professional-administered intra-articular injection of vehicle.
Lorecivivint
Healthcare professional-administered intra-articular injections of lorecivivint.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Compliance with procedures in study SM04690-OA-11, in the opinion of the Investigator
3. Fully understanding study requirements and willingness to comply with study visits and assessments
4. Understanding and signing of the informed consent form (ICF) prior to any study-related procedures
Exclusion Criteria
2. Any contraindications for an intra-articular (IA) injection in the target knee in the opinion of the Investigator
3. Any known reason identified by the Investigator or Sponsor that the subject may not be compliant with study visits or may no longer be an appropriate candidate for the study (e.g. planned major surgery, knee replacement during the parent study, planning to move away from the research site, or initiation of a prohibited concomitant medication including, but not limited to, IA injection of glucocorticoids, hyaluronic acid derivatives, platelet-rich plasma, stem cell therapies, or other agents with therapeutic intent into the target knee)
4. Participation in a clinical research trial (other than the prior SM04690-OA-11 study) that included the receipt of an investigational product (IP) or any experimental therapeutic procedure within 12 weeks before any study injection, or planned participation in any such trial
5. Current or pending disability claim, workers' compensation, or litigation(s) that may compromise response to treatment
6. 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 Visit 1E (Day 1)
7. Women who are not post-menopausal or permanently surgically sterile who are sexually active, and who are not willing to use birth control (as outlined in the protocol) during the study period
41 Years
81 Years
ALL
No
Sponsors
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Biosplice Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Ismail Simsek, MD
Role: STUDY_DIRECTOR
Biosplice Therapeutics, Inc.
Locations
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Research Site
Tucson, Arizona, United States
Research Site
Anaheim, California, United States
Research Site
Pomona, California, United States
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San Diego, California, United States
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Thousand Oaks, California, United States
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Denver, Colorado, United States
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Hialeah, Florida, United States
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Miami, Florida, United States
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Miami Lakes, Florida, United States
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Port Orange, Florida, United States
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West Palm Beach, Florida, United States
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Winter Haven, Florida, United States
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Winter Park, Florida, United States
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Newnan, Georgia, United States
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Woodstock, Georgia, United States
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Gurnee, Illinois, United States
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Oak Brook, Illinois, United States
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Valparaiso, Indiana, United States
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New Orleans, Louisiana, United States
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Bay City, Michigan, United States
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Troy, Michigan, United States
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Hazelwood, Missouri, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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Hartsdale, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Charlotte, North Carolina, United States
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Salisbury, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Fort Mill, South Carolina, United States
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Mt. Pleasant, South Carolina, United States
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Rapid City, South Dakota, United States
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Carrollton, Texas, United States
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Plano, Texas, United States
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San Antonio, Texas, United States
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Draper, Utah, United States
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Salt Lake City, Utah, United States
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Charlottesville, Virginia, United States
Countries
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Other Identifiers
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SM04690-OA-07
Identifier Type: -
Identifier Source: org_study_id