A Long-Term Safety and Efficacy Study of Lorecivivint in Subjects With Osteoarthritis of the Knee

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Osteoarthritis, Knee

In brief

Study OA-07 was a randomized, double-blind, placebo-controlled, Phase 3, multicenter, 2-year clinical trial that enrolled subjects from the recently completed Study OA-11 (NCT03928184). The first 48 weeks of OA-07 the trial was placebo-controlled with subjects receiving the same randomized treatment received in OA-11. Investigators, research staff and subjects remained blinded to treatment allocation. At Week 48, all subjects were administered LOR in the open-label portion of the trial.

Key facts

Study ID

NCT04520607

Run by

Biosplice Therapeutics, Inc.

People needed

276

Starts

2020-08-25

Expected to finish

2023-06-30

Last updated by the study team

2026-03-24

Who can join

Age: 41 and older, up to 81. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Completion of the Study SM04690-OA-11 (NCT03928184)
• Compliance with procedures in study SM04690-OA-11, in the opinion of the Investigator
• Fully understanding study requirements and willingness to comply with study visits and assessments
• Understanding and signing of the informed consent form (ICF) prior to any study-related procedures

You may not qualify if…

• Any condition that, in the opinion of the Investigator, constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation
• Any contraindications for an intra-articular (IA) injection in the target knee in the opinion of the Investigator
• 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)
• 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
• Current or pending disability claim, workers' compensation, or litigation(s) that may compromise response to treatment
• 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)
• 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

Where it is running

• Research Site — Tucson, Arizona, United States
• Research Site — Anaheim, California, United States
• Research Site — Pomona, California, United States
• Research Site — San Diego, California, United States
• Research Site — Thousand Oaks, California, United States
• Research Site — Denver, Colorado, United States
• Research Site — Hialeah, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Miami Lakes, Florida, United States
• Research Site — Port Orange, Florida, United States
• Research Site — West Palm Beach, Florida, United States
• Research Site — Winter Haven, Florida, United States
• Research Site — Winter Park, Florida, United States
• Research Site — Newnan, Georgia, United States
• Research Site — Woodstock, Georgia, United States
• Research Site — Gurnee, Illinois, United States
• Research Site — Oak Brook, Illinois, United States
• Research Site — Valparaiso, Indiana, United States
• Research Site — New Orleans, Louisiana, United States
• Research Site — Bay City, Michigan, United States
• Research Site — Troy, Michigan, United States
• Research Site — Hazelwood, Missouri, United States
• Research Site — St Louis, Missouri, United States
• Research Site — Omaha, Nebraska, United States
• Research Site — Hartsdale, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.