3-year, Open-Label Study Evaluating Safety, Tolerability, and Efficacy of Lorecivivint in Knee Osteoarthritis

Stopped early · Phase 3

Conditions studied: Osteoarthritis of the Knee

In brief

This study is designed as a 3-year, multicenter, open-label study evaluating the safety, tolerability, and efficacy of intra-articular (IA) Lorecivivint (LOR) in subjects with osteoarthritis of the knee in a real-world setting.

Key facts

Study ID

NCT04931667

Run by

Biosplice Therapeutics, Inc.

People needed

72

Starts

2021-07-15

Expected to finish

2021-12-13

Last updated by the study team

2026-03-31

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
• Femorotibial OA by standard American College of Rheumatology (ACR) criteria; knee OA is not to be secondary to any rheumatologic conditions (e.g., rheumatoid arthritis).
• Pain compatible with knee OA for at least 26 weeks prior to the Screening Visit
• Negative drug test for amphetamine, buprenorphine, cocaine, methadone, opiates, phencyclidine (PCP), propoxyphene, barbiturates, and benzodiazepine, unless any of these drugs are prescribed by a physician to treat a specific condition
• Full understanding of the requirements of the study and willingness to comply with all study visits and assessments
• Subjects must have read and understood the informed consent form (ICF), and must have signed and dated it prior to any study-related procedure being performed

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 Screening and 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 during the study period
• Any surgery (e.g., arthroscopy) in either knee within 26 weeks prior to Day 1
• Intra-articular (IA) injection into either 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
• 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 comorbid condition that could affect study endpoint assessments of the knee, including, but not limited to, rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, gout or pseudogout, and fibromyalgia
• Any contraindications for an IA injection in the knee(s) to be injected at Day 1 in the opinion of the Investigator

Where it is running

• Research Site — Tucson, Arizona, United States
• Research Site — Winter Park, Florida, United States
• Research Site — Oak Brook, Illinois, United States
• Research Site — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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