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

  • STATUS
    Recruiting
  • End date
    Jul 1, 2026
  • participants needed
    300
  • sponsor
    Biosplice Therapeutics, Inc.
Updated on 17 September 2021
Investigator
Biosplice Clinical Trials
Primary Contact
Research Site (7.0 mi away) Contact
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Summary

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.

Description

At Day 1, after a screening period of up to 14 days, subjects will receive an IA injection of 0.07 mg LOR into one or both knees, followed by a 36-month evaluation period. Clinic visits will be scheduled at Day 1, and Months 3, 12, 24, and 36 [End of study (EOS)] or Early Termination (ET) for completion of all Patient Reported Outcome (PRO) measurements Western Ontario and McMaster University Arthritis Index (WOMAC), Knee Injury and Ostheoarthritis Outcome Score (KOOS), pain Numeric Rating Scale (NRS), Study Form (SF)-12, Patient Acceptable Symptom State Questionnaire (PASS), Work Productivity and Activity Impairment Questionnaire (WPAI)], functional tests [40-meter walk test and Time Up and Go (TUG) test at a subset of sites], and safety evaluations. On Day 1, the Charlson Comorbidity Index and Widespread Pain Index and Symptom Severity [WPI&SS] assessments will also be completed. A phone visit for safety follow-up will occur 4 weeks after the injection on Day 1. Subjects may also have Unscheduled Injection Visits for additional injections of LOR, glucocorticoid, or hyaluronic acid (HA). Following each injection, subjects will return to the clinic for 3-Month Post-Injection Follow-Up Visits, unless another visit has occurred between the injection and the 3-month post injection date. At these injection visits and 3-Month Post-Injection Follow-Up Visits, subjects will complete PRO measurements and functional tests (at a subset of sites).

Details
Condition Osteoarthritis of knee, Gonarthrosis, knee osteoarthritis
Treatment Lorecivivint
Clinical Study IdentifierNCT04931667
SponsorBiosplice Therapeutics, Inc.
Last Modified on17 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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