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

Biosplice Therapeutics

Status and phase: Terminated; Phase 3

Conditions: Osteoarthritis of the Knee

Treatments: Drug: Lorecivivint

Study type: Interventional

Funder types: Industry

Identifiers

NCT04931667

SM04690-OA-17

Details and patient eligibility

About

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.

Full 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).

All Patient Reported Outcome (PRO) measurements, including Western Ontario and McMaster University Osteoarthritis Index (WOMAC), and Pain Numeric Rating Scale (NRS), as well as safety evaluations will be conducted at each clinic visit. An additional phone follow-up visit for safety will occur 4 weeks after the injection on Day 1.

Study was terminated by Sponsor based on a business decision not due to safety. The study report was finalized without any statistical analysis.

Enrollment: 72 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Males and females between 40 and 80 years of age, inclusive, in general good health apart from their knee OA
2. 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).
3. Pain compatible with knee OA for at least 26 weeks prior to the Screening Visit
4. 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
5. Full understanding of the requirements of the study and willingness to comply with all study visits and assessments
6. 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

1. 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
2. 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
3. Any surgery (e.g., arthroscopy) in either knee within 26 weeks prior to Day 1
4. 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
5. 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
6. 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
7. Any contraindications for an IA injection in the knee(s) to be injected at Day 1 in the opinion of the Investigator

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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72 participants in 1 patient group

0.07 mg Lorecivivint

Experimental group

Description:

One intra-articular injection of 0.07 mg Lorecivivint in 2 ml vehicle in one or both knees as clinically indicated. Bilateral injection of 0.07 mg LOR are allowed. Lorecivivint: Healthcare professional-administered intra-articular injection

Treatment:

Drug: Lorecivivint