Coral Gables, Florida 33134

  • Osteoarthritis, Knee

Purpose:

This study is designed as a 1-year extension to the Phase 3 parent-study SM04690-OA-11. It aims to evaluate the safety and efficacy of a second year of use of lorecivivint in subjects with knee osteoarthritis (OA). Subjects must enroll no later than 6 weeks following completion of the parent-study.


Study summary:

At the first visit (Visit 1E; Day 1) in this study, all subjects will complete Patient Acceptable Symptom State (PASS) and pain numeric rating scale (NRS) assessments, and then receive a blinded study injection into their target knee (the same target knee injected in the parent-study), with subjects receiving the same treatment (either 0.07 mg lorecivivint or placebo) as they received in the parent-study. Subjects will have clinic visits at Visit 2E (Week 24) and Visit 3E (End of Study; Week 48) for subsequent pain and function assessments and for collection of adverse events. Subjects will also undergo knee radiographs at Visit 2E and Visit 3E.


Criteria:

Inclusion Criteria: 1. Completion of the Samumed study SM04690-OA-11 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: 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 2. Any contraindications for an intra-articular (IA) injection in the target knee in the opinion of the Investigator 3. Any known reason 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 Samumed 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 8. Men who are sexually active and of reproductive potential, who have a partner who is capable of becoming pregnant, and who are not willing to use birth control (as outlined in the protocol) during the study period


NCT ID:

NCT04520607


Primary Contact:

Study Director
Ismail Simsek, MD
Biosplice Therapeutics, Inc.

Biosplice Clinical Trials
Phone: 1-855-222-0515
Email: clinicaltrials@biosplice.com


Backup Contact:

N/A


Location Contact:

Coral Gables, Florida 33134
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 19, 2021

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