A Study Utilizing Patient-Reported Outcomes to Evaluate the Safety and Efficacy of Lorecivivint (SM04690) for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis (STRIDES)

Knee Osteoarthritis Clinical Trial

Official title:

A Phase 3, 16-Week, Multicenter, Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a Single Injection of Lorecivivint 0.07 mg Dose in the Target Knee Joint of Subjects With Moderate to Severe Osteoarthritis Pain of the Knee

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05603754
• Other study ID #: SM04690-OA-21
• Status: Completed
• Phase: Phase 3
• Start date: November 18, 2022
• Est. completion date: February 20, 2024

Study information

• Verified date: February 2024
• Source: Biosplice Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This phase 3 study is a multicenter, randomized, double-blind, placebo-controlled study of lorecivivint injected intra-articularly (IA) into the target (most painful) knee joint of moderately to severely symptomatic osteoarthritis (OA) subjects at a single dose of 0.07 mg lorecivivint per 2 mL injection. This study will utilize standard outcomes to evaluate the safety and efficacy of lorecivivint.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 496
• Est. completion date: February 20, 2024
• Est. primary completion date: February 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Males and females between 40 and 80 years of age, inclusive, in general good health apart from their knee OA
• Ambulatory (single assistive devices such as canes allowed if needed less than 50% of the time, subjects requiring a walker are excluded)
• Diagnosis of femorotibial OA in the target knee by standard American College of Rheumatology (ACR) criteria at the Screening Visit (clinical AND radiographic criteria); OA of the knee is not to be secondary to any rheumatologic conditions (e.g., rheumatoid arthritis)
• Radiographic disease Stage 2 or 3 in target knee within 24 weeks of the Screening Visit according to the Kellgren-Lawrence (KL) grading of knee OA as assessed by independent central readers
• Qualifying mean score on the 24-h average pain score (0-10 numeric rating scale)
• Pain compatible with OA of the knee(s) for at least 26 weeks prior to the Screening Visit
• Primary source of pain throughout the body is due to OA in the target knee
• Body mass index (BMI) = 35 kg/m2 at the Screening Visit

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 the Screening Visit or Day 1
• Partial or complete joint replacement in either knee
• Currently requires use of a lower extremity prosthesis, and/or a structural knee brace (i.e., a knee brace that contains hardware)
• Any surgery (e.g., arthroscopy) in either knee within 26 weeks prior to Day 1
• Intra-articular (IA) injection into the target 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 allowed
• Previous treatment with lorecivivint (SM04690)
• Participation in a clinical research trial that included the receipt of an investigational product or any experimental therapeutic procedure within 26 weeks prior to the Screening Visit, or planned participation in any such trial
• Subjects requiring the use of opioids > 1x per week within 12 weeks prior to Day 1
• History of malignancy within the last 5 years; not including subjects with prior history of adequately treated in situ cervical cancer or basal or squamous cell skin cancer
• Clinically significant abnormal screening hematology values, blood chemistry values, or urinalysis values as determined by the Investigator
• Any known active infections, including urinary tract infection, upper respiratory tract infection, sinusitis, suspicion of IA infection, hepatitis B or hepatitis C infection, and/or infections that may compromise the immune system such as human immunodeficiency virus (HIV) at Day 1
• Use of APAP or NSAIDs during washout period (between Screening Visit 2 and Day 1). Use of aspirin (up to 325 mg/day) for thrombosis prophylaxis is permitted.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Lorecivivint
One intra-articular injection of 0.07 mg lorecivivint in 2 mL vehicle
• Placebo
One intra-articular injection of 0 mg lorecivivint in 2 mL vehicle

Locations

Country	Name	City	State
United States	Albuquerque Clinical Trials	Albuquerque	New Mexico
United States	Skylight Health Research	Burlington	Massachusetts
United States	Core Healthcare Research	Cerritos	California
United States	Clinical Trials of South Carolina	Charleston	South Carolina
United States	Chicago Clinical Research Institute	Chicago	Illinois
United States	Hightop Medical Research Center	Cincinnati	Ohio
United States	Zenos Clinical Research	Dallas	Texas
United States	Unique Clinical Trials	Doral	Florida
United States	Conrad Clinical Research	Edmond	Oklahoma
United States	MediSphere Medical Research Center, LLC	Evansville	Indiana
United States	Piedmont Research Partners, LLC	Fort Mill	South Carolina
United States	Healthcare Research Network	Hazelwood	Missouri
United States	Eastern Research, Inc.	Hialeah	Florida
United States	TecTum Research	Hollywood	Florida
United States	Synergy Groups Medical, LLC	Houston	Texas
United States	Synergy Groups Medical, LLC	Houston	Texas
United States	BioSolutions Clinical Research Center	La Mesa	California
United States	DelRicht Research - Mandeville	Mandeville	Louisiana
United States	Advance Medical Research Center	Miami	Florida
United States	AppleMed Research Group, LLC	Miami	Florida
United States	BioMed Research and Medical Center	Miami	Florida
United States	Columbus Clinical Services, LLC	Miami	Florida
United States	Health and Life Research Institute, LLC	Miami	Florida
United States	Well Pharma Medical Research, Corp	Miami	Florida
United States	South Florida Research Phase I-IV, Inc.	Miami Springs	Florida
United States	DelRicht Research	New Orleans	Louisiana
United States	Infinity Clinical Research	Norco	California
United States	Clinical Investigations of Texas	Plano	Texas
United States	Dream Team Clinical Research	Pomona	California
United States	DelRicht Research - Prairieville	Prairieville	Louisiana
United States	Health Concepts	Rapid City	South Dakota
United States	DelRicht Research - Rockville	Rockville	Maryland
United States	Wasatch Clinical Research, LLC	Salt Lake City	Utah
United States	Diagnostic Research Group	San Antonio	Texas
United States	Artemis Institute for Clinical Research	San Diego	California
United States	Encompass Clinical Research	Spring Valley	California
United States	Pinnacle Trials, Inc.	Stockbridge	Georgia
United States	Tampa Pain Relief Center	Tampa	Florida
United States	Premier Medical Associates	The Villages	Florida
United States	Millennium Clinical Trials, LLC	Thousand Oaks	California
United States	Oakland Medical Research	Troy	Michigan
United States	Tucson Orthopaedic Institute	Tucson	Arizona
United States	DelRicht Research - Tulsa	Tulsa	Oklahoma
United States	Conquest Research, LLC	Winter Park	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Biosplice Therapeutics, Inc.	NBCD A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline OA pain in the target knee as assessed by weekly average of daily pain numeric rating scale (NRS) at Week 12	Evaluate change from baseline OA pain in the target knee as assessed by weekly average of daily pain NRS at Week 12. The pain NRS is an 11-point scale [0-10] for subject self-reporting of average knee pain in the last 24 hours; 0 indicates no pain, and 10 indicates pain as bad as you can imagine.	Baseline and Week 12
Secondary	Change from baseline OA function as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical function subscore (WOMAC Function) at Week 12	Evaluate change from baseline OA function as assessed by WOMAC Function at Week 12. The WOMAC is a widely-used, proprietary outcome measurement tool used to evaluate the condition of subjects with OA of the knee and hip, including pain (5 questions), stiffness (2 questions) and physical functioning (17 questions) of the joints. Each question is measured on an 11-point NRS scale [0-10]; 0 indicates no pain / no stiffness / no difficulty, and 10 indicates extreme pain / extreme stiffness / extreme difficulty. The WOMAC Function subscore is scaled to range from 0 to 100.	Baseline and Week 12
Secondary	Change from baseline OA disease activity as assessed by Patient Global Assessment at Week 12	Evaluate change from baseline OA disease activity as assessed by Patient Global Assessment at Week 12. The Patient Global Assessment is an 11-point NRS [0-10] for subject self-reporting of how they feel their target knee is impacting them; 0 indicates very good, and 10 indicates very bad.	Baseline and Week 12