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)

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

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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Drug: Lorecivivint; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 496
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Biosplice Clinical Trials; Phone Number: 1-855-222-0515; Email: clinicaltrials@biosplice.com

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85712
      • Tucson Orthopaedic Institute
  • California
    • Cerritos, California, United States, 90703
      • Core Healthcare Research
    • La Mesa, California, United States, 91942
      • Biosolutions Clinical Research Center
    • Norco, California, United States, 92860
      • Infinity Clinical Research
    • Pomona, California, United States, 91767
      • Dream Team Clinical Research
    • San Diego, California, United States, 92103
      • Artemis Institute for Clinical Research
    • Spring Valley, California, United States, 97978
      • Encompass Clinical Research
    • Thousand Oaks, California, United States, 91360
      • Millennium Clinical Trials, LLC
  • Florida
    • Doral, Florida, United States, 33172
      • Unique Clinical Trials
    • Hialeah, Florida, United States, 33013
      • Eastern Research, Inc.
    • Hollywood, Florida, United States, 33024
      • TecTum Research
    • Miami, Florida, United States, 33155
      • Health and Life Research Institute, LLC
    • Miami, Florida, United States, 33135
      • Advance Medical Research Center
    • Miami, Florida, United States, 33125
      • Columbus Clinical Services, LLC
    • Miami, Florida, United States, 33173
      • Well Pharma Medical Research, Corp
    • Miami, Florida, United States, 33126
      • AppleMed Research Group, LLC
    • Miami, Florida, United States, 33156
      • BioMed Research and Medical Center
    • Miami Springs, Florida, United States, 33166
      • South Florida Research Phase I-Iv, Inc.
    • Tampa, Florida, United States, 33603
      • Tampa Pain Relief Center
    • The Villages, Florida, United States, 32159
      • Premier Medical Associates
    • Winter Park, Florida, United States, 32789
      • Conquest Research, LLC
  • Georgia
    • Stockbridge, Georgia, United States, 30281
      • Pinnacle Trials, Inc.
  • Illinois
    • Chicago, Illinois, United States, 60607
      • Chicago Clinical Research Institute
  • Indiana
    • Evansville, Indiana, United States, 47714
      • Medisphere Medical Research Center, Llc
  • Louisiana
    • Mandeville, Louisiana, United States, 70471
      • DelRicht Research - Mandeville
    • New Orleans, Louisiana, United States, 70124
      • Delricht Research
    • Prairieville, Louisiana, United States, 70817
      • DelRicht Research - Prairieville
  • Maryland
    • Rockville, Maryland, United States, 20852
      • DelRicht Research - Rockville
  • Massachusetts
    • Burlington, Massachusetts, United States, 01803
      • Skylight Health Research
  • Michigan
    • Troy, Michigan, United States, 48085
      • Oakland Medical Research
  • Missouri
    • Hazelwood, Missouri, United States, 63042
      • Healthcare Research Network
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Albuquerque Clinical Trials
  • Ohio
    • Cincinnati, Ohio, United States, 45224
      • Hightop Medical Research Center
  • Oklahoma
    • Edmond, Oklahoma, United States, 73013
      • Conrad Clinical Research
    • Tulsa, Oklahoma, United States, 74133
      • DelRicht Research - Tulsa
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Clinical Trials of South Carolina
    • Fort Mill, South Carolina, United States, 29707
      • Piedmont Research Partners, LLC
  • South Dakota
    • Rapid City, South Dakota, United States, 57702
      • Health Concepts
  • Texas
    • Dallas, Texas, United States, 75230
      • Zenos Clinical Research
    • Houston, Texas, United States, 77036
      • Synergy Groups Medical, LLC
    • Houston, Texas, United States, 77061
      • Synergy Groups Medical, LLC
    • Plano, Texas, United States, 75075
      • Clinical Investigations of Texas
    • San Antonio, Texas, United States, 78229
      • Diagnostic Research Group
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Wasatch Clinical Research, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lorecivivint; Healthcare professional-administered intra-articular injection; performed on Day 1.	Drug: Lorecivivint; One intra-articular injection of 0.07 mg lorecivivint in 2 mL vehicle; Other Names: SM04690
Placebo Comparator: Vehicle; Healthcare professional-administered intra-articular injection; performed on Day 1.	Drug: Placebo; One intra-articular injection of 0 mg lorecivivint in 2 mL vehicle; Other Names: Vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Biosplice Therapeutics, Inc.
• Collaborators: NBCD A/S
• Investigators: Study Director: Yusuf Yazici, MD, Biosplice Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2022
• Primary Completion (Actual): February 20, 2024
• Study Completion (Actual): February 20, 2024

Study Registration Dates

• First Submitted: October 27, 2022
• First Submitted That Met QC Criteria: October 27, 2022
• First Posted (Actual): November 3, 2022

Study Record Updates

• Last Update Posted (Actual): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Anti-Inflammatory Agents; Lorecivivint
• Other Study ID Numbers: SM04690-OA-21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No