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)

NCT05603754 | Completed Phase 3 FDA Drug

• 1 other identifier: SM04690-OA-21
• Study Type: interventional
• Target: 496
• Locations: 1 country
• Sites: 44

Brief 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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change from baseline OA function as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical function subscore (WOMAC Function) at Week 12

  Baseline and Week 12

• Change from baseline OA disease activity as assessed by Patient Global Assessment at Week 12

  Baseline and Week 12

Study Arms (2)

Lorecivivint

EXPERIMENTAL

Healthcare professional-administered intra-articular injection; performed on Day 1.

Drug: Lorecivivint

Vehicle

PLACEBO COMPARATOR

Healthcare professional-administered intra-articular injection; performed on Day 1.

Drug: Placebo

Interventions

Lorecivivint DRUG

One intra-articular injection of 0.07 mg lorecivivint in 2 mL vehicle

Also known as: SM04690

Lorecivivint

Placebo DRUG

One intra-articular injection of 0 mg lorecivivint in 2 mL vehicle

Also known as: Vehicle

Vehicle

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biosplice Therapeutics, Inc.: lead
• NBCD A/S: collaborator

Study Sites (44)

Tucson Orthopaedic Institute

Tucson, Arizona, 85712, United States

Location

Core Healthcare Research

Cerritos, California, 90703, United States

Location

BioSolutions Clinical Research Center

La Mesa, California, 91942, United States

Location

Infinity Clinical Research

Norco, California, 92860, United States

Location

Dream Team Clinical Research

Pomona, California, 91767, United States

Location

Artemis Institute for Clinical Research

San Diego, California, 92103, United States

Location

Encompass Clinical Research

Spring Valley, California, 97978, United States

Location

Millennium Clinical Trials, LLC

Thousand Oaks, California, 91360, United States

Location

Unique Clinical Trials

Doral, Florida, 33172, United States

Location

Eastern Research, Inc.

Hialeah, Florida, 33013, United States

Location

TecTum Research

Hollywood, Florida, 33024, United States

Location

Columbus Clinical Services, LLC

Miami, Florida, 33125, United States

Location

AppleMed Research Group, LLC

Miami, Florida, 33126, United States

Location

Advance Medical Research Center

Miami, Florida, 33135, United States

Location

Health and Life Research Institute, LLC

Miami, Florida, 33155, United States

Location

BioMed Research and Medical Center

Miami, Florida, 33156, United States

Location

Well Pharma Medical Research, Corp

Miami, Florida, 33173, United States

Location

South Florida Research Phase I-IV, Inc.

Miami Springs, Florida, 33166, United States

Location

Tampa Pain Relief Center

Tampa, Florida, 33603, United States

Location

Premier Medical Associates

The Villages, Florida, 32159, United States

Location

Conquest Research, LLC

Winter Park, Florida, 32789, United States

Location

Pinnacle Trials, Inc.

Stockbridge, Georgia, 30281, United States

Location

Chicago Clinical Research Institute

Chicago, Illinois, 60607, United States

Location

MediSphere Medical Research Center, LLC

Evansville, Indiana, 47714, United States

Location

DelRicht Research - Mandeville

Mandeville, Louisiana, 70471, United States

Location

DelRicht Research

New Orleans, Louisiana, 70124, United States

Location

DelRicht Research - Prairieville

Prairieville, Louisiana, 70817, United States

Location

DelRicht Research - Rockville

Rockville, Maryland, 20852, United States

Location

Skylight Health Research

Burlington, Massachusetts, 01803, United States

Location

Oakland Medical Research

Troy, Michigan, 48085, United States

Location

Healthcare Research Network

Hazelwood, Missouri, 63042, United States

Location

Albuquerque Clinical Trials

Albuquerque, New Mexico, 87102, United States

Location

Hightop Medical Research Center

Cincinnati, Ohio, 45224, United States

Location

Conrad Clinical Research

Edmond, Oklahoma, 73013, United States

Location

DelRicht Research - Tulsa

Tulsa, Oklahoma, 74133, United States

Location

Clinical Trials of South Carolina

Charleston, South Carolina, 29406, United States

Location

Piedmont Research Partners, LLC

Fort Mill, South Carolina, 29707, United States

Location

Health Concepts

Rapid City, South Dakota, 57702, United States

Location

Zenos Clinical Research

Dallas, Texas, 75230, United States

Location

Synergy Groups Medical, LLC

Houston, Texas, 77036, United States

Location

Synergy Groups Medical, LLC

Houston, Texas, 77061, United States

Location

Clinical Investigations of Texas

Plano, Texas, 75075, United States

Location

Diagnostic Research Group

San Antonio, Texas, 78229, United States

Location

Wasatch Clinical Research, LLC

Salt Lake City, Utah, 84107, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

lorecivivint

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Yusuf Yazici, MD

  Biosplice Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: November 3, 2022
• Study Start: November 18, 2022
• Primary Completion: February 20, 2024
• Study Completion: February 20, 2024
• Last Updated: July 25, 2024

Record last verified: 2024-07

Locations

US (44)