Clinical trial NCT05603754: 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)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Knee Osteoarthritis
Lead sponsor: Biosplice Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: NBCD A/S
First posted: 2022-11-03
Enrollment: 496
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline OA pain in the target knee as assessed by weekly average of daily pain numeric rating scale (NRS) at Week 12
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change from baseline OA function as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical function subscore (WOMAC Function) at Week 12
timeFrame: Baseline and Week 12
measure: Change from baseline OA disease activity as assessed by Patient Global Assessment at Week 12
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Tucson Orthopaedic Institute
state: Arizona
city: Cerritos
country: United States
facility: Core Healthcare Research
state: California
city: La Mesa
country: United States
facility: BioSolutions Clinical Research Center
state: California
city: Norco
country: United States
facility: Infinity Clinical Research
state: California
city: Pomona
country: United States
facility: Dream Team Clinical Research
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Spring Valley
country: United States
facility: Encompass Clinical Research
state: California
city: Thousand Oaks
country: United States
facility: Millennium Clinical Trials, LLC
state: California
city: Doral
country: United States
facility: Unique Clinical Trials
state: Florida
city: Hialeah
country: United States
facility: Eastern Research, Inc.
state: Florida
city: Hollywood
country: United States
facility: TecTum Research
state: Florida
city: Miami Springs
country: United States
facility: South Florida Research Phase I-IV, Inc.
state: Florida
city: Miami
country: United States
facility: Columbus Clinical Services, LLC
state: Florida
city: Miami
country: United States
facility: AppleMed Research Group, LLC
state: Florida
city: Miami
country: United States
facility: Advance Medical Research Center
state: Florida
city: Miami
country: United States
facility: Health and Life Research Institute, LLC
state: Florida
city: Miami
country: United States
facility: BioMed Research and Medical Center
state: Florida
city: Miami
country: United States
facility: Well Pharma Medical Research, Corp
state: Florida
city: Tampa
country: United States
facility: Tampa Pain Relief Center
state: Florida
city: The Villages
country: United States
facility: Premier Medical Associates
state: Florida
city: Winter Park
country: United States
facility: Conquest Research, LLC
state: Florida
city: Stockbridge
country: United States
facility: Pinnacle Trials, Inc.
state: Georgia
city: Chicago
country: United States
facility: Chicago Clinical Research Institute
state: Illinois
city: Evansville
country: United States
facility: MediSphere Medical Research Center, LLC
state: Indiana
city: Mandeville
country: United States
facility: DelRicht Research - Mandeville
state: Louisiana
city: New Orleans
country: United States
facility: DelRicht Research
state: Louisiana
city: Prairieville
country: United States
facility: DelRicht Research - Prairieville
state: Louisiana
city: Rockville
country: United States
facility: DelRicht Research - Rockville
state: Maryland
city: Burlington
country: United States
facility: Skylight Health Research
state: Massachusetts
city: Troy
country: United States
facility: Oakland Medical Research
state: Michigan
city: Hazelwood
country: United States
facility: Healthcare Research Network
state: Missouri
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials
state: New Mexico
city: Cincinnati
country: United States
facility: Hightop Medical Research Center
state: Ohio
city: Edmond
country: United States
facility: Conrad Clinical Research
state: Oklahoma
city: Tulsa
country: United States
facility: DelRicht Research - Tulsa
state: Oklahoma
city: Charleston
country: United States
facility: Clinical Trials of South Carolina
state: South Carolina
city: Fort Mill
country: United States
facility: Piedmont Research Partners, LLC
state: South Carolina
city: Rapid City
country: United States
facility: Health Concepts
state: South Dakota
city: Dallas
country: United States
facility: Zenos Clinical Research
state: Texas
city: Houston
country: United States
facility: Synergy Groups Medical, LLC
state: Texas
city: Houston
country: United States
facility: Synergy Groups Medical, LLC
state: Texas
city: Plano
country: United States
facility: Clinical Investigations of Texas
state: Texas
city: San Antonio
country: United States
facility: Diagnostic Research Group
state: Texas
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research, LLC
state: Utah
Study officials:
affiliation: Biosplice Therapeutics, Inc.
name: Yusuf Yazici, MD
role: STUDY_DIRECTOR
References: