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STRIDES-1: 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

Sponsor
Biosplice Therapeutics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04385303
Collaborator
(none)
498
Enrollment
76
Locations
2
Arms
15.4
Actual Duration (Months)
6.6
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This phase 3 study is a multicenter, randomized, double-blind, placebo-controlled study of lorecivivint injected intraarticularly (IA) into the target knee (most painful) 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 patient reported outcomes (PROs) to evaluate the safety and efficacy of lorecivivint.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
498 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 3, 28-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a Single Injection of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects
Actual Study Start Date :
May 26, 2020
Actual Primary Completion Date :
Sep 8, 2021
Actual Study Completion Date :
Sep 8, 2021

Arms and Interventions

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 m 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 m vehicle
    Other Names:
  • Vehicle

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline OA pain in the target knee as assessed by the weekly average of daily pain numeric rating scale (NRS) at Week 12 [Baseline and Week 12]

      Evaluate change from baseline OA pain in the target knee as assessed by the 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 represents the worst possible pain.

    Secondary Outcome Measures

    1. Change from baseline OA pain in the target knee as assessed by the weekly average of daily pain numeric rating scale (NRS) at Week 24 [Baseline and Week 24]

      Evaluate change from baseline OA pain in the target knee as assessed by the weekly average of daily pain NRS at Week 24. 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 represents the worst possible pain.

    2. Change from baseline OA function in the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical function subscore (WOMAC Function) at Weeks 12 and 24 [Baseline, Weeks 12 and 24]

      Evaluate change from baseline OA function in the target knee as assessed by WOMAC Function subscore at Weeks 12 and 24. 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 a scale from 0 (lowest pain/lowest stiffness/highest function) to 4 (highest pain/highest stiffness/lowest function). The WOMAC Function subscore ranges from 0 to 68.

    3. Change from baseline OA disease activity as assessed by Patient Global Assessment at Weeks 12 and 24 [Baseline, Weeks 12 and 24]

      Evaluate change from baseline OA disease activity as assessed by Patient Global Assessment at Weeks 12 and 24. The Patient Global Assessment is an 11-point [0-10] Numeric Rating Scale [NRS] on which the subjects will rate how they feel their target knee OA is doing, considering all the ways in which their target knee OA may affect them. The NRS is anchored by descriptors at each end ("Very Good" on the left and "Very Bad" on the right).

    4. Change from baseline in usage of nonsteroidal anti-inflammatory drugs (NSAIDs) and acetaminophen for target knee OA pain at Week 24 [Baseline, Week 24]

      Evaluate change from baseline in usage of NSAIDs and acetaminophen for target knee OA pain at Week 24.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Key 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

    • Negative drug test for amphetamine, buprenorphine, cocaine, methadone, opiates, phencyclidine (PCP), propoxyphene, barbiturates, benzodiazepine, methaqualone, and tricyclic antidepressants, unless any of these drugs are allowed per protocol and prescribed by a physician to treat a specific condition

    Key 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

    • Significant malalignment of anatomical axis (medial angle formed by the femur and tibia) of the target knee (varus > 10°, valgus > 10°) by radiograph within 24 weeks of the Screening Visit as assessed by independent central readers

    • 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)

    • Subjects who have previously failed screening on this protocol and fail to meet re-screening criteria

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Birmingham Alabama United States 35205
    2 Research Site Birmingham Alabama United States 35215
    3 Research Site Mobile Alabama United States 36608
    4 Research Site Phoenix Arizona United States 85018
    5 Research Site Phoenix Arizona United States 85053
    6 Research Site Tucson Arizona United States 85712
    7 Research Site Little Rock Arkansas United States 72205
    8 Research Site Anaheim California United States 92805
    9 Research Site Beverly Hills California United States 90211
    10 Research Site Canoga Park California United States 91303
    11 Research Site Garden Grove California United States 92840
    12 Research Site La Mesa California United States 91942
    13 Research Site Norco California United States 92860
    14 Research Site Pomona California United States 91767
    15 Research Site San Diego California United States 92103
    16 Research Site Santa Monica California United States 90404
    17 Research Site Thousand Oaks California United States 91360
    18 Research Site Westminster California United States 92683
    19 Research Site Boulder Colorado United States 80301
    20 Research Site Hamden Connecticut United States 06517
    21 Reserach Site Clearwater Florida United States 33761
    22 Research Site Edgewater Florida United States 32132
    23 Research Site Gulf Breeze Florida United States 32561
    24 Research Site Miami Lakes Florida United States 33014
    25 Research Site Miami Florida United States 33125
    26 Research Site Miami Florida United States 33173
    27 Research Site Sunrise Florida United States 33351
    28 Research Site Sweetwater Florida United States 33172
    29 Research Site West Palm Beach Florida United States 33409
    30 Research Site Winter Haven Florida United States 33880
    31 Research Site 1 Winter Park Florida United States 32789
    32 Research Site Marietta Georgia United States 30060
    33 Research Site Newnan Georgia United States 30265
    34 Research Site Woodstock Georgia United States 30189
    35 Research Site Boise Idaho United States 83713
    36 Research Site Chicago Illinois United States 60607
    37 Research Site Gurnee Illinois United States 60031
    38 Research Site Oak Brook Illinois United States 60523
    39 Research Site Evansville Indiana United States 47714
    40 Research Site Greenwood Indiana United States 46143
    41 Research Site Valparaiso Indiana United States 46383
    42 Research Site New Orleans Louisiana United States 70124
    43 Research Site Wheaton Maryland United States 20902
    44 Research Site Boston Massachusetts United States 02111
    45 Research Site Troy Michigan United States 48085
    46 Research Site Hazelwood Missouri United States 63042
    47 Research Site Kansas City Missouri United States 64114
    48 Research Site 1 Saint Louis Missouri United States 63141
    49 Research Site 2 Saint Louis Missouri United States 63141
    50 Research Site Omaha Nebraska United States 68114
    51 Research Site Las Vegas Nevada United States 89119
    52 Research Site Reno Nevada United States 89519
    53 Research Site Freehold New Jersey United States 07728
    54 Research Site Albuquerque New Mexico United States 87102
    55 Research Site Hartsdale New York United States 10530
    56 Research Site Rochester New York United States 14642
    57 Research Site Greensboro North Carolina United States 27408
    58 Research Site Salisbury North Carolina United States 28144
    59 Research Site Winston-Salem North Carolina United States 27103
    60 Research Site Cincinnati Ohio United States 45224
    61 Research Site Edmond Oklahoma United States 73013
    62 Research Site Duncansville Pennsylvania United States 16635
    63 Research Site Charleston South Carolina United States 29406
    64 Research Site Fort Mill South Carolina United States 29707
    65 Research Site Mount Pleasant South Carolina United States 29464
    66 Research Site Rapid City South Dakota United States 57702
    67 Research Site Bellaire Texas United States 77401
    68 Research Site Carrollton Texas United States 75007
    69 Research Site Dallas Texas United States 75231
    70 Research Site Houston Texas United States 77029
    71 Research Site Plano Texas United States 75075
    72 Research Site Draper Utah United States 84020
    73 Research Site Ogden Utah United States 84405
    74 Research Site Salt Lake City Utah United States 84107
    75 Research Site Charlottesville Virginia United States 22911
    76 Research Site Richmond Virginia United States 23219

    Sponsors and Collaborators

    • Biosplice Therapeutics, Inc.

    Investigators

    • Study Director: Yusuf Yazici, M.D., Biosplice Therapeutics, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Biosplice Therapeutics, Inc.
    ClinicalTrials.gov Identifier:
    NCT04385303
    Other Study ID Numbers:
    • SM04690-OA-10
    First Posted:
    May 12, 2020
    Last Update Posted:
    Mar 3, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Biosplice Therapeutics, Inc.
    SM04690
    Wnt pathway inhibitor
    osteoarthritis
    Samumed
    lorecivivint
    Additional relevant MeSH terms:
    Osteoarthritis
    Osteoarthritis, Knee
    Lorecivivint

    Study Results

    No Results Posted as of Mar 3, 2022