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Befejeződött3. fázis

Safety and Efficacy of Lorecivivint (SM04690) for the Treatment of Knee Osteoarthritis (STRIDES)

A legfontosabb adatok

Ki végzi
Biosplice Therapeutics, Inc.
Hol
Albuquerque, Burlington, Cerritos, Charleston, Chicago, Cincinnati, Dallas, Doral, Edmond, Evansville, Fort Mill, Hazelwood, Hialeah, Hollywood, Houston, La Mesa, Mandeville, Miami, Miami Springs, New Orleans, Norco, Plano, Pomona, Prairieville, Rapid City, Rockville, Salt Lake City, San Antonio, San Diego, Spring Valley, Stockbridge, Tampa, The Villages, Thousand Oaks, Troy, Tucson, Tulsa és Winter Park (Egyesült Államok)Mind a 43 helyszín megnézése
Azonosító
Állapot
Befejeződött
Fázis
3. fázis
Résztvevők
499 fő vett részt
Kezdés
2022. nov. 18.
Befejezés
2024. febr. 20.
A vizsgálat típusa
Beavatkozással járó, 2 csoportAz egyik csoport placebót (hatóanyag nélküli szert) kap, összehasonlításként.
A vizsgált kezelések
  • Lorecivivint
  • Placebo
A regiszteradat frissítve
2026. szeptember 1.

Ki vehet részt

Életkor
40 év – 80 év
Nem
Nők és férfiak
Egészséges önkéntesek
Nem vehetnek részt

A regiszter feltételei, szó szerint

Mind a 20 feltétel megnézéseKevesebb

Ki vehet részt

  • 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

Ki nem vehet részt

  • Any surgery (e.g., arthroscopy) in either knee within 26 weeks prior to Day 1
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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)
  • Clinically significant abnormal screening hematology values, blood chemistry values, or urinalysis values as determined by the Investigator

Helyszínek itt: Egyesült Államok

  • Albuquerque Clinical TrialsAlbuquerque, Egyesült ÁllamokNo longer taking part
  • Skylight Health ResearchBurlington, Egyesült ÁllamokNo longer taking part
  • Core Healthcare ResearchCerritos, Egyesült ÁllamokNo longer taking part
  • Clinical Trials of South CarolinaCharleston, Egyesült ÁllamokNo longer taking part
  • Chicago Clinical Research InstituteChicago, Egyesült ÁllamokNo longer taking part
  • Hightop Medical Research CenterCincinnati, Egyesült ÁllamokNo longer taking part
  • Zenos Clinical ResearchDallas, Egyesült ÁllamokNo longer taking part
  • Unique Clinical TrialsDoral, Egyesült ÁllamokNo longer taking part
  • Conrad Clinical ResearchEdmond, Egyesült ÁllamokNo longer taking part
  • MediSphere Medical Research Center, LLCEvansville, Egyesült ÁllamokNo longer taking part
  • Piedmont Research Partners LLCFort Mill, Egyesült ÁllamokNo longer taking part
  • Healthcare Research NetworkHazelwood, Egyesült ÁllamokNo longer taking part
  • Eastern Research, Inc.Hialeah, Egyesült ÁllamokNo longer taking part
  • TecTum ResearchHollywood, Egyesült ÁllamokNo longer taking part
  • Synergy Groups Medical LLCHouston, Egyesült ÁllamokNo longer taking part
  • Biosolutions Clinical Research CenterLa Mesa, Egyesült ÁllamokNo longer taking part
  • DelRicht Research - MandevilleMandeville, Egyesült ÁllamokNo longer taking part
  • Advance Medical Research CenterMiami, Egyesült ÁllamokNo longer taking part
  • AppleMed Research Group, LLCMiami, Egyesült ÁllamokNo longer taking part
  • BioMed Research and Medical CenterMiami, Egyesült ÁllamokNo longer taking part
  • Columbus Clinical Services LLCMiami, Egyesült ÁllamokNo longer taking part
  • Health and Life Research Institute, LLCMiami, Egyesült ÁllamokNo longer taking part
  • Well Pharma Medical Research Corp.Miami, Egyesült ÁllamokNo longer taking part
  • South Florida Research Phase I-IV INCMiami Springs, Egyesült ÁllamokNo longer taking part
  • Delricht ResearchNew Orleans, Egyesült ÁllamokNo longer taking part
  • Infinity Clinical ResearchNorco, Egyesült ÁllamokNo longer taking part
  • Clinical Investigations of TexasPlano, Egyesült ÁllamokNo longer taking part
  • Dream Team Clinical ResearchPomona, Egyesült ÁllamokNo longer taking part
  • DelRicht Research - PrairievillePrairieville, Egyesült ÁllamokNo longer taking part
  • Health ConceptsRapid City, Egyesült ÁllamokNo longer taking part
  • DelRicht Research - RockvilleRockville, Egyesült ÁllamokNo longer taking part
  • Wasatch Clinical Research, LLCSalt Lake City, Egyesült ÁllamokNo longer taking part
  • Diagnostic Research GroupSan Antonio, Egyesült ÁllamokNo longer taking part
  • Artemis Institute for Clinical ResearchSan Diego, Egyesült ÁllamokNo longer taking part
  • Encompass Clinical ResearchSpring Valley, Egyesült ÁllamokNo longer taking part
  • Pinnacle Trials, Inc.Stockbridge, Egyesült ÁllamokNo longer taking part
  • Tampa Pain Relief CenterTampa, Egyesült ÁllamokNo longer taking part
  • Premier Medical AssociatesThe Villages, Egyesült ÁllamokNo longer taking part
  • Millennium Clinical Trials, LLCThousand Oaks, Egyesült ÁllamokNo longer taking part
  • Oakland Medical ResearchTroy, Egyesült ÁllamokNo longer taking part
  • Tucson Orthopaedic InstituteTucson, Egyesült ÁllamokNo longer taking part
  • DelRicht Research - TulsaTulsa, Egyesült ÁllamokNo longer taking part
  • Conquest Research, LLCWinter Park, Egyesült ÁllamokNo longer taking part

A vizsgálatról

Mit akar kideríteni a vizsgálat

This phase 3 study was 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 utilized standard outcomes to evaluate the safety and efficacy of lorecivivint.

A vizsgálat 2 csoportja

  • LorecivivintA vizsgált kezelés

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

  • VehiclePlacebo, összehasonlításként

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

    Kezelés: Placebo

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
A Phase 3, Multicenter, Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a Single Injection of Lorecivivint 0.07 mg in Subjects With Moderate to Severe Osteoarthritis Pain of the Knee
A regiszteradat frissítve
2026. szeptember 1.