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Leállítva2. fázis

A Dose-Finding Study to Evaluate the Efficacy and Safety of GSK3858279 in Adults With Knee Osteoarthritis (OA) Pain

A legfontosabb adatok

Ki végzi
GlaxoSmithKline
Hol
Cerritos, Charlottesville, Cooper City, Cutler Bay, Duncansville, Greensboro, Henderson, Huntington Beach, Louisville, Miami, New Orleans, Santa Clara, Wichita és Williamsville (Egyesült Államok)Mind a 14 helyszín megnézéseMég 12 másik országban, 71 helyszínen
Állapot
Leállítva
Fázis
2. fázis
Résztvevők
314 fő vett részt
Kezdés
2023. szept. 13.
Befejezés
2024. dec. 3.
A vizsgálat típusa
Beavatkozással járó, 5 csoportAz egyik csoport placebót (hatóanyag nélküli szert) kap, összehasonlításként.
A vizsgált kezelések
  • GSK3858279
  • Placebo
A regiszteradat frissítve
2025. november 10.
Miért állt le
The study met futility criteria at pre-planned interim analysis, showing no clinical efficacy of the investigational drug. Based on the lack of efficacy at the interim data review, the sponsor decided to terminate the study.

Ki vehet részt

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

A regiszter feltételei, szó szerint

Mind a 18 feltétel megnézéseKevesebb

Ki vehet részt

  • Participant must be 40 to 80 years of age inclusive
  • OA of the index knee as defined by symptomatic for ≥ 6 months with a clinical diagnosis of OA as per American College of Rheumatology (ACR) clinical diagnosis criteria
  • Kellgren and Lawrence (KL) score ≥ 2 on X-ray in the index knee
  • An average of the average daily pain score of ≥4 and less than or equal to (≤) 9 by the 11-point NRS (0-10)
  • Body mass index (BMI) of < 40 kilogram per meter square (kg/m\^2) (inclusive)
  • Capable of giving signed informed consent

Ki nem vehet részt

  • Current or previous active Mycobacterium tuberculosis
  • History or presence of cardiovascular, renal, gastrointestinal, lymphatic disorders which in the opinion of the investigator would interfere with the study procedures and/or assessments
  • History or current evidence of any inflammatory arthritis such as rheumatoid arthritis, infective arthritis, Paget's disease, osteonecrosis, osteoporotic fracture, or any other joint disease that in the Investigator's opinion would interfere with the assessment of pain and other symptoms of osteoarthritis
  • History of significant trauma or surgery to a knee or hip within the last 6 months
  • Current immunodeficiency diseases including but not limited to acquired immunodeficiency disorder or immunoglobulin deficiency
  • History or evidence of clinically significant multiple or severe drug allergies
  • History of malignancy within the last 5 years, except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
  • Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
  • Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study
  • Alanine transaminase (ALT) >1.5 times upper limit of normal (ULN)
  • Bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35 percent (%)
  • Evidence of renal insufficiency, indicated by estimated creatinine clearance < 60 milliliter/ minute (mL/min)/1.73 square meter (m\^2) at screening

Helyszínek itt: Egyesült Államok

Még 12 másik országban, 71 helyszínen

  • Cerritos, CaliforniaHospital not named in the registry
  • Charlottesville, VirginiaHospital not named in the registry
  • Cooper City, FloridaHospital not named in the registry
  • Cutler Bay, FloridaHospital not named in the registry
  • Duncansville, PennsylvaniaHospital not named in the registry
  • Greensboro, North CarolinaHospital not named in the registry
  • Henderson, NevadaHospital not named in the registry
  • Huntington Beach, CaliforniaHospital not named in the registry
  • Louisville, KentuckyHospital not named in the registry
  • Miami, FloridaHospital not named in the registry
  • New Orleans, LouisianaHospital not named in the registry
  • Santa Clara, CaliforniaHospital not named in the registry
  • Wichita, KansasHospital not named in the registry
  • Williamsville, New YorkHospital not named in the registry

A vizsgálatról

Mit akar kideríteni a vizsgálat

This is dose-finding study of GSK3858279 in participants with moderate to severe knee osteoarthritis pain. The purpose of this study is to investigate and provide the data necessary to select the optimal effective and safe dose(s) of GSK3858279.

A vizsgálat 5 csoportja

  • GSK3858279 - 60 mg weeklyA vizsgált kezelés

    Participants received GSK3858279 60 milligram (mg) SC injection once per week for 16 weeks.

    Kezelés: GSK3858279

  • GSK3858279 - 240 mg every 2 weeksA vizsgált kezelés

    Participants received GSK3858279 240 mg SC injection every other week for 16 weeks. Placebo was given in the intervening week to maintain the blinding.

    Kezelés: GSK3858279

  • GSK3858279 - 240 mg weeklyA vizsgált kezelés

    Participants received GSK3858279 240 mg SC injection once per week for 16 weeks.

    Kezelés: GSK3858279

  • GSK3858279 - 360 mg weeklyA vizsgált kezelés

    Participants received GSK3858279 360 mg SC injection once per week for 16 weeks.

    Kezelés: GSK3858279

  • PlaceboPlacebo, összehasonlításként

    Participants received placebo subcutaneous (SC) injection once per week for 16 weeks

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on és az EU hivatalos vizsgálati nyilvántartásában (CTIS).
Hivatalos cím
A Multicentre Randomized, Double-blind, Placebo Controlled, Dose-finding, Phase 2 Study (MARS-17) of GSK3858279 in Adult Participants With Moderate to Severe Pain Due to Knee Osteoarthritis
A regiszteradat frissítve
2025. november 10.