A Dose-Finding Study to Evaluate the Efficacy and Safety of GSK3858279 in Adults With Knee Osteoarthritis Pain (MARS-17)
Pain
About this trial
This is an interventional treatment trial for Pain focused on measuring Osteoarthritis, Musculoskeletal Diseases, 209978, GSK3858279, Efficacy, Safety, Pharmacokinetics
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. Current or previous active Mycobacterium tuberculosis 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. 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 (%) Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) Evidence of renal insufficiency, indicated by estimated creatinine clearance < 60 millilitre/ minute (mL/min)/1.73 m^2 at screening. 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.
Sites / Locations
- GSK Investigational SiteRecruiting
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
GSK3858279 Dose 1
GSK3858279 Dose 2
GSK3858279 Dose 3
GSK3858279 Dose 4
Placebo
Participants will receive GSK3858279 dose 1.
Participants will receive GSK3858279 dose 2.
Participants will receive GSK3858279 dose 3.
Participants will receive GSK3858279 dose 4.
Participants will receive placebo.