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

• Status: Not yet recruiting
• Trial end date: 2025-06-10
• Target enrollment: 0
• Participant gender: All

Summary

This is dose-finding study of GSK3858279 in participants with moderate to severe knee osteoarthritis (OA) 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline

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.