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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Pain, Osteoarthritis, Knee

In brief

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.

Key facts

Study ID

NCT05838742

Run by

GlaxoSmithKline

People needed

314

Starts

2023-09-13

Expected to finish

2024-12-03

Last updated by the study team

2025-11-10

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 milliliter/ minute (mL/min)/1.73 square meter (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.

Where it is running

• GSK Investigational Site — Shanghai, China
• GSK Investigational Site — Shanghai, China
• GSK Investigational Site — Shanghai, China
• GSK Investigational Site — Shenyang, China
• GSK Investigational Site — Shijiazhuang, China
• GSK Investigational Site — Tianjin, China
• GSK Investigational Site — Zhuzhou, China
• GSK Investigational Site — Dax, France
• GSK Investigational Site — Hohhot, China
• GSK Investigational Site — Cerritos, California, United States
• GSK Investigational Site — Huntington Beach, California, United States
• GSK Investigational Site — Santa Clara, California, United States
• GSK Investigational Site — Cooper City, Florida, United States
• GSK Investigational Site — Cutler Bay, Florida, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Wichita, Kansas, United States
• GSK Investigational Site — Louisville, Kentucky, United States
• GSK Investigational Site — New Orleans, Louisiana, United States
• GSK Investigational Site — Henderson, Nevada, United States
• GSK Investigational Site — Williamsville, New York, United States
• GSK Investigational Site — Greensboro, North Carolina, United States
• GSK Investigational Site — Duncansville, Pennsylvania, United States
• GSK Investigational Site — Charlottesville, Virginia, United States
• GSK Investigational Site — Nanjing, China

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.