A Dose-Finding Study to Evaluate the Efficacy and Safety of GSK3858279 in Adults With Knee Osteoarthritis (OA) Pain
Reason given: 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.
Key facts
- Where
- Cerritos, Charlottesville, Cooper City, Cutler Bay, Duncansville, Greensboro, Henderson, Huntington Beach, Louisville, Miami, New Orleans, Santa Clara, Wichita, and Williamsville, United StatesSee the 14 sites
- Phase
- Phase 2
Where in United States
- Cerritos, CaliforniaHospital not named in the registryNo longer taking part
- Charlottesville, VirginiaHospital not named in the registryNo longer taking part
- Cooper City, FloridaHospital not named in the registryNo longer taking part
- Cutler Bay, FloridaHospital not named in the registryNo longer taking part
- Duncansville, PennsylvaniaHospital not named in the registryNo longer taking part
- Greensboro, North CarolinaHospital not named in the registryNo longer taking part
- Henderson, NevadaHospital not named in the registryNo longer taking part
- Huntington Beach, CaliforniaHospital not named in the registryNo longer taking part
- Louisville, KentuckyHospital not named in the registryNo longer taking part
- Miami, FloridaHospital not named in the registryNo longer taking part
- New Orleans, LouisianaHospital not named in the registryNo longer taking part
- Santa Clara, CaliforniaHospital not named in the registryNo longer taking part
- Wichita, KansasHospital not named in the registryNo longer taking part
- Williamsville, New YorkHospital not named in the registryNo longer taking part
Trial details
- Who runs it
- GlaxoSmithKline
- Trial code
- NCT05838742EU 2022-502799-22-00
- Record updated
- 10 November 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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.