A Dose-Finding Study to Evaluate the Efficacy and Safety of GSK3858279 in Adults With Knee Osteoarthritis (OA) Pain
NCT ID: NCT05838742
Last Updated: 2025-11-10
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE2
314 participants
INTERVENTIONAL
2023-09-13
2024-12-03
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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GSK3858279 - 60 mg weekly
Participants received GSK3858279 60 milligram (mg) SC injection once per week for 16 weeks.
GSK3858279
GSK3858279 will be administered.
GSK3858279 - 240 mg every 2 weeks
Participants received GSK3858279 240 mg SC injection every other week for 16 weeks. Placebo was given in the intervening week to maintain the blinding.
GSK3858279
GSK3858279 will be administered.
GSK3858279 - 240 mg weekly
Participants received GSK3858279 240 mg SC injection once per week for 16 weeks.
GSK3858279
GSK3858279 will be administered.
GSK3858279 - 360 mg weekly
Participants received GSK3858279 360 mg SC injection once per week for 16 weeks.
GSK3858279
GSK3858279 will be administered.
Placebo
Participants received placebo subcutaneous (SC) injection once per week for 16 weeks
Placebo
Placebo will be administered.
Interventions
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GSK3858279
GSK3858279 will be administered.
Placebo
Placebo will be administered.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
40 Years
80 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Cerritos, California, United States
GSK Investigational Site
Huntington Beach, California, United States
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Santa Clara, California, United States
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Cooper City, Florida, United States
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Cutler Bay, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Wichita, Kansas, United States
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Louisville, Kentucky, United States
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New Orleans, Louisiana, United States
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Henderson, Nevada, United States
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Williamsville, New York, United States
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Greensboro, North Carolina, United States
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Duncansville, Pennsylvania, United States
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Charlottesville, Virginia, United States
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Buenos Aires, , Argentina
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Buenos Aires-San Isidro, , Argentina
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Ciudad Autonoma Buenos Aires, , Argentina
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Ciudad AutOnoma de Buenos Aire, , Argentina
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Ciudad Autonoma de Buenos Aire, , Argentina
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Mar del Plata, , Argentina
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Botany, New South Wales, Australia
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Kotara, New South Wales, Australia
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Sydney, New South Wales, Australia
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Camberwell, Victoria, Australia
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Victoria, British Columbia, Canada
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Brampton, Ontario, Canada
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Guelph, Ontario, Canada
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Sarnia, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Winchester, Ontario, Canada
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Joliette, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Trois-Rivières, Quebec, Canada
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Beijing, , China
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Beijing, , China
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Changchun, , China
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Chengdu, , China
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Guangzhou, , China
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Hohhot, , China
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Nanjing, , China
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Shanghai, , China
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Shanghai, , China
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Shanghai, , China
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Shenyang, , China
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Shijiazhuang, , China
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Tianjin, , China
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Zhuzhou, , China
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Dax, , France
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La Roche-sur-Yon, , France
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La Rochelle, , France
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Montpellier, , France
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Paris, , France
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Berlin, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Magdeburg, , Germany
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Fukuoka, , Japan
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Ibaraki, , Japan
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Ibaraki, , Japan
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Nagano, , Japan
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Nagano, , Japan
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Osaka, , Japan
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Saitama, , Japan
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Shimane, , Japan
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Tokyo, , Japan
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Tokyo, , Japan
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Tokyo, , Japan
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Chihuahua City, , Mexico
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Guadalajara, , Mexico
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Mexicali, , Mexico
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Mérida, , Mexico
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Torreón, , Mexico
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Cape Town, , South Africa
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Cape Town, , South Africa
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Gauteng, , South Africa
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Johannesburg, , South Africa
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Stellenbosch, , South Africa
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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A Coruña, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Madrid, , Spain
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Santander, , Spain
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Santiago de Compostela, , Spain
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Seville, , Spain
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Blackpool, , United Kingdom
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Cannock, , United Kingdom
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London, , United Kingdom
GSK Investigational Site
Manchester, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2022-502799-22-00
Identifier Type: OTHER
Identifier Source: secondary_id
209978
Identifier Type: -
Identifier Source: org_study_id