A Multicentre Randomized, Double-blind, Placebo Controlle... | EligiMed

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

TerminadoFase 2ClinicalTrials.gov

ID: NCT05838742Tipo: INTERVENTIONALInicio: 13 de sept de 2023Fin estimado: 3 de dic de 2024

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 40 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

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
Participant must be 40 to 80 years of age inclusive
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.

Criterios de exclusión

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.

Intervenciones

drug

GSK3858279

GSK3858279 will be administered.

drug

Placebo

Placebo will be administered.

Ubicaciones

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires-San Isidro, Argentina

GSK Investigational Site

Ciudad Autonoma Buenos Aires, Argentina

GSK Investigational Site

Ciudad AutOnoma de Buenos Aire, Argentina

GSK Investigational Site

Ciudad Autonoma de Buenos Aire, Argentina

GSK Investigational Site

Mar del Plata, Argentina

Patrocinadores

PrincipalGlaxoSmithKline

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