A Ph2 dose-finding study (MARS-17) to evaluate the efficacy and safety of GSK3858279 in adults with knee osteoarthritis pain.

You likely can't join if

• 1. History of significant medical illness which would interfere with the study procedures 2. Recent myocardial infarction or unstable angina, or cerebrovascular event 3. Recent unstable or life-threatening cardiac arrhythmia requiring intervention 4. New York Heart Association Class III and IV Heart failure 5. Prolonged corrected QT interval 6. History or current evidence of any inflammatory arthritis, infective arthritis, Paget's disease, osteonecrosis, osteoporotic fracture or any other joint disease 7. Active flare of gout or pseudogout within last year 8. Recent history of significant trauma or surgery to a knee or hip 9. Radiographic evidence of sub-chondral fractures or abnormalities not consistent with osteoarthritis 10. History of infected joint prosthesis, chronic leg ulcers, permanent in-dwelling catheters, chronic sinusitis, recurrent chest infections or urinary tract infections 11. Any focal or widespread pain syndrome that may interfere with understanding of pain response in index knee 12. Significant pain in any joint other than the index knee or any referred pain that would impact ability to assess pain in index knee 13. Current immunodeficiency diseases 14. Symptomatic herpes zoster within 3 months prior to screening 15. Current or previous active Mycobacterium tuberculosis 16. Evidence of latent tuberculosis 17. History or evidence of any clinically significant psychiatric disorder 18. History or evidence of clinically significant multiple or severe drug allergies 19. Malignancy with protocol defined exceptions 20. Liver • Alanine transferase >1.5x upper limit of normal (ULN) • Bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%) • Current or chronic history of liver disease or known hepatic or biliary abnormalities 21. estimated creatinine clearance <60 mL/min/1.73m2 23. Planned surgical procedure over the duration of the study 24. Participants with recurrent or chronic infection or with an active infection 25. Live vaccine(s) or live attenuated vaccine(s) within the last 30 days 26. Recent use of intra-articular therapy in either knee 27. Immunomodulators use within protocol defined timeframes 28. Unable or unwilling to discontinue all pain medications 29. Major surgery within 3 months prior to randomization 30.Current enrolment or recent past participation in a clinical study of an investigational medicinal product intervention 31. Exposure to more than 4 investigational medicinal products within 12 months 32. Previous exposure to GSK3858279 33. Participants who are a family member of the site staff 34. Participants who cannot be contacted by phone in an emergency 35. Participants who are unlikely to comply with the protocol 36. Positive human immunodeficiency virus antibody test 38. Positive Hepatitis C antibody test result 39. Positive Hepatitis C RNA test result at screening or within 3 months prior to first IMP dose 40. Active or suspected COVID-19 infection 41. Participants who have had a negative PCR assay initially but have since developed clinical features suggestive of COVID-19 or have had known exposure to COVID-19 42. A positive drug screen test 43. Pregnant or lactating, or women planning to become pregnant or initiating breastfeeding 44. Current drug or a history of drug or alcohol abuse or dependence within a year 45. Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that contraindicates participation in the study
• 22. Hematological laboratory values at screening: • White blood cell (WBC) count <3.0×109/L • Platelet count <125×109/L • Hemoglobin: Males and females with hemoglobin <11.0 g/dL are excluded. Males with hemoglobin level ≥11.0 g/dL to <13.8 g/dL and females with hemoglobin level ≥11.0 g/dL to <12 g/dL will only be eligible in the absence of signs of acute blood loss and if the hemoglobin level at screening is considered stable
• 37. Evidence of an active hepatitis B infection