A Dose-Finding Study to Evaluate the Efficacy and Safety of GSK3858279 in Adults with Knee Osteoarthritis (OA) PainMARS-17
Trial overview
Change From Baseline in Weekly Average of Average Daily Knee Pain Intensity using Numeric Rating Scale at Week 12
Timeframe: Baseline (Day -7 to Day -1) and at Week 12
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score At Week 12
Timeframe: Baseline (Day 1) and at Week 12
Change From Baseline in WOMAC Physical Function Subscale Score at Week 12
Timeframe: Baseline (Day 1) and at Week 12
Change From Baseline in Patient Global Assessment Of Disease (PtGA) at Week 12
Timeframe: Baseline (Day 1) and at Week 12
Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESI)
Timeframe: Up to 31 weeks
Number of Participants with Greater Than or Equal to (>=) Grade 3 Hematological/Clinical Chemistry Abnormalities According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCICTCAE)
Timeframe: Up to 31 weeks
Maximum Concentration (Cmax) of GSK3858279
Timeframe: Pre-dose: Day 1, Weeks 1, 2, 4, 8, 10, 11 and 12
Time to Maximum Plasma Concentration (Tmax) of GSK3858279
Timeframe: Pre-dose: Day 1, Weeks 1, 2, 4, 8, 10, 11 and 12
Pre-Dose (Trough) Concentration at the End of the Dosing Interval (Ctau) of GSK3858279
Timeframe: Pre-dose: Day 1, Weeks 1, 2, 4, 8, 10, 11 and 12
Average Concentration Over a Dosing Interval (Cavg) of GSK3858279
Timeframe: Pre-dose: Day 1, Weeks 1, 2, 4, 8, 10, 11 and 12
Area Under the Time-Concentration Curve (AUC) Over the Dosing Interval (0-Tau) (AUC[0-Tau]) of GSK3858279
Timeframe: Pre-dose: Day 1, Weeks 1, 2, 4, 8, 10, 11 and 12
- 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.
- 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.
- 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.
Participant must be 40 to 80 years of age inclusive
- 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.
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.
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Plain language summaries
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