A Dose-Finding Study to Evaluate the Efficacy and Safety of GSK3858279 in Adults With Knee Osteoarthritis (OA) Pain (MARS-17)

GlaxoSmithKline (GSK)

Status and phase: Terminated; Phase 2

Conditions: Pain; Osteoarthritis, Knee

Treatments: Drug: Placebo; Drug: GSK3858279

Study type: Interventional

Funder types: Industry

Identifiers

NCT05838742

2022-502799-22-00 (Other Identifier)

209978

Details and patient eligibility

About

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.

Enrollment: 314 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 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.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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314 participants in 5 patient groups, including a placebo group

GSK3858279 - 60 mg weekly

Experimental group

Description:

Participants received GSK3858279 60 milligram (mg) SC injection once per week for 16 weeks.

Treatment:

Drug: GSK3858279

GSK3858279 - 240 mg every 2 weeks

Experimental group

Description:

Participants received GSK3858279 240 mg SC injection every other week for 16 weeks. Placebo was given in the intervening week to maintain the blinding.

Treatment:

Drug: GSK3858279

GSK3858279 - 240 mg weekly

Experimental group

Description:

Participants received GSK3858279 240 mg SC injection once per week for 16 weeks.

Treatment:

Drug: GSK3858279

GSK3858279 - 360 mg weekly

Experimental group

Description:

Participants received GSK3858279 360 mg SC injection once per week for 16 weeks.

Treatment:

Drug: GSK3858279

Placebo

Placebo Comparator group

Description:

Participants received placebo subcutaneous (SC) injection once per week for 16 weeks

Treatment:

Drug: Placebo