MARS-17 Study in Adults with Pain due to Osteoarthritis of the Knee

• Research type

  Research Study

• Full title

  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

• IRAS ID

  1007164

• Contact name

  Yulia Green

• Contact email

  yulia.x.green@gsk.com

• Sponsor organisation

  GSK Research & Development Limited

• Eudract number

  2022-502799-22

• Research summary

  Arthritis is a condition that causes pain and swelling in the joints. Osteoarthritis (OA) is a most common type of arthritis affecting the small and large joints of the knees, hands, hips, and spine. It occurs when the cartilage that protects or cushions the ends of the bones in joints gradually worsen over time. Current available therapies provide modest improvement in pain and are associated with many side effects.

  This study will test a new drug GSK3858279 which is a monoclonal antibody in adult participants with moderate to severe pain due to knee osteoarthritis. The purpose of this study is to see if study drug GSK3858279 can reduce the knee pain in people with OA and to collect data on the safety of the drug and the levels of drug in the body. It will also help to determine what dose of the drug works best. The study is sponsored by GlaxoSmithKline.

  The study will involve around 420 adults who are between 40-80 years of age. Approximately 20 subjects will be enrolled in the UK. The total study period will be up to 36 weeks which includes a 5-week screening period, 16 weeks of treatment period and 15 weeks of off treatment follow- up period.

  GSK3858279 is delivered via an injection under the skin. All study participants will be divided into 5 groups. Four groups will receive different doses of GSK3858279 and 1 group will receive placebo.

  Tests undertaken will include but not limited to:
  - Blood tests
  - X-rays of the knee
  - Physical examination
  - Urine test
  - Questionnaires for daily knee pain, daily activities and quality of life

• REC name

  Wales REC 5

• REC reference

  23/WA/0141

• Date of REC Opinion

  25 Aug 2023

• REC opinion

  Further Information Favourable Opinion