Last updated: 10/24/2025 16:20:08

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

GSK study ID
209978
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official 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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

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

Secondary outcomes:

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

Interventions:
  • Drug: GSK3858279
  • Drug: Placebo
  • Enrollment:
    314
    Primary completion date:
    2024-12-08
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Pain, Osteoarthritis, Knee
    Product
    GSK3858279
    Collaborators
    Not applicable
    Study date(s)
    September 2023 to December 2024
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    40 - 80 Years
    Accepts healthy volunteers
    No
    • 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    London, United Kingdom, EN5 3DJ
    Status
    Study Complete
    Location
    GSK Investigational Site
    Beijing, China, 100730
    Status
    Study Complete
    Location
    GSK Investigational Site
    Berlin, Germany, 10117
    Status
    Study Complete
    Location
    GSK Investigational Site
    Blackpool, United Kingdom, FY2 0JH
    Status
    Study Complete
    Location
    GSK Investigational Site
    Botany, NSW, Australia, 2019
    Status
    Study Complete
    Location
    GSK Investigational Site
    Brampton, ON, Canada, L6T 0G1
    Status
    Study Complete
    Showing 1 - 6 of 99 Results

    Study documents

    Protocol
    Available language(s): English
    Statistical analysis plan
    Available language(s): English

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Other
    Actual primary completion date
    2024-12-08
    Actual study completion date
    2024-03-12

    Plain language summaries

    Summary of results in plain language
    Available language(s): English, Afrikaans, French (Canadian), French, German, Japanese, Korean, Chinese (Simplified), Spanish (Argentina), Spanish (Mexico), Spanish, Spanish (United States), Zulu

    To view plain language summaries on trialsummaries.com click here.

    Additional information about the trial

    Additional information
    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website