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
    Location
    GSK Investigational Site
    Cannock, United Kingdom, WS11 0BN
    Status
    Study Complete
    Location
    GSK Investigational Site
    Cape Town, South Africa, 7405
    Status
    Study Complete
    Location
    GSK Investigational Site
    Barcelona, Spain, 08540
    Status
    Study Complete
    Location
    GSK Investigational Site
    Cerritos, CA, United States, 90703
    Status
    Study Complete
    Location
    GSK Investigational Site
    Changchun, China, 130021
    Status
    Study Complete
    Location
    GSK Investigational Site
    Charlottesville, VA, United States, 22911
    Status
    Study Complete
    Location
    GSK Investigational Site
    Chihuahua, Mexico, 31000
    Status
    Study Complete
    Location
    GSK Investigational Site
    Ciudad Autonoma de Buenos Aire, Argentina, C1046AAQ
    Status
    Study Complete
    Location
    GSK Investigational Site
    Ciudad Autonoma de Buenos Aires, Argentina, C1128AAF
    Status
    Study Complete
    Location
    GSK Investigational Site
    Ciudad AutOnoma de Buenos Aire, Argentina, 1118
    Status
    Study Complete
    Location
    GSK Investigational Site
    Cooper City, FL, United States, 33024
    Status
    Study Complete
    Location
    GSK Investigational Site
    Cutler Bay, FL, United States, 33189
    Status
    Study Complete
    Location
    GSK Investigational Site
    Dax, France, 40107
    Status
    Study Complete
    Location
    GSK Investigational Site
    Duncansville, PA, United States, 16635
    Status
    Study Complete
    Location
    GSK Investigational Site
    Fukuoka, Japan, 834-0115
    Status
    Study Complete
    Location
    GSK Investigational Site
    Greensboro, NC, United States, 27410
    Status
    Study Complete
    Location
    GSK Investigational Site
    Guadalajara, Mexico, 44650
    Status
    Study Complete
    Location
    GSK Investigational Site
    Guangzhou, China, 510000
    Status
    Study Complete
    Location
    GSK Investigational Site
    Hamburg, Germany, 20095
    Status
    Study Complete
    Location
    GSK Investigational Site
    Huhhot, China, 010017
    Status
    Study Complete
    Location
    GSK Investigational Site
    Huntington Beach, CA, United States, 92647
    Status
    Study Complete
    Location
    GSK Investigational Site
    Ibaraki, Japan, 300-1253
    Status
    Study Complete
    Location
    GSK Investigational Site
    Kotara, NSW, Australia, 2289
    Status
    Study Complete
    Location
    GSK Investigational Site
    La Roche Sur Yon, France, 85925
    Status
    Study Complete
    Location
    GSK Investigational Site
    La Rochelle Cedex 1, France, 17019
    Status
    Study Complete
    Location
    GSK Investigational Site
    Louisville, KY, United States, 40213
    Status
    Study Complete
    Location
    GSK Investigational Site
    Manchester, United Kingdom, M13 9NQ
    Status
    Study Complete
    Location
    GSK Investigational Site
    Mar del Plata, Argentina, B7600FYK
    Status
    Study Complete
    Location
    GSK Investigational Site
    Mexicali, Mexico, 21200
    Status
    Study Complete
    Location
    GSK Investigational Site
    Miami, FL, United States, 33173
    Status
    Study Complete
    Location
    GSK Investigational Site
    Miami, FL, United States, 33185
    Status
    Study Complete
    Location
    GSK Investigational Site
    Montpellier cedex 5, France, 34000
    Status
    Study Complete
    Location
    GSK Investigational Site
    Nagano, Japan, 390-8601
    Status
    Study Complete
    Location
    GSK Investigational Site
    Nagano, Japan, 395-8505
    Status
    Study Complete
    Location
    GSK Investigational Site
    Nanjing, China, 210009
    Status
    Study Complete
    Location
    GSK Investigational Site
    New Orleans, LA, United States, 70115
    Status
    Study Complete
    Location
    GSK Investigational Site
    Norwich, United Kingdom, NR4 7UY
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Osaka, Japan, 543-0027
    Status
    Study Complete
    Location
    GSK Investigational Site
    Joliette, QC, Canada, J6E 6A9
    Status
    Study Complete
    Location
    GSK Investigational Site
    Sarnia, ON, Canada, N7T 4X3
    Status
    Study Complete
    Location
    GSK Investigational Site
    Seoul, South Korea, 03080
    Status
    Study Complete
    Location
    GSK Investigational Site
    Shanghai, China, 200011
    Status
    Study Complete
    Location
    GSK Investigational Site
    Shanghai, China, 200040
    Status
    Study Complete
    Location
    GSK Investigational Site
    Shanghai, China, 200065
    Status
    Study Complete
    Location
    GSK Investigational Site
    Shijiazhuang, China, 050051
    Status
    Study Complete
    Location
    GSK Investigational Site
    Stellenbosch, South Africa, 7600
    Status
    Study Complete
    Location
    GSK Investigational Site
    Santa Clara, CA, United States, 95054
    Status
    Study Complete
    Location
    GSK Investigational Site
    Tianjin, China, 300192
    Status
    Study Complete
    Location
    GSK Investigational Site
    Tokyo, Japan, 104-0031
    Status
    Study Complete
    Location
    GSK Investigational Site
    Toronto, ON, Canada, M5T 2S8
    Status
    Study Complete
    Location
    GSK Investigational Site
    Victoria, BC, Canada, V8V 4A1
    Status
    Study Complete
    Location
    GSK Investigational Site
    Wichita, KS, United States, 67207
    Status
    Study Complete
    Location
    GSK Investigational Site
    Williamsville, NY, United States, 14221
    Status
    Study Complete
    Location
    GSK Investigational Site
    Winchester, ON, Canada, K0C 2K0
    Status
    Study Complete
    Location
    GSK Investigational Site
    ZhuZhou, China, 412007
    Status
    Study Complete
    Location
    GSK Investigational Site
    A CORUNA, Spain, 15006
    Status
    Study Complete
    Location
    GSK Investigational Site
    Madrid, Spain, 28046
    Status
    Study Complete
    Location
    GSK Investigational Site
    Santander, Spain, 39008
    Status
    Study Complete
    Location
    GSK Investigational Site
    Santiago de Compostela, Spain, 15702
    Status
    Study Complete
    Location
    GSK Investigational Site
    Johannesburg, South Africa, 2113
    Status
    Study Complete
    Location
    GSK Investigational Site
    Sherbrooke, QC, Canada, J1L 0H8
    Status
    Study Complete
    Location
    GSK Investigational Site
    Cape Town, South Africa, 7130
    Status
    Study Complete
    Location
    GSK Investigational Site
    Trois-Rivieres, QC, Canada, G9A 3X2
    Status
    Study Complete
    Location
    GSK Investigational Site
    Beijing, China, 100083
    Status
    Study Complete
    Location
    GSK Investigational Site
    Camberwell, VIC, Australia, 3124
    Status
    Study Complete
    Location
    GSK Investigational Site
    Chengdu, China, 610041
    Status
    Study Complete
    Location
    GSK Investigational Site
    Ciudad Autonoma Buenos Aires, Argentina, C1417
    Status
    Study Complete
    Location
    GSK Investigational Site
    Guelph, ON, Canada, N1H 1B1
    Status
    Study Complete
    Location
    GSK Investigational Site
    Hamburg, Germany, 22415
    Status
    Study Complete
    Location
    GSK Investigational Site
    Henderson, NV, United States, 89052
    Status
    Study Complete
    Location
    GSK Investigational Site
    Ibaraki, Japan, 300-1234
    Status
    Study Complete
    Location
    GSK Investigational Site
    Gauteng, South Africa, 1619
    Status
    Study Complete
    Location
    GSK Investigational Site
    Barcelona, Spain, 08430
    Status
    Study Complete
    Location
    GSK Investigational Site
    Magdeburg, Germany, 39120
    Status
    Study Complete
    Location
    GSK Investigational Site
    Merida, Mexico, CP 97070
    Status
    Study Complete
    Location
    GSK Investigational Site
    Paris, France, 75012
    Status
    Study Complete
    Location
    GSK Investigational Site
    Saitama, Japan, 330-0074
    Status
    Study Complete
    Location
    GSK Investigational Site
    Buenos Aires-San Isidro, Argentina, 1643
    Status
    Study Complete
    Location
    GSK Investigational Site
    Sevilla, Spain, 41014
    Status
    Study Complete
    Location
    GSK Investigational Site
    Shenyang, China, 110022
    Status
    Study Complete
    Location
    GSK Investigational Site
    Shimane, Japan, 693-8501
    Status
    Study Complete
    Location
    GSK Investigational Site
    Tokyo, Japan, 113-8431
    Status
    Study Complete
    Location
    GSK Investigational Site
    Toronto, ON, Canada, M9V 4B4
    Status
    Study Complete
    Location
    GSK Investigational Site
    Torreon, Mexico, 27000
    Status
    Study Complete
    Location
    GSK Investigational Site
    Sydney, NSW, Australia, 2010
    Status
    Study Complete
    Location
    GSK Investigational Site
    Tokyo, Japan, 103-0027
    Status
    Study Complete
    Location
    GSK Investigational Site
    Barcelona, Spain, 08023
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Cahors, France, 46005
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Madrid, Spain, 28223
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Rendsburg, Germany, 24768
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Saint-Priest en Jarez, France, 42270
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Seongnam-si, South Korea, 463712
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Vancouver, BC, Canada, V5Z 1K3
    Status
    Terminated/Withdrawn

    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
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