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
Terminated (halted prematurely)
Terminated (halted prematurely)
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
Observational study model:
Not applicable
Primary completion date:
2024-12-08
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
Terminated (halted prematurely)
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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