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

Last updated: October 24, 2025
Sponsor: GlaxoSmithKline
Overall Status: Terminated

Phase

2

Condition

Pain

Osteoarthritis

Musculoskeletal Diseases

Treatment

GSK3858279

Placebo

Clinical Study ID

NCT05838742
209978
2022-502799-22-00
  • Ages 40-80
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 clinicaldiagnosis of OA as per American College of Rheumatology (ACR) clinical diagnosiscriteria.

  • 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 bythe 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

Exclusion Criteria:

  • History or presence of cardiovascular, renal, gastrointestinal, lymphatic disorderswhich in the opinion of the investigator would interfere with the study proceduresand/or assessments.

  • History or current evidence of any inflammatory arthritis such as rheumatoidarthritis, infective arthritis, Paget's disease, osteonecrosis, osteoporoticfracture, or any other joint disease that in the Investigator's opinion wouldinterfere 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 acquiredimmunodeficiency 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 squamousepithelial carcinomas of the skin that have been resected with no evidence ofmetastatic 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 ifbilirubin is fractionated and direct bilirubin < 35 percent (%)

  • Current or chronic history of liver disease, or known hepatic or biliaryabnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)

  • Evidence of renal insufficiency, indicated by estimated creatinine clearance < 60milliliter/ minute (mL/min)/1.73 square meter (m^2) at screening.

  • Sensitivity to any of the study interventions, or components thereof, or drug orother allergy that, in the opinion of the investigator or medical monitor,contraindicates participation in the study.

Study Design

Total Participants: 314
Treatment Group(s): 2
Primary Treatment: GSK3858279
Phase: 2
Study Start date:
September 13, 2023
Estimated Completion Date:
December 03, 2024

Connect with a study center

  • GSK Investigational Site

    Ciudad Autonoma Buenos aires, Buenos Aires C1046AAQ
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Buenos Aires 3435910, C1128AAF
    Argentina

    Site Not Available

  • GSK Investigational Site

    Buenos Aires-San Isidro, 1643
    Argentina

    Site Not Available

  • GSK Investigational Site

    Ciudad AutOnoma de Buenos Aire, 1118
    Argentina

    Site Not Available

  • GSK Investigational Site

    Ciudad Autonoma Buenos Aires, C1417
    Argentina

    Site Not Available

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aire, C1046AAQ
    Argentina

    Site Not Available

  • GSK Investigational Site

    Mar del Plata 3430863, B7600FYK
    Argentina

    Site Not Available

  • GSK Investigational Site

    Botany, New South Wales 2019
    Australia

    Site Not Available

  • GSK Investigational Site

    Kotara, New South Wales 2289
    Australia

    Site Not Available

  • GSK Investigational Site

    Botany 2174563, New South Wales 2155400 2019
    Australia

    Site Not Available

  • GSK Investigational Site

    Kotara 2161029, New South Wales 2155400 2289
    Australia

    Site Not Available

  • GSK Investigational Site

    Sydney 2147714, New South Wales 2155400 2010
    Australia

    Site Not Available

  • GSK Investigational Site

    Camberwell, Victoria 3124
    Australia

    Site Not Available

  • GSK Investigational Site

    Camberwell 2172686, Victoria 2145234 3124
    Australia

    Site Not Available

  • GSK Investigational Site

    Sydney, 2010
    Australia

    Site Not Available

  • GSK Investigational Site

    Victoria, British Columbia V8V 4A1
    Canada

    Site Not Available

  • GSK Investigational Site

    Victoria 6174041, British Columbia 5909050 V8V 4A1
    Canada

    Site Not Available

  • GSK Investigational Site

    Brampton, Ontario L6T 0G1
    Canada

    Site Not Available

  • GSK Investigational Site

    Guelph, Ontario N1H 1B1
    Canada

    Site Not Available

  • GSK Investigational Site

    Sarnia, Ontario N7T 4X3
    Canada

    Site Not Available

  • GSK Investigational Site

    Toronto, Ontario M5T 2S8
    Canada

    Site Not Available

  • GSK Investigational Site

    Winchester, Ontario K0C 2K0
    Canada

    Site Not Available

  • GSK Investigational Site

    Brampton 5907364, Ontario 6093943 L6T 0G1
    Canada

    Site Not Available

  • GSK Investigational Site

    Guelph 5967629, Ontario 6093943 N1H 1B1
    Canada

    Site Not Available

  • GSK Investigational Site

    Sarnia 6141190, Ontario 6093943 N7T 4X3
    Canada

    Site Not Available

  • GSK Investigational Site

    Toronto 6167865, Ontario 6093943 M5T 2S8
    Canada

    Site Not Available

  • GSK Investigational Site

    Winchester 6182823, Ontario 6093943 K0C 2K0
    Canada

    Site Not Available

  • GSK Investigational Site

    Joliette 5987650, Quebec 6115047 J6E 6A9
    Canada

    Site Not Available

  • GSK Investigational Site

    Sherbrooke 6146143, Quebec 6115047 J1L 0H8
    Canada

    Site Not Available

  • GSK Investigational Site

    Trois-Rivières 6169141, Quebec 6115047 G9A 3X2
    Canada

    Site Not Available

  • GSK Investigational Site

    Joliette, J6E 6A9
    Canada

    Site Not Available

  • GSK Investigational Site

    Sherbrooke, J1L 0H8
    Canada

    Site Not Available

  • GSK Investigational Site

    Trois-Rivieres, G9A 3X2
    Canada

    Site Not Available

  • GSK Investigational Site

    Beijing, 100730
    China

    Site Not Available

  • GSK Investigational Site

    Beijing 1816670, 100083
    China

    Site Not Available

  • GSK Investigational Site

    Changchun 2038180, 130021
    China

    Site Not Available

  • GSK Investigational Site

    Chengdu 1815286, 610041
    China

    Site Not Available

  • GSK Investigational Site

    Guangzhou 1809858, 510000
    China

    Site Not Available

  • GSK Investigational Site

    Hohhot 2036892, 010017
    China

    Site Not Available

  • GSK Investigational Site

    Nanjing 1799962, 210009
    China

    Site Not Available

  • GSK Investigational Site

    Shanghai, 200011
    China

    Site Not Available

  • GSK Investigational Site

    Shanghai 1796236, 200065
    China

    Site Not Available

  • GSK Investigational Site

    Shenyang 2034937, 110022
    China

    Site Not Available

  • GSK Investigational Site

    Shijiazhuang 1795270, 050051
    China

    Site Not Available

  • GSK Investigational Site

    Tianjin 1792947, 300192
    China

    Site Not Available

  • GSK Investigational Site

    Zhuzhou 1783763, 412007
    China

    Site Not Available

  • GSK Investigational Site

    Dax 3021670, 40107
    France

    Site Not Available

  • GSK Investigational Site

    La Roche-sur-Yon 3006767, 85925
    France

    Site Not Available

  • GSK Investigational Site

    La Rochelle 3006787, 17019
    France

    Site Not Available

  • GSK Investigational Site

    Montpellier 2992166, 34000
    France

    Site Not Available

  • GSK Investigational Site

    Paris 2988507, 75012
    France

    Site Not Available

  • GSK Investigational Site

    Berlin 2950159, 10117
    Germany

    Site Not Available

  • GSK Investigational Site

    Hamburg, 22415
    Germany

    Site Not Available

  • GSK Investigational Site

    Hamburg 2911298, 20095
    Germany

    Site Not Available

  • GSK Investigational Site

    Magdeburg 2874545, 39120
    Germany

    Site Not Available

  • GSK Investigational Site

    Fukuoka 1863967, 834-0115
    Japan

    Site Not Available

  • GSK Investigational Site

    Ibaraki, 300-1234
    Japan

    Site Not Available

  • GSK Investigational Site

    Ibaraki 1862033, 300-1253
    Japan

    Site Not Available

  • GSK Investigational Site

    Nagano, 390-8601
    Japan

    Site Not Available

  • GSK Investigational Site

    Nagano 1856215, 390-8601
    Japan

    Site Not Available

  • GSK Investigational Site

    Osaka 1853909, 543-0027
    Japan

    Site Not Available

  • GSK Investigational Site

    Saitama 6940394, 330-0074
    Japan

    Site Not Available

  • GSK Investigational Site

    Shimane 10987750, 693-8501
    Japan

    Site Not Available

  • GSK Investigational Site

    Tokyo, 113-8431
    Japan

    Site Not Available

  • GSK Investigational Site

    Tokyo 1850147, 103-0027
    Japan

    Site Not Available

  • GSK Investigational Site

    Seoul, 06973
    Korea, Republic of

    Site Not Available

  • GSK Investigational Site

    Chihuahua City 4014338, 31000
    Mexico

    Site Not Available

  • GSK Investigational Site

    Guadalajara 4005539, 44650
    Mexico

    Site Not Available

  • GSK Investigational Site

    Mexicali 3996069, 21200
    Mexico

    Site Not Available

  • GSK Investigational Site

    Mérida 3523349, CP 97070
    Mexico

    Site Not Available

  • GSK Investigational Site

    Torreón 3981254, 27000
    Mexico

    Site Not Available

  • GSK Investigational Site

    Cape Town, 7405
    South Africa

    Site Not Available

  • GSK Investigational Site

    Cape Town 3369157, 7130
    South Africa

    Site Not Available

  • GSK Investigational Site

    Gauteng, 1619
    South Africa

    Site Not Available

  • GSK Investigational Site

    Johannesburg 993800, 2113
    South Africa

    Site Not Available

  • GSK Investigational Site

    Stellenbosch 3361025, 7600
    South Africa

    Site Not Available

  • GSK Investigational Site

    Seoul 1835848, 07441
    South Korea

    Site Not Available

  • GSK Investigational Site

    A Coruña 3119841, 15006
    Spain

    Site Not Available

  • GSK Investigational Site

    Barcelona, 08540
    Spain

    Site Not Available

  • GSK Investigational Site

    Barcelona 3128760, 08540
    Spain

    Site Not Available

  • GSK Investigational Site

    Madrid 3117735, 28046
    Spain

    Site Not Available

  • GSK Investigational Site

    Santander 3109718, 39008
    Spain

    Site Not Available

  • GSK Investigational Site

    Santiago de Compostela 3109642, 15702
    Spain

    Site Not Available

  • GSK Investigational Site

    Seville 2510911, 41014
    Spain

    Site Not Available

  • GSK Investigational Site

    Blackpool 2655459, FY2 0JH
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Cannock 2653883, WS11 0BN
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    London 2643743, EN5 3DJ
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Manchester 2643123, M13 9NQ
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Cerritos 5335663, California 5332921 90703
    United States

    Site Not Available

  • GSK Investigational Site

    Huntington Beach 5358705, California 5332921 92647
    United States

    Site Not Available

  • GSK Investigational Site

    Santa Clara 5393015, California 5332921 95054
    United States

    Site Not Available

  • GSK Investigational Site

    Miami, Florida 33185
    United States

    Site Not Available

  • GSK Investigational Site

    Cooper City 4151824, Florida 4155751 33024
    United States

    Site Not Available

  • GSK Investigational Site

    Cutler Bay 6332309, Florida 4155751 33189
    United States

    Site Not Available

  • GSK Investigational Site

    Miami 4164138, Florida 4155751 33173
    United States

    Site Not Available

  • GSK Investigational Site

    Wichita 4281730, Kansas 4273857 67207
    United States

    Site Not Available

  • GSK Investigational Site

    Louisville 4299276, Kentucky 6254925 40213
    United States

    Site Not Available

  • GSK Investigational Site

    New Orleans 4335045, Louisiana 4331987 70115
    United States

    Site Not Available

  • GSK Investigational Site

    Henderson 5505411, Nevada 5509151 89052
    United States

    Site Not Available

  • GSK Investigational Site

    Williamsville 5144588, New York 5128638 14221
    United States

    Site Not Available

  • GSK Investigational Site

    Greensboro 4469146, North Carolina 4482348 27410
    United States

    Site Not Available

  • GSK Investigational Site

    Duncansville 5187508, Pennsylvania 6254927 16635
    United States

    Site Not Available

  • GSK Investigational Site

    Charlottesville 4752031, Virginia 6254928 22911
    United States

    Site Not Available

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