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

Last updated: April 1, 2025
Sponsor: GlaxoSmithKline
Overall Status: Terminated

Phase

2

Condition

Pain

Osteoarthritis

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

    San Isidro, Buenos Aires 1643
    Argentina

    Site Not Available

  • GSK Investigational Site

    Buenos Aires, 1118
    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

    Ciudad Autonoma de Buenos Aires, C1128AAF
    Argentina

    Site Not Available

  • GSK Investigational Site

    Mar del Plata, B7600FYK
    Argentina

    Site Not Available

  • GSK Investigational Site

    Botany, New South Wales 2019
    Australia

    Site Not Available

  • GSK Investigational Site

    Campbelltown, New South Wales 2560
    Australia

    Site Not Available

  • GSK Investigational Site

    Kotara, New South Wales 2289
    Australia

    Site Not Available

  • GSK Investigational Site

    Sydney, New South Wales 2010
    Australia

    Site Not Available

  • GSK Investigational Site

    Camberwell, Victoria 3124
    Australia

    Site Not Available

  • GSK Investigational Site

    Vancouver, British Columbia V5Z 1K3
    Canada

    Site Not Available

  • GSK Investigational Site

    Victoria, British Columbia 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

    London, Ontario N5W 6A2
    Canada

    Site Not Available

  • GSK Investigational Site

    Sarnia, Ontario N7T 4X3
    Canada

    Site Not Available

  • GSK Investigational Site

    Toronto, Ontario M9V 4B4
    Canada

    Site Not Available

  • GSK Investigational Site

    Winchester, Ontario K0C 2K0
    Canada

    Site Not Available

  • GSK Investigational Site

    Joliette, Quebec J6E 6A9
    Canada

    Site Not Available

  • GSK Investigational Site

    Saint-Charles-Borromée, Quebec J6E 2B4
    Canada

    Site Not Available

  • GSK Investigational Site

    Sherbrooke, Quebec J1L 0H8
    Canada

    Site Not Available

  • GSK Investigational Site

    Trois-Rivieres, Quebec G9A 3X2
    Canada

    Site Not Available

  • GSK Investigational Site

    Shijiazhuang City, Hebei 050051
    China

    Site Not Available

  • GSK Investigational Site

    Beijing, 100083
    China

    Site Not Available

  • GSK Investigational Site

    Changchun, 130021
    China

    Site Not Available

  • GSK Investigational Site

    Chengdu, 610041
    China

    Site Not Available

  • GSK Investigational Site

    Guangzhou, 510000
    China

    Site Not Available

  • GSK Investigational Site

    Huhhot, 010017
    China

    Site Not Available

  • GSK Investigational Site

    Nanjing, 210009
    China

    Site Not Available

  • GSK Investigational Site

    Shanghai, 200065
    China

    Site Not Available

  • GSK Investigational Site

    Shenyang, 110022
    China

    Site Not Available

  • GSK Investigational Site

    Shijiazhuang, 050051
    China

    Site Not Available

  • GSK Investigational Site

    Tianjin, 300192
    China

    Site Not Available

  • GSK Investigational Site

    ZhuZhou, 412007
    China

    Site Not Available

  • GSK Investigational Site

    Cahors, 46005
    France

    Site Not Available

  • GSK Investigational Site

    Dax, 40107
    France

    Site Not Available

  • GSK Investigational Site

    La Roche Sur Yon, 85925
    France

    Site Not Available

  • GSK Investigational Site

    La Rochelle, 17019
    France

    Site Not Available

  • GSK Investigational Site

    La Rochelle Cedex 1, 17019
    France

    Site Not Available

  • GSK Investigational Site

    Montpellier, 34000
    France

    Site Not Available

  • GSK Investigational Site

    Montpellier cedex 5, 34000
    France

    Site Not Available

  • GSK Investigational Site

    Paris, 75012
    France

    Site Not Available

  • GSK Investigational Site

    Saint Priest en Jarez, 42270
    France

    Site Not Available

  • GSK Investigational Site

    Saint-Priest en Jarez, 42270
    France

    Site Not Available

  • GSK Investigational Site

    Berlin, 10117
    Germany

    Site Not Available

  • GSK Investigational Site

    Hamburg, 22415
    Germany

    Site Not Available

  • GSK Investigational Site

    Magdeburg, 39120
    Germany

    Site Not Available

  • GSK Investigational Site

    Rendsburg, 24768
    Germany

    Site Not Available

  • GSK Investigational Site

    Fukuoka, 834-0115
    Japan

    Site Not Available

  • GSK Investigational Site

    Ibaraki, 300-1253
    Japan

    Site Not Available

  • GSK Investigational Site

    Nagano, 390-8601
    Japan

    Site Not Available

  • GSK Investigational Site

    Osaka, 543-0027
    Japan

    Site Not Available

  • GSK Investigational Site

    Saitama, 330-0074
    Japan

    Site Not Available

  • GSK Investigational Site

    Shimane, 693-8501
    Japan

    Site Not Available

  • GSK Investigational Site

    Tokyo, 104-0031
    Japan

    Site Not Available

  • GSK Investigational Site

    Seongnam-si, 463712
    Korea, Republic of

    Site Not Available

  • GSK Investigational Site

    Seoul, 07441
    Korea, Republic of

    Site Not Available

  • GSK Investigational Site

    Chihuahua, 31000
    Mexico

    Site Not Available

  • GSK Investigational Site

    Guadalajara, 44650
    Mexico

    Site Not Available

  • GSK Investigational Site

    Merida, CP 97070
    Mexico

    Site Not Available

  • GSK Investigational Site

    Mexicali, 21200
    Mexico

    Site Not Available

  • GSK Investigational Site

    Torreon, 27000
    Mexico

    Site Not Available

  • GSK Investigational Site

    Cape Town, 7130
    South Africa

    Site Not Available

  • GSK Investigational Site

    Gauteng, 1619
    South Africa

    Site Not Available

  • GSK Investigational Site

    Johannesburg, 2113
    South Africa

    Site Not Available

  • GSK Investigational Site

    Kempton Park, 1619
    South Africa

    Site Not Available

  • GSK Investigational Site

    Stellenbosch, 7600
    South Africa

    Site Not Available

  • GSK Investigational Site

    A Coruna, 15006
    Spain

    Site Not Available

  • GSK Investigational Site

    Barcelona, 08430
    Spain

    Site Not Available

  • GSK Investigational Site

    Centelles (Barcelona), 08540
    Spain

    Site Not Available

  • GSK Investigational Site

    La Roca Del Valles (Barcelona), 08430
    Spain

    Site Not Available

  • GSK Investigational Site

    Madrid, 28046
    Spain

    Site Not Available

  • GSK Investigational Site

    Pozuelo De Alarcón/Madrid, 28223
    Spain

    Site Not Available

  • GSK Investigational Site

    Santander, 39008
    Spain

    Site Not Available

  • GSK Investigational Site

    Santiago de Compostela, 15702
    Spain

    Site Not Available

  • GSK Investigational Site

    Sevilla, 41014
    Spain

    Site Not Available

  • GSK Investigational Site

    Barnet, Hertfordshire EN5 3DJ
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Blackpool, FY2 0JH
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Cannock, WS11 0BN
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    London, EN5 3DJ
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Manchester, M13 9NQ
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Norwich, NR4 7UY
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Cerritos, California 90703
    United States

    Site Not Available

  • GSK Investigational Site

    Huntington Beach, California 92647
    United States

    Site Not Available

  • GSK Investigational Site

    Santa Clara, California 95054
    United States

    Site Not Available

  • GSK Investigational Site

    Sunnyvale, California 94087
    United States

    Site Not Available

  • GSK Investigational Site

    Cooper City, Florida 33024
    United States

    Site Not Available

  • GSK Investigational Site

    Cutler Bay, Florida 33189
    United States

    Site Not Available

  • GSK Investigational Site

    Miami, Florida 33185
    United States

    Site Not Available

  • GSK Investigational Site

    Wichita, Kansas 67207
    United States

    Site Not Available

  • GSK Investigational Site

    Louisville, Kentucky 40213
    United States

    Site Not Available

  • GSK Investigational Site

    New Orleans, Louisiana 70115
    United States

    Site Not Available

  • GSK Investigational Site

    Henderson, Nevada 89052
    United States

    Site Not Available

  • GSK Investigational Site

    Williamsville, New York 14221
    United States

    Site Not Available

  • GSK Investigational Site

    Greensboro, North Carolina 27410
    United States

    Site Not Available

  • GSK Investigational Site

    Duncansville, Pennsylvania 16635
    United States

    Site Not Available

  • GSK Investigational Site

    Charlottesville, Virginia 22911
    United States

    Site Not Available

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