A Dose-Finding Study to Evaluate the Efficacy and Safety of GSK3858279 in Adults With Knee Osteoarthritis Pain (MARS-17)

October 11, 2023 updated by: GlaxoSmithKline

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

This is dose-finding study of GSK3858279 in participants with moderate to severe knee osteoarthritis (OA) 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

420

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1118
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Damaris Alvarez
    • Buenos Aires
      • Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina, C1417
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Raul Ceitlin
        • Contact:
        • Contact:
      • Ciudad Autonoma Buenos aires, Buenos Aires, Argentina, C1046AAQ
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Pablo Alejandro Mannucci Walter
        • Contact:
        • Contact:
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1128AAF
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Julio Hofman
        • Contact:
        • Contact:
      • Mar del Plata, Buenos Aires, Argentina, B7600FYK
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Gladys Alicia Testa
        • Contact:
        • Contact:
      • San Isidro, Buenos Aires, Argentina, 1643
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Maria Alicia Lazaro
        • Contact:
        • Contact:
  • Australia
    • New South Wales
      • Botany, New South Wales, Australia, 2019
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Paul Bird
      • Campbelltown, New South Wales, Australia, 2560
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kevin D. Pile
      • Kotara, New South Wales, Australia, 2289
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Oscar Maxwell Cumming
    • Victoria
      • Camberwell, Victoria, Australia, 3124
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Stephen Hall
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1K3
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • James K. Lai
      • Victoria, British Columbia, Canada, V8V 4A1
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michael B Jones
    • Ontario
      • Brampton, Ontario, Canada, L6T 0G1
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Naresh K. Aggarwal
        • Contact:
        • Contact:
      • Guelph, Ontario, Canada, N1H 1B1
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Douglas Friars
      • London, Ontario, Canada, N5W 6A2
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Peter Dzongowski
        • Contact:
        • Contact:
      • Sarnia, Ontario, Canada, N7T 4X3
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sean Peterson
      • Toronto, Ontario, Canada, M5T 2S8
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michael Zywiel
      • Toronto, Ontario, Canada, M9V 4B4
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Anil Gupta
      • Winchester, Ontario, Canada, K0C 2K0
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mary Naciuk
    • Quebec
      • Saint-Charles-Borromée, Quebec, Canada, J6E 2B4
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jean-Sebastien Paquette
        • Contact:
        • Contact:
  • China
      • Beijing, China, 100730
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Xisheng Weng
      • Beijing, China, 100083
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Hua Tian
        • Contact:
        • Contact:
      • Guangzhou, China, 510000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Zhanjun Shi
      • Shanghai, China, 200040
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yu Xue
      • Shanghai, China, 200011
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jie Zhao
      • Shanghai, China, 200065
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Biao Cheng
      • Tianjin, China, 300457
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Qun Xia
    • Hebei
      • Shijiazhuang City, Hebei, China, 050051
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Fang Li
        • Contact:
        • Contact:
    • Hunan
      • ZhuZhou, Hunan, China, 412007
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Zhenhua Wen
    • Inner Mongolia
      • Huhhot, Inner Mongolia, China, 010017
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yongsheng Xu
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Principal Investigator:
          • Jun Lu
        • Contact:
    • Jilin
      • Changchun, Jilin, China, 130021
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Zhenyu Jiang
        • Contact:
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China, 110022
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Ning Zhang
        • Contact:
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Bin Shen
  • France
      • Cahors, France, 46005
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Slim Lassoued
        • Contact:
        • Contact:
      • Dax, France, 40107
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Emilie Shipley
      • La Roche Sur Yon, France, 85925
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Grégoire CORMIER
      • La Rochelle, France, 17019
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Léa Rousselet-Prats
      • Montpellier, France, 34000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Christian Jorgensen
      • Paris, France, 75012
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Francis Berenbaum
      • Saint Priest en Jarez, France, 42270
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Thierry Thomas
  • Germany
      • Berlin, Germany, 10117
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Stanislav Ignatenko
      • Hamburg, Germany, 20095
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Andrea Everding
        • Contact:
        • Contact:
      • Hamburg, Germany, 22415
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Georg Peter Dahmen
    • Sachsen-Anhalt
      • Magdeburg, Sachsen-Anhalt, Germany, 39120
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gabriele Illies
    • Schleswig-Holstein
      • Rendsburg, Schleswig-Holstein, Germany, 24768
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ralf Jochen Walter
  • Japan
      • Fukuoka, Japan, 834-0115
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shinkichi Himeno
      • Ibaraki, Japan, 300-1234
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hideki Okuda
      • Ibaraki, Japan, 300-1253
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ken Shimizu
      • Nagano, Japan, 395-8505
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yukio Nakamura
      • Nagano, Japan, 390-8601
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Masashi Nawata
      • Osaka, Japan, 543-0027
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kenji Miki
      • Saitama, Japan, 330-0074
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Takao Kodama
      • Shimane, Japan, 693-8501
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yuji Uchio
      • Tokyo, Japan, 113-8431
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Muneaki Ishijima
      • Tokyo, Japan, 104-0031
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Akiyoshi Uchiyama
        • Contact:
        • Contact:
  • Korea, Republic of
      • Seongnam-si, Korea, Republic of, 463712
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Won Chul Choi
      • Seoul, Korea, Republic of, 02841
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Seung-Beom Hahn
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hyuk-Soo Han
      • Seoul, Korea, Republic of, 06973
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Seong Hwan Kim
      • Seoul, Korea, Republic of, ?07441
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Joong Il Kim
  • Mexico
      • Chihuahua, Mexico, 31000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Cesar Francisco Pacheco Tena
    • Baja California Norte
      • Mexicali, Baja California Norte, Mexico, 21200
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Francisco Fidencio Cons-Molina
    • Coahuila
      • Torreon, Coahuila, Mexico, 27000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sandra Sicsik Ayala
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44650
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Sergio Duran-Barragan
        • Contact:
        • Contact:
    • Yucatán
      • Merida, Yucatán, Mexico, CP 97070
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Principal Investigator:
          • Aaron Alejandro Barrera Rodriguez
        • Contact:
  • South Africa
      • Cape Town, South Africa, 7405
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Catherine E Spargo
        • Contact:
        • Contact:
      • Kempton Park, South Africa, 1619
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jennifer Rosa
        • Contact:
        • Contact:
      • Stellenbosch, South Africa, 7600
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Gareth Scott Tarr
        • Contact:
        • Contact:
  • Spain
      • A Coruna, Spain, 15006
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Francisco Javier Blanco Garcia
      • Barcelona, Spain, 08023
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Noel Manuel Bordn Garca
      • Centelles (Barcelona), Spain, 08540
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Silvia Narejos Perez
        • Contact:
        • Contact:
      • La Roca Del Valles (Barcelona), Spain, 08430
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Merce Perez Vera
      • Madrid, Spain, 28046
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alejandro Balsa Criado
      • Pozuelo De Alarcón/Madrid, Spain, 28223
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Esteban Jodar Gimeno
      • Santander, Spain, 39008
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Ricardo Blanco Alonso
        • Contact:
        • Contact:
      • Santiago de Compostela, Spain, 15702
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Juan José Amarelo Ramos
        • Contact:
        • Contact:
      • Sevilla, Spain, 41014
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Ignacio Salamanca De La Cueva
        • Contact:
        • Contact:
  • United Kingdom
      • Manchester, United Kingdom, M13 9NQ
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Halah Almadhi
      • Norwich, United Kingdom, NR4 7UY
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Iain McNamara
    • Hertfordshire
      • Barnet, Hertfordshire, United Kingdom, EN5 3DJ
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hasan Tahir
    • Lancashire
      • Blackpool, Lancashire, United Kingdom, FY2 0JH
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Abimbola Babajide
    • Staffordshire
      • Cannock, Staffordshire, United Kingdom, WS11 0BN
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lucy McLellan
  • United States
    • California
      • Cerritos, California, United States, 90703
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Francisco Badar
      • Huntington Beach, California, United States, 92647
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Manuchehr Darani
      • Sunnyvale, California, United States, 94087
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marisa Jayakar
    • Florida
      • Cooper City, Florida, United States, 33024
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Mark Jaffe
        • Contact:
        • Contact:
      • Cutler Bay, Florida, United States, 33189
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rawan Jumean
      • Miami, Florida, United States, 33173
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Eddie Armas
      • Miami, Florida, United States, 33185
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rafael Chiong
    • Kansas
      • Wichita, Kansas, United States, 67207
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Thomas C Klein
    • Kentucky
      • Louisville, Kentucky, United States, 40213
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Harold E. Bays
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • George Stanley Walker
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Vikas Sayal
    • New York
      • Williamsville, New York, United States, 14221
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • James E Wild
    • North Carolina
      • Greensboro, North Carolina, United States, 27410
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Richard Lewis Montgomery
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Frederick Murphy
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • James R Clark
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 clinical diagnosis of OA as per American College of Rheumatology (ACR) clinical diagnosis criteria.
  • 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 by the 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 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.
  • History of significant trauma or surgery to a knee or hip within the last 6 months.
  • Current immunodeficiency diseases including but not limited to acquired immunodeficiency 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 squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic 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 if bilirubin is fractionated and direct bilirubin < 35 percent (%)
  • Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
  • Evidence of renal insufficiency, indicated by estimated creatinine clearance < 60 millilitre/ minute (mL/min)/1.73 m^2 at screening.
  • Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants will receive placebo.
Drug: Placebo
Placebo will be administered.
Experimental: GSK3858279 Dose 1
Participants will receive GSK3858279 dose 1.
Drug: GSK3858279
GSK3858279 will be administered.
Experimental: GSK3858279 Dose 2
Participants will receive GSK3858279 dose 2.
Drug: GSK3858279
GSK3858279 will be administered.
Experimental: GSK3858279 Dose 3
Participants will receive GSK3858279 dose 3.
Drug: GSK3858279
GSK3858279 will be administered.
Experimental: GSK3858279 Dose 4
Participants will receive GSK3858279 dose 4.
Drug: GSK3858279
GSK3858279 will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline at Week 12 in weekly average of average daily knee pain intensity, assessed on the Numeric Rating Scale (NRS)
Time Frame: Baseline and Week 12
To capture information on the self-reported average knee pain intensity in index knee, over the past 24 hours, participants will be asked to mark their average pain-intensity daily, using the NRS, on an 11-point scale (0-10), with 0 = no pain, and 10 = pain as bad as you can imagine. Daily scores for each participant will be averaged over 7 days to obtain a weekly score.
Baseline and Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline at Week 12 in Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score
Time Frame: Baseline and Week 12
The WOMAC proprietary set of standardized questionnaires used by health professionals and to evaluate the condition of participants with osteoarthritis of the knee and hip, including pain, stiffness of the joints. The questionnaire covers pain, stiffness and function related to OA in the index knee over the past 48 hours. Participants will respond to each question using an 11- point NRS (0-10), with 0 = no pain/stiffness/difficulty, and 10 = extreme pain/stiffness/difficulty.
Baseline and Week 12
Change from baseline at Week 12 in WOMAC function subscale score
Time Frame: Baseline and Week 12
The WOMAC is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of participants with osteoarthritis of the knee and hip, for physical functioning of the joints. The questionnaire covers pain, stiffness and function related to OA in the index knee over the past 48 hours. Participants will respond to each question using an 11- point NRS (0-10), with 0 = no pain/stiffness/difficulty, and 10 = extreme pain/stiffness/difficulty.
Baseline and Week 12
Change from baseline at Week 12 in patient global assessment of disease (PtGA)
Time Frame: Baseline and Week 12
The PtGA is assessment of study participant for disease conditions and intensity of knee OA pain. Participants will respond on a Likert scale ranging from 1-5. Higher scores indicate worse condition.
Baseline and Week 12
Occurrence of adverse events (AEs), serious AE (SAEs) and AEs of special interest (AESI)
Time Frame: Up to 31 weeks
AEs, SAEs, and AESIs will be collected. Any untoward medical occurrence in participant, temporally associated with use of study intervention, whether or not considered related to medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, medically important were categorized as SAE. AESIs of the study drug includes serious and opportunistic infections, tuberculosis (TB) and TB reactivation, serious hypersensitivity reactions and Injection site reactions.
Up to 31 weeks
Change from Baseline in Haematology Parameters: neutrophils, lymphocytes, monocytes, eosinophils, basophils, white blood cell (WBC), and platelet count (Giga cells per liter)
Time Frame: Baseline and up to Week 31
Baseline and up to Week 31
Change from Baseline in Haematology Parameters: Red blood cell (RBC) count, (Trillion cells per liter)
Time Frame: Baseline and up to Week 31
Baseline and up to Week 31
Change from baseline in haematology parameter: Haemoglobin (Hb) (Grams per liter)
Time Frame: Baseline and up to Week 31
Baseline and up to Week 31
Change from baseline in haematology parameter: Haematocrit (Proportion of red blood cells in blood)
Time Frame: Baseline and up to Week 31
Baseline and up to Week 31
Change from baseline in clinical chemistry parameters: Aspartate aminotransferase (AST), alanine aminotransferase (ALT), Gamma-glutamyl transferase (GGT), and Alkaline Phosphatase (AP) (International units per liter)
Time Frame: Baseline and up to Week 31
Baseline and up to Week 31
Change from baseline in clinical chemistry parameter: Total bilirubin (Micromoles per liter)
Time Frame: Baseline and up to Week 31
Baseline and up to Week 31
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)
Time Frame: Up to 31 weeks
Hematological/clinical chemistry abnormalities summarized according to NCI CTCAE grade
Up to 31 weeks
Population parameters for the model describing the relationship between Dose, PK and response assessed on the NRS
Time Frame: At Week 12
Longitudinal dose-exposure-response (D-E-R) relationship between GSK3858279 dose, PK and weekly average of average daily knee pain intensity, assessed on the Numeric Rating Scale (NRS). Where the pain is scored on a 11-point scale (0-10), with 0 = no pain, and 10 = extreme pain as bad as you can imagine.
At Week 12
Maximum observed concentration (Cmax) of GSK3858279
Time Frame: At Week 12
Cmax predicted from the D-E-R model fitted to GSK3859279 serum concentration time data collected at the indicated time points for PK analysis.
At Week 12
The amount of time for GSK3858279 to reach Cmax (tmax)
Time Frame: At Week 12
Tmax predicted from the D-E-R model fitted to GSK3859279 serum concentration time data collected at the indicated time points for PK analysis.
At Week 12
Pre-dose (trough) concentration at the end of the dosing interval (Ctau) of GSK3858279
Time Frame: At Week 12
Ctau predicted from the D-E-R model fitted to GSK3859279 serum concentration time data collected at the indicated time points for PK analysis.
At Week 12
Average concentration over a dosing interval (Cavg) of GSK3858279
Time Frame: At Week 12
Cavg predicted from the D-E-R model fitted to GSK3859279 serum concentration time data collected at the indicated time points for PK analysis.
At Week 12
Area under the time-concentration curve (AUC) over the dosing interval (0-tau) (AUC[0-tau]) of GSK3858279
Time Frame: At Week 12
AUC(0-tau) predicted from the D-E-R model fitted to GSK3859279 serum concentration time data collected at the indicated time points for PK analysis.
At Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2023

Primary Completion (Estimated)

July 7, 2025

Study Completion (Estimated)

October 20, 2025

Study Registration Dates

First Submitted

April 20, 2023

First Submitted That Met QC Criteria

April 20, 2023

First Posted (Actual)

May 3, 2023

Study Record Updates

Last Update Posted (Actual)

October 12, 2023

Last Update Submitted That Met QC Criteria

October 11, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 209978
  • 2022-502799-22-00 (Other Identifier: EU-CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

IPD Sharing Time Frame

Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.

IPD Sharing Access Criteria

Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Medical Conditions

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Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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Locations

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