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

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ClinicalTrials.gov Identifier: NCT05838742
Recruitment Status : Recruiting
First Posted : May 3, 2023
Last Update Posted : October 12, 2023
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pain Drug: GSK3858279 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Click here to enter text.
Primary Purpose: Treatment
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
Actual Study Start Date : September 13, 2023
Estimated Primary Completion Date : July 7, 2025
Estimated Study Completion Date : October 20, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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Arm Intervention/treatment
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.
Placebo Comparator: Placebo
Participants will receive placebo.
 Drug: Placebo
Placebo will be administered.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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 ]
  6. Change from Baseline in Haematology Parameters: Red blood cell (RBC) count, (Trillion cells per liter) [ Time Frame: Baseline and up to Week 31 ]
  7. Change from baseline in haematology parameter: Haemoglobin (Hb) (Grams per liter) [ Time Frame: Baseline and up to Week 31 ]
  8. Change from baseline in haematology parameter: Haematocrit (Proportion of red blood cells in blood) [ Time Frame: Baseline and up to Week 31 ]
  9. 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 ]
  10. Change from baseline in clinical chemistry parameter: Total bilirubin (Micromoles per liter) [ Time Frame: Baseline and up to Week 31 ]
  11. 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

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05838742


Contacts
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Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

Locations
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Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT05838742    
Other Study ID Numbers: 209978
2022-502799-22-00 ( Other Identifier: EU-CT )
First Posted: May 3, 2023    Key Record Dates
Last Update Posted: October 12, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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/
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
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.
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.
URL: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

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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
Keywords provided by GlaxoSmithKline:
Osteoarthritis
Musculoskeletal Diseases
209978
GSK3858279
 Efficacy
Safety
Pharmacokinetics
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases