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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05838742




Registration number
NCT05838742
Ethics application status
Date submitted
20/04/2023
Date registered
3/05/2023

Titles & IDs
Public title
A Dose-Finding Study to Evaluate the Efficacy and Safety of GSK3858279 in Adults With Knee Osteoarthritis Pain
Scientific 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
Secondary ID [1] 0 0
2022-502799-22-00
Secondary ID [2] 0 0
209978
Universal Trial Number (UTN)
Trial acronym
MARS-17
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GSK3858279
Treatment: Drugs - Placebo

Experimental: GSK3858279 Dose 1 - Participants will receive GSK3858279 dose 1.

Experimental: GSK3858279 Dose 2 - Participants will receive GSK3858279 dose 2.

Experimental: GSK3858279 Dose 3 - Participants will receive GSK3858279 dose 3.

Experimental: GSK3858279 Dose 4 - Participants will receive GSK3858279 dose 4.

Placebo comparator: Placebo - Participants will receive placebo.


Treatment: Drugs: GSK3858279
GSK3858279 will be administered.

Treatment: Drugs: Placebo
Placebo will be administered.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline at Week 12 in weekly average of average daily knee pain intensity, assessed on the Numeric Rating Scale (NRS)
Timepoint [1] 0 0
Baseline and Week 12
Secondary outcome [1] 0 0
Change from baseline at Week 12 in Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score
Timepoint [1] 0 0
Baseline and Week 12
Secondary outcome [2] 0 0
Change from baseline at Week 12 in WOMAC function subscale score
Timepoint [2] 0 0
Baseline and Week 12
Secondary outcome [3] 0 0
Change from baseline at Week 12 in patient global assessment of disease (PtGA)
Timepoint [3] 0 0
Baseline and Week 12
Secondary outcome [4] 0 0
Occurrence of adverse events (AEs), serious AE (SAEs) and AEs of special interest (AESI)
Timepoint [4] 0 0
Up to 31 weeks
Secondary outcome [5] 0 0
Change from Baseline in Haematology Parameters: neutrophils, lymphocytes, monocytes, eosinophils, basophils, white blood cell (WBC), and platelet count (Giga cells per liter)
Timepoint [5] 0 0
Baseline and up to Week 31
Secondary outcome [6] 0 0
Change from Baseline in Haematology Parameters: Red blood cell (RBC) count, (Trillion cells per liter)
Timepoint [6] 0 0
Baseline and up to Week 31
Secondary outcome [7] 0 0
Change from baseline in haematology parameter: Haemoglobin (Hb) (Grams per liter)
Timepoint [7] 0 0
Baseline and up to Week 31
Secondary outcome [8] 0 0
Change from baseline in haematology parameter: Haematocrit (Proportion of red blood cells in blood)
Timepoint [8] 0 0
Baseline and up to Week 31
Secondary outcome [9] 0 0
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)
Timepoint [9] 0 0
Baseline and up to Week 31
Secondary outcome [10] 0 0
Change from baseline in clinical chemistry parameter: Total bilirubin (Micromoles per liter)
Timepoint [10] 0 0
Baseline and up to Week 31
Secondary outcome [11] 0 0
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)
Timepoint [11] 0 0
Up to 31 weeks
Secondary outcome [12] 0 0
Population parameters for the model describing the relationship between Dose, PK and response assessed on the NRS
Timepoint [12] 0 0
At Week 12
Secondary outcome [13] 0 0
Maximum observed concentration (Cmax) of GSK3858279
Timepoint [13] 0 0
At Week 12
Secondary outcome [14] 0 0
The amount of time for GSK3858279 to reach Cmax (tmax)
Timepoint [14] 0 0
At Week 12
Secondary outcome [15] 0 0
Pre-dose (trough) concentration at the end of the dosing interval (Ctau) of GSK3858279
Timepoint [15] 0 0
At Week 12
Secondary outcome [16] 0 0
Average concentration over a dosing interval (Cavg) of GSK3858279
Timepoint [16] 0 0
At Week 12
Secondary outcome [17] 0 0
Area under the time-concentration curve (AUC) over the dosing interval (0-tau) (AUC[0-tau]) of GSK3858279
Timepoint [17] 0 0
At Week 12

Eligibility
Key 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.
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/09/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
20/10/2025
Actual
Sample size
Target
420
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Botany
Recruitment hospital [2] 0 0
GSK Investigational Site - Campbelltown
Recruitment hospital [3] 0 0
GSK Investigational Site - Kotara
Recruitment hospital [4] 0 0
GSK Investigational Site - Camberwell
Recruitment postcode(s) [1] 0 0
2019 - Botany
Recruitment postcode(s) [2] 0 0
2560 - Campbelltown
Recruitment postcode(s) [3] 0 0
2289 - Kotara
Recruitment postcode(s) [4] 0 0
3124 - Camberwell
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Kansas
Country [4] 0 0
United States of America
State/province [4] 0 0
Kentucky
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Nevada
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
Virginia
Country [11] 0 0
Argentina
State/province [11] 0 0
Buenos Aires
Country [12] 0 0
Canada
State/province [12] 0 0
British Columbia
Country [13] 0 0
Canada
State/province [13] 0 0
Ontario
Country [14] 0 0
Canada
State/province [14] 0 0
Quebec
Country [15] 0 0
China
State/province [15] 0 0
Hebei
Country [16] 0 0
China
State/province [16] 0 0
Hunan
Country [17] 0 0
China
State/province [17] 0 0
Inner Mongolia
Country [18] 0 0
China
State/province [18] 0 0
Jiangsu
Country [19] 0 0
China
State/province [19] 0 0
Jilin
Country [20] 0 0
China
State/province [20] 0 0
Liaoning
Country [21] 0 0
China
State/province [21] 0 0
Sichuan
Country [22] 0 0
China
State/province [22] 0 0
Beijing
Country [23] 0 0
China
State/province [23] 0 0
Guangzhou
Country [24] 0 0
China
State/province [24] 0 0
Shanghai
Country [25] 0 0
China
State/province [25] 0 0
Tianjin
Country [26] 0 0
France
State/province [26] 0 0
Cahors
Country [27] 0 0
France
State/province [27] 0 0
Dax
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France
State/province [28] 0 0
La Roche Sur Yon
Country [29] 0 0
France
State/province [29] 0 0
La Rochelle
Country [30] 0 0
France
State/province [30] 0 0
Montpellier
Country [31] 0 0
France
State/province [31] 0 0
Paris
Country [32] 0 0
France
State/province [32] 0 0
Saint Priest en Jarez
Country [33] 0 0
Germany
State/province [33] 0 0
Sachsen-Anhalt
Country [34] 0 0
Germany
State/province [34] 0 0
Schleswig-Holstein
Country [35] 0 0
Germany
State/province [35] 0 0
Berlin
Country [36] 0 0
Germany
State/province [36] 0 0
Hamburg
Country [37] 0 0
Japan
State/province [37] 0 0
Fukuoka
Country [38] 0 0
Japan
State/province [38] 0 0
Ibaraki
Country [39] 0 0
Japan
State/province [39] 0 0
Nagano
Country [40] 0 0
Japan
State/province [40] 0 0
Osaka
Country [41] 0 0
Japan
State/province [41] 0 0
Saitama
Country [42] 0 0
Japan
State/province [42] 0 0
Shimane
Country [43] 0 0
Japan
State/province [43] 0 0
Tokyo
Country [44] 0 0
Korea, Republic of
State/province [44] 0 0
Seongnam-si
Country [45] 0 0
Korea, Republic of
State/province [45] 0 0
Seoul
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Mexico
State/province [46] 0 0
Baja California Norte
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Mexico
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Coahuila
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Mexico
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Jalisco
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Mexico
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Yucatán
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Mexico
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Chihuahua
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South Africa
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Cape Town
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South Africa
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Kempton Park
Country [53] 0 0
South Africa
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Stellenbosch
Country [54] 0 0
Spain
State/province [54] 0 0
A Coruna
Country [55] 0 0
Spain
State/province [55] 0 0
Barcelona
Country [56] 0 0
Spain
State/province [56] 0 0
Centelles (Barcelona)
Country [57] 0 0
Spain
State/province [57] 0 0
La Roca Del Valles (Barcelona)
Country [58] 0 0
Spain
State/province [58] 0 0
Madrid
Country [59] 0 0
Spain
State/province [59] 0 0
Pozuelo De Alarcón/Madrid
Country [60] 0 0
Spain
State/province [60] 0 0
Santander
Country [61] 0 0
Spain
State/province [61] 0 0
Santiago de Compostela
Country [62] 0 0
Spain
State/province [62] 0 0
Sevilla
Country [63] 0 0
United Kingdom
State/province [63] 0 0
Hertfordshire
Country [64] 0 0
United Kingdom
State/province [64] 0 0
Lancashire
Country [65] 0 0
United Kingdom
State/province [65] 0 0
Staffordshire
Country [66] 0 0
United Kingdom
State/province [66] 0 0
Manchester
Country [67] 0 0
United Kingdom
State/province [67] 0 0
Norwich

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
US GSK Clinical Trials Call Center
Address 0 0
Country 0 0
Phone 0 0
877-379-3718
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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 document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.gsk.com/en-gb/innovation/trials/data-transparency/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05838742