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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04134728




Registration number
NCT04134728
Ethics application status
Date submitted
18/10/2019
Date registered
22/10/2019
Date last updated
17/07/2023

Titles & IDs
Public title
Efficacy and Safety of GSK3196165 (Otilimab) Versus Placebo and Sarilumab in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biological Disease-modifying Antirheumatic Drug (DMARDs) and/or Janus Kinase (JAK) Inhibitors
Scientific title
A 24-week, Phase 3, Multicentre, Randomised, Double-blind, Efficacy and Safety Study, Comparing GSK3196165 With Placebo and With Sarilumab, in Combination With Conventional Synthetic DMARDs, in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biological DMARDs and/or Janus Kinase Inhibitors
Secondary ID [1] 0 0
202018
Universal Trial Number (UTN)
Trial acronym
contRAst 3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - GSK3196165 (Otilimab)
Other interventions - Sarilumab
Treatment: Drugs - Placebo to GSK3196165/ Sarilumab
Treatment: Drugs - csDMARDs

Experimental: GSK3196165 90 mg - Entire treatment period (24 Weeks): GSK3196165 90 mg SC injection once weekly. Participants will also receive a stable dose of csDMARD(s) as standard of care (SoC).

Experimental: GSK3196165 150 mg - Entire treatment period (24 Weeks): GSK3196165 150 mg SC injection once weekly. Participants will also receive a stable dose of csDMARD(s) as SoC.

Active Comparator: Sarilumab 200 mg - Entire treatment period (24 Weeks): Sarilumab 200 mg SC injection every other week + placebo SC injection in the intervening weeks. Participants will also receive a stable dose of csDMARD(s) as SoC.

Placebo Comparator: Placebo sequence 1 - From Week 0-11: Placebo SC injection once weekly. From Week 12 onwards: GSK3196165 90 mg SC injection once weekly. Participants will also receive a stable dose of csDMARD(s) as SoC.

Placebo Comparator: Placebo sequence 2 - From Week 0-11: Placebo SC injection once weekly. From Week 12 onwards: GSK3196165 150 mg SC injection once weekly. Participants will also receive a stable dose of csDMARD(s) as SoC.

Placebo Comparator: Placebo sequence 3 - From Week 0-11: Placebo SC injection once weekly. From Week 12 onwards: Sarilumab 200 mg SC injection every other week + placebo SC injection in the intervening weeks. Participants will also receive a stable dose of csDMARD(s) as SoC.


Other interventions: GSK3196165 (Otilimab)
GSK3196165 solution in vial/pre-filled syringe (PFS) to be administered SC.

Other interventions: Sarilumab
Sarilumab solution in PFS to be administered SC.

Treatment: Drugs: Placebo to GSK3196165/ Sarilumab
Placebo sterile 0.9 percentage (%) weight by volume (w/v) sodium chloride solution in vial/PFS to be administered SC.

Treatment: Drugs: csDMARDs
Stable dose of csDMARD(s) as SoC.
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With 20% Improvement in American College of Rheumatology Criteria (ACR20) at Week 12 Superiority Comparison With Placebo
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) (Versus Placebo) at Week 12
Timepoint [1] 0 0
Baseline (Day 01) and Week 12
Secondary outcome [2] 0 0
Percentage of Participants With Clinical Disease Activity Index (CDAI) Total Score <=10 (CDAI Low Disease Activity [LDA]) at Week 12
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Percentage of Participants With CDAI Total Score <=10 (CDAI LDA) at Week 24 for Treatment Arms That Started Study Intervention From Day 1
Timepoint [3] 0 0
Week 24
Secondary outcome [4] 0 0
Percentage of Participants With CDAI Total Score <=10 (CDAI LDA) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12
Timepoint [4] 0 0
Week 24
Secondary outcome [5] 0 0
Change From Baseline in CDAI Total Score at Week 12
Timepoint [5] 0 0
Baseline (Day 01) and Week 12
Secondary outcome [6] 0 0
Change From Baseline in CDAI Total Score at Week 24 for Treatment Arms That Started Study Intervention From Day 1
Timepoint [6] 0 0
Baseline (Day 01) and Week 24
Secondary outcome [7] 0 0
Change From Baseline in CDAI Total Score at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12
Timepoint [7] 0 0
Baseline (Day 01) and Week 24
Secondary outcome [8] 0 0
Change From Baseline in Arthritis Pain Visual Analogue Scale (VAS) at Week 12
Timepoint [8] 0 0
Baseline (Day 01) and Week 12
Secondary outcome [9] 0 0
Change From Baseline in Arthritis Pain VAS at Week 24 for Treatment Arms That Started Study Intervention From Day 1
Timepoint [9] 0 0
Baseline (Day 01) and Week 24
Secondary outcome [10] 0 0
Change From Baseline in Arthritis Pain VAS at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12
Timepoint [10] 0 0
Baseline (Day 01) and Week 24
Secondary outcome [11] 0 0
Percentage of Participants With CDAI Total Score <=2.8 (CDAI Remission) at Week 12
Timepoint [11] 0 0
Week 12
Secondary outcome [12] 0 0
Percentage of Participants With CDAI Total Score <=2.8 (CDAI Remission) at Week 24 for Treatment Arms That Started Study Intervention From Day 1
Timepoint [12] 0 0
Week 24
Secondary outcome [13] 0 0
Percentage of Participants With CDAI Total Score <=2.8 (CDAI Remission) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12
Timepoint [13] 0 0
Week 24
Secondary outcome [14] 0 0
Percentage of Participants With ACR20 at Week 24 for Treatment Arms That Started Study Intervention From Day 1
Timepoint [14] 0 0
Week 24
Secondary outcome [15] 0 0
Percentage of Participants With ACR20 at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12
Timepoint [15] 0 0
Week 24
Secondary outcome [16] 0 0
Percentage of Participants With 50% Improvement in American College of Rheumatology Criteria (ACR50) at Week 12
Timepoint [16] 0 0
Week 12
Secondary outcome [17] 0 0
Percentage of Participants With ACR50 at Week 24 for Treatment Arms That Started Study Intervention From Day 1
Timepoint [17] 0 0
Week 24
Secondary outcome [18] 0 0
Percentage of Participants With ACR50 at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12
Timepoint [18] 0 0
Week 24
Secondary outcome [19] 0 0
Percentage of Participants With 70% Improvement in American College of Rheumatology Criteria (ACR70) at Week 12
Timepoint [19] 0 0
Week 12
Secondary outcome [20] 0 0
Percentage of Participants With ACR70 at Week 24 for Treatment Arms That Started Study Intervention From Day 1
Timepoint [20] 0 0
Week 24
Secondary outcome [21] 0 0
Percentage of Participants With ACR70 at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12
Timepoint [21] 0 0
Week 24
Secondary outcome [22] 0 0
Percentage of Participants With Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP) <=3.2 (DAS28-CRP LDA) at Week 12
Timepoint [22] 0 0
Week 12
Secondary outcome [23] 0 0
Percentage of Participants With DAS28-CRP <=3.2 (DAS28-CRP LDA) at Week 24 for Treatment Arms That Started Study Intervention From Day 1
Timepoint [23] 0 0
Week 24
Secondary outcome [24] 0 0
Percentage of Participants With DAS28-CRP <=3.2 (DAS28-CRP LDA) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12
Timepoint [24] 0 0
Week 24
Secondary outcome [25] 0 0
Percentage of Participants With DAS28 Erythrocyte Sedimentation Rate (ESR) <=3.2 (DAS28-ESR LDA) at Week 12
Timepoint [25] 0 0
Week 12
Secondary outcome [26] 0 0
Percentage of Participants With DAS28-ESR <=3.2 (DAS28-ESR LDA) at Week 24 for Treatment Arms That Started Study Intervention From Day 1
Timepoint [26] 0 0
Week 24
Secondary outcome [27] 0 0
Percentage of Participants With DAS28-ESR <=3.2 (DAS28-ESR LDA) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12
Timepoint [27] 0 0
Week 24
Secondary outcome [28] 0 0
Percentage of Participants With DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 12
Timepoint [28] 0 0
Week 12
Secondary outcome [29] 0 0
Percentage of Participants With DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 24 for Treatment Arms That Started Study Intervention From Day 1
Timepoint [29] 0 0
Week 24
Secondary outcome [30] 0 0
Percentage of Participants With DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12
Timepoint [30] 0 0
Week 24
Secondary outcome [31] 0 0
Percentage of Participants With DAS28-ESR <2.6 (DAS28-ESR Remission) at Week 12
Timepoint [31] 0 0
Week 12
Secondary outcome [32] 0 0
Percentage of Participants With DAS28-ESR <2.6 (DAS28-ESR Remission) Week 24 for Treatment Arms That Started Study Intervention From Day 1
Timepoint [32] 0 0
Week 24
Secondary outcome [33] 0 0
Percentage of Participants With DAS28-ESR <2.6 (DAS28-ESR Remission) Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12
Timepoint [33] 0 0
Week 24
Secondary outcome [34] 0 0
Percentage of Participants With a Good/Moderate European League Against Rheumatism (EULAR) Response at Week 12
Timepoint [34] 0 0
Week 12
Secondary outcome [35] 0 0
Percentage of Participants With a Good/Moderate EULAR Response at Week 24 for Treatment Arms That Started Study Intervention From Day 1
Timepoint [35] 0 0
Week 24
Secondary outcome [36] 0 0
Percentage of Participants With a Good/Moderate EULAR Response at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12
Timepoint [36] 0 0
Week 24
Secondary outcome [37] 0 0
Percentage of Participants With ACR/EULAR Remission at Week 12
Timepoint [37] 0 0
Week 12
Secondary outcome [38] 0 0
Percentage of Participants With ACR/EULAR Remission at Week 24 for Treatment Arms That Started Study Intervention From Day 1
Timepoint [38] 0 0
Week 24
Secondary outcome [39] 0 0
Percentage of Participants With ACR/EULAR Remission at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12
Timepoint [39] 0 0
Week 24
Secondary outcome [40] 0 0
Change From Baseline in DAS28-CRP and DAS28-ESR at Week 12
Timepoint [40] 0 0
Baseline (Day 01) and Week 12
Secondary outcome [41] 0 0
Change From Baseline in DAS28-CRP and DAS28-ESR at Week 24 for Treatment Arms That Started Study Intervention From Day 1
Timepoint [41] 0 0
Baseline (Day 01) and Week 24
Secondary outcome [42] 0 0
Change From Baseline in DAS28-CRP and DAS28-ESR at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12
Timepoint [42] 0 0
Baseline (Day 01) and Week 24
Secondary outcome [43] 0 0
Change From Baseline in HAQ-DI at Week 24 for Treatment Arms That Started Study Intervention From Day 1
Timepoint [43] 0 0
Baseline (Day 01) and Week 24
Secondary outcome [44] 0 0
Change From Baseline in HAQ-DI at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12
Timepoint [44] 0 0
Baseline (Day 01) and Week 24
Secondary outcome [45] 0 0
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue at Week 12
Timepoint [45] 0 0
Baseline (Day 01) and Week 12
Secondary outcome [46] 0 0
Change From Baseline in FACIT-Fatigue at Week 24 for Treatment Arms That Started Study Intervention From Day 1
Timepoint [46] 0 0
Baseline (Day 01) and Week 24
Secondary outcome [47] 0 0
Change From Baseline in FACIT-Fatigue at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12
Timepoint [47] 0 0
Baseline (Day 01) and Week 24
Secondary outcome [48] 0 0
Change From Baseline in Subject-completed Medical Outcomes Study Short-Form 36 (SF-36) Physical Component Scores (PCS) at Week 12
Timepoint [48] 0 0
Baseline (Day 01) and Week 12
Secondary outcome [49] 0 0
Change From Baseline in SF-36 PCS at Week 24 for Treatment Arms That Started Study Intervention From Day 1
Timepoint [49] 0 0
Baseline (Day 01) and Week 24
Secondary outcome [50] 0 0
Change From Baseline in SF-36 PCS at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12
Timepoint [50] 0 0
Baseline (Day 01) and Week 24
Secondary outcome [51] 0 0
Change From Baseline in SF-36 Mental Component Scores (MCS) at Week 12
Timepoint [51] 0 0
Baseline (Day 01) and Week 12
Secondary outcome [52] 0 0
Change From Baseline in SF-36 MCS at Week 24 for Treatment Arms That Started Study Intervention From Day 1
Timepoint [52] 0 0
Baseline (Day 01) and Week 24
Secondary outcome [53] 0 0
Change From Baseline in SF-36 MCS at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12
Timepoint [53] 0 0
Baseline (Day 01) and Week 24
Secondary outcome [54] 0 0
Change From Baseline in SF-36 Domain Scores at Week 12
Timepoint [54] 0 0
Baseline (Day 01) and Week 12
Secondary outcome [55] 0 0
Change From Baseline in SF-36 Domain Scores at Week 24 for Treatment Arms That Started Study Intervention From Day 1
Timepoint [55] 0 0
Baseline (Day 01) and Week 24
Secondary outcome [56] 0 0
Change From Baseline in SF-36 Domain Scores at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12
Timepoint [56] 0 0
Baseline (Day 01) and Week 24
Secondary outcome [57] 0 0
Incidence of Adverse Events (AEs), Serious Adverse Event (SAEs), Adverse Events of Special Interest (AESI)
Timepoint [57] 0 0
Up to Week 24
Secondary outcome [58] 0 0
Change From Baseline in Neutrophil, Lymphocyte, Platelet Count (Giga Cells Per Liter) at Week 12
Timepoint [58] 0 0
Baseline (Day 01) and Week 12
Secondary outcome [59] 0 0
Change From Baseline in Neutrophil, Lymphocyte, Platelet Count (Giga Cells Per Liter) at Week 24 for Treatment Arms That Started Study Intervention From Day 1
Timepoint [59] 0 0
Baseline (Day 01) and Week 24
Secondary outcome [60] 0 0
Change From Baseline in Neutrophil, Lymphocyte, Platelet Count (Giga Cells Per Liter) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12
Timepoint [60] 0 0
Baseline (Week 12) and Week 24
Secondary outcome [61] 0 0
Change From Baseline in White Blood Cell (WBC) Count (Giga Cells Per Liter) at Week 12
Timepoint [61] 0 0
Baseline (Day 01) and Week 12
Secondary outcome [62] 0 0
Change From Baseline in WBC Count (Giga Cells Per Liter) at Week 24 for Treatment Arms That Started Study Intervention From Day 1
Timepoint [62] 0 0
Baseline (Day 01) and Week 24
Secondary outcome [63] 0 0
Change From Baseline in WBC Count (Giga Cells Per Liter) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12
Timepoint [63] 0 0
Baseline (Week 12) and Week 24
Secondary outcome [64] 0 0
Change From Baseline in Hemoglobin Level (Grams Per Liter) Week 12
Timepoint [64] 0 0
Baseline (Day 01) and Week 12
Secondary outcome [65] 0 0
Change From Baseline in Hemoglobin Level (Grams Per Liter) Week 24 for Treatment Arms That Started Study Intervention From Day 1
Timepoint [65] 0 0
Baseline (Day 01) and Week 24
Secondary outcome [66] 0 0
Change From Baseline in Hemoglobin Level (Grams Per Liter) Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12
Timepoint [66] 0 0
Baseline (Week 12) and Week 24
Secondary outcome [67] 0 0
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP) Gamma-glutamyl Transferase(GGT) Levels (International Units Per Liter) at Week 12
Timepoint [67] 0 0
Baseline (Day 01) and Week 12
Secondary outcome [68] 0 0
Change From Baseline in AST, ALT, AP, GGT Levels (International Units Per Liter) at Week 24 for Treatment Arms That Started Study Intervention From Day 1
Timepoint [68] 0 0
Baseline (Day 01) and Week 24
Secondary outcome [69] 0 0
Change From Baseline in AST, ALT, AP, GGT Levels (International Units Per Liter) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12
Timepoint [69] 0 0
Baseline (Week 12) and Week 24
Secondary outcome [70] 0 0
Change From Baseline in Albumin Level (Grams Per Liter) at Week 12
Timepoint [70] 0 0
Baseline (Day 01) and Week 12
Secondary outcome [71] 0 0
Change From Baseline in Albumin Level (Grams Per Liter) at Week 24 for Treatment Arms That Started Study Intervention From Day 1
Timepoint [71] 0 0
Baseline (Day 01) and Week 24
Secondary outcome [72] 0 0
Change From Baseline in Albumin Level (Grams Per Liter) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12
Timepoint [72] 0 0
Baseline (Week 12) and Week 24
Secondary outcome [73] 0 0
Change From Baseline in Total Bilirubin (Micromoles Per Liter) at Week 12
Timepoint [73] 0 0
Baseline (Day 01) and Week 12
Secondary outcome [74] 0 0
Change From Baseline in Total Bilirubin (Micromoles Per Liter) at Week 24 for Treatment Arms That Started Study Intervention From Day 1
Timepoint [74] 0 0
Baseline (Day 01) and Week 24
Secondary outcome [75] 0 0
Change From Baseline in Total Bilirubin (Micromoles Per Liter) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12
Timepoint [75] 0 0
Baseline (Week 12) and Week 24
Secondary outcome [76] 0 0
Change From Baseline in Total Cholesterol (Millimoles Per Liter) at Week 12
Timepoint [76] 0 0
Baseline (Day 01) and Week 12
Secondary outcome [77] 0 0
Change From Baseline in Total Cholesterol (Millimoles Per Liter) at Week 24 for Treatment Arms That Started Study Intervention From Day 1
Timepoint [77] 0 0
Baseline (Day 01) and Week 24
Secondary outcome [78] 0 0
Change From Baseline in Total Cholesterol (Millimoles Per Liter) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12
Timepoint [78] 0 0
Baseline (Week 12) and Week 24
Secondary outcome [79] 0 0
Change From Baseline in Fasting Lipid Profile: Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol (Millimoles Per Liter) at Week 12
Timepoint [79] 0 0
Baseline (Day 01) and Week 12
Secondary outcome [80] 0 0
Change From Baseline in Fasting Lipid Profile: LDL Cholesterol, HDL Cholesterol (Millimoles Per Liter) at Week 24 for Treatment Arms That Started Study Intervention From Day 1
Timepoint [80] 0 0
Baseline (Day 01) and Week 24
Secondary outcome [81] 0 0
Change From Baseline in Fasting Lipid Profile: LDL Cholesterol, HDL Cholesterol (Millimoles Per Liter) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12
Timepoint [81] 0 0
Baseline (Week 12) and Week 24
Secondary outcome [82] 0 0
Change From Baseline in Fasting Lipid Profile Triglycerides (Millimoles Per Liter) at Week 12
Timepoint [82] 0 0
Baseline (Day 01) and Week 12
Secondary outcome [83] 0 0
Change From Baseline in Fasting Lipid Profile Triglycerides (Millimoles Per Liter) at Week 24 for Treatment Arms That Started Study Intervention From Day 1
Timepoint [83] 0 0
Baseline (Day 01) and Week 24
Secondary outcome [84] 0 0
Change From Baseline in Fasting Lipid Profile Triglycerides (Millimoles Per Liter) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12
Timepoint [84] 0 0
Baseline (Week 12) and Week 24
Secondary outcome [85] 0 0
Number of Participants With National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) >=Grade 3 Hematological/Clinical Chemistry Abnormalities for Treatment Arms That Started Study Intervention From Day 1
Timepoint [85] 0 0
Up to Week 24
Secondary outcome [86] 0 0
Concentrations of Granulocyte-macrophage Colony Stimulating Factor (GM-CSF) Autoantibody
Timepoint [86] 0 0
At baseline
Secondary outcome [87] 0 0
Number of Participants With Anti-GSK3196165 Antibodies
Timepoint [87] 0 0
Up to Week 24

Eligibility
Key inclusion criteria
Key inclusion criteria:

- >=18 years of age

- Has had RA for >=6 months and was not diagnosed before 16 years of age

- Has active disease, as defined by having both:*

- >=6/68 tender/painful joints (tender joint count [TJC]), and

- >=6/66 swollen joints (swollen joint count [SJC])

- Has had an inadequate response despite currently taking at least one and at the most
two concomitant csDMARDs for at least 12 weeks, from the following:

- Methotrexate (MTX)

- Hydroxychloroquine or chloroquine

- Sulfasalazine

- Leflunomide

- Bucillamine

- Iguratimod

- Tacrolimus

- Has had inadequate response to at least one bDMARD at an approved dose and/or at least
one JAK inhibitors at an approved dose. In both cases this may be with or without
combination with a csDMARD.

- If surgical treatment of a joint has been performed, that joint cannot be counted
in the TJC or SJC.

Key exclusion criteria:

- Has had any active and/or recurrent infections (excluding recurrent fungal infections
of the nail bed) or has required management of acute or chronic infections.

- Has received prior treatment with an antagonist of GM-CSF or its receptor.

- Has known infection with human immunodeficiency virus (HIV) or current acute or
chronic hepatitis B and/or hepatitis C.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

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 assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/10/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2022
Sample size
Target
Accrual to date
Final
550
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
Nebraska
Country [8] 0 0
United States of America
State/province [8] 0 0
New Hampshire
Country [9] 0 0
United States of America
State/province [9] 0 0
North Dakota
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Oklahoma
Country [12] 0 0
United States of America
State/province [12] 0 0
South Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
Argentina
State/province [14] 0 0
Buenos Aires
Country [15] 0 0
Argentina
State/province [15] 0 0
Ciudad Autónoma de Buenos Aires
Country [16] 0 0
Argentina
State/province [16] 0 0
San Juan
Country [17] 0 0
Belgium
State/province [17] 0 0
Mons
Country [18] 0 0
Canada
State/province [18] 0 0
Ontario
Country [19] 0 0
Canada
State/province [19] 0 0
Quebec
Country [20] 0 0
Czechia
State/province [20] 0 0
Brno
Country [21] 0 0
Czechia
State/province [21] 0 0
Ostrava
Country [22] 0 0
Czechia
State/province [22] 0 0
Praha 11
Country [23] 0 0
Czechia
State/province [23] 0 0
Praha 2
Country [24] 0 0
Czechia
State/province [24] 0 0
Praha 5
Country [25] 0 0
Czechia
State/province [25] 0 0
Uherske Hradiste
Country [26] 0 0
Czechia
State/province [26] 0 0
Zlin
Country [27] 0 0
Germany
State/province [27] 0 0
Schleswig-Holstein
Country [28] 0 0
Germany
State/province [28] 0 0
Hamburg
Country [29] 0 0
Germany
State/province [29] 0 0
Magdeburg
Country [30] 0 0
Hungary
State/province [30] 0 0
Budapest
Country [31] 0 0
Hungary
State/province [31] 0 0
Szekesfehervar
Country [32] 0 0
Hungary
State/province [32] 0 0
Veszprem
Country [33] 0 0
Italy
State/province [33] 0 0
Veneto
Country [34] 0 0
Japan
State/province [34] 0 0
Aichi
Country [35] 0 0
Japan
State/province [35] 0 0
Chiba
Country [36] 0 0
Japan
State/province [36] 0 0
Fukuoka
Country [37] 0 0
Japan
State/province [37] 0 0
Hokkaido
Country [38] 0 0
Japan
State/province [38] 0 0
Hyogo
Country [39] 0 0
Japan
State/province [39] 0 0
Ibaraki
Country [40] 0 0
Japan
State/province [40] 0 0
Kagoshima
Country [41] 0 0
Japan
State/province [41] 0 0
Kanagawa
Country [42] 0 0
Japan
State/province [42] 0 0
Kochi
Country [43] 0 0
Japan
State/province [43] 0 0
Kumamoto
Country [44] 0 0
Japan
State/province [44] 0 0
Miyagi
Country [45] 0 0
Japan
State/province [45] 0 0
Nagasaki
Country [46] 0 0
Japan
State/province [46] 0 0
Saitama
Country [47] 0 0
Japan
State/province [47] 0 0
Tokyo
Country [48] 0 0
Korea, Republic of
State/province [48] 0 0
Incheon
Country [49] 0 0
Korea, Republic of
State/province [49] 0 0
Seoul
Country [50] 0 0
Lithuania
State/province [50] 0 0
Klaipeda
Country [51] 0 0
Lithuania
State/province [51] 0 0
Siauliai
Country [52] 0 0
Poland
State/province [52] 0 0
Bialystok
Country [53] 0 0
Poland
State/province [53] 0 0
Bydgoszcz
Country [54] 0 0
Poland
State/province [54] 0 0
Gdansk
Country [55] 0 0
Poland
State/province [55] 0 0
Gdynia
Country [56] 0 0
Poland
State/province [56] 0 0
Katowice
Country [57] 0 0
Poland
State/province [57] 0 0
Kraków
Country [58] 0 0
Poland
State/province [58] 0 0
Lodz
Country [59] 0 0
Poland
State/province [59] 0 0
Poznan
Country [60] 0 0
Poland
State/province [60] 0 0
Sochaczew
Country [61] 0 0
Poland
State/province [61] 0 0
Torun
Country [62] 0 0
Poland
State/province [62] 0 0
Warszawa
Country [63] 0 0
Poland
State/province [63] 0 0
Wroclaw
Country [64] 0 0
South Africa
State/province [64] 0 0
Gauteng
Country [65] 0 0
South Africa
State/province [65] 0 0
KwaZulu- Natal
Country [66] 0 0
South Africa
State/province [66] 0 0
Cape Town
Country [67] 0 0
South Africa
State/province [67] 0 0
Kempton Park
Country [68] 0 0
South Africa
State/province [68] 0 0
Pretoria
Country [69] 0 0
South Africa
State/province [69] 0 0
Stellenbosch
Country [70] 0 0
Spain
State/province [70] 0 0
A Coruña
Country [71] 0 0
Spain
State/province [71] 0 0
Elche
Country [72] 0 0
Spain
State/province [72] 0 0
Santander
Country [73] 0 0
Spain
State/province [73] 0 0
Santiago de Compostela
Country [74] 0 0
Spain
State/province [74] 0 0
Valencia
Country [75] 0 0
United Kingdom
State/province [75] 0 0
Essex
Country [76] 0 0
United Kingdom
State/province [76] 0 0
Middlesex

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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


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/ct2/show/NCT04134728