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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/NCT03733444
Registration number
NCT03733444
Ethics application status
Date submitted
5/11/2018
Date registered
7/11/2018
Date last updated
29/07/2022
Titles & IDs
Public title
A Clinical Study to Test How Effective and Safe GLPG1690 is for Participants With Idiopathic Pulmonary Fibrosis (IPF) When Used Together With Standard of Care
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Scientific title
A Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Two Doses of GLPG1690 in Addition to Local Standard of Care for Minimum 52 Weeks in Subjects With Idiopathic Pulmonary Fibrosis
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Secondary ID [1]
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2018-001406-29
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Secondary ID [2]
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GLPG1690-CL-304
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Universal Trial Number (UTN)
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Trial acronym
ISABELA2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Idiopathic Pulmonary Fibrosis
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Inflammatory and Immune System
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Connective tissue diseases
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - GLPG1690
Treatment: Drugs - Placebo
Experimental: GLPG1690, 600 milligrams (mg) - Participants received GLPG1690 (ziritaxestat) 600 mg as film-coated tablet orally, once daily (mean treatment duration was 332.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).
Experimental: GLPG1690, 200 mg - Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet orally, once daily (mean treatment duration was 336.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).
Experimental: Placebo - Participants received GLPG1690 (ziritaxestat) matching placebo tablets orally, once daily (mean treatment duration was 346.2 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).
Treatment: Drugs: GLPG1690
GLPG1690, film-coated tablets for oral use.
Treatment: Drugs: Placebo
Matching placebo, film-coated tablets for oral use.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Annual Rate of Decline in Forced Vital Capacity (FVC) up to Week 52
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Assessment method [1]
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FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.
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Timepoint [1]
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Baseline up to week 52
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Secondary outcome [1]
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Percentage of Participants With Disease Progression Up to 52 Weeks
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Assessment method [1]
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Disease progression was defined as the composite occurrence of more than or equal to (>=)10 percent (%) absolute decline in percent predicted forced vital capacity (%FVC) or all-cause mortality. FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.
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Timepoint [1]
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Up to week 52
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Secondary outcome [2]
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Percentage of Participants With Respiratory-Related Hospitalization Until End of Study (EoS)
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Assessment method [2]
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Percentage of participants with respiratory related to hospitalization were reported in this measure.
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Timepoint [2]
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Up to EoS (week 125)
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Secondary outcome [3]
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Change From Baseline in St.George's Respiratory Questionnaire (SGRQ) Total Score at Week 52
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Assessment method [3]
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SGRQ is a 50-item paper questionnaire designed to measure and quantify the impact of chronic respiratory disease on health-related quality of life (QOL) and well-being, split into 3 domains: symptoms score assessing the frequency and severity of respiratory symptoms (Items 1-8), activity score assessing the effects of breathlessness on mobility and physical activity (Items 11-17 and 36 to 44), and impacts score assessing the psychosocial impact of the disease (Items 9-10, 18-35 and 45-50). Each item has a specific weight.
Domain scores = 100 * summed weights from positive items in that component/sum of maximum weights for all non-missing items in that component
Total score = 100 * summed weights from positive items in the questionnaire/sum of maximum weights for all non-missing items in the questionnaire
Scores were weighted such that each domain score ranged from 0 to 100 and the total score ranged from 0 to 100, with higher scores indicating the poorer health-related QOL.
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Timepoint [3]
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Baseline, week 52
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Secondary outcome [4]
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Annual Rate of Decline of FVC Until EoS
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Assessment method [4]
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FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.
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Timepoint [4]
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Baseline up to EoS (week 125)
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Secondary outcome [5]
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Percentage of Participants With Disease Progression Until EoS
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Assessment method [5]
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Disease progression was defined as the composite occurrence of >=10% absolute decline in percent predicted %FVC or all-cause mortality. FVC (in mL]) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.
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Timepoint [5]
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Up to EoS (week 125)
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Secondary outcome [6]
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Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 100
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Assessment method [6]
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0
SGRQ is a 50-item paper questionnaire designed to measure and quantify the impact of chronic respiratory disease on health-related quality of life (QOL) and well-being, split into 3 domains: symptoms score assessing the frequency and severity of respiratory symptoms (Items 1-8), activity score assessing the effects of breathlessness on mobility and physical activity (Items 11-17 and 36 to 44), and impacts score assessing the psychosocial impact of the disease (Items 9-10, 18-35 and 45-50). Each item has a specific weight.
Domain scores = 100 * summed weights from positive items in that component/sum of maximum weights for all non-missing items in that component
Total score = 100 * summed weights from positive items in the questionnaire/sum of maximum weights for all non-missing items in the questionnaire
Scores were weighted such that each domain score ranged from 0 to 100 and the total score ranged from 0 to 100, with higher scores indicating the poorer health-related QOL.
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Timepoint [6]
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Baseline, week 100
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Secondary outcome [7]
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Percentage of Participants With All Cause Hospitalization Until EoS
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Assessment method [7]
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Percentage of participants with all cause hospitalization was reported for this measure.
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Timepoint [7]
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Up to EoS (week 125)
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Secondary outcome [8]
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Percentage of Participants With Respiratory Related Mortality Until EoS
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Assessment method [8]
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Percentage of participants with respiratory related mortality until end of study were reported for this study.
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Timepoint [8]
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Up to EoS (week 125)
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Secondary outcome [9]
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Percentage of Participants Hospitalized for Non-Elective Lung Transplant Until EoS
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Assessment method [9]
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Percentage of Participants who were hospitalized for lung transplant were reported for this measure.
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Timepoint [9]
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Up to EoS (week 125)
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Secondary outcome [10]
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Percentage of Participants With Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation Until EoS
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Assessment method [10]
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Percentage of participants with acute IPF exacerbation until end of study were reported for this measure.
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Timepoint [10]
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Up to EoS (week 125)
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Secondary outcome [11]
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Percentage of Participants With All Cause Mortality or Hospitalization for Non-elective Lung Transplant Until EoS
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Assessment method [11]
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Percentage of participants with all-cause mortality or hospitalization for non-elective lung transplant were reported for this measure.
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Timepoint [11]
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Up to EoS (week 125)
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Secondary outcome [12]
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Percentage of Participants With All Cause Mortality, Hospitalization for Non-elective Lung Transplant or Hospitalization for Qualifying for Lung Transplant Until EoS
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Assessment method [12]
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Percentage of participants with all-cause mortality or hospitalization for qualifying for lung transplant were reported for this measure.
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Timepoint [12]
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Up to EoS (week 125)
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Secondary outcome [13]
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Percentage of Participants With All-Cause Mortality or Hospitalization That Meets >=10% Absolute Decline in %FVC or Respiratory-Related Hospitalization Until EoS
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Assessment method [13]
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Percentage of participants with all-cause mortality or respiratory related hospitalization that meets >=10% absolute decline in %FVC or respiratory-related hospitalization were reported for this measure.
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Timepoint [13]
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Up to EoS (week 125)
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Secondary outcome [14]
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Percentage of Participants With All-Cause Mortality or Respiratory-Related Hospitalizations Until EoS
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Assessment method [14]
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Percentage of participants with all-cause mortality or respiratory related hospitalization were reported for this measure.
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Timepoint [14]
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Up to EoS (week 125)
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Secondary outcome [15]
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FVC at Week 52
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Assessment method [15]
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FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.
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Timepoint [15]
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Week 52
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Secondary outcome [16]
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Change From Baseline in FVC at Week 52
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Assessment method [16]
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FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.
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Timepoint [16]
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Baseline, week 52
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Secondary outcome [17]
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Percent Change From Baseline in FVC at Week 52
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Assessment method [17]
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FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.
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Timepoint [17]
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Baseline, week 52
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Secondary outcome [18]
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FVC at Week 100
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Assessment method [18]
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FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.
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Timepoint [18]
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Week 100
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Secondary outcome [19]
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Change From Baseline in FVC at Week 100
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Assessment method [19]
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FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.
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Timepoint [19]
0
0
Baseline, week 100
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Secondary outcome [20]
0
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Percent Change From Baseline in FVC at Week 100
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Assessment method [20]
0
0
FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.
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Timepoint [20]
0
0
Baseline, week 100
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Secondary outcome [21]
0
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Percentage of Participants With Absolute Categorical Change From Baseline in Percent FVC at Week 52: FVC Change Within =5
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Assessment method [21]
0
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FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.
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Timepoint [21]
0
0
Baseline, week 52
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Secondary outcome [22]
0
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Percentage of Participants With Absolute Categorical Change From Baseline in Percent FVC at Week 100: FVC Change Within =5
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Assessment method [22]
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FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.
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Timepoint [22]
0
0
Baseline, week 100
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Secondary outcome [23]
0
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Percentage of Participants With Absolute Categorical Change From Baseline in Percent FVC at Week 52: FVC Change Within =10
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Assessment method [23]
0
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FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.
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Timepoint [23]
0
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Baseline, week 52
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Secondary outcome [24]
0
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Percentage of Participants With Absolute Categorical Change From Baseline in Percent FVC at Week 100: FVC Change Within =10
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Assessment method [24]
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FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.
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Timepoint [24]
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Baseline, week 100
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Secondary outcome [25]
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Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
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Assessment method [25]
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Safety was assessed by adverse events (AEs), which included abnormalities identified during a medical test (e.g. laboratory tests, vital signs, electrocardiogram, etc.) if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study drug or was clinically significant. A Treatment emergent AE (TEAE) was defined as any AE that started or worsened after the first dose of study drug up to 30 days after the last dose of study drug. AEs were considered serious (SAEs) if the AE resulted in death, was life-threatening, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, resulted in congenital anomaly, or birth defect or required inpatient hospitalization or led to prolongation of hospitalization.
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Timepoint [25]
0
0
Baseline up to EoS (up to Week 125)
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Secondary outcome [26]
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Changes From Baseline in Leicester Cough Questionnaire (LCQ) Total Score and Individual Domain Score at Week 52 and Week 100
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Assessment method [26]
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Cough was evaluated using the LCQ. The LCQ is a 19-item questionnaire split into three domains: physical, psychological, and social. Scores were calculated by domain (range from 1 to 7) and then the total score was calculated by adding the individual domain score. Total score ranged from 3 to 21, with higher scores indicated a better health status.
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Timepoint [26]
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Baseline, week 52, week 100
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Secondary outcome [27]
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Changes From Baseline in Visual Analogue Score (VAS): Cough at Week 52 and Week 100
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Assessment method [27]
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Cough was assessed using VAS score, ranged from 0 (no cough) to 100 millimeter (mm) (worst possible cough).
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Timepoint [27]
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Baseline, week 52, week 100
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Secondary outcome [28]
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Change From Baseline in Visual Analogue Score (VAS): Urge to Cough at Week 52 and Week 100
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Assessment method [28]
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Urge to Cough was assessed using VAS score, ranged from 0 (no urge to cough) to 100 mm (highest urge to cough).
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Timepoint [28]
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Baseline, week 52, week 100
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Secondary outcome [29]
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Changes From Baseline in EuroQOL 5-Dimensions Questionnaire at Week 52 and Week 100
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Assessment method [29]
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EuroQol outcome measurements was a printed 20 centimeter (cm) EQ visual analogue scale (EQ VAS) that appears somewhat like a thermometer, on which a score from 0 (worst imaginable health state or death) to 100 (best imaginable health state) was marked by the participant (or, when necessary, their proxy) with the scale in view.
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Timepoint [29]
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Baseline, week 52, week 100
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Secondary outcome [30]
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Changes From Baseline in King's Brief Interstitial Lung Disease (K-BILD) at Week 52 and Week 100
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Assessment method [30]
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The King's Brief Interstitial Lung Disease questionnaire (K-BILD) was specifically developed to analyze the health status of participants with OLD, the questionnaire consists of of 15 items (assessed by participants on scale ranging from 1 to 7, where 1 and 7 represents worst and best health status). Items are compiled into 3 domains: breathlessness and activities (range: 0-21), psychological (range: 0-34), and chest symptoms (range: 0-8). To score the K-BILD, the Likert response scale weightings for individual items are combined and scores are transformed to a range of 0-100 by using logit values (higher scores indicate better health status).
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Timepoint [30]
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Baseline, week 52, week 100
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Secondary outcome [31]
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Area Under The Concentration Time Curve of Ziritaxtestat
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Assessment method [31]
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Area under the concentration time curve of ziritaxtestat was reported
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Timepoint [31]
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Sparse samples collected on day 1 pre-dose, day 85 post-dose, day 237 post-dose, day 183 pre-dose, day 365 pre-dose
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Secondary outcome [32]
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Maximum Observed Plasma Concentration (Cmax) of Ziritaxtestat
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Assessment method [32]
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Maximum Observed Plasma Concentration of Ziritaxtestat was reported.
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Timepoint [32]
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Sparse samples collected on day 1 pre-dose, day 85 post-dose, day 237 post-dose, day 183 pre-dose, day 365 pre-dose
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Secondary outcome [33]
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Change From Baseline in Functional Exercise Capacity, Assessed by The 6-Minute Walk Test (6MWT) Distance, at Week 52 and Week 100
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Assessment method [33]
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The 6MWT depicts the total distance covered by a participant during 6 minutes walking.
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Timepoint [33]
0
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Baseline, week 52, week 100
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Secondary outcome [34]
0
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Change From Baseline in Diffusing Capacity of Lung for Carbon Monoxide (DLCO) (Corrected for Hemoglobin [Hb]) at Week 52 and Week 100
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Assessment method [34]
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Change from baseline in diffusing capacity of the lung for carbon monoxide (percent predicted hemoglobin level corrected) was reported for this measure.
mmol/min/kPa: Millimole per minute per kilopascal
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Timepoint [34]
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Baseline, week 52 and week 100
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Eligibility
Key inclusion criteria
- Male or female subject aged =40 years on the day of signing the Informed Consent Form
(ICF).
- A diagnosis of IPF within 5 years prior to the screening visit, as per applicable
American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese
Respiratory Society (JRS)/Latin American Thoracic Association (ALAT) guidelines at the
time of diagnosis.
- Chest high-resolution computed tomography (HRCT) historically performed within 12
months prior to the screening visit and according to the minimum requirements for IPF
diagnosis by central review based on subject's HRCT only (if no lung biopsy (LB)
available), or based on both HRCT and LB (with application of the different criteria
in either situation). If an evaluable HRCT <12 months prior to screening is not
available, an HRCT can be performed at screening to determine eligibility, according
to the same requirements as the historical HRCT.
- Subjects receiving local standard of care for the treatment of IPF, defined as either
pirfenidone or nintedanib, at a stable dose for at least two months before screening,
and during screening; or neither pirfenidone or nintedanib (for any reason). A stable
dose is defined as the highest dose tolerated by the subject during those two months.
- The extent of fibrotic changes is greater than the extent of emphysema on the most
recent HRCT scan (investigator-determined).
- Meeting all of the following criteria during the screening period: FVC =45% predicted
of normal, Forced expiratory volume in 1 second (FEV1)/FVC =0.7, diffusing capacity of
the lung for carbon monoxide (DLCO) corrected for Hb =30% predicted of normal.
- Estimated minimum life expectancy of at least 30 months for non IPF related disease in
the opinion of the investigator.
- Male subjects and female subjects of childbearing potential agree to use highly
effective contraception/preventive exposure measures from the time of first dose of
investigational medicinal product (IMP) (for the male subject) or the signing of the
ICF (for the female subject), during the study, and until 90 days (male) or 30 days
(female) after the last dose of IMP.
- Able to walk at least 150 meters during the 6-Minute Walk Test (6MWT) at screening
Visit 1; without having a contraindication to perform the 6MWT or without a condition
putting the subject at risk of falling during the test (investigator's discretion).
The use of a cane is allowed, the use of a stroller is not allowed at all for any
condition. At Visit 2, for the oxygen titration test, resting oxygen saturation (SpO2)
should be =88% with maximum 6 L O2/minute; during the walk, SpO2 should be =83% with 6
L O2/minute or =88% with 0, 2 or 4 L O2/minute.
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Minimum age
40
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- History of malignancy within the past 5 years (except for carcinoma in situ of the
uterine cervix, basal cell carcinoma of the skin that has been treated with no
evidence of recurrence, prostate cancer that has been medically managed through active
surveillance or watchful waiting, squamous cell carcinoma of the skin if fully
resected, and Ductal Carcinoma In Situ).
- Clinically significant abnormalities detected on ECG of either rhythm or conduction, a
QT interval corrected for heart rate using Fridericia's formula (QTcF) >450 ms, or a
known long QT syndrome. Patients with implantable cardiovascular devices (e.g.
pacemaker) affecting the QT interval time may be enrolled in the study based upon
investigator judgment following cardiologist consultation if deemed necessary, and
only after discussion with the medical monitor.
- Acute IPF exacerbation within 6 months prior to screening and/or during the screening
period. The definition of an acute IPF exacerbation is as follows: Previous or
concurrent diagnosis of IPF; Acute worsening or development of dyspnea typically < 1
month duration; Computed tomography with new bilateral ground-glass opacity and/or
consolidation superimposed on a background pattern consistent with usual interstitial
pneumonia pattern and deterioration not fully explained by cardiac failure or fluid
overload.
- Lower respiratory tract infection requiring treatment within 4 weeks prior to
screening and/or during the screening period.
- Interstitial lung disease associated with known primary diseases (e.g. sarcoidosis and
amyloidosis), exposures (e.g. radiation, silica, asbestos, and coal dust), or drugs
(e.g. amiodarone).
- Diagnosis of severe pulmonary hypertension (investigator determined).
- Unstable cardiovascular, pulmonary (other than IPF), or other disease within 6 months
prior to screening or during the screening period (e.g. acute coronary disease, heart
failure, and stroke).
- Had gastric perforation within 3 months prior to screening or during screening, and/or
underwent major surgery within 3 months prior to screening, during screening or have
major surgery planned during the study period.
- History of nintedanib-related increase in ALT and/or AST of >5 x upper limit of the
normal range (ULN) and increased susceptibility to elevated LFT; moderate to severe
hepatic impairment (Child-Pugh B or C) and/or abnormal liver function test (LFT) at
screening, defined as aspartate aminotransferase (AST), and/or alanine
aminotransferase (ALT), and/or total bilirubin =1.5 x upper limit of the normal range
(ULN), and/or gamma glutamyl transferase (GGT) =3 x ULN. Retesting is allowed once for
abnormal LFT.
- Abnormal renal function defined as estimated creatinine clearance, calculated
according to Cockcroft-Gault calculation (CCr) <30 mL/min. Retesting is allowed once.
- Use of any of the following therapies within 4 weeks prior to screening and during the
screening period, or planned during the study: warfarin, imatinib, ambrisentan,
azathioprine, cyclophosphamide, cyclosporine A, bosentan, methotrexate, sildenafil
(except for occasional use), prednisone at steady dose >10 mg/day or equivalent.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
5/11/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/03/2021
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Sample size
Target
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Accrual to date
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Final
781
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Alabama
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Arizona
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Country [3]
0
0
United States of America
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State/province [3]
0
0
California
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Florida
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Georgia
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Illinois
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Kansas
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Massachusetts
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Michigan
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Minnesota
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Country [11]
0
0
United States of America
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State/province [11]
0
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Missouri
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France
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Germany
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Germany
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Germany
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Israel
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Forlì
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Italy
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Milano
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Italy
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Italy
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Shizuoka
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Japan
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Bunkyo
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Japan
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Japan
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Japan
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Hamamatsu
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Japan
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Japan
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Japan
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Hyogo
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Japan
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Kumamoto
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Japan
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Japan
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Japan
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Okayama
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Japan
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Sakai
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Japan
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Sendai
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Japan
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Seto
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Japan
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Tokushima
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Japan
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Tokyo
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Yokohama
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Korea, Republic of
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Gyeonggi-do
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Seoul
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Mexico
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Heerlen
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Auckland
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Christchurch
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Hamilton
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Poland
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Bialystok
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Gdansk
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Katowice
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Kraków
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Lublin
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Warszawa
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Lódz
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Cape Town
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South Africa
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Durban
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South Africa
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Johannesburg
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Galapagos NV
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Address
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Ethics approval
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Summary
Brief summary
The main purpose of this study was to see how GLPG1690 works together with the current
standard treatment on your lung function and IPF disease in general. The study also
investigated how well GLPG1690 is tolerated (for example if you get any side effects while on
study drug).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03733444
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Public notes
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Contacts
Principal investigator
Name
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Galapagos Study Director
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Address
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Galapagos NV
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03733444
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