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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/NCT02134028
Registration number
NCT02134028
Ethics application status
Date submitted
30/04/2014
Date registered
8/05/2014
Date last updated
28/03/2022
Titles & IDs
Public title
Long-Term Safety Evaluation of Dupilumab in Patients With Asthma (LIBERTY ASTHMA TRAVERSE)
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Scientific title
Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Dupilumab in Patients With Asthma Who Participated in a Previous Dupilumab Asthma Clinical Study
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Secondary ID [1]
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2013-003856-19
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Secondary ID [2]
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LTS12551
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Asthma
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Condition category
Condition code
Respiratory
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Asthma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Dupilumab
Experimental: dupilumab treatment - For participants coming from the DRI12544 study: dupilumab loading dose subcutaneous (SC) on Day 1, followed by 1* Dose every 2 weeks added to current controller medications.
For participants coming from other studies: dupilumab 1 * Dose SC every 2 weeks added to current controller medications.
Treatment: Drugs: Dupilumab
Pharmaceutical form: Solution for injection Routes of administration: Subcutaneous
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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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Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
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Assessment method [1]
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An Adverse Event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which did not necessarily had to have causal relationship with treatment. TEAEs were defined as AEs that developed, worsened, or became serious during the treatment emergent AE period (time from first dose of investigational medicinal product [IMP] in LTS12551 up to the last dose of dupilumab plus 14 weeks). A Serious AE (SAE) was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event.
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Timepoint [1]
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From the first IMP injection in LTS12551 to the last IMP injection plus 14 weeks (up to 108 weeks)
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Secondary outcome [1]
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Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period
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Assessment method [1]
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Criteria for potentially clinically significant vital sign abnormalities:
Systolic blood pressure (SBP): Less than or equal to (=) 95 Adults (=90 Adolescents) millimeters of mercury (mmHg) and decrease from baseline (DFB) greater than or equal to (=) 20 mmHg; = 160 Adults (= 119 Adolescents) mmHg and increase from baseline (IFB) = 20 mmHg.
Diastolic blood pressure (DBP): = 45 Adults (=54 Adolescents) mmHg and DFB = 10 mmHg; = 110 Adults (=78 Adolescents) mmHg and IFB = 10 mmHg.
Heart rate (HR): = 50 beats per minute (bpm) and DFB = 20 bpm; = 120 bpm and IFB = 20 bpm.
Respiratory rate: less than (<) 12 breaths/min(b/m); greater than (>) 20 b/m.
Weight (kg): = 5 percent (%) DFB; = 5% IFB.
Temperature: = 38.0 degree Celsius (°C) rectal/ear/temporal; = 37.5°C oral; = 37.2°C axillary.
TEAE period was defined as the time from first dose of IMP in LTS12551 up to the last dose of dupilumab plus 14 weeks.
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Timepoint [1]
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From the first IMP injection in LTS12551 to the last IMP injection plus 14 weeks (up to 108 weeks)
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Secondary outcome [2]
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Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period
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Assessment method [2]
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Criteria for potentially clinically significant abnormalities:
Hemoglobin (Hb): = 115 grams per liter (g/L)(Male [M]), = 95 g/L (Female[ F]) (< 100 g/L Adolescents); = 185 g/L (M), = 165 g/L (F) (= 200 g/L Adolescents); DFB = 20 g/L.
Hematocrit: = 0.37 volume/volume (v/v) (M); = 0.32 v/v (F) (<0.32 v/v Adolescents); = 0.55 v/v (M); 0.5 v/v (F) (>0.47 v/v Adolescents).
RBCs: = 6 Tera/L.
Platelets: < 100 Giga(G)/L; = 700 G/L.
TEAE period was defined as the time from first dose of IMP in LTS12551 up to the last dose of dupilumab plus 14 weeks.
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Timepoint [2]
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From the first IMP injection in LTS12551 to the last IMP injection plus 14 weeks (up to 108 weeks)
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Secondary outcome [3]
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Number of Severe Exacerbation Events
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Assessment method [3]
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Severe asthma exacerbation events were defined as a deterioration of asthma which required: use of systemic corticosteroids for = 3 days, (participants from study EFC13691 (NCT02528214), and who were taking systemic corticosteroids: the use of systemic corticosteroids at least double the current dose and for =3 days.) or, hospitalization or emergency room visit because of asthma, required systemic corticosteroids.
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Timepoint [3]
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From the first IMP injection in LTS12551 to the last IMP injection plus 2 weeks (up to 96 weeks)
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Secondary outcome [4]
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Annualized Event Rate Per Participant-Years for Severe Exacerbation
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Assessment method [4]
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The annualized event rate per participant-years was defined as the total number of events that occurred during the treatment period divided by the total number of participant-years during the treatment period.
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Timepoint [4]
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From the first IMP injection in LTS12551 to the last IMP injection plus 2 weeks (up to 96 weeks)
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Secondary outcome [5]
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Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Weeks 48 and 96
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Assessment method [5]
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FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. For this analysis, baseline was defined as respective parent study baseline.
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Timepoint [5]
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Baseline of parent study, Week 48 and Week 96 of this extension study
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Secondary outcome [6]
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Change From Baseline in Percent Predicted FEV1 at Weeks 48 and 96
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Assessment method [6]
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FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. For this analysis, baseline was defined as respective parent study baseline.
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Timepoint [6]
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Baseline of parent study, Week 48 and Week 96 of this extension study
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Secondary outcome [7]
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Change From Baseline in Forced Vital Capacity (FVC) at Weeks 48 and 96
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Assessment method [7]
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FVC was a standard pulmonary function test used to quantify respiratory muscle weakness. FVC was the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. For this analysis, baseline was defined as respective parent study baseline.
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Timepoint [7]
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Baseline of parent study, Week 48, and Week 96 of this extension study
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Secondary outcome [8]
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Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 48 and 96
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Assessment method [8]
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FEF was the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEF 25-75% was defined as the mean FEF between 25% and 75% of the FVC, where FVC was defined as the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. For this analysis, baseline was defined as respective parent study baseline.
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Timepoint [8]
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Baseline of parent study, Week 48, and Week 96 of this extension study
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Secondary outcome [9]
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Change From Baseline in Asthma Control Questionnaire 5-Question Version (ACQ-5) Mean Scores at Weeks 24 and 48
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Assessment method [9]
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The ACQ-5 had 5 questions, reflecting the top-scoring five asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath and wheeze. Participants were asked to recall how their asthma had been during the previous week and to respond to each of the five symptom questions on a 7-point scale ranged from 0 (no impairment) to 6 (maximum impairment). ACQ-5 total mean score was mean of the scores of all 5 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled), higher scores indicated lower asthma control. For this analysis, baseline was defined as respective parent study baseline.
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Timepoint [9]
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Baseline of parent study, Weeks 24, and 48 of this extension study
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Secondary outcome [10]
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Percentage of Participants Achieving ACQ-5 Score Response (ACQ-5 Responders) at Weeks 24 and 48
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Assessment method [10]
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ACQ-5 response was defined as change from baseline in ACQ-5 scores = 0.5. The ACQ-5 had 5 questions, reflecting the top-scoring five asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath and wheeze. Participants were asked to recall how their asthma had been during the previous week and to respond to each of the five symptom questions on a 7-point scale ranged from 0 (no impairment) to 6 (maximum impairment). ACQ-5 mean total score was mean of the scores of all 5 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicated lower asthma control.
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Timepoint [10]
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At Weeks 24, and 48 of this extension study
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Secondary outcome [11]
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Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Global Scores at Weeks 24 and 48
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Assessment method [11]
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The AQLQ was designed to measure the functional impairments that are most troublesome to adults as a result of their asthma. The AQLQ comprised of 32 items in 4 domains: symptoms (12 items), activity limitation (11 items), emotional function (5 items), and environmental stimuli (4 items). Each item was scored on a 7-point likert scale ranged from 1=severely impaired to 7=not impaired. The 32 items of the questionnaire were averaged to produce one overall quality of life score ranging from 1 (severely impaired) to 7 (not impaired); higher scores indicated better quality of life. For this analysis, baseline was defined as respective parent study baseline.
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Timepoint [11]
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Baseline of parent study, Weeks 24, and 48 of this extension study
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Secondary outcome [12]
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Percentage of Participants Achieving AQLQ Global Score Response (AQLQ Responders) at Weeks 24 and 48
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Assessment method [12]
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AQLQ global response was defined as participants with change from baseline in AQLQ global score = 0.5. The AQLQ was designed to measure the functional impairments that are most troublesome to adults as a result of their asthma. The AQLQ comprised of 32 items in 4 domains: symptoms (12 items), activity limitation (11 items), emotional function (5 items), environmental stimuli (4 items). Each item was scored on a 7-point likert scale (1=severely impaired, 7=not impaired). The 32 items of the questionnaire are averaged to produce one overall quality of life score ranging from 1 (severely impaired) to 7 (not impaired). Higher scores indicated better quality of life.
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Timepoint [12]
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At Weeks 24, and 48 of this extension study
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Secondary outcome [13]
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Serum Concentrations of Dupilumab Over Time Till Week 96
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Assessment method [13]
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For this analysis, baseline was defined as respective parent study baseline. Here, 'number analyzed'=number of participants with available data for each specified category.
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Timepoint [13]
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Baseline of parent study, Weeks 0, 4, 12, 24, 48, 72, and 96 of this extension study
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Secondary outcome [14]
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Percentage of Participants With Antidrug Antibodies (ADA) Response
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Assessment method [14]
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ADA response were categorized as: treatment emergent and treatment boosted response. 1) Treatment emergent was defined as an ADA positive response in the assay post first dose in LTS12551, when baseline results were negative or missing. 2) Treatment boosted was defined as: an ADA positive response in the assay post first dose that was greater-than or equal to 4-fold over baseline titer levels, when baseline results were positive. The criteria for positive was defined as "30 to > 10,000", where low titer (< 1,000); moderate (1,000 = titer = 10,000) and high titer (> 10,000).
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Timepoint [14]
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From the first IMP injection in LTS12551 to the last IMP injection plus 2 weeks (up to 96 weeks)
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Secondary outcome [15]
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Change From Baseline in Blood Eosinophils Cells Count at Weeks 48 and 96
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Assessment method [15]
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For this analysis, baseline was defined as respective parent study baseline.
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Timepoint [15]
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Baseline of parent study, Week 48 and Week 96 of this extension study
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Secondary outcome [16]
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Change From Baseline in Morning Peak Expiratory Flow (PEF) at Weeks 48 and 96: Participants From Study DRI12544
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Assessment method [16]
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The PEF was a participant's maximum speed of expiration, as measured with a peak flow meter. Peak flow testing for PEF was performed at morning and evening. Morning PEF was performed within 15 minutes after arising (between 5:30 AM and 10 AM) prior to taking any salbutamol/albuterol or levosalbutamol/levalbuterol. For this analysis, baseline was defined as parent study DRI12544 baseline.
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Timepoint [16]
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Baseline of parent study, Week 48 and Week 96 of this extension study
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Secondary outcome [17]
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Change From Baseline in Evening Peak Expiratory Flow (PEF) at Weeks 48 and 96: Participants From Study DRI12544
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Assessment method [17]
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The PEF was a participant's maximum speed of expiration, as measured with a peak flow meter. Peak flow testing for PEF was performed at morning and evening. Evening PEF was performed in the evening (between 5:30 PM and 10 PM) prior to taking any salbutamol/albuterol or levosalbutamol/levalbuterol. For this analysis, baseline was defined as parent DRI12544 study baseline.
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Timepoint [17]
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Baseline of parent study, Week 48 and Week 96 of this extension study
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Secondary outcome [18]
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Change From Baseline in Morning Asthma Symptom Scores at Weeks 48 and 96: Participants From Study DRI12544
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Assessment method [18]
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Morning asthma symptom score was determined using AM (ante meridiem) symptom scoring system which evaluated participant's overall asthma symptoms experienced during the night. It ranges from 0 to 4 as: 0=no asthma symptoms, slept through the night, 1=slept well, but some complaints in the morning. No nighttime awakenings, 2=woke up once because of asthma (including early awakening), 3=woke up several times because of asthma (including early awakening), 4=bad night, awake most of the night because of asthma; higher scores indicated more severe symptoms. For this analysis, baseline was defined as parent DRI12544 study baseline.
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Timepoint [18]
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Baseline of parent study, Week 48 and Week 96 of this extension study
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Secondary outcome [19]
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Change From Baseline in Evening Asthma Symptom Scores at Weeks 48 and 96: Participants From Study DRI12544
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Assessment method [19]
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Evening asthma symptom score was determined using PM (post meridiem) symptom scoring system which evaluated participant's overall asthma symptoms experienced during the day. It ranged from 0 to 4 as: 0=very well, no asthma symptoms, 1=one episode of wheezing, cough, or breathlessness, 2=more than one episode of wheezing, cough, or breathlessness without interference of normal activities, 3=wheezing, cough, or breathlessness most of the day, which interfered to some extent with normal activities, 4=asthma very bad, unable to carry out daily activities as usual; higher scores indicated more severe symptoms. For this analysis, baseline was defined as parent DRI12544 study baseline.
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Timepoint [19]
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Baseline of parent study, Week 48, and Week 96 of this extension study
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Secondary outcome [20]
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Change From Baseline in Number of Inhalations Per Day of Salbutamol/Albuterol or Levosalbutamol/Levalbuterol for Symptom Relief at Weeks 48 and 96: Participants From Study DRI12544
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Assessment method [20]
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The number of salbutamol/albuterol or levosalbutamol/levalbuterol inhalations was recorded daily by the participants in an electronic diary/PEF meter. Mean number of inhalations in last 7 days prior to each visit was calculated and was used in computation of data reported. For this analysis, baseline was defined as parent DRI12544 study baseline.
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Timepoint [20]
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Baseline of parent study, Week 48, and Week 96 of this extension study
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Secondary outcome [21]
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Change From Baseline in Number of Nocturnal Awakenings at Weeks 48 and 96: Participants From Study DRI12544
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Assessment method [21]
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The number of nocturnal awakening because of asthma symptoms were recorded every morning by the participants in an electronic diary. Mean number of awakenings in last 7 days prior to each visit was calculated and was used in computation of data reported. For this analysis, baseline was defined as parent DRI12544 study baseline.
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Timepoint [21]
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Baseline of parent study, Week 48 and Week 96 of this extension study
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Secondary outcome [22]
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Percent Change From Baseline in Oral Corticosteroid (OCS) Dose at Weeks 48, and 96: Participants From Study EFC13691
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Assessment method [22]
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OCS was allowed as background controller medication for the participants from study EFC13691 only. For this analysis, baseline was defined as parent study EFC13691 baseline.
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Timepoint [22]
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Baseline of parent study, Weeks 48 and 96 of this extension study
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Secondary outcome [23]
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Percentage of Participants Achieving a Reduction of 50% or Greater (= 50% ) in OCS Dose Over Time at Weeks 48 and 96: Participants From Study EFC13691
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Assessment method [23]
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OCS was allowed as background controller medication for the participants from study EFC13691 only. Percentage of participants who achieved a reduction of = 50% in OCS dose were reported.
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Timepoint [23]
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Weeks 48 and 96 of this extension study
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Secondary outcome [24]
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Percentage of Participants With Background OCS Completely Tapered Off Over Time at Weeks 48 and 96: Participants From Study EFC13691
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Assessment method [24]
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OCS was allowed as background controller medication for the participants from study EFC13691 only. Number of participants who gradually discontinued or reduced therapeutic dose were reported in this outcome measure.
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Timepoint [24]
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Weeks 48, and 96 of this extension study
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Secondary outcome [25]
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Change From Baseline in European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L) Index Scores at Weeks 48 and 96: Participants From Study DRI12544
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Assessment method [25]
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EQ-5D-3L: validated and reliable self-report health status questionnaire consisted of EQ-5D descriptive system and visual analogue scale (VAS). EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension measured on 3 levels: no problem, some problems, and severe problems. The 5 dimensional 3-level systems was converted into single index utility score, and the score was 0 - 100, where 100=best health state; and 0=worst health state; where higher scores indicated better outcome. For this analysis, baseline was defined as parent DRI12544 study baseline.
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Timepoint [25]
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Baseline of parent study, Week 48 and Week 96 of this extension study
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Secondary outcome [26]
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Change From Baseline in EQ-5D-3L VAS Scores at Weeks 48 and 96: Participants From Study DRI12544
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Assessment method [26]
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EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0=worst imaginable health state and 100=best imaginable health state, where higher states indicated better outcomes. For this analysis, baseline was defined as parent DRI12544 study baseline.
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Timepoint [26]
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Baseline of parent study, Week 48 and Week 96 of this extension study
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Eligibility
Key inclusion criteria
Inclusion criteria:
- Participants with asthma who completed the treatment period in a previous dupilumab
asthma clinical study (i.e., PDY14192, EFC13579 or EFC13691) or participants with asthma
who completed the treatment and follow-up periods in previous dupilumab asthma Study
DRI12544.
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Minimum age
12
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
Exclusion criteria:
- Participants who experienced any hypersensitivity reactions to Investigational Medicinal
Product (IMP) in the previous dupilumab asthma study, which, in the opinion of the
Investigator, could indicate that continued treatment with dupilumab, may present an
unreasonable risk for the participant.
The above information was not intended to contain all considerations relevant to a
Participant's potential participation in a clinical trial.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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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
Completed
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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
5/08/2014
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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
11/10/2019
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Sample size
Target
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Accrual to date
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Final
2282
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Investigational Site Number 036004 - Adelaide
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Recruitment hospital [2]
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Investigational Site Number 036005 - Campbelltown
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Recruitment hospital [3]
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Investigational Site Number 036001 - Clayton
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Recruitment hospital [4]
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Investigational Site Number 036008 - Frankston
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Recruitment hospital [5]
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Investigational Site Number 036093 - Murdoch
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Recruitment hospital [6]
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Investigational Site Number 036003 - Nedlands
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Recruitment hospital [7]
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Investigational Site Number 036094 - Parkville
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Recruitment hospital [8]
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Investigational Site Number 036009 - Prahran
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Recruitment hospital [9]
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Investigational Site Number 036006 - Woolloongabba
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment postcode(s) [2]
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2560 - Campbelltown
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Recruitment postcode(s) [3]
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3168 - Clayton
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Recruitment postcode(s) [4]
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3199 - Frankston
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Recruitment postcode(s) [5]
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0
6150 - Murdoch
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Recruitment postcode(s) [6]
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0
6009 - Nedlands
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Recruitment postcode(s) [7]
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0
3050 - Parkville
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Recruitment postcode(s) [8]
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0
3004 - Prahran
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Recruitment postcode(s) [9]
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0
4102 - Woolloongabba
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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
Arkansas
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Country [4]
0
0
United States of America
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State/province [4]
0
0
California
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Colorado
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Connecticut
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Florida
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Idaho
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Illinois
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Kentucky
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Maine
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Country [12]
0
0
United States of America
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State/province [12]
0
0
Maryland
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Country [13]
0
0
United States of America
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State/province [13]
0
0
Massachusetts
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Country [14]
0
0
United States of America
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State/province [14]
0
0
Minnesota
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Country [15]
0
0
United States of America
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State/province [15]
0
0
Missouri
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Country [16]
0
0
United States of America
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State/province [16]
0
0
Montana
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Country [17]
0
0
United States of America
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State/province [17]
0
0
Nebraska
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Country [18]
0
0
United States of America
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State/province [18]
0
0
New Jersey
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Country [19]
0
0
United States of America
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State/province [19]
0
0
New York
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Country [20]
0
0
United States of America
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State/province [20]
0
0
North Carolina
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Country [21]
0
0
United States of America
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State/province [21]
0
0
Ohio
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Oklahoma
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Oregon
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Pennsylvania
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
South Carolina
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Texas
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
Utah
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
Vermont
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
Virginia
Query!
Country [30]
0
0
United States of America
Query!
State/province [30]
0
0
Washington
Query!
Country [31]
0
0
Argentina
Query!
State/province [31]
0
0
Bahia Blanca
Query!
Country [32]
0
0
Argentina
Query!
State/province [32]
0
0
Buenos Aires
Query!
Country [33]
0
0
Argentina
Query!
State/province [33]
0
0
Caba
Query!
Country [34]
0
0
Argentina
Query!
State/province [34]
0
0
Capital Federal
Query!
Country [35]
0
0
Argentina
Query!
State/province [35]
0
0
La Plata
Query!
Country [36]
0
0
Argentina
Query!
State/province [36]
0
0
Rosario
Query!
Country [37]
0
0
Argentina
Query!
State/province [37]
0
0
San Miguel De Tucuman
Query!
Country [38]
0
0
Argentina
Query!
State/province [38]
0
0
San Miguel De Tucumán
Query!
Country [39]
0
0
Belgium
Query!
State/province [39]
0
0
Brussels
Query!
Country [40]
0
0
Belgium
Query!
State/province [40]
0
0
Gent
Query!
Country [41]
0
0
Belgium
Query!
State/province [41]
0
0
Leuven
Query!
Country [42]
0
0
Brazil
Query!
State/province [42]
0
0
Florianópolis
Query!
Country [43]
0
0
Brazil
Query!
State/province [43]
0
0
Porto Alegre
Query!
Country [44]
0
0
Brazil
Query!
State/province [44]
0
0
Salvador
Query!
Country [45]
0
0
Brazil
Query!
State/province [45]
0
0
Sao Paulo
Query!
Country [46]
0
0
Brazil
Query!
State/province [46]
0
0
Sorocaba
Query!
Country [47]
0
0
Brazil
Query!
State/province [47]
0
0
São Bernardo Do Campo
Query!
Country [48]
0
0
Brazil
Query!
State/province [48]
0
0
São Paulo
Query!
Country [49]
0
0
Canada
Query!
State/province [49]
0
0
Burlington
Query!
Country [50]
0
0
Canada
Query!
State/province [50]
0
0
Calgary
Query!
Country [51]
0
0
Canada
Query!
State/province [51]
0
0
Hamilton
Query!
Country [52]
0
0
Canada
Query!
State/province [52]
0
0
Mississauga
Query!
Country [53]
0
0
Canada
Query!
State/province [53]
0
0
Montreal
Query!
Country [54]
0
0
Canada
Query!
State/province [54]
0
0
Ottawa
Query!
Country [55]
0
0
Canada
Query!
State/province [55]
0
0
Quebec
Query!
Country [56]
0
0
Canada
Query!
State/province [56]
0
0
Sherbrooke
Query!
Country [57]
0
0
Canada
Query!
State/province [57]
0
0
Toronto
Query!
Country [58]
0
0
Canada
Query!
State/province [58]
0
0
Trois-Rivieres
Query!
Country [59]
0
0
Canada
Query!
State/province [59]
0
0
Vancouver
Query!
Country [60]
0
0
Chile
Query!
State/province [60]
0
0
Quillota
Query!
Country [61]
0
0
Chile
Query!
State/province [61]
0
0
Santiago
Query!
Country [62]
0
0
Chile
Query!
State/province [62]
0
0
Talcahuano
Query!
Country [63]
0
0
Chile
Query!
State/province [63]
0
0
Talca
Query!
Country [64]
0
0
Chile
Query!
State/province [64]
0
0
Valdivia
Query!
Country [65]
0
0
Chile
Query!
State/province [65]
0
0
Viña Del Mar
Query!
Country [66]
0
0
Colombia
Query!
State/province [66]
0
0
Bogota
Query!
Country [67]
0
0
Colombia
Query!
State/province [67]
0
0
Bogotá
Query!
Country [68]
0
0
Denmark
Query!
State/province [68]
0
0
Hvidovre
Query!
Country [69]
0
0
Denmark
Query!
State/province [69]
0
0
København Nv
Query!
Country [70]
0
0
France
Query!
State/province [70]
0
0
Brest
Query!
Country [71]
0
0
France
Query!
State/province [71]
0
0
La Tronche
Query!
Country [72]
0
0
France
Query!
State/province [72]
0
0
Lille Cedex
Query!
Country [73]
0
0
France
Query!
State/province [73]
0
0
Lyon
Query!
Country [74]
0
0
France
Query!
State/province [74]
0
0
Marseille
Query!
Country [75]
0
0
France
Query!
State/province [75]
0
0
Montpellier
Query!
Country [76]
0
0
France
Query!
State/province [76]
0
0
Nantes
Query!
Country [77]
0
0
France
Query!
State/province [77]
0
0
Nimes Cedex 9
Query!
Country [78]
0
0
France
Query!
State/province [78]
0
0
Strasbourg
Query!
Country [79]
0
0
France
Query!
State/province [79]
0
0
Vandoeuvre-Les-Nancy Cedex
Query!
Country [80]
0
0
Germany
Query!
State/province [80]
0
0
Berlin
Query!
Country [81]
0
0
Germany
Query!
State/province [81]
0
0
Bochum
Query!
Country [82]
0
0
Germany
Query!
State/province [82]
0
0
Frankfurt Am Main
Query!
Country [83]
0
0
Germany
Query!
State/province [83]
0
0
Großhansdorf
Query!
Country [84]
0
0
Germany
Query!
State/province [84]
0
0
Koblenz
Query!
Country [85]
0
0
Germany
Query!
State/province [85]
0
0
Rüdersdorf Bei Berlin
Query!
Country [86]
0
0
Hungary
Query!
State/province [86]
0
0
Balassagyarmat
Query!
Country [87]
0
0
Hungary
Query!
State/province [87]
0
0
Edelény
Query!
Country [88]
0
0
Hungary
Query!
State/province [88]
0
0
Gödöllö
Query!
Country [89]
0
0
Israel
Query!
State/province [89]
0
0
Haifa
Query!
Country [90]
0
0
Israel
Query!
State/province [90]
0
0
Kfar Saba
Query!
Country [91]
0
0
Israel
Query!
State/province [91]
0
0
Petah-Tikva
Query!
Country [92]
0
0
Israel
Query!
State/province [92]
0
0
Rehovot
Query!
Country [93]
0
0
Italy
Query!
State/province [93]
0
0
Ancona
Query!
Country [94]
0
0
Italy
Query!
State/province [94]
0
0
Catania
Query!
Country [95]
0
0
Italy
Query!
State/province [95]
0
0
Ferrara
Query!
Country [96]
0
0
Italy
Query!
State/province [96]
0
0
Foggia
Query!
Country [97]
0
0
Italy
Query!
State/province [97]
0
0
Genova
Query!
Country [98]
0
0
Italy
Query!
State/province [98]
0
0
Modena
Query!
Country [99]
0
0
Italy
Query!
State/province [99]
0
0
Padova
Query!
Country [100]
0
0
Italy
Query!
State/province [100]
0
0
Palermo
Query!
Country [101]
0
0
Italy
Query!
State/province [101]
0
0
Pisa
Query!
Country [102]
0
0
Japan
Query!
State/province [102]
0
0
Akashi-Shi
Query!
Country [103]
0
0
Japan
Query!
State/province [103]
0
0
Asahi-Shi
Query!
Country [104]
0
0
Japan
Query!
State/province [104]
0
0
Chiyoda-Ku
Query!
Country [105]
0
0
Japan
Query!
State/province [105]
0
0
Chuo-Ku
Query!
Country [106]
0
0
Japan
Query!
State/province [106]
0
0
Edogawa-Ku
Query!
Country [107]
0
0
Japan
Query!
State/province [107]
0
0
Fukuoka-Shi
Query!
Country [108]
0
0
Japan
Query!
State/province [108]
0
0
Fukuyama-Shi
Query!
Country [109]
0
0
Japan
Query!
State/province [109]
0
0
Habikino-Shi
Query!
Country [110]
0
0
Japan
Query!
State/province [110]
0
0
Himeji-Shi
Query!
Country [111]
0
0
Japan
Query!
State/province [111]
0
0
Hirakata-Shi
Query!
Country [112]
0
0
Japan
Query!
State/province [112]
0
0
Hiroshima-Shi
Query!
Country [113]
0
0
Japan
Query!
State/province [113]
0
0
Iizuka-Shi
Query!
Country [114]
0
0
Japan
Query!
State/province [114]
0
0
Isesaki-Shi
Query!
Country [115]
0
0
Japan
Query!
State/province [115]
0
0
Kanazawa-Shi
Query!
Country [116]
0
0
Japan
Query!
State/province [116]
0
0
Kasuga-Shi
Query!
Country [117]
0
0
Japan
Query!
State/province [117]
0
0
Kishiwada-Shi
Query!
Country [118]
0
0
Japan
Query!
State/province [118]
0
0
Kobe-Shi
Query!
Country [119]
0
0
Japan
Query!
State/province [119]
0
0
Kodaira-Shi
Query!
Country [120]
0
0
Japan
Query!
State/province [120]
0
0
Kokubunji-Shi
Query!
Country [121]
0
0
Japan
Query!
State/province [121]
0
0
Koushi-Shi
Query!
Country [122]
0
0
Japan
Query!
State/province [122]
0
0
Kurashiki-Shi
Query!
Country [123]
0
0
Japan
Query!
State/province [123]
0
0
Kyoto-Shi
Query!
Country [124]
0
0
Japan
Query!
State/province [124]
0
0
Machida-Shi
Query!
Country [125]
0
0
Japan
Query!
State/province [125]
0
0
Matsuyama-Shi
Query!
Country [126]
0
0
Japan
Query!
State/province [126]
0
0
Minato-Ku
Query!
Country [127]
0
0
Japan
Query!
State/province [127]
0
0
Mizunami-Shi
Query!
Country [128]
0
0
Japan
Query!
State/province [128]
0
0
Muroran-Shi
Query!
Country [129]
0
0
Japan
Query!
State/province [129]
0
0
Nagoya-Shi
Query!
Country [130]
0
0
Japan
Query!
State/province [130]
0
0
Naka-Gun
Query!
Country [131]
0
0
Japan
Query!
State/province [131]
0
0
Naruto-Shi
Query!
Country [132]
0
0
Japan
Query!
State/province [132]
0
0
Obihiro-Shi
Query!
Country [133]
0
0
Japan
Query!
State/province [133]
0
0
Ome-Shi
Query!
Country [134]
0
0
Japan
Query!
State/province [134]
0
0
Osaka Sayama-Shi
Query!
Country [135]
0
0
Japan
Query!
State/province [135]
0
0
Osaki-Shi
Query!
Country [136]
0
0
Japan
Query!
State/province [136]
0
0
Ota-Ku
Query!
Country [137]
0
0
Japan
Query!
State/province [137]
0
0
Ota-Shi
Query!
Country [138]
0
0
Japan
Query!
State/province [138]
0
0
Sagamihara-Shi
Query!
Country [139]
0
0
Japan
Query!
State/province [139]
0
0
Sakai-Shi
Query!
Country [140]
0
0
Japan
Query!
State/province [140]
0
0
Sakaide-Shi
Query!
Country [141]
0
0
Japan
Query!
State/province [141]
0
0
Sapporo-Shi
Query!
Country [142]
0
0
Japan
Query!
State/province [142]
0
0
Setagaya-Ku
Query!
Country [143]
0
0
Japan
Query!
State/province [143]
0
0
Seto-Shi
Query!
Country [144]
0
0
Japan
Query!
State/province [144]
0
0
Shibuya-Ku
Query!
Country [145]
0
0
Japan
Query!
State/province [145]
0
0
Shinagawa-Ku
Query!
Country [146]
0
0
Japan
Query!
State/province [146]
0
0
Shinjuku-Ku
Query!
Country [147]
0
0
Japan
Query!
State/province [147]
0
0
Sumida-Ku
Query!
Country [148]
0
0
Japan
Query!
State/province [148]
0
0
Tachikawa-Shi
Query!
Country [149]
0
0
Japan
Query!
State/province [149]
0
0
Tomakomai-Shi
Query!
Country [150]
0
0
Japan
Query!
State/province [150]
0
0
Tsu-Shi
Query!
Country [151]
0
0
Japan
Query!
State/province [151]
0
0
Uozu-Shi
Query!
Country [152]
0
0
Japan
Query!
State/province [152]
0
0
Urasoe-Shi
Query!
Country [153]
0
0
Japan
Query!
State/province [153]
0
0
Uruma-Shi
Query!
Country [154]
0
0
Japan
Query!
State/province [154]
0
0
Yokohama-Shi
Query!
Country [155]
0
0
Korea, Republic of
Query!
State/province [155]
0
0
Bucheon-Si
Query!
Country [156]
0
0
Korea, Republic of
Query!
State/province [156]
0
0
Cheongju-Si
Query!
Country [157]
0
0
Korea, Republic of
Query!
State/province [157]
0
0
Incheon
Query!
Country [158]
0
0
Korea, Republic of
Query!
State/province [158]
0
0
Seoul
Query!
Country [159]
0
0
Korea, Republic of
Query!
State/province [159]
0
0
Suwon
Query!
Country [160]
0
0
Mexico
Query!
State/province [160]
0
0
Chihuahua
Query!
Country [161]
0
0
Mexico
Query!
State/province [161]
0
0
Cuautitlan Izcalli
Query!
Country [162]
0
0
Mexico
Query!
State/province [162]
0
0
Distrito Federal
Query!
Country [163]
0
0
Mexico
Query!
State/province [163]
0
0
Durango
Query!
Country [164]
0
0
Mexico
Query!
State/province [164]
0
0
Guadalajara
Query!
Country [165]
0
0
Mexico
Query!
State/province [165]
0
0
Mexico City
Query!
Country [166]
0
0
Mexico
Query!
State/province [166]
0
0
Monterrey
Query!
Country [167]
0
0
Mexico
Query!
State/province [167]
0
0
México
Query!
Country [168]
0
0
Mexico
Query!
State/province [168]
0
0
San Juan Del Rio
Query!
Country [169]
0
0
Mexico
Query!
State/province [169]
0
0
Veracruz
Query!
Country [170]
0
0
Netherlands
Query!
State/province [170]
0
0
Arnhem
Query!
Country [171]
0
0
Netherlands
Query!
State/province [171]
0
0
Dordrecht
Query!
Country [172]
0
0
Poland
Query!
State/province [172]
0
0
Bialystok
Query!
Country [173]
0
0
Poland
Query!
State/province [173]
0
0
Gdansk
Query!
Country [174]
0
0
Poland
Query!
State/province [174]
0
0
Krakow
Query!
Country [175]
0
0
Poland
Query!
State/province [175]
0
0
Lodz
Query!
Country [176]
0
0
Poland
Query!
State/province [176]
0
0
Poznan
Query!
Country [177]
0
0
Poland
Query!
State/province [177]
0
0
Strzelce Opolskie
Query!
Country [178]
0
0
Poland
Query!
State/province [178]
0
0
Warszawa
Query!
Country [179]
0
0
Poland
Query!
State/province [179]
0
0
Znin
Query!
Country [180]
0
0
Romania
Query!
State/province [180]
0
0
Bucharest
Query!
Country [181]
0
0
Romania
Query!
State/province [181]
0
0
Cluj-Napoca
Query!
Country [182]
0
0
Romania
Query!
State/province [182]
0
0
Timisoara
Query!
Country [183]
0
0
Russian Federation
Query!
State/province [183]
0
0
Ekaterinburg
Query!
Country [184]
0
0
Russian Federation
Query!
State/province [184]
0
0
Moscow
Query!
Country [185]
0
0
Russian Federation
Query!
State/province [185]
0
0
Novosibirsk
Query!
Country [186]
0
0
Russian Federation
Query!
State/province [186]
0
0
Ryazan
Query!
Country [187]
0
0
Russian Federation
Query!
State/province [187]
0
0
Saint-Petersburg
Query!
Country [188]
0
0
Russian Federation
Query!
State/province [188]
0
0
St-Petersburg
Query!
Country [189]
0
0
Russian Federation
Query!
State/province [189]
0
0
Yaroslavl
Query!
Country [190]
0
0
South Africa
Query!
State/province [190]
0
0
Brandfort
Query!
Country [191]
0
0
South Africa
Query!
State/province [191]
0
0
Cape Town
Query!
Country [192]
0
0
South Africa
Query!
State/province [192]
0
0
Durban
Query!
Country [193]
0
0
South Africa
Query!
State/province [193]
0
0
Pretoria
Query!
Country [194]
0
0
Spain
Query!
State/province [194]
0
0
Barcelona
Query!
Country [195]
0
0
Spain
Query!
State/province [195]
0
0
Palma De Mallorca
Query!
Country [196]
0
0
Spain
Query!
State/province [196]
0
0
Pozuelo De Alarcón
Query!
Country [197]
0
0
Spain
Query!
State/province [197]
0
0
Sabadell
Query!
Country [198]
0
0
Spain
Query!
State/province [198]
0
0
Sant Boi De Llobregat
Query!
Country [199]
0
0
Spain
Query!
State/province [199]
0
0
Santiago De Compostela
Query!
Country [200]
0
0
Spain
Query!
State/province [200]
0
0
Sevilla
Query!
Country [201]
0
0
Spain
Query!
State/province [201]
0
0
Valencia
Query!
Country [202]
0
0
Taiwan
Query!
State/province [202]
0
0
New Taipei City
Query!
Country [203]
0
0
Taiwan
Query!
State/province [203]
0
0
Taichung
Query!
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Taiwan
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Taipei
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Turkey
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Ankara
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Turkey
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Bursa
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Turkey
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Istanbul
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Turkey
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Izmir
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Turkey
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Kirikkale
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Turkey
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Mersin
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Turkey
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Rize
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Ukraine
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Chernivtsi
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Ukraine
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Dnipro
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Ukraine
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Ivano-Frankivsk
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Ukraine
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Kharkiv
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Ukraine
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Kyiv
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Ukraine
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Odesa
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Ukraine
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Poltava
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Ukraine
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Ternopil
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Ukraine
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Vinnytsya
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Ukraine
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Yalta
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Ukraine
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Zaporizhzhya
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United Kingdom
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Bradford
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United Kingdom
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London
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United Kingdom
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Oxford
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United Kingdom
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Portsmouth
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United Kingdom
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South Shields
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Sanofi
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Commercial sector/Industry
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Regeneron Pharmaceuticals
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Summary
Brief summary
Primary Objective:
To evaluate the long-term safety and tolerability of dupilumab in participants with asthma
who participated in a previous dupilumab asthma study (DRI12544, PDY14192, EFC13579,
EFC13691).
Secondary Objectives:
To evaluate the long-term efficacy of dupilumab in participants with asthma who participated
in a previous dupilumab asthma clinical study.
To evaluate dupilumab in participants with asthma who participated in a previous dupilumab
asthma clinical study, with regards to:
- Systemic exposure
- Anti-drug antibodies
- Biomarkers
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02134028
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Contacts
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Clinical Sciences & Operations
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Sanofi
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02134028
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