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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02948959




Registration number
NCT02948959
Ethics application status
Date submitted
27/10/2016
Date registered
31/10/2016

Titles & IDs
Public title
Evaluation of Dupilumab in Children With Uncontrolled Asthma
Scientific title
A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Children 6 to <12 Years of Age With Uncontrolled Persistent Asthma
Secondary ID [1] 0 0
2016-001607-23
Secondary ID [2] 0 0
EFC14153
Universal Trial Number (UTN)
Trial acronym
VOYAGE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Dupilumab
Treatment: Drugs - Placebo
Treatment: Drugs - Asthma Controller Therapies
Treatment: Drugs - Asthma Reliever Therapies

Placebo comparator: Placebo - Placebo (for Dupilumab), subcutaneous (SC) injection every 2 weeks (q2w) for 52 weeks in combination with stable-dose background therapy of medium-dose inhaled corticosteroids (ICS) with a second controller medication (i.e., long-acting ß2 agonist \[LABA\], long acting muscarinic antagonist \[LAMA\], leukotriene receptor antagonist \[LTRA\] or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication. Participants were followed up for 12 weeks after last dose (i.e. up to Week 64).

Experimental: Dupilumab - Dupilumab 200 milligrams (mg) (in 1.14 milliliters \[mL\] for \>30 kilograms \[kg\] bodyweight \[BW\]) or 100 mg (in 0.67 mL for less than or equal to (\<=) 30 kg BW), SC injection q2w for 52 weeks in combination with stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA\] or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication. Participants were followed up for 12 weeks after last dose (i.e. up to Week 64).


Treatment: Drugs: Dupilumab
Pharmaceutical form: Solution

Route of administration: Subcutaneous

Treatment: Drugs: Placebo
Pharmaceutical form: Solution

Route of administration: Subcutaneous

Treatment: Drugs: Asthma Controller Therapies
Pharmaceutical form: Aerosol, capsules, tablets, oral solution

Route of administration: Inhaled, oral

Treatment: Drugs: Asthma Reliever Therapies
Pharmaceutical form: Nebulized, aerosol

Route of administration: Inhaled
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Annualized Rate of Severe Exacerbation Events During the 52-Week Treatment Period: Baseline Blood Eosinophils >=300 Cells Per Microliter Population
Timepoint [1] 0 0
Baseline to Week 52
Primary outcome [2] 0 0
Annualized Rate of Severe Exacerbation Events During the 52-Week Treatment Period: Type 2 Inflammatory Asthma Phenotype Population
Timepoint [2] 0 0
Baseline to Week 52
Secondary outcome [1] 0 0
Change From Baseline in Pre-bronchodilator Percent Predicted Forced Expiratory Volume in 1 (FEV1) Second at Week 12: Baseline Blood Eosinophils >=300 Cells Per Microliter Population
Timepoint [1] 0 0
Baseline, Week 12
Secondary outcome [2] 0 0
Change From Baseline in Pre-bronchodilator Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Week 12: Type 2 Inflammatory Asthma Phenotype Population
Timepoint [2] 0 0
Baseline, Week 12
Secondary outcome [3] 0 0
Change From Baseline in Asthma Control Questionnaire-Interviewer Administered, 7-question Version (ACQ-7-IA) at Week 24: Baseline Blood Eosinophils >=300 Cells Per Microliter Population
Timepoint [3] 0 0
Baseline, Week 24
Secondary outcome [4] 0 0
Change From Baseline in Asthma Control Questionnaire-Interviewer Administered, 7-question Version at Week 24: Type 2 Inflammatory Asthma Phenotype Population
Timepoint [4] 0 0
Baseline, Week 24
Secondary outcome [5] 0 0
Change From Baseline in Fractional Exhaled Nitric Oxide Level at Week 12: Baseline Blood Eosinophils >=300 Cells Per Microliter Population
Timepoint [5] 0 0
Baseline, Week 12
Secondary outcome [6] 0 0
Change From Baseline in Fractional Exhaled Nitric Oxide Level at Week 12: Type 2 Inflammatory Asthma Phenotype Population
Timepoint [6] 0 0
Baseline, Week 12
Secondary outcome [7] 0 0
Change From Baseline in Pre-bronchodilator Percent Predicted Forced Expiratory Volume in 1 Second at Weeks 2, 4, 8, 24, 36 and 52: Type 2 Inflammatory Asthma Phenotype Population
Timepoint [7] 0 0
Baseline, Weeks 2, 4, 8, 24, 36, 52
Secondary outcome [8] 0 0
Change From Baseline in Pre-bronchodilator Percent Predicted Forced Expiratory Volume in 1 Second at Weeks 2, 4, 8, 24, 36 and 52: Baseline Blood Eosinophils >=300 Cells Per Microliter Population
Timepoint [8] 0 0
Baseline, Weeks 2, 4, 8, 24, 36, 52
Secondary outcome [9] 0 0
Time to First Severe Exacerbation Event: Kaplan-Meier Estimates During 52-week Treatment Period: Type 2 Inflammatory Asthma Phenotype Population
Timepoint [9] 0 0
Baseline up to Week 52
Secondary outcome [10] 0 0
Time to First Severe Exacerbation Event: Kaplan-Meier Estimates During 52-week Treatment Period: Baseline Blood Eosinophils >=300 Cells Per Microliter Population
Timepoint [10] 0 0
Baseline up to Week 52
Secondary outcome [11] 0 0
Time to First Loss of Asthma Control (LOAC) Event: Kaplan-Meier Estimates During 52-week Treatment Period: Type 2 Inflammatory Asthma Phenotype Population
Timepoint [11] 0 0
Baseline up to Week 52
Secondary outcome [12] 0 0
Time to First Loss of Asthma Control Event: Kaplan-Meier Estimates During 52-week Treatment Period: Baseline Blood Eosinophils >=300 Cells Per Microliter Population
Timepoint [12] 0 0
Baseline up to Week 52
Secondary outcome [13] 0 0
Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 12, 24, 36, 52: Type 2 Inflammatory Asthma Phenotype Population
Timepoint [13] 0 0
Baseline, Weeks 2, 4, 8, 12, 24, 36, 52
Secondary outcome [14] 0 0
Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 12, 24, 36, 52: Baseline Blood Eosinophils >=300 Cells Per Microliter Population
Timepoint [14] 0 0
Baseline, Weeks 2, 4, 8, 12, 24, 36, 52
Secondary outcome [15] 0 0
Percent Change From Baseline in Pre-Bronchodilator Percent Predicted FEV1 at Weeks 2, 4, 8, 12, 24, 36, 52: Type 2 Inflammatory Asthma Phenotype Population
Timepoint [15] 0 0
Baseline, Weeks 2, 4, 8, 12, 24, 36, 52
Secondary outcome [16] 0 0
Percent Change From Baseline in Pre-Bronchodilator Percent Predicted FEV1 at Weeks 2, 4, 8, 12, 24, 36, 52: Baseline Blood Eosinophils >=300 Cells Per Microliter Population
Timepoint [16] 0 0
Baseline, Weeks 2, 4, 8, 12, 24, 36, 52
Secondary outcome [17] 0 0
Change From Baseline in Morning (AM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: Type 2 Inflammatory Asthma Phenotype Population
Timepoint [17] 0 0
Baseline, Weeks 2, 4, 8, 12, 24, 36, 52
Secondary outcome [18] 0 0
Change From Baseline in Evening (PM) Peak Expiratory Flow at Weeks 2, 4, 8, 12, 24, 36, and 52: Type 2 Inflammatory Asthma Phenotype Population
Timepoint [18] 0 0
Baseline, Weeks 2, 4, 8, 12, 24, 36, 52
Secondary outcome [19] 0 0
Change From Baseline in Morning (AM) Peak Expiratory Flow at Weeks 2, 4, 8, 12, 24, 36, and 52: Baseline Blood Eosinophils >=300 Cells Per Microliter Population
Timepoint [19] 0 0
Baseline, Weeks 2, 4, 8, 12, 24, 36, 52
Secondary outcome [20] 0 0
Change From Baseline in Evening (PM) Peak Expiratory Flow at Weeks 2, 4, 8, 12, 24, 36, and 52: Baseline Blood Eosinophils >=300 Cells Per Microliter Population
Timepoint [20] 0 0
Baseline, Weeks 2, 4, 8, 12, 24, 36, 52
Secondary outcome [21] 0 0
Change From Baseline in Forced Vital Capacity (FVC) at Weeks 2, 4, 8, 12, 24, 36, 52: Type 2 Inflammatory Asthma Phenotype Population
Timepoint [21] 0 0
Baseline, Weeks 2, 4, 8, 12, 24, 36, 52
Secondary outcome [22] 0 0
Change From Baseline in Forced Vital Capacity at Weeks 2, 4, 8, 12, 24, 36, 52: Baseline Blood Eosinophils >=300 Cells Per Microliter Population
Timepoint [22] 0 0
Baseline, Weeks 2, 4, 8, 12, 24, 36, 52
Secondary outcome [23] 0 0
Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 2, 4, 8, 12, 24, 36, 52: Type 2 Inflammatory Asthma Phenotype Population
Timepoint [23] 0 0
Baseline, Weeks 2, 4, 8, 12, 24, 36, 52
Secondary outcome [24] 0 0
Change From Baseline in Forced Expiratory Flow 25-75% at Weeks 2, 4, 8, 12, 24, 36, 52: Baseline Blood Eosinophils >=300 Cells Per Microliter Population
Timepoint [24] 0 0
Baseline, Weeks 2, 4, 8, 12, 24, 36, 52
Secondary outcome [25] 0 0
Change From Baseline in Post-Bronchodilator FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: Type 2 Inflammatory Asthma Phenotype Population
Timepoint [25] 0 0
Baseline, Weeks 2, 4, 8, 12, 24, 36, 52
Secondary outcome [26] 0 0
Change From Baseline in Post-Bronchodilator FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: Baseline Blood Eosinophils >=300 Cells Per Microliter Population
Timepoint [26] 0 0
Baseline, Weeks 2, 4, 8, 12, 24, 36, 52
Secondary outcome [27] 0 0
Change From Baseline in Morning Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: Type 2 Inflammatory Asthma Phenotype Population
Timepoint [27] 0 0
Baseline, Weeks 2, 4, 8, 12, 24, 36, 52
Secondary outcome [28] 0 0
Change From Baseline in Evening Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: Type 2 Inflammatory Asthma Phenotype Population
Timepoint [28] 0 0
Baseline, Weeks 2, 4, 8, 12, 24, 36, 52
Secondary outcome [29] 0 0
Change From Baseline in Morning Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: Baseline Blood Eosinophils >=300 Cells Per Microliter Population
Timepoint [29] 0 0
Baseline, Weeks 2, 4, 8, 12, 24, 36, 52
Secondary outcome [30] 0 0
Change From Baseline in Evening Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: Baseline Blood Eosinophils >=300 Cells Per Microliter Population
Timepoint [30] 0 0
Baseline, Weeks 2, 4, 8, 12, 24, 36, 52
Secondary outcome [31] 0 0
Change From Baseline in Asthma Control Questionnaire-Interviewer Administered, 5-question Version (ACQ-5-IA) at Weeks 2, 4, 8, 12, 24, 36, and 52: Type 2 Inflammatory Asthma Phenotype Population
Timepoint [31] 0 0
Baseline, Weeks 2, 4, 8, 12, 24, 36, 52
Secondary outcome [32] 0 0
Change From Baseline in Asthma Control Questionnaire-Interviewer Administered, 5-question Version at Weeks 2, 4, 8, 12, 24, 36, and 52: Baseline Blood Eosinophils >=300 Cells Per Microliter Population
Timepoint [32] 0 0
Baseline, Weeks 2, 4, 8, 12, 24, 36, 52
Secondary outcome [33] 0 0
Change From Baseline in Asthma Control Questionnaire-Interviewer Administered, 7-question Version at Weeks 2, 4, 8, 12, 36, and 52: Baseline Blood Eosinophils >=300 Cells Per Microliter Population
Timepoint [33] 0 0
Baseline, Weeks 2, 4, 8,12, 36, 52
Secondary outcome [34] 0 0
Change From Baseline in Asthma Control Questionnaire-Interviewer Administered, 7-question Version at Weeks 2, 4, 8, 12, 36, and 52: Type 2 Inflammatory Asthma Phenotype Population
Timepoint [34] 0 0
Baseline, Weeks 2, 4, 8,12, 36, 52
Secondary outcome [35] 0 0
Change From Baseline in Number of Puffs of Reliever Medication Used Per 24 Hours at Weeks 2, 4, 8, 12, 24, 36, and 52: Type 2 Inflammatory Asthma Phenotype Population
Timepoint [35] 0 0
Baseline, Weeks 2, 4, 8, 12, 24, 36, 52
Secondary outcome [36] 0 0
Change From Baseline in Number of Puffs of Reliever Medication Used Per 24 Hours at Weeks 2, 4, 8, 12, 24, 36, and 52: Baseline Blood Eosinophils >=300 Cells Per Microliter Population
Timepoint [36] 0 0
Baseline, Weeks 2, 4, 8, 12, 24, 36, 52
Secondary outcome [37] 0 0
Change From Baseline in Number of Nocturnal Awakenings Per Night at Weeks 2, 4, 8, 12, 24, 36, and 52: Type 2 Inflammatory Asthma Phenotype Population
Timepoint [37] 0 0
Baseline, Weeks 2, 4, 8, 12, 24, 36, 52
Secondary outcome [38] 0 0
Change From Baseline in Number of Nocturnal Awakenings Per Night at Weeks 2, 4, 8, 12, 24, 36, and 52: Baseline Blood Eosinophils >=300 Cells Per Microliter Population
Timepoint [38] 0 0
Baseline, Weeks 2, 4, 8, 12, 24, 36, 52
Secondary outcome [39] 0 0
Change From Baseline in Pediatric Asthma Quality of Life (QoL) Questionnaire With Standardized Activities-Interviewer Administered (PAQLQ[S] IA) Scores at Weeks 12, 24, 36, and 52: Type 2 Inflammatory Asthma Phenotype Population
Timepoint [39] 0 0
Baseline, Weeks 12, 24, 36, 52
Secondary outcome [40] 0 0
Change From Baseline in Pediatric Asthma Quality of Life Questionnaire With Standardized Activities-Interviewer Administered Scores at Weeks 12, 24, 36, and 52: Baseline Blood Eosinophils >=300 Cells Per Microliter Population
Timepoint [40] 0 0
Baseline, Weeks 12, 24, 36, 52
Secondary outcome [41] 0 0
Healthcare Resource Utilization (HCRU): Number of School and Work Days Missed Due to LOAC: Type 2 Inflammatory Asthma Phenotype Population
Timepoint [41] 0 0
Baseline to Week 52
Secondary outcome [42] 0 0
Healthcare Resource Utilization: Number of School and Work Days Missed Due to LOAC: Baseline Blood Eosinophils >=300 Cells Per Microliter Population
Timepoint [42] 0 0
Baseline to Week 52
Secondary outcome [43] 0 0
Healthcare Resource Utilization: Percentage of Participants Who Had Missed Greater Than or Equal to 5 School/Work Days Due to LOAC: Type 2 Inflammatory Asthma Phenotype Population
Timepoint [43] 0 0
Baseline to Week 52
Secondary outcome [44] 0 0
Healthcare Resource Utilization: Percentage of Participants Who Had Missed Greater Than or Equal to 5 School/Work Days Due to LOAC: Baseline Blood Eosinophils >=300 Cells Per Microliter Population
Timepoint [44] 0 0
Baseline to Week 52
Secondary outcome [45] 0 0
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Timepoint [45] 0 0
From Baseline up to Week 64
Secondary outcome [46] 0 0
Pharmacokinetics (PK) Assessment: Functional Dupilumab Concentration in Serum
Timepoint [46] 0 0
Baseline, Weeks 6, 12, 24, 52, 64
Secondary outcome [47] 0 0
Percentage of Participants With Treatment Emergent Antidrug Antibodies (ADA) Response
Timepoint [47] 0 0
From Baseline up to Week 64
Secondary outcome [48] 0 0
Percentage of Participants With Seroconversion
Timepoint [48] 0 0
From Baseline up to Week 64

Eligibility
Key inclusion criteria
Inclusion criteria :

Children 6 to <12 years of age, with a physician diagnosis of persistent asthma for greater than or equal to (>=)12 months prior to screening, based on clinical history and examination, pulmonary function parameters according to Global initiative for asthma (GINA) 2015 Guidelines and the following criteria:

* Existing background therapy of medium-dose ICS with second controller medication (i.e., long-acting ß2 agonist , leukotriene receptor antagonist, long acting muscarinic antagonist, or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller, for at least 3 months with a stable dose >=1 month prior to Screening Visit 1.
* Pre-bronchodilator forced expiratory volume in 1 second (FEV1) <=95 percentage (%) of predicted normal or pre bronchodilator FEV1/forced vital capacity ratio <0.85 at Screening and Baseline Visits.
* Reversibility of at least 10% in FEV1 after the administration of 200 to 400 micrograms (mcg; 2 to 4 puff inhalations with metered-dose inhaler [MDI]) of albuterol/salbutamol or 45 to 90 mcg (2 to 4 puffs with MDI) of levalbuterol/levosalbutamol reliever medication before randomization (up to 3 opportunities during the same visit were allowed with a maximum of 12 puffs of reliever medication if tolerated by the participant).
* Must had experienced, within 1 year prior to Screening Visit 1, any of the following events:

* Treatment with a systemic corticosteroid (oral or parenteral), as prescribed by a healthcare professional for worsening asthma at least once or,
* Hospitalization or emergency visit for worsening asthma.
* Evidence of uncontrolled asthma, with at least one of the following criteria during the 4 (±1) weeks Screening Period:

* Asthma Control Questionnaire-Interviewer Administered (ACQ-IA) ACQ-5 score >=1.5 on at least one day of the Screening Period.
* Use of reliever medication (i.e., albuterol/salbutamol or levalbuterol/levosalbutamol), other than as a preventive for exercise induced bronchospasm, on 3 or more days per week, in at least one week during the Screening Period.
* Sleep awakening due to asthma symptoms requiring use of reliever medication at least once during the Screening Period.
* Asthma symptoms 3 or more days per week in at least one week during the Screening Period.
Minimum age
6 Years
Maximum age
11 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

* Participants <6 or >=12 years of age.
* Participants with <16 kg bodyweight.
* Any other chronic lung disease (cystic fibrosis, bronchopulmonary dysplasia, etc.), which may impair lung function.
* A participant with any history of life threatening asthma (ie, extreme exacerbation that requires intubation).
* Co-morbid disease that might interfere with the evaluation of investigational medicinal product.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

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

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/04/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/08/2020
Sample size
Target
Accrual to date
Final
408
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigational Site Number 036001 - Campbelltown
Recruitment hospital [2] 0 0
Investigational Site Number 036005 - North Adelaide
Recruitment hospital [3] 0 0
Investigational Site Number 036003 - Parkville/Melbourne
Recruitment hospital [4] 0 0
Investigational Site Number 036002 - South Brisbane
Recruitment postcode(s) [1] 0 0
2560 - Campbelltown
Recruitment postcode(s) [2] 0 0
5006 - North Adelaide
Recruitment postcode(s) [3] 0 0
3052 - Parkville/Melbourne
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Kentucky
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
Nebraska
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Oklahoma
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Wisconsin
Country [14] 0 0
Argentina
State/province [14] 0 0
Buenos Aires
Country [15] 0 0
Argentina
State/province [15] 0 0
Caba
Country [16] 0 0
Argentina
State/province [16] 0 0
Mendoza
Country [17] 0 0
Brazil
State/province [17] 0 0
Blumenau
Country [18] 0 0
Brazil
State/province [18] 0 0
Porto Alegre
Country [19] 0 0
Brazil
State/province [19] 0 0
Sao Paulo
Country [20] 0 0
Brazil
State/province [20] 0 0
Sorocaba
Country [21] 0 0
Canada
State/province [21] 0 0
Edmonton
Country [22] 0 0
Canada
State/province [22] 0 0
Hamilton
Country [23] 0 0
Canada
State/province [23] 0 0
Montreal
Country [24] 0 0
Canada
State/province [24] 0 0
Quebec
Country [25] 0 0
Chile
State/province [25] 0 0
Santiago
Country [26] 0 0
Chile
State/province [26] 0 0
Valdivia
Country [27] 0 0
Chile
State/province [27] 0 0
Viña Del Mar
Country [28] 0 0
Colombia
State/province [28] 0 0
Antioquia
Country [29] 0 0
Colombia
State/province [29] 0 0
Cali
Country [30] 0 0
Hungary
State/province [30] 0 0
Budapest
Country [31] 0 0
Hungary
State/province [31] 0 0
Gyula
Country [32] 0 0
Hungary
State/province [32] 0 0
Mezokövesd
Country [33] 0 0
Hungary
State/province [33] 0 0
Szeged
Country [34] 0 0
Hungary
State/province [34] 0 0
Szigetvár
Country [35] 0 0
Hungary
State/province [35] 0 0
Székesfehérvár
Country [36] 0 0
Hungary
State/province [36] 0 0
Töröbálint
Country [37] 0 0
Hungary
State/province [37] 0 0
Zalaegerszeg
Country [38] 0 0
Italy
State/province [38] 0 0
Catania
Country [39] 0 0
Italy
State/province [39] 0 0
Firenze
Country [40] 0 0
Italy
State/province [40] 0 0
Padova
Country [41] 0 0
Italy
State/province [41] 0 0
Roma
Country [42] 0 0
Italy
State/province [42] 0 0
Verona
Country [43] 0 0
Lithuania
State/province [43] 0 0
Kaunas
Country [44] 0 0
Lithuania
State/province [44] 0 0
Siauliai
Country [45] 0 0
Lithuania
State/province [45] 0 0
Utena
Country [46] 0 0
Lithuania
State/province [46] 0 0
Vilnius
Country [47] 0 0
Mexico
State/province [47] 0 0
Chihuahua
Country [48] 0 0
Mexico
State/province [48] 0 0
Durango
Country [49] 0 0
Mexico
State/province [49] 0 0
Monterrey
Country [50] 0 0
Mexico
State/province [50] 0 0
Veracruz
Country [51] 0 0
Poland
State/province [51] 0 0
Lodz
Country [52] 0 0
Poland
State/province [52] 0 0
Poznan
Country [53] 0 0
Romania
State/province [53] 0 0
Bucuresti
Country [54] 0 0
Russian Federation
State/province [54] 0 0
Moscow
Country [55] 0 0
Russian Federation
State/province [55] 0 0
Perm
Country [56] 0 0
Russian Federation
State/province [56] 0 0
Saint Petersburg
Country [57] 0 0
Russian Federation
State/province [57] 0 0
Saint-Petersburg
Country [58] 0 0
South Africa
State/province [58] 0 0
Cape Town
Country [59] 0 0
Spain
State/province [59] 0 0
Barcelona
Country [60] 0 0
Spain
State/province [60] 0 0
Esplugues De Llobregat
Country [61] 0 0
Spain
State/province [61] 0 0
Pozuelo De Alarcón
Country [62] 0 0
Spain
State/province [62] 0 0
Santiago De Compostela
Country [63] 0 0
Spain
State/province [63] 0 0
Valencia
Country [64] 0 0
Turkey
State/province [64] 0 0
Adana
Country [65] 0 0
Turkey
State/province [65] 0 0
Ankara
Country [66] 0 0
Turkey
State/province [66] 0 0
Bursa
Country [67] 0 0
Turkey
State/province [67] 0 0
Istanbul
Country [68] 0 0
Ukraine
State/province [68] 0 0
Chernivtsi
Country [69] 0 0
Ukraine
State/province [69] 0 0
Dnipro
Country [70] 0 0
Ukraine
State/province [70] 0 0
Ivano-Frankivsk
Country [71] 0 0
Ukraine
State/province [71] 0 0
Kharkiv
Country [72] 0 0
Ukraine
State/province [72] 0 0
Kryvyi Rig
Country [73] 0 0
Ukraine
State/province [73] 0 0
Kyiv
Country [74] 0 0
Ukraine
State/province [74] 0 0
Zaporizhzhya

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Regeneron Pharmaceuticals
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02948959