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Evaluation of Dupilumab in Children With Uncontrolled Asthma (VOYAGE)

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ClinicalTrials.gov Identifier: NCT02948959
Recruitment Status : Active, not recruiting
First Posted : October 31, 2016
Last Update Posted : October 14, 2019
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE October 27, 2016
First Posted Date  ICMJE October 31, 2016
Last Update Posted Date October 14, 2019
Actual Study Start Date  ICMJE April 21, 2017
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 24, 2018)
Annualized rate of severe exacerbation events during the placebo-controlled treatment period [ Time Frame: Baseline, Week 52 ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 27, 2016)
Annualized rate of severe exacerbation events during treatment period [ Time Frame: Baseline, Week 52 ]
Change History Complete list of historical versions of study NCT02948959 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2018)
  • Change from baseline in pre-bronchodilator % predicted forced expiratory volume in 1 second (FEV1) [ Time Frame: Baseline, Week 12 ]
  • Change from baseline in pre-bronchodilator % predicted FEV1 [ Time Frame: Baseline, Weeks 2, 4, 8, 24, 36, 52 ]
  • Time to first severe exacerbation event [ Time Frame: Up to 52 weeks ]
  • Time to first loss of asthma control event [ Time Frame: Up to 52 weeks ]
  • Change from baseline in other lung function measurements: absolute and relative FEV1 [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 24, 36, 52 ]
  • Change from baseline in other lung function measurements: AM/PM peak expiratory flow (PEF) [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 24, 36, 52 ]
  • Change from baseline in other lung function measurements: Forced Vital Capacity [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 24, 36, 52 ]
  • Change from baseline in other lung function measurements: Forced expiratory flow (FEF) 25-75% [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 24, 36, 52 ]
  • Change from baseline in other lung function measurements: Post bronchodilator % predicted FEV1 [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 24, 36, 52 ]
  • The effect of dupilumab on healthcare resource utilization [ Time Frame: Baseline, Week 12 ]
  • Change from baseline in morning asthma symptom score [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 24, 36, 52 ]
  • Change from baseline in evening asthma symptom score [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 24, 36, 52 ]
  • Number of nocturnal awakenings due to asthma symptoms requiring the use of reliever medication [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 24, 36, 52 ]
  • Number of rescue medication inhalations [ Time Frame: Baseline, Week 2, 4, 8, 12, 24, 36, 52 ]
  • Assessment of Patient Reported Outcomes: Asthma control questionnaire [ Time Frame: Baseline, Weeks 2, 4, 8,12, 24, 36, 52 ]
  • Assessment of Patient Reported Outcomes: Pediatric Asthma quality of life questionnaire [ Time Frame: Baseline, Weeks 12, 24, 36, 52 ]
  • Assessment of IgG responses to vaccination during dupilumab treatment (may be analyzed as exploratory endpoint if insufficient power) [ Time Frame: 2 blood draws per vaccine scheduled:1 prevaccination and 1 post-vaccination. ]
  • Adverse Events [ Time Frame: Up to Week 64 ]
  • Anti-Drug Antibodies [ Time Frame: Baseline, Weeks 12, 24, 52, 64 ]
  • Serum Dupilumab Concentrations [ Time Frame: Baseline, Weeks 6, 12, 24, 52, 64 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2016)
  • Change from baseline in pre-bronchodilator % predicted FEV1 [ Time Frame: Baseline, Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 ]
  • Time to first severe exacerbation event [ Time Frame: Up to 52 weeks ]
  • Time to first loss of asthma control event [ Time Frame: Up to 52 weeks ]
  • Change from baseline in other lung function measurements [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 24, 36, 52 ]
  • Change from baseline in morning asthma symptom score [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 24, 36, 52 ]
  • Change from baseline in evening asthma symptom score [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 24, 36, 52 ]
  • Number of rescue medication inhalations [ Time Frame: Baseline, Week 2, 4, 8, 12, 24, 36, 52 ]
  • Assessment of Patient Reported Outcomes by Asthma Control Questionnaire [ Time Frame: Baseline, Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 ]
  • Assessment of Patient Reported Outcomes by Pediatric Asthma Quality of Life Questionnaire [ Time Frame: Baseline, Weeks 12, 24, 36, 52 ]
  • Assessment of Immunoglobulin G (IgG) responses to vaccination during dupilumab treatment by blood sample collection (may be analyzed as exploratory endpoint if insufficient power) [ Time Frame: 8 weeks prior to vaccination and up to 6 weeks after vaccination ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Dupilumab in Children With Uncontrolled Asthma
Official Title  ICMJE 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
Brief Summary

Primary Objective:

To evaluate the efficacy of dupilumab in children 6 to <12 years of age with uncontrolled persistent asthma.

Secondary Objectives:

To evaluate in children 6 to <12 years of age with uncontrolled persistent asthma:

  • The safety and tolerability of dupilumab.
  • To evaluate the effect of dupilumab in improving patient-reported outcomes (PROs) including health related quality of life (HRQoL).
  • The dupilumab systemic exposure and incidence of anti-drug antibodies.
  • To evaluate the association between dupilumab treatment and pediatric immune responses to vaccines: any vaccination for tetanus, diphtheria, pertussis and/or seasonal trivalent/quadrivalent influenza vaccine.
Detailed Description The total study duration per patient will be up to 69 weeks, consisting of a screening period of 3-5 weeks, a randomized treatment period of 52 weeks and a post-treatment period of 12 weeks.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • Drug: Dupilumab
    Pharmaceutical form:Solution Route of administration: subcutaneous
    Other Name: SAR231893 (REGN668)
  • Other: Placebo
    Pharmaceutical form:Solution Route of administration: subcutaneous
  • Drug: Asthma Controller Therapies (incl. prednisone/prednisolone)
    Pharmaceutical form:Aerosol, capsules, tablets, oral solution Route of administration: inhaled, oral
  • Drug: Asthma Reliever Therapies
    Pharmaceutical form:Nebulized, aerosol Route of administration: inhaled
Study Arms  ICMJE
  • Experimental: Dupilumab
    Doses of dupilumab will be administered every 2 weeks added to current controller medications
    Interventions:
    • Drug: Dupilumab
    • Drug: Asthma Controller Therapies (incl. prednisone/prednisolone)
    • Drug: Asthma Reliever Therapies
  • Placebo Comparator: Placebo
    Placebo (for dupilumab) will be administered every 2 weeks added to current controller medications
    Interventions:
    • Other: Placebo
    • Drug: Asthma Controller Therapies (incl. prednisone/prednisolone)
    • Drug: Asthma Reliever Therapies
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 30, 2019)
408
Original Estimated Enrollment  ICMJE
 (submitted: October 27, 2016)
294
Estimated Study Completion Date  ICMJE November 2020
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria :

Children 6 to <12 years of age, with a physician diagnosis of persistent asthma for ≥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 inhaled corticosteroids (ICS) with second controller medication (ie, long-acting β2 agonist [LABA], leukotriene receptor antagonist [LTRA], long acting muscarinic antagonist [LAMA], 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% of predicted normal or pre bronchodilator FEV1/forced vital capacity (FVC) ratio <0.85 at Screening and Baseline Visits.
  • Reversibility of at least 10% in FEV1 after the administration of 200 to 400 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 are allowed with a maximum of 12 puffs of reliever medication if tolerated by the patient).
  • Must have experienced within 1 year prior to Screening Visit 1 any of the following events:

    • Treatment with a systemic corticosteroid (SCS, oral or parenteral), as prescribed by a healthcare professional for worsening asthma at least once or,
    • Hospitalization or emergency room 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 (ie, 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.

Exclusion criteria:

  • Patients <6 or ≥12 years of age.
  • Patients with <16 kg bodyweight.
  • Any other chronic lung disease (cystic fibrosis, bronchopulmonary dysplasia, etc) which may impair lung function.
  • A subject 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 (IMP).

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 11 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Chile,   Russian Federation,   Argentina,   Australia,   Brazil,   Canada,   Colombia,   Hungary,   Italy,   Lithuania,   Mexico,   Poland,   Romania,   South Africa,   Spain,   Turkey,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02948959
Other Study ID Numbers  ICMJE EFC14153
2016-001607-23 ( EudraCT Number )
U1111-1179-4851 ( Other Identifier: UTN )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Not available for request
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Regeneron Pharmaceuticals
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP