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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

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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Dupilumab Other: Placebo Drug: Asthma Controller Therapies (incl. prednisone/prednisolone) Drug: Asthma Reliever Therapies Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 408 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : April 21, 2017
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Dupilumab

Arm Intervention/treatment
Experimental: Dupilumab
Doses of dupilumab will be administered every 2 weeks added to current controller medications
Drug: Dupilumab
Pharmaceutical form:Solution Route of administration: subcutaneous
Other Name: SAR231893 (REGN668)

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

Placebo Comparator: Placebo
Placebo (for dupilumab) will be administered every 2 weeks added to current controller medications
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




Primary Outcome Measures :
  1. Annualized rate of severe exacerbation events during the placebo-controlled treatment period [ Time Frame: Baseline, Week 52 ]

Secondary Outcome Measures :
  1. Change from baseline in pre-bronchodilator % predicted forced expiratory volume in 1 second (FEV1) [ Time Frame: Baseline, Week 12 ]
  2. Change from baseline in pre-bronchodilator % predicted FEV1 [ Time Frame: Baseline, Weeks 2, 4, 8, 24, 36, 52 ]
  3. Time to first severe exacerbation event [ Time Frame: Up to 52 weeks ]
  4. Time to first loss of asthma control event [ Time Frame: Up to 52 weeks ]
  5. Change from baseline in other lung function measurements: absolute and relative FEV1 [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 24, 36, 52 ]
  6. 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 ]
  7. Change from baseline in other lung function measurements: Forced Vital Capacity [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 24, 36, 52 ]
  8. 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 ]
  9. Change from baseline in other lung function measurements: Post bronchodilator % predicted FEV1 [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 24, 36, 52 ]
  10. The effect of dupilumab on healthcare resource utilization [ Time Frame: Baseline, Week 12 ]
  11. Change from baseline in morning asthma symptom score [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 24, 36, 52 ]
  12. Change from baseline in evening asthma symptom score [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 24, 36, 52 ]
  13. 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 ]
  14. Number of rescue medication inhalations [ Time Frame: Baseline, Week 2, 4, 8, 12, 24, 36, 52 ]
  15. Assessment of Patient Reported Outcomes: Asthma control questionnaire [ Time Frame: Baseline, Weeks 2, 4, 8,12, 24, 36, 52 ]
  16. Assessment of Patient Reported Outcomes: Pediatric Asthma quality of life questionnaire [ Time Frame: Baseline, Weeks 12, 24, 36, 52 ]
  17. 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. ]
  18. Adverse Events [ Time Frame: Up to Week 64 ]
  19. Anti-Drug Antibodies [ Time Frame: Baseline, Weeks 12, 24, 52, 64 ]
  20. Serum Dupilumab Concentrations [ Time Frame: Baseline, Weeks 6, 12, 24, 52, 64 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02948959


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Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02948959     History of Changes
Other Study ID Numbers: EFC14153
2016-001607-23 ( EudraCT Number )
U1111-1179-4851 ( Other Identifier: UTN )
First Posted: October 31, 2016    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not available for request

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Prednisone
Prednisolone
Antibodies, Monoclonal
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunologic Factors