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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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Locations
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United States, Alabama
Investigational Site Number 840031
Birmingham, Alabama, United States, 35209
United States, Arizona
Investigational Site Number 840002
Gilbert, Arizona, United States, 85234
Investigational Site Number 840012
Tucson, Arizona, United States, 85724-5030
United States, California
Investigational Site Number 840001
Rolling Hills Estates, California, United States, 90274
United States, Kentucky
Investigational Site Number 840036
Owensboro, Kentucky, United States, 42301
United States, Michigan
Investigational Site Number 840016
Ann Arbor, Michigan, United States, 48106
United States, Missouri
Investigational Site Number 840006
Saint Louis, Missouri, United States, 63110-1077
United States, Nebraska
Investigational Site Number 840022
Lincoln, Nebraska, United States, 68505
United States, New York
Investigational Site Number 840023
Great Neck, New York, United States, 11021
Investigational Site Number 840035
New York, New York, United States, 00000
Investigational Site Number 840013
New York, New York, United States, 10032
Investigational Site Number 840007
Rochester, New York, United States, 14607
United States, North Carolina
Investigational Site Number 840004
Charlotte, North Carolina, United States, 28277
Investigational Site Number 840021
Durham, North Carolina, United States, 27710
United States, Ohio
Investigational Site Number 840008
Cincinnati, Ohio, United States, 45229
United States, Oklahoma
Investigational Site Number 840024
Edmond, Oklahoma, United States, 73034
United States, Texas
Investigational Site Number 840003
San Antonio, Texas, United States, 78229
United States, Wisconsin
Investigational Site Number 840018
La Crosse, Wisconsin, United States, 54601
Argentina
Investigational Site Number 032004
Buenos Aires, Argentina, B1602DQD
Investigational Site Number 032003
Buenos Aires, Argentina, C1121ABE
Investigational Site Number 032002
Caba, Argentina, C1122AAK
Investigational Site Number 032001
Caba, Argentina, C1414AIF
Investigational Site Number 032006
Mendoza, Argentina, 5500
Australia
Investigational Site Number 036001
Campbelltown, Australia, 2560
Investigational Site Number 036005
North Adelaide, Australia, 5006
Investigational Site Number 036003
Parkville/Melbourne, Australia, 3052
Investigational Site Number 036002
South Brisbane, Australia, 4101
Brazil
Investigational Site Number 076008
Blumenau, Brazil, 89030-100
Investigational Site Number 076001
Porto Alegre, Brazil, 90020-090
Investigational Site Number 076007
Porto Alegre, Brazil, 90610-000
Investigational Site Number 076003
Sao Paulo, Brazil, 02189-010
Investigational Site Number 076002
Sao Paulo, Brazil, 04037-002
Investigational Site Number 076004
Sao Paulo, Brazil, 05403-000
Investigational Site Number 076006
Sorocaba, Brazil, 18040-425
Canada
Investigational Site Number 124004
Edmonton, Canada, T6G 2B7
Investigational Site Number 124002
Hamilton, Canada, L8S1G5
Investigational Site Number 124001
Montreal, Canada, H3T 1C5
Investigational Site Number 124003
Quebec, Canada, G1V 4W2
Chile
Investigational Site Number 152003
Santiago, Chile, 7560994
Investigational Site Number 152005
Santiago, Chile, 838-0418
Investigational Site Number 152009
Santiago, Chile, 8380453
Investigational Site Number 152001
Valdivia, Chile
Investigational Site Number 152007
Viña Del Mar, Chile, 2520024
Investigational Site Number 152002
Viña Del Mar, Chile, 2520594
Colombia
Investigational Site Number 170004
Antioquia, Colombia, 050010
Investigational Site Number 170002
Cali, Colombia, 760043
Hungary
Investigational Site Number 348006
Budapest, Hungary, 1089
Investigational Site Number 348002
Gyula, Hungary, 5700
Investigational Site Number 348012
Mezőkövesd, Hungary, 3400
Investigational Site Number 348005
Szeged, Hungary, 6720
Investigational Site Number 348008
Szigetvár, Hungary, 7900
Investigational Site Number 348001
Székesfehérvár, Hungary, 8000
Investigational Site Number 348003
Töröbálint, Hungary, 2045
Investigational Site Number 348007
Zalaegerszeg, Hungary, 8900
Italy
Investigational Site Number 380007
Catania, Italy, 95123
Investigational Site Number 380003
Firenze, Italy, 50139
Investigational Site Number 380004
Padova, Italy, 35128
Investigational Site Number 380005
Roma, Italy, 00146
Investigational Site Number 380001
Verona, Italy, 37126
Lithuania
Investigational Site Number 440002
Kaunas, Lithuania, LT-50161
Investigational Site Number 440005
Siauliai, Lithuania, LT-76231
Investigational Site Number 440003
Utena, Lithuania, LT-28151
Investigational Site Number 440001
Vilnius, Lithuania, LT-08406
Investigational Site Number 440004
Vilnius, Lithuania, LT-09108
Mexico
Investigational Site Number 484006
Chihuahua, Mexico, 31000
Investigational Site Number 484004
Chihuahua, Mexico, 31200
Investigational Site Number 484003
Durango, Mexico, 34080
Investigational Site Number 484001
Monterrey, Mexico, 64460
Investigational Site Number 484002
Veracruz, Mexico, 91910
Poland
Investigational Site Number 616001
Lodz, Poland, 90-329
Investigational Site Number 616002
Poznan, Poland, 60-693
Romania
Investigational Site Number 642001
Bucuresti, Romania, 020395
Russian Federation
Investigational Site Number 643006
Moscow, Russian Federation, 119333
Investigational Site Number 643004
Perm, Russian Federation, 614066
Investigational Site Number 643005
Saint Petersburg, Russian Federation, 191144
Investigational Site Number 643002
Saint Petersburg, Russian Federation, 193312
Investigational Site Number 643001
Saint-Petersburg, Russian Federation, 194100
Investigational Site Number 643003
Saint-Petersburg, Russian Federation, 196240
South Africa
Investigational Site Number 710004
Cape Town, South Africa, 7500
Investigational Site Number 710001
Cape Town, South Africa, 7700
Spain
Investigational Site Number 724001
Barcelona, Spain, 08035
Investigational Site Number 724006
Esplugues De Llobregat, Spain, 08950
Investigational Site Number 724005
Pozuelo De Alarcón, Spain, 28223
Investigational Site Number 724002
Santiago De Compostela, Spain, 15706
Investigational Site Number 724003
Valencia, Spain, 46017
Turkey
Investigational Site Number 792005
Adana, Turkey
Investigational Site Number 792008
Ankara, Turkey, 06500
Investigational Site Number 792001
Ankara, Turkey
Investigational Site Number 792006
Bursa, Turkey
Investigational Site Number 792003
İstanbul, Turkey
Investigational Site Number 792004
Istanbul, Turkey
Ukraine
Investigational Site Number 804007
Chernivtsi, Ukraine, 58023
Investigational Site Number 804004
Dnipro, Ukraine, 49101
Investigational Site Number 804011
Ivano-Frankivsk, Ukraine, 76014
Investigational Site Number 804005
Kharkiv, Ukraine, 61093
Investigational Site Number 804008
Kryvyi Rig, Ukraine, 50082
Investigational Site Number 804001
Kyiv, Ukraine, 03115
Investigational Site Number 804002
Zaporizhzhya, Ukraine, 69063
Investigational Site Number 804003
Zaporizhzhya, Ukraine, 69076
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