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Clinical Trials/EUCTR2016-001607-23-HU
EUCTR2016-001607-23-HU
Active, not recruiting
Phase 1

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 - Liberty Asthma Voyage

Sanofi-Aventis Recherche & Développement0 sites785 target enrollmentMay 16, 2017
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ConditionsAsthmaMedDRA version: 20.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Asthma
Sponsor
Sanofi-Aventis Recherche & Développement
Enrollment
785
Status
Active, not recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 16, 2017
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility 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 ß2 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 400mcg (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 prescibed 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.

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).

Outcomes

Primary Outcomes

Not specified

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