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Evaluation of Dupilumab in Patients With Persistent Asthma (Liberty Asthma Quest)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02414854
First Posted: April 13, 2015
Last Update Posted: December 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
  Purpose

Primary Objective:

To evaluate the efficacy of dupilumab (SAR231893 / REGN668) in patients with persistent asthma.

Secondary Objectives:

To evaluate the safety and tolerability of dupilumab. To evaluate the effect of dupilumab in improving patient-reported outcomes including health-related quality of life.

To evaluate dupilumab systemic exposure and incidence of antidrug antibodies.


Condition Intervention Phase
Asthma Drug: Dupilumab Drug: placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Persistent Asthma

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Annualized rate of severe exacerbation events [ Time Frame: 52 weeks ]
  • Absolute change from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1) [ Time Frame: Week 12 ]

Secondary Outcome Measures:
  • Percent change from baseline in pre-bronchodilator FEV1 [ Time Frame: Week 12 ]
  • Absolute change from baseline in pre-bronchodilator FEV1 [ Time Frame: Weeks 2, 4, 8, 24, 36, and 52 ]
  • Percent change from baseline in pre-bronchodilator FEV1 [ Time Frame: Weeks 2, 4, 8, 24, 36, and 52 ]
  • Annualized rate of loss of asthma control (LOAC) event [ Time Frame: 52 weeks ]
  • Annualized rate of severe exacerbation events resulting in hospitalization or emergency room visit [ Time Frame: 52 weeks ]
  • Time to first severe exacerbation event [ Time Frame: 52 weeks ]
  • Time to first loss of asthma control event [ Time Frame: 52 weeks ]

Enrollment: 1902
Study Start Date: April 27, 2015
Study Completion Date: November 23, 2017
Primary Completion Date: July 29, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: dupilumab dose 1
Dupilumab dose 1 every 2 weeks (loading dose with a double dose) added to current controller medications
Drug: Dupilumab

Pharmaceutical form:solution

Route of administration: subcutaneous

Other Names:
  • SAR231893
  • REGN668
Experimental: dupilumab dose 2
Dupilumab dose 2 every 2 weeks (loading dose with a double dose) added to current controller medications
Drug: Dupilumab

Pharmaceutical form:solution

Route of administration: subcutaneous

Other Names:
  • SAR231893
  • REGN668
Placebo Comparator: placebo (for dupilumab dose 1)
Placebo (for dupilumab dose 1) every 2 weeks (loading dose with a double dose) added to current controller medications
Drug: placebo

Pharmaceutical form:solution

Route of administration: subcutaneous

Placebo Comparator: placebo (for dupilumab dose 2)
Placebo (for dupilumab dose 2) every 2 weeks (loading dose with a double dose) added to current controller medications
Drug: placebo

Pharmaceutical form:solution

Route of administration: subcutaneous


Detailed Description:
The total duration of study period for each patient is 67 to 69 weeks, including a screening period of 3 to 5 weeks, treatment period of 52 weeks, and posttreatment period of 12 weeks.
  Eligibility

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.


Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Adults and adolescent patients with a physician diagnosis of asthma for ≥12 months, based on the Global Initiative for Asthma (GINA) 2014 Guidelines and the following criteria:
  • Existing treatment with medium to high dose inhaled corticosteroid [ICS] (≥250 mcg of fluticasone propionate twice daily or equipotent ICS daily dosage to a maximum of 2000 mcg/day of fluticasone propionate or equivalent) in combination with a second controller (eg, long-acting beta agonist, leukotriene receptor antagonist) for at least 3 months with a stable dose ≥1 month prior to Visit 1.
  • Note for Japan: for subjects aged 18 years and older, ICS must be on ≥200 mcg of fluticasone propionate twice daily or equivalent; for subjects aged 12 to 17 years, ICS must be ≥100 mcg of fluticasone propionate twice daily or equivalent).
  • Patients requiring a third controller for their asthma will be considered eligible for this study, and it should also be used for at least 3 months with a stable dose ≥1 month prior to Visit 1.

Exclusion criteria:

  • Patients <12 years of age or the minimum legal age for adolescents in the country of the investigative site, whichever is higher (For those countries where local regulations permit enrollment of adults only, subject recruitment will be restricted to those who are ≥18 years of age).
  • Weight is less than 30 kilograms.
  • Chronic obstructive pulmonary disease or other lung diseases (eg, idiopathic pulmonary fibrosis, Churg-Strauss Syndrome, etc) which may impair lung function.
  • A subject who experiences a severe asthma exacerbation (defined as a deterioration of asthma that results in emergency treatment, hospitalization due to asthma, or treatment with systemic steroids at any time from 1 month prior to the Screening Visit up to and including the Baseline Visit).
  • Evidence of lung disease(s) other than asthma, either clinical evidence or imaging (Chest X-ray, CT, MRI) within 12 months of Visit 1 or at the screening visit, as per local standard of care.
  • Note for Japan: According to the request from the health authority, chest X-ray should be performed at screening visit if there is no chest imaging (Chest X-ray, CT, MRI) available within 3 months prior to screening to exclude patients with suspected active or untreated latent tuberculosis.
  • Current smoker or cessation of smoking within 6 months prior to Visit 1.
  • Previous smoker with a smoking history >10 pack-years.
  • Comorbid disease that might interfere with the evaluation of Investigational Medicinal Product.

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

  Contacts and Locations
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): NCT02414854


  Show 389 Study Locations
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02414854     History of Changes
Other Study ID Numbers: EFC13579
2014-004940-36 ( EudraCT Number )
U1111-1163-1293 ( Other Identifier: UTN )
First Submitted: April 8, 2015
First Posted: April 13, 2015
Last Update Posted: December 15, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases