An Evaluation of Dupilumab in Patients With Moderate to Severe Uncontrolled Asthma

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Sanofi
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01854047
First received: May 10, 2013
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

Primary Objective:

To evaluate the efficacy of different doses and regimens of dupilumab in patients with moderate to severe, uncontrolled asthma

Secondary Objective:

To evaluate different doses and regimens of dupilumab in patients with moderate to severe uncontrolled asthma, with regard to:

  • Safety and tolerability
  • Dupilumab systemic exposure and anti-drug antibodies

Condition Intervention Phase
Asthma
Drug: dupilumab SAR231893 (REGN668)
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate Dupilumab in Patients With Moderate to Severe Uncontrolled Asthma

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change from baseline in forced expiratory volume (FEV1) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Relative change from baseline in FEV1 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Annualized rate of loss of asthma control - Time Frame: Week 24 - Safety issue: No [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Time to loss of asthma control [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Change from baseline in asthma symptom scores [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 750
Study Start Date: June 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: dupilumab treatment 1
dupilumab loading Dose 1x2, followed by Dose 1 every 2 weeks in combination with inhaled corticosteroid/long-acting beta-2 agonist
Drug: dupilumab SAR231893 (REGN668)
Pharmaceutical form:solution Route of administration: subcutaneous
Experimental: dupilumab treatment 2
dupilumab loading Dose 2x2, followed by Dose 2 every 2 weeks in combination with inhaled corticosteroid/long-acting beta-2 agonist
Drug: dupilumab SAR231893 (REGN668)
Pharmaceutical form:solution Route of administration: subcutaneous
Experimental: dupilumab treatment 3
dupilumab loading Dose 1x2, followed by Dose 1 alternating with placebo every 2 weeks in combination with inhaled corticosteroid/long-acting beta-2 agonist
Drug: dupilumab SAR231893 (REGN668)
Pharmaceutical form:solution Route of administration: subcutaneous
Experimental: dupilumab treatment 4
dupilumab loading Dose 2x2, followed by Dose 2 alternating with placebo every 2 weeks in combination with inhaled corticosteroid/long-acting beta-2 agonist
Drug: dupilumab SAR231893 (REGN668)
Pharmaceutical form:solution Route of administration: subcutaneous
Placebo Comparator: placebo treatment 5
placebo loading dose x2, followed by placebo dose every 2 weeks in combination with inhaled corticosteroid/long-acting beta-2 agonist
Drug: placebo
Pharmaceutical form:solution Route of administration: subcutaneous

Detailed Description:

Screening Period (14-21 days) + Randomized Treatment Period (24 weeks) + Post-treatment Period (16 weeks) = 42-43 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

Patients with a physician diagnosis of moderate to severe, uncontrolled asthma for ≥12 months, based on the Global Initiative for Asthma (GINA) 2009 Guidelines and:

  • Existing treatment with moderate- or high-dose inhaled corticosteroid / long-acting beta-2 agonist
  • Forced expiratory volume (FEV1) 40 to 80% of predicted normal
  • Juniper Asthma Control Questionnaire, 5-question version (ACQ-5) score ≥1.5
  • Reversibility of at least 12% and 200 mL in forced expiratory volume (FEV1)
  • Has experienced, within prior year: hospitalization, emergency or urgent care visit or systemic corticosteroid treatment for worsening asthma

Exclusion criteria:

  • Patients <18 years
  • Chronic obstructive pulmonary disease (COPD) or other lung diseases (eg, emphysema, idiopathic pulmonary fibrosis, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis) which impair pulmonary function tests
  • Chest X-ray within 12 months of screening visit or at screening visit with clinically significant findings of lung disease(s) other than asthma
  • Current smoker or cessation of smoking within 6 months prior to Visit 1
  • Previous smoker with a smoking history >10 pack-years

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

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01854047

Contacts
Contact: For site information, send an email with site number to Contact-Us@sanofi.com

  Show 207 Study Locations
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01854047     History of Changes
Other Study ID Numbers: DRI12544, 2013-000856-16, U1111-1138-3962
Study First Received: May 10, 2013
Last Updated: July 21, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 24, 2014