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

NCT01854047

CompletedPhase 2

Sponsor: Sanofi

Conditions: Asthma

Interventions: Dupilumab, placebo, ICS/LABA therapy, Salbutamol/albuterol, Levosalbutamol/levalbuterol

Countries: United States, Argentina, Australia, Chile, France, Italy, Japan, Mexico

Primary Objective: To evaluate the efficacy of different doses and regimens of dupilumab in participants with moderate to severe uncontrolled asthma. Secondary Objective: To evaluate different doses and regimens of dupilumab in participants with moderate to severe uncontrolled asthma, with regard to: * Safety and tolerability * Dupilumab systemic exposure and anti-drug antibodies

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion criteria:

Participants 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
* Asthma Control Questionnaire, 5-question version (ACQ-5) score \>=1.5
* Reversibility of at least 12% and 200 mL in forced expiratory volume (FEV1)
* Had experienced, within prior year: hospitalization, emergency or urgent care visit or systemic corticosteroid treatment for worsening asthma

Exclusion criteria:

* Participants \<18 years
* Chronic obstructive pulmonary disease (COPD) or other lung diseases (eg, emphysema, idiopathic pulmonary fibrosis, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis) which impaired 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 was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Locations (201)
  • Fullerton, California, United States
  • Huntington Beach, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Mission Viejo, California, United States
  • Newport Beach, California, United States
  • Riverside, California, United States
  • Rolling Hills Estates, California, United States
  • San Jose, California, United States
  • Colorado Springs, Colorado, United States
  • Colorado Springs, Colorado, United States
  • Denver, Colorado, United States
  • Denver, Colorado, United States
  • Denver, Colorado, United States
  • Daytona Beach, Florida, United States
  • Miami, Florida, United States
  • Albany, Georgia, United States
  • River Forest, Illinois, United States
  • Evansville, Indiana, United States
  • Louisville, Kentucky, United States
  • Owensboro, Kentucky, United States
  • Baltimore, Maryland, United States
  • Wheaton, Maryland, United States
  • North Dartmouth, Massachusetts, United States
  • Novi, Michigan, United States
  • Novi, Michigan, United States
  • Minneapolis, Minnesota, United States
  • St Louis, Missouri, United States
  • St Louis, Missouri, United States
  • + 171 more on CT.gov