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

Completed · Phase 2 · Has a placebo group

Conditions studied: Asthma

In brief

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

Key facts

Study ID

NCT01854047

Run by

Sanofi

People needed

776

Starts

2013-06-01

Expected to finish

2015-04-01

Last updated by the study team

2017-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Investigational Site Number 840041 — Huntington Beach, California, United States
• Investigational Site Number 840019 — Los Angeles, California, United States
• Investigational Site Number 840029 — Los Angeles, California, United States
• Investigational Site Number 840022 — Los Angeles, California, United States
• Investigational Site Number 840013 — Mission Viejo, California, United States
• Investigational Site Number 840044 — Newport Beach, California, United States
• Investigational Site Number 840007 — Riverside, California, United States
• Investigational Site Number 840014 — Rolling Hills Estates, California, United States
• Investigational Site Number 840036 — San Jose, California, United States
• Investigational Site Number 840032 — Colorado Springs, Colorado, United States
• Investigational Site Number 840040 — Colorado Springs, Colorado, United States
• Investigational Site Number 840043 — Denver, Colorado, United States
• Investigational Site Number 840006 — Denver, Colorado, United States
• Investigational Site Number 840024 — Denver, Colorado, United States
• Investigational Site Number 840027 — Daytona Beach, Florida, United States
• Investigational Site Number 840039 — Miami, Florida, United States
• Investigational Site Number 840048 — Albany, Georgia, United States
• Investigational Site Number 840026 — River Forest, Illinois, United States
• Investigational Site Number 840053 — Evansville, Indiana, United States
• Investigational Site Number 840017 — Louisville, Kentucky, United States
• Investigational Site Number 840030 — Owensboro, Kentucky, United States
• Investigational Site Number 840028 — Baltimore, Maryland, United States
• Investigational Site Number 840052 — Wheaton, Maryland, United States
• Investigational Site Number 840045 — North Dartmouth, Massachusetts, United States
• Investigational Site Number 840050 — Fullerton, California, United States

Full record on ClinicalTrials.gov

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