Efficacy, Safety, and Tolerability of Dupilumab in Patients With Persistent Moderate to Severe Eosinophilic Asthma

Completed · Phase 2 · Has a placebo group

Conditions studied: Asthma

In brief

Primary Objective: To investigate the effects of Dupilumab (SAR231893/REGN668) administered subcutaneously (SC) once weekly (qw) for 12 weeks as compared to placebo on reducing the incidence of asthma exacerbation in participants with persistent moderate to severe eosinophilic asthma. Secondary Objectives: * To assess the safety and tolerability of Dupilumab administered SC qw for 12 weeks in participants with persistent moderate to severe eosinophilic asthma. * To assess Dupilumab serum concentrations following qw SC dosing for 12 weeks in participants with persistent moderate to severe eosinophilic asthma.

Key facts

Study ID

NCT01312961

Run by

Sanofi

People needed

104

Starts

2011-03-01

Expected to finish

2012-10-01

Last updated by the study team

2017-06-08

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Medical diagnosis of persistent asthma for at least 12 months whose:
• airway inflammation likely to be eosinophilic,
• asthma partially controlled or uncontrolled on ICS plus LABA therapy.
• On a stable dose of either Fluticasone/Salmeterol, Budesonide/Formoterol, Mometasone/Formoterol combination therapy for at least 1 month prior to screening.
• Signed an Informed Consent Form and Health Insurance Portability and Accountability Act (HIPAA) Authorization Form.

You may not qualify if…

• Less than 18 years or greater than 65 years of age.
• Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further evaluation.
• Chronic obstructive pulmonary disease and/or other lung diseases impairing Pulmonary Function Tests.
• Beta-adrenergic receptor blockers required for any reason.
• Current smoker or cessation of smoking within the 6 months prior to screening.
• Previous smoking with a smoking history >10 cigarette pack/years.
• Participation in another study within 6 months prior to screening if the study medication was an antibody or within 30 days prior to screening for all other study medications.
• Known or suspected non-compliance, alcohol or drug abuse.
• Inability to follow the procedures of the study (e.g, due to language problems, psychological disorders).
• Concomitant severe diseases or diseases for which the use of ICS or LABA were contraindicated.
• Known allergy to doxycycline or related compounds.
• Pregnancy or intention to become pregnant during the course of the study, breast feeding, or unwillingness to use a highly effective method of contraception throughout the study in women of childbearing potential.
• Recent history of a parasitic infection or travel to a parasitic endemic area within 6 months prior to screening.
• The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Where it is running

• Investigational Site Number 840047 — Anaheim, California, United States
• Investigational Site Number 840046 — Long Beach, California, United States
• Investigational Site Number 840032 — Los Angeles, California, United States
• Investigational Site Number 840036 — Los Angeles, California, United States
• Investigational Site Number 840005 — Mission Viejo, California, United States
• Investigational Site Number 840007 — Orange, California, United States
• Investigational Site Number 840048 — Riverside, California, United States
• Investigational Site Number 840035 — Rolling Hills Estates, California, United States
• Investigational Site Number 840041 — San Francisco, California, United States
• Investigational Site Number 840042 — San Francisco, California, United States
• Investigational Site Number 840039 — San Jose, California, United States
• Investigational Site Number 840024 — Santa Rosa, California, United States
• Investigational Site Number 840002 — Stockton, California, United States
• Investigational Site Number 840031 — Colorado Springs, Colorado, United States
• Investigational Site Number 840011 — Denver, Colorado, United States
• Investigational Site Number 840017 — Denver, Colorado, United States
• Investigational Site Number 840026 — New Haven, Connecticut, United States
• Investigational Site Number 840044 — Tallahassee, Florida, United States
• Investigational Site Number 840029 — Tampa, Florida, United States
• Investigational Site Number 840028 — Indianapolis, Indiana, United States
• Investigational Site Number 840038 — Iowa City, Iowa, United States
• Investigational Site Number 840021 — Overland Park, Kansas, United States
• Investigational Site Number 840053 — Owensboro, Kentucky, United States
• Investigational Site Number 840014 — Baltimore, Maryland, United States
• Investigational Site Number 840015 — North Dartmouth, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.