Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT01312961

CompletedPhase 2

Sponsor: Sanofi

Conditions: Asthma

Interventions: Dupilumab, Placebo (for Dupilumab), Fluticasone/Salmeterol combination therapy, Fluticasone monotherapy, Albuterol

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion criteria:

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.

Exclusion criteria:

* 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.
Locations (50)
  • Anaheim, California, United States
  • Long Beach, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Mission Viejo, California, United States
  • Orange, California, United States
  • Riverside, California, United States
  • Rolling Hills Estates, California, United States
  • San Francisco, California, United States
  • San Francisco, California, United States
  • San Jose, California, United States
  • Santa Rosa, California, United States
  • Stockton, California, United States
  • Colorado Springs, Colorado, United States
  • Denver, Colorado, United States
  • Denver, Colorado, United States
  • New Haven, Connecticut, United States
  • Tallahassee, Florida, United States
  • Tampa, Florida, United States
  • Indianapolis, Indiana, United States
  • Iowa City, Iowa, United States
  • Overland Park, Kansas, United States
  • Owensboro, Kentucky, United States
  • Baltimore, Maryland, United States
  • North Dartmouth, Massachusetts, United States
  • Minneapolis, Minnesota, United States
  • Minneapolis, Minnesota, United States
  • St Louis, Missouri, United States
  • St Louis, Missouri, United States
  • Bozeman, Montana, United States
  • + 20 more on CT.gov