Clinical trial NCT01312961: Efficacy, Safety, and Tolerability of Dupilumab in Patients With Persistent Moderate to Severe Eosinophilic Asthma
Official title: Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety, and Tolerability of SAR231893/REGN668 Administered Subcutaneously Once Weekly for 12 Weeks in Patients With Persistent Moderate to Severe Eosinophilic Asthma Who Are Partially Controlled/Uncontrolled by Inhaled Corticosteroid Plus Long-acting beta2 Agonist Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2011-03-11
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The total duration of the study period per participant was 20-22 weeks broken down as follows:

* Screening period: up to 14 days,
* Treatment period: 12 weeks,
* Follow-up period: 6-8 weeks.

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.

Primary outcomes:
measure: Percentage of Participants With Asthma Exacerbation
timeFrame: Baseline up to Week 12
Secondary outcomes:
measure: Time to First Asthma Exacerbation: Kaplan-Meier Estimates at Week 4, Week 8 and Week 12
timeFrame: Baseline up to Week 12
measure: Percentage of Participants With Composite Asthma Events
timeFrame: Baseline up to Week 12
measure: Change From Baseline in Forced Expiratory Flow in One Second (FEV1) to Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Peak Expiratory Flow (PEF) to Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Asthma Control Questionnaire (5-question Version [ACQ-5]) to Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in 22-item Sinonasal Outcome Test (SNOT-22) Score to Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Morning Asthma Symptom Scores to Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Evening Asthma Symptom Scores to Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Number of Nocturnal Awakenings Per Day to Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Number of Inhalations Per Day of Albuterol or Levalbuterol to Week 12
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Investigational Site Number 840047
state: California
city: Long Beach
country: United States
facility: Investigational Site Number 840046
state: California
city: Los Angeles
country: United States
facility: Investigational Site Number 840032
state: California
city: Los Angeles
country: United States
facility: Investigational Site Number 840036
state: California
city: Mission Viejo
country: United States
facility: Investigational Site Number 840005
state: California
city: Orange
country: United States
facility: Investigational Site Number 840007
state: California
city: Riverside
country: United States
facility: Investigational Site Number 840048
state: California
city: Rolling Hills Estates
country: United States
facility: Investigational Site Number 840035
state: California
city: San Francisco
country: United States
facility: Investigational Site Number 840041
state: California
city: San Francisco
country: United States
facility: Investigational Site Number 840042
state: California
city: San Jose
country: United States
facility: Investigational Site Number 840039
state: California
city: Santa Rosa
country: United States
facility: Investigational Site Number 840024
state: California
city: Stockton
country: United States
facility: Investigational Site Number 840002
state: California
city: Colorado Springs
country: United States
facility: Investigational Site Number 840031
state: Colorado
city: Denver
country: United States
facility: Investigational Site Number 840011
state: Colorado
city: Denver
country: United States
facility: Investigational Site Number 840017
state: Colorado
city: New Haven
country: United States
facility: Investigational Site Number 840026
state: Connecticut
city: Tallahassee
country: United States
facility: Investigational Site Number 840044
state: Florida
city: Tampa
country: United States
facility: Investigational Site Number 840029
state: Florida
city: Indianapolis
country: United States
facility: Investigational Site Number 840028
state: Indiana
city: Iowa City
country: United States
facility: Investigational Site Number 840038
state: Iowa
city: Overland Park
country: United States
facility: Investigational Site Number 840021
state: Kansas
city: Owensboro
country: United States
facility: Investigational Site Number 840053
state: Kentucky
city: Baltimore
country: United States
facility: Investigational Site Number 840014
state: Maryland
city: North Dartmouth
country: United States
facility: Investigational Site Number 840015
state: Massachusetts
city: Minneapolis
country: United States
facility: Investigational Site Number 840003
state: Minnesota
city: Minneapolis
country: United States
facility: Investigational Site Number 840010
state: Minnesota
city: Saint Louis
country: United States
facility: Investigational Site Number 840006
state: Missouri
city: Saint Louis
country: United States
facility: Investigational Site Number 840013
state: Missouri
city: Bozeman
country: United States
facility: Investigational Site Number 840022
state: Montana
city: Omaha
country: United States
facility: Investigational Site Number 840025
state: Nebraska
city: Papillion
country: United States
facility: Investigational Site Number 840008
state: Nebraska
city: Princeton
country: United States
facility: Investigational Site Number 840018
state: New Jersey
city: Winston-Salem
country: United States
facility: Investigational Site Number 840004
state: North Carolina
city: Sylvania
country: United States
facility: Investigational Site Number 840023
state: Ohio
city: Oklahoma City
country: United States
facility: Investigational Site Number 840045
state: Oklahoma
city: Lake Oswego
country: United States
facility: Investigational Site Number 840001
state: Oregon
city: Medford
country: United States
facility: Investigational Site Number 840012
state: Oregon
city: Portland
country: United States
facility: Investigational Site Number 840016
state: Oregon
city: Hershey
country: United States
facility: Investigational Site Number 840040
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Investigational Site Number 840037
state: Pennsylvania
city: Upland
country: United States
facility: Investigational Site Number 840009
state: Pennsylvania
city: Charleston
country: United States
facility: Investigational Site Number 840027
state: South Carolina
city: El Paso
country: United States
facility: Investigational Site Number 840030
state: Texas
city: San Antonio
country: United States
facility: Investigational Site Number 840050
state: Texas
city: South Burlington
country: United States
facility: Investigational Site Number 840052
state: Vermont
city: Richmond
country: United States
facility: Investigational Site Number 840049
state: Virginia
city: Seattle
country: United States
facility: Investigational Site Number 840020
state: Washington
city: Tacoma
country: United States
facility: Investigational Site Number 840019
state: Washington
city: Madison
country: United States
facility: Investigational Site Number 840034
state: Wisconsin
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: Wenzel S, Ford L, Pearlman D, Spector S, Sher L, Skobieranda F, Wang L, Kirkesseli S, Rocklin R, Bock B, Hamilton J, Ming JE, Radin A, Stahl N, Yancopoulos GD, Graham N, Pirozzi G. Dupilumab in persistent asthma with elevated eosinophil levels. N Engl J Med. 2013 Jun 27;368(26):2455-66. doi: 10.1056/NEJMoa1304048. Epub 2013 May 21.