Efficacy, Safety, and Tolerability of Dupilumab in Patients With Persistent Moderate to Severe Eosinophilic Asthma
NCT ID: NCT01312961
Last Updated: 2017-06-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
104 participants
INTERVENTIONAL
2011-03-31
2012-10-31
Brief Summary
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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.
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Detailed Description
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* Screening period: up to 14 days,
* Treatment period: 12 weeks,
* Follow-up period: 6-8 weeks.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo (for Dupilumab)
Placebo (for Dupilumab) subcutaneous (SC) injection once weekly (qw) for 12 weeks added to background therapy of inhaled corticosteroids/long-acting beta2-adrenergic agonist (ICS/LABA) (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
Placebo (for Dupilumab)
Solution for injection, one subcutaneous injection.
Fluticasone/Salmeterol combination therapy
Oral inhalation twice daily.
Fluticasone monotherapy
Oral inhalation twice daily.
Albuterol
Oral inhalation as needed.
Levalbuterol
Oral inhalation as needed.
Dupilumab 300 mg qw
Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
Dupilumab
Solution for injection, one subcutaneous injection.
Fluticasone/Salmeterol combination therapy
Oral inhalation twice daily.
Fluticasone monotherapy
Oral inhalation twice daily.
Albuterol
Oral inhalation as needed.
Levalbuterol
Oral inhalation as needed.
Interventions
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Dupilumab
Solution for injection, one subcutaneous injection.
Placebo (for Dupilumab)
Solution for injection, one subcutaneous injection.
Fluticasone/Salmeterol combination therapy
Oral inhalation twice daily.
Fluticasone monotherapy
Oral inhalation twice daily.
Albuterol
Oral inhalation as needed.
Levalbuterol
Oral inhalation as needed.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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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
Investigational Site Number 840003
Minneapolis, Minnesota, United States
Investigational Site Number 840010
Minneapolis, Minnesota, United States
Investigational Site Number 840006
St Louis, Missouri, United States
Investigational Site Number 840013
St Louis, Missouri, United States
Investigational Site Number 840022
Bozeman, Montana, United States
Investigational Site Number 840025
Omaha, Nebraska, United States
Investigational Site Number 840008
Papillion, Nebraska, United States
Investigational Site Number 840018
Princeton, New Jersey, United States
Investigational Site Number 840004
Winston-Salem, North Carolina, United States
Investigational Site Number 840023
Sylvania, Ohio, United States
Investigational Site Number 840045
Oklahoma City, Oklahoma, United States
Investigational Site Number 840001
Lake Oswego, Oregon, United States
Investigational Site Number 840012
Medford, Oregon, United States
Investigational Site Number 840016
Portland, Oregon, United States
Investigational Site Number 840040
Hershey, Pennsylvania, United States
Investigational Site Number 840037
Pittsburgh, Pennsylvania, United States
Investigational Site Number 840009
Upland, Pennsylvania, United States
Investigational Site Number 840027
Charleston, South Carolina, United States
Investigational Site Number 840030
El Paso, Texas, United States
Investigational Site Number 840050
San Antonio, Texas, United States
Investigational Site Number 840052
South Burlington, Vermont, United States
Investigational Site Number 840049
Richmond, Virginia, United States
Investigational Site Number 840020
Seattle, Washington, United States
Investigational Site Number 840019
Tacoma, Washington, United States
Investigational Site Number 840034
Madison, Wisconsin, United States
Countries
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References
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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.
Other Identifiers
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U1111-1117-7826
Identifier Type: OTHER
Identifier Source: secondary_id
ACT11457
Identifier Type: -
Identifier Source: org_study_id
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