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

Primary Purpose

Asthma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dupilumab
Placebo (for Dupilumab)
Fluticasone/Salmeterol combination therapy
Fluticasone monotherapy
Albuterol
Levalbuterol
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigational Site Number 840047
  • Investigational Site Number 840046
  • Investigational Site Number 840032
  • Investigational Site Number 840036
  • Investigational Site Number 840005
  • Investigational Site Number 840007
  • Investigational Site Number 840048
  • Investigational Site Number 840035
  • Investigational Site Number 840041
  • Investigational Site Number 840042
  • Investigational Site Number 840039
  • Investigational Site Number 840024
  • Investigational Site Number 840002
  • Investigational Site Number 840031
  • Investigational Site Number 840011
  • Investigational Site Number 840017
  • Investigational Site Number 840026
  • Investigational Site Number 840044
  • Investigational Site Number 840029
  • Investigational Site Number 840028
  • Investigational Site Number 840038
  • Investigational Site Number 840021
  • Investigational Site Number 840053
  • Investigational Site Number 840014
  • Investigational Site Number 840015
  • Investigational Site Number 840003
  • Investigational Site Number 840010
  • Investigational Site Number 840006
  • Investigational Site Number 840013
  • Investigational Site Number 840022
  • Investigational Site Number 840025
  • Investigational Site Number 840008
  • Investigational Site Number 840018
  • Investigational Site Number 840004
  • Investigational Site Number 840023
  • Investigational Site Number 840045
  • Investigational Site Number 840001
  • Investigational Site Number 840012
  • Investigational Site Number 840016
  • Investigational Site Number 840040
  • Investigational Site Number 840037
  • Investigational Site Number 840009
  • Investigational Site Number 840027
  • Investigational Site Number 840030
  • Investigational Site Number 840050
  • Investigational Site Number 840052
  • Investigational Site Number 840049
  • Investigational Site Number 840020
  • Investigational Site Number 840019
  • Investigational Site Number 840034

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo (for Dupilumab)

Dupilumab 300 mg qw

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Percentage of Participants With Asthma Exacerbation
An asthma exacerbation was defined as the occurrence of any of the following: ≥30% reduction from baseline in morning PEF on 2 consecutive days; or ≥6 additional reliever puffs of albuterol or levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days; or deterioration of asthma, as determined by the investigator, requiring systemic steroid treatment, or an increase in inhaled corticosteroid (ICS) of ≥4 times the last dose received prior to discontinuation from the study, or hospitalization. The occurrence of asthma exacerbations by individual criteria are reported.

Secondary Outcome Measures

Time to First Asthma Exacerbation: Kaplan-Meier Estimates at Week 4, Week 8 and Week 12
The time-to-asthma exacerbation was defined as the time from the date of randomization to the date of the first asthma exacerbation event; for participants without asthma exacerbation, it was censored at the end of treatment visit date. The median time to first asthma exacerbation was not estimated because the number of asthma exacerbations was too low in the Dupilumab arm. Therefore, alternative Kaplan-Meier statistics, the probability of asthma exacerbation at Week 4, 8 and 12, are presented as the descriptive measure statistics.
Percentage of Participants With Composite Asthma Events
Composite asthma event was defined as a 30% or greater reduction from baseline in morning PEF on 2 consecutive days together with 6 or more additional reliever puffs of albuterol or levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days.
Change From Baseline in Forced Expiratory Flow in One Second (FEV1) to Week 12
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.
Change From Baseline in Peak Expiratory Flow (PEF) to Week 12
The PEF is a participant's maximum speed of expiration, as measured with a peak flow meter. Peak flow testing for PEF was performed at home (morning and evening) while sitting or standing prior to using any medication (if needed) for asthma.
Change From Baseline in Asthma Control Questionnaire (5-question Version [ACQ-5]) to Week 12
ACQ-5 questionnaire is a validated questionnaire comprising of 5 questions for asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath, and wheeze. Participants were asked to rate their asthma symptoms during the previous week on a 7-point scale as 0=no impairment, 6=maximum impairment. ACQ-5 score is the mean of the 5 questions and range between 0 (disease totally controlled) and 6 (disease severely uncontrolled), a higher score indicated lower asthma control.
Change From Baseline in 22-item Sinonasal Outcome Test (SNOT-22) Score to Week 12
The SNOT-22 is a validated measure of health related quality of life in sinonasal disease. It is a 22 item questionnaire with each item assigned a score ranging from 0-5. The total score may range from 0 (no disease) -110 (worst disease), lower scores represent better health related quality of life.
Change From Baseline in Morning Asthma Symptom Scores to Week 12
AM (ante meridiem) symptom scoring system rates were participant's overall asthma symptoms experienced during the night. It ranges from 0 to 4 as: 0 = No asthma symptoms, slept through the night, 1= Slept well, but some complaints in the morning. No nighttime awakenings,2= Woke up once because of asthma (including early awakening),3= Woke up several times because of asthma (including early awakening), 4= Bad night, awake most of the night because of asthma.
Change From Baseline in Evening Asthma Symptom Scores to Week 12
PM (post meridiem) symptom scoring system rates were participant's overall asthma symptoms experienced during the day. It ranges from 0 to 4 as: 0=very well, no asthma symptoms, 1=one episode of wheezing, cough, or breathlessness, 2=more than one episode of wheezing, cough, or breathlessness without interference of normal activities, 3=wheezing, cough, or breathlessness most of the day, which interfered to some extent with normal activities, 4=asthma very bad, unable to carry out daily activities as usual.
Change From Baseline in Number of Nocturnal Awakenings Per Day to Week 12
Participants recorded every morning on awakening the number of asthma-related nocturnal awakenings requiring use of rescue medication that occurred during the previous night.
Change From Baseline in Number of Inhalations Per Day of Albuterol or Levalbuterol to Week 12
Number of Albuterol or Levalbuterol inhalations were recorded daily by the participants in their electronic diary as Albuterol or Levalbuterol was to be used only as needed for symptoms, not on a regular basis or prophylactically.

Full Information

First Posted
March 9, 2011
Last Updated
June 7, 2017
Sponsor
Sanofi
Collaborators
Regeneron Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01312961
Brief Title
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

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
Collaborators
Regeneron Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo (for Dupilumab)
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Dupilumab 300 mg qw
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dupilumab
Other Intervention Name(s)
SAR231893, REGN668
Intervention Description
Solution for injection, one subcutaneous injection.
Intervention Type
Drug
Intervention Name(s)
Placebo (for Dupilumab)
Intervention Description
Solution for injection, one subcutaneous injection.
Intervention Type
Drug
Intervention Name(s)
Fluticasone/Salmeterol combination therapy
Intervention Description
Oral inhalation twice daily.
Intervention Type
Drug
Intervention Name(s)
Fluticasone monotherapy
Intervention Description
Oral inhalation twice daily.
Intervention Type
Drug
Intervention Name(s)
Albuterol
Intervention Description
Oral inhalation as needed.
Intervention Type
Drug
Intervention Name(s)
Levalbuterol
Intervention Description
Oral inhalation as needed.
Primary Outcome Measure Information:
Title
Percentage of Participants With Asthma Exacerbation
Description
An asthma exacerbation was defined as the occurrence of any of the following: ≥30% reduction from baseline in morning PEF on 2 consecutive days; or ≥6 additional reliever puffs of albuterol or levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days; or deterioration of asthma, as determined by the investigator, requiring systemic steroid treatment, or an increase in inhaled corticosteroid (ICS) of ≥4 times the last dose received prior to discontinuation from the study, or hospitalization. The occurrence of asthma exacerbations by individual criteria are reported.
Time Frame
Baseline up to Week 12
Secondary Outcome Measure Information:
Title
Time to First Asthma Exacerbation: Kaplan-Meier Estimates at Week 4, Week 8 and Week 12
Description
The time-to-asthma exacerbation was defined as the time from the date of randomization to the date of the first asthma exacerbation event; for participants without asthma exacerbation, it was censored at the end of treatment visit date. The median time to first asthma exacerbation was not estimated because the number of asthma exacerbations was too low in the Dupilumab arm. Therefore, alternative Kaplan-Meier statistics, the probability of asthma exacerbation at Week 4, 8 and 12, are presented as the descriptive measure statistics.
Time Frame
Baseline up to Week 12
Title
Percentage of Participants With Composite Asthma Events
Description
Composite asthma event was defined as a 30% or greater reduction from baseline in morning PEF on 2 consecutive days together with 6 or more additional reliever puffs of albuterol or levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days.
Time Frame
Baseline up to Week 12
Title
Change From Baseline in Forced Expiratory Flow in One Second (FEV1) to Week 12
Description
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.
Time Frame
Baseline, Week 12
Title
Change From Baseline in Peak Expiratory Flow (PEF) to Week 12
Description
The PEF is a participant's maximum speed of expiration, as measured with a peak flow meter. Peak flow testing for PEF was performed at home (morning and evening) while sitting or standing prior to using any medication (if needed) for asthma.
Time Frame
Baseline, Week 12
Title
Change From Baseline in Asthma Control Questionnaire (5-question Version [ACQ-5]) to Week 12
Description
ACQ-5 questionnaire is a validated questionnaire comprising of 5 questions for asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath, and wheeze. Participants were asked to rate their asthma symptoms during the previous week on a 7-point scale as 0=no impairment, 6=maximum impairment. ACQ-5 score is the mean of the 5 questions and range between 0 (disease totally controlled) and 6 (disease severely uncontrolled), a higher score indicated lower asthma control.
Time Frame
Baseline, Week 12
Title
Change From Baseline in 22-item Sinonasal Outcome Test (SNOT-22) Score to Week 12
Description
The SNOT-22 is a validated measure of health related quality of life in sinonasal disease. It is a 22 item questionnaire with each item assigned a score ranging from 0-5. The total score may range from 0 (no disease) -110 (worst disease), lower scores represent better health related quality of life.
Time Frame
Baseline, Week 12
Title
Change From Baseline in Morning Asthma Symptom Scores to Week 12
Description
AM (ante meridiem) symptom scoring system rates were participant's overall asthma symptoms experienced during the night. It ranges from 0 to 4 as: 0 = No asthma symptoms, slept through the night, 1= Slept well, but some complaints in the morning. No nighttime awakenings,2= Woke up once because of asthma (including early awakening),3= Woke up several times because of asthma (including early awakening), 4= Bad night, awake most of the night because of asthma.
Time Frame
Baseline, Week 12
Title
Change From Baseline in Evening Asthma Symptom Scores to Week 12
Description
PM (post meridiem) symptom scoring system rates were participant's overall asthma symptoms experienced during the day. It ranges from 0 to 4 as: 0=very well, no asthma symptoms, 1=one episode of wheezing, cough, or breathlessness, 2=more than one episode of wheezing, cough, or breathlessness without interference of normal activities, 3=wheezing, cough, or breathlessness most of the day, which interfered to some extent with normal activities, 4=asthma very bad, unable to carry out daily activities as usual.
Time Frame
Baseline, Week 12
Title
Change From Baseline in Number of Nocturnal Awakenings Per Day to Week 12
Description
Participants recorded every morning on awakening the number of asthma-related nocturnal awakenings requiring use of rescue medication that occurred during the previous night.
Time Frame
Baseline, Week 12
Title
Change From Baseline in Number of Inhalations Per Day of Albuterol or Levalbuterol to Week 12
Description
Number of Albuterol or Levalbuterol inhalations were recorded daily by the participants in their electronic diary as Albuterol or Levalbuterol was to be used only as needed for symptoms, not on a regular basis or prophylactically.
Time Frame
Baseline, Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 840047
City
Anaheim
State/Province
California
ZIP/Postal Code
92804
Country
United States
Facility Name
Investigational Site Number 840046
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Investigational Site Number 840032
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Investigational Site Number 840036
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Investigational Site Number 840005
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
Investigational Site Number 840007
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Investigational Site Number 840048
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
Investigational Site Number 840035
City
Rolling Hills Estates
State/Province
California
ZIP/Postal Code
90274
Country
United States
Facility Name
Investigational Site Number 840041
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Investigational Site Number 840042
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Investigational Site Number 840039
City
San Jose
State/Province
California
ZIP/Postal Code
95117
Country
United States
Facility Name
Investigational Site Number 840024
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95405
Country
United States
Facility Name
Investigational Site Number 840002
City
Stockton
State/Province
California
ZIP/Postal Code
95207
Country
United States
Facility Name
Investigational Site Number 840031
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Investigational Site Number 840011
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
Investigational Site Number 840017
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
Investigational Site Number 840026
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Investigational Site Number 840044
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Investigational Site Number 840029
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Investigational Site Number 840028
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46208
Country
United States
Facility Name
Investigational Site Number 840038
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52240
Country
United States
Facility Name
Investigational Site Number 840021
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
Investigational Site Number 840053
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42303
Country
United States
Facility Name
Investigational Site Number 840014
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Investigational Site Number 840015
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Investigational Site Number 840003
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402
Country
United States
Facility Name
Investigational Site Number 840010
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402
Country
United States
Facility Name
Investigational Site Number 840006
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Investigational Site Number 840013
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Investigational Site Number 840022
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59718
Country
United States
Facility Name
Investigational Site Number 840025
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Investigational Site Number 840008
City
Papillion
State/Province
Nebraska
ZIP/Postal Code
27103
Country
United States
Facility Name
Investigational Site Number 840018
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
Facility Name
Investigational Site Number 840004
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1071
Country
United States
Facility Name
Investigational Site Number 840023
City
Sylvania
State/Province
Ohio
ZIP/Postal Code
43560
Country
United States
Facility Name
Investigational Site Number 840045
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Investigational Site Number 840001
City
Lake Oswego
State/Province
Oregon
ZIP/Postal Code
97035
Country
United States
Facility Name
Investigational Site Number 840012
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Investigational Site Number 840016
City
Portland
State/Province
Oregon
ZIP/Postal Code
97209
Country
United States
Facility Name
Investigational Site Number 840040
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Investigational Site Number 840037
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Investigational Site Number 840009
City
Upland
State/Province
Pennsylvania
ZIP/Postal Code
19013
Country
United States
Facility Name
Investigational Site Number 840027
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Investigational Site Number 840030
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Facility Name
Investigational Site Number 840050
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Investigational Site Number 840052
City
South Burlington
State/Province
Vermont
ZIP/Postal Code
05403
Country
United States
Facility Name
Investigational Site Number 840049
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23229
Country
United States
Facility Name
Investigational Site Number 840020
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Investigational Site Number 840019
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98415-0299
Country
United States
Facility Name
Investigational Site Number 840034
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23688323
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.
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Efficacy, Safety, and Tolerability of Dupilumab in Patients With Persistent Moderate to Severe Eosinophilic Asthma

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