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Long-Term Safety Evaluation of Dupilumab in Patients With Asthma (LIBERTY ASTHMA TRAVERSE)

Primary Purpose

Asthma

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Dupilumab

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

- Participants with asthma who completed the treatment period in a previous dupilumab asthma clinical study (i.e., PDY14192, EFC13579 or EFC13691) or participants with asthma who completed the treatment and follow-up periods in previous dupilumab asthma Study DRI12544.

Exclusion criteria:

- Participants who experienced any hypersensitivity reactions to Investigational Medicinal Product (IMP) in the previous dupilumab asthma study, which, in the opinion of the Investigator, could indicate that continued treatment with dupilumab, may present an unreasonable risk for the participant.

The above information was not intended to contain all considerations relevant to a Participant's potential participation in a clinical trial.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

dupilumab treatment

Arm Description

For participants coming from the DRI12544 study: dupilumab loading dose subcutaneous (SC) on Day 1, followed by 1* Dose every 2 weeks added to current controller medications. For participants coming from other studies: dupilumab 1 * Dose SC every 2 weeks added to current controller medications.

Outcomes

Primary Outcome Measures

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

An Adverse Event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which did not necessarily had to have causal relationship with treatment. TEAEs were defined as AEs that developed, worsened, or became serious during the treatment emergent AE period (time from first dose of investigational medicinal product [IMP] in LTS12551 up to the last dose of dupilumab plus 14 weeks). A Serious AE (SAE) was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event.

Secondary Outcome Measures

Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period

Criteria for potentially clinically significant vital sign abnormalities: Systolic blood pressure (SBP): Less than or equal to (≤) 95 Adults (≤90 Adolescents) millimeters of mercury (mmHg) and decrease from baseline (DFB) greater than or equal to (≥) 20 mmHg; ≥ 160 Adults (≥ 119 Adolescents) mmHg and increase from baseline (IFB) ≥ 20 mmHg. Diastolic blood pressure (DBP): ≤ 45 Adults (≤54 Adolescents) mmHg and DFB ≥ 10 mmHg; ≥ 110 Adults (≥78 Adolescents) mmHg and IFB ≥ 10 mmHg. Heart rate (HR): ≤ 50 beats per minute (bpm) and DFB ≥ 20 bpm; ≥ 120 bpm and IFB ≥ 20 bpm. Respiratory rate: less than (<) 12 breaths/min(b/m); greater than (>) 20 b/m. Weight (kg): ≥ 5 percent (%) DFB; ≥ 5% IFB. Temperature: ≥ 38.0 degree Celsius (°C) rectal/ear/temporal; ≥ 37.5°C oral; ≥ 37.2°C axillary. TEAE period was defined as the time from first dose of IMP in LTS12551 up to the last dose of dupilumab plus 14 weeks.

Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period

Criteria for potentially clinically significant abnormalities: Hemoglobin (Hb): ≤ 115 grams per liter (g/L)(Male [M]), ≤ 95 g/L (Female[ F]) (< 100 g/L Adolescents); ≥ 185 g/L (M), ≥ 165 g/L (F) (≥ 200 g/L Adolescents); DFB ≥ 20 g/L. Hematocrit: ≤ 0.37 volume/volume (v/v) (M); ≤ 0.32 v/v (F) (<0.32 v/v Adolescents); ≥ 0.55 v/v (M); 0.5 v/v (F) (>0.47 v/v Adolescents). RBCs: ≥ 6 Tera/L. Platelets: < 100 Giga(G)/L; ≥ 700 G/L. TEAE period was defined as the time from first dose of IMP in LTS12551 up to the last dose of dupilumab plus 14 weeks.

Number of Severe Exacerbation Events

Severe asthma exacerbation events were defined as a deterioration of asthma which required: use of systemic corticosteroids for ≥ 3 days, (participants from study EFC13691 (NCT02528214), and who were taking systemic corticosteroids: the use of systemic corticosteroids at least double the current dose and for ≥3 days.) or, hospitalization or emergency room visit because of asthma, required systemic corticosteroids.

Annualized Event Rate Per Participant-Years for Severe Exacerbation

The annualized event rate per participant-years was defined as the total number of events that occurred during the treatment period divided by the total number of participant-years during the treatment period.

Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Weeks 48 and 96

FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. For this analysis, baseline was defined as respective parent study baseline.

Change From Baseline in Percent Predicted FEV1 at Weeks 48 and 96

FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. For this analysis, baseline was defined as respective parent study baseline.

Change From Baseline in Forced Vital Capacity (FVC) at Weeks 48 and 96

FVC was a standard pulmonary function test used to quantify respiratory muscle weakness. FVC was the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. For this analysis, baseline was defined as respective parent study baseline.

Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 48 and 96

FEF was the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEF 25-75% was defined as the mean FEF between 25% and 75% of the FVC, where FVC was defined as the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. For this analysis, baseline was defined as respective parent study baseline.

Change From Baseline in Asthma Control Questionnaire 5-Question Version (ACQ-5) Mean Scores at Weeks 24 and 48

The ACQ-5 had 5 questions, reflecting the top-scoring five 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 recall how their asthma had been during the previous week and to respond to each of the five symptom questions on a 7-point scale ranged from 0 (no impairment) to 6 (maximum impairment). ACQ-5 total mean score was mean of the scores of all 5 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled), higher scores indicated lower asthma control. For this analysis, baseline was defined as respective parent study baseline.

Percentage of Participants Achieving ACQ-5 Score Response (ACQ-5 Responders) at Weeks 24 and 48

ACQ-5 response was defined as change from baseline in ACQ-5 scores ≥ 0.5. The ACQ-5 had 5 questions, reflecting the top-scoring five 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 recall how their asthma had been during the previous week and to respond to each of the five symptom questions on a 7-point scale ranged from 0 (no impairment) to 6 (maximum impairment). ACQ-5 mean total score was mean of the scores of all 5 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicated lower asthma control.

Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Global Scores at Weeks 24 and 48

The AQLQ was designed to measure the functional impairments that are most troublesome to adults as a result of their asthma. The AQLQ comprised of 32 items in 4 domains: symptoms (12 items), activity limitation (11 items), emotional function (5 items), and environmental stimuli (4 items). Each item was scored on a 7-point likert scale ranged from 1=severely impaired to 7=not impaired. The 32 items of the questionnaire were averaged to produce one overall quality of life score ranging from 1 (severely impaired) to 7 (not impaired); higher scores indicated better quality of life. For this analysis, baseline was defined as respective parent study baseline.

Percentage of Participants Achieving AQLQ Global Score Response (AQLQ Responders) at Weeks 24 and 48

AQLQ global response was defined as participants with change from baseline in AQLQ global score ≥ 0.5. The AQLQ was designed to measure the functional impairments that are most troublesome to adults as a result of their asthma. The AQLQ comprised of 32 items in 4 domains: symptoms (12 items), activity limitation (11 items), emotional function (5 items), environmental stimuli (4 items). Each item was scored on a 7-point likert scale (1=severely impaired, 7=not impaired). The 32 items of the questionnaire are averaged to produce one overall quality of life score ranging from 1 (severely impaired) to 7 (not impaired). Higher scores indicated better quality of life.

Serum Concentrations of Dupilumab Over Time Till Week 96

For this analysis, baseline was defined as respective parent study baseline. Here, 'number analyzed'=number of participants with available data for each specified category.

Percentage of Participants With Antidrug Antibodies (ADA) Response

ADA response were categorized as: treatment emergent and treatment boosted response. 1) Treatment emergent was defined as an ADA positive response in the assay post first dose in LTS12551, when baseline results were negative or missing. 2) Treatment boosted was defined as: an ADA positive response in the assay post first dose that was greater-than or equal to 4-fold over baseline titer levels, when baseline results were positive. The criteria for positive was defined as "30 to > 10,000", where low titer (< 1,000); moderate (1,000 ≤ titer ≤ 10,000) and high titer (> 10,000).

Change From Baseline in Blood Eosinophils Cells Count at Weeks 48 and 96

For this analysis, baseline was defined as respective parent study baseline.

Change From Baseline in Morning Peak Expiratory Flow (PEF) at Weeks 48 and 96: Participants From Study DRI12544

The PEF was a participant's maximum speed of expiration, as measured with a peak flow meter. Peak flow testing for PEF was performed at morning and evening. Morning PEF was performed within 15 minutes after arising (between 5:30 AM and 10 AM) prior to taking any salbutamol/albuterol or levosalbutamol/levalbuterol. For this analysis, baseline was defined as parent study DRI12544 baseline.

Change From Baseline in Evening Peak Expiratory Flow (PEF) at Weeks 48 and 96: Participants From Study DRI12544

The PEF was a participant's maximum speed of expiration, as measured with a peak flow meter. Peak flow testing for PEF was performed at morning and evening. Evening PEF was performed in the evening (between 5:30 PM and 10 PM) prior to taking any salbutamol/albuterol or levosalbutamol/levalbuterol. For this analysis, baseline was defined as parent DRI12544 study baseline.

Change From Baseline in Morning Asthma Symptom Scores at Weeks 48 and 96: Participants From Study DRI12544

Morning asthma symptom score was determined using AM (ante meridiem) symptom scoring system which evaluated 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; higher scores indicated more severe symptoms. For this analysis, baseline was defined as parent DRI12544 study baseline.

Change From Baseline in Evening Asthma Symptom Scores at Weeks 48 and 96: Participants From Study DRI12544

Evening asthma symptom score was determined using PM (post meridiem) symptom scoring system which evaluated participant's overall asthma symptoms experienced during the day. It ranged 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; higher scores indicated more severe symptoms. For this analysis, baseline was defined as parent DRI12544 study baseline.

Change From Baseline in Number of Inhalations Per Day of Salbutamol/Albuterol or Levosalbutamol/Levalbuterol for Symptom Relief at Weeks 48 and 96: Participants From Study DRI12544

The number of salbutamol/albuterol or levosalbutamol/levalbuterol inhalations was recorded daily by the participants in an electronic diary/PEF meter. Mean number of inhalations in last 7 days prior to each visit was calculated and was used in computation of data reported. For this analysis, baseline was defined as parent DRI12544 study baseline.

Change From Baseline in Number of Nocturnal Awakenings at Weeks 48 and 96: Participants From Study DRI12544

The number of nocturnal awakening because of asthma symptoms were recorded every morning by the participants in an electronic diary. Mean number of awakenings in last 7 days prior to each visit was calculated and was used in computation of data reported. For this analysis, baseline was defined as parent DRI12544 study baseline.

Percent Change From Baseline in Oral Corticosteroid (OCS) Dose at Weeks 48, and 96: Participants From Study EFC13691

OCS was allowed as background controller medication for the participants from study EFC13691 only. For this analysis, baseline was defined as parent study EFC13691 baseline.

Percentage of Participants Achieving a Reduction of 50% or Greater (≥ 50% ) in OCS Dose Over Time at Weeks 48 and 96: Participants From Study EFC13691

OCS was allowed as background controller medication for the participants from study EFC13691 only. Percentage of participants who achieved a reduction of ≥ 50% in OCS dose were reported.

Percentage of Participants With Background OCS Completely Tapered Off Over Time at Weeks 48 and 96: Participants From Study EFC13691

OCS was allowed as background controller medication for the participants from study EFC13691 only. Number of participants who gradually discontinued or reduced therapeutic dose were reported in this outcome measure.

Change From Baseline in European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L) Index Scores at Weeks 48 and 96: Participants From Study DRI12544

EQ-5D-3L: validated and reliable self-report health status questionnaire consisted of EQ-5D descriptive system and visual analogue scale (VAS). EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension measured on 3 levels: no problem, some problems, and severe problems. The 5 dimensional 3-level systems was converted into single index utility score, and the score was 0 - 100, where 100=best health state; and 0=worst health state; where higher scores indicated better outcome. For this analysis, baseline was defined as parent DRI12544 study baseline.

Change From Baseline in EQ-5D-3L VAS Scores at Weeks 48 and 96: Participants From Study DRI12544

EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0=worst imaginable health state and 100=best imaginable health state, where higher states indicated better outcomes. For this analysis, baseline was defined as parent DRI12544 study baseline.

Full Information

NCT ID

NCT02134028

First Posted

April 30, 2014

Last Updated

March 21, 2022

Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02134028

Brief Title

Long-Term Safety Evaluation of Dupilumab in Patients With Asthma (LIBERTY ASTHMA TRAVERSE)

Official Title

Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Dupilumab in Patients With Asthma Who Participated in a Previous Dupilumab Asthma Clinical Study

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

August 5, 2014 (Actual)

Primary Completion Date

October 11, 2019 (Actual)

Study Completion Date

October 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Primary Objective: To evaluate the long-term safety and tolerability of dupilumab in participants with asthma who participated in a previous dupilumab asthma study (DRI12544, PDY14192, EFC13579, EFC13691). Secondary Objectives: To evaluate the long-term efficacy of dupilumab in participants with asthma who participated in a previous dupilumab asthma clinical study. To evaluate dupilumab in participants with asthma who participated in a previous dupilumab asthma clinical study, with regards to: Systemic exposure Anti-drug antibodies Biomarkers

Detailed Description

A screening period, up to 3 weeks, applied only for participants who came from DRI12544 study. The total study duration, per participant, was a maximum of 108 weeks (or 111 weeks considering a maximum screening period of 3 weeks for study DRI12544) for the participants enrolled prior to Amendment 04 approval and a maximum of 60 weeks for the participants enrolled after Amendment 04 approval. Following amendment 04 (dated 31 Oct 2016) the open-label treatment duration was amended to 48 weeks (1 year); and the 16-week post-treatment period was shortened to 12 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 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

2282 (Actual)

8. Arms, Groups, and Interventions

Arm Title

dupilumab treatment

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Dupilumab

Other Intervention Name(s)

SAR231893, REGN668

Intervention Description

Pharmaceutical form: Solution for injection Routes of administration: Subcutaneous

Primary Outcome Measure Information:

Title

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Description

Time Frame

From the first IMP injection in LTS12551 to the last IMP injection plus 14 weeks (up to 108 weeks)

Secondary Outcome Measure Information:

Title

Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period

Description

Time Frame

From the first IMP injection in LTS12551 to the last IMP injection plus 14 weeks (up to 108 weeks)

Title

Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period

Description

Time Frame

From the first IMP injection in LTS12551 to the last IMP injection plus 14 weeks (up to 108 weeks)

Title

Number of Severe Exacerbation Events

Description

Time Frame

From the first IMP injection in LTS12551 to the last IMP injection plus 2 weeks (up to 96 weeks)

Title

Annualized Event Rate Per Participant-Years for Severe Exacerbation

Description

Time Frame

From the first IMP injection in LTS12551 to the last IMP injection plus 2 weeks (up to 96 weeks)

Title

Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Weeks 48 and 96

Description

FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. For this analysis, baseline was defined as respective parent study baseline.

Time Frame

Baseline of parent study, Week 48 and Week 96 of this extension study

Title

Change From Baseline in Percent Predicted FEV1 at Weeks 48 and 96

Description

FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. For this analysis, baseline was defined as respective parent study baseline.

Time Frame

Baseline of parent study, Week 48 and Week 96 of this extension study

Title

Change From Baseline in Forced Vital Capacity (FVC) at Weeks 48 and 96

Description

Time Frame

Baseline of parent study, Week 48, and Week 96 of this extension study

Title

Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 48 and 96

Description

Time Frame

Baseline of parent study, Week 48, and Week 96 of this extension study

Title

Change From Baseline in Asthma Control Questionnaire 5-Question Version (ACQ-5) Mean Scores at Weeks 24 and 48

Description

Time Frame

Baseline of parent study, Weeks 24, and 48 of this extension study

Title

Percentage of Participants Achieving ACQ-5 Score Response (ACQ-5 Responders) at Weeks 24 and 48

Description

Time Frame

At Weeks 24, and 48 of this extension study

Title

Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Global Scores at Weeks 24 and 48

Description

Time Frame

Baseline of parent study, Weeks 24, and 48 of this extension study

Title

Percentage of Participants Achieving AQLQ Global Score Response (AQLQ Responders) at Weeks 24 and 48

Description

Time Frame

At Weeks 24, and 48 of this extension study

Title

Serum Concentrations of Dupilumab Over Time Till Week 96

Description

For this analysis, baseline was defined as respective parent study baseline. Here, 'number analyzed'=number of participants with available data for each specified category.

Time Frame

Baseline of parent study, Weeks 0, 4, 12, 24, 48, 72, and 96 of this extension study

Title

Percentage of Participants With Antidrug Antibodies (ADA) Response

Description

Time Frame

From the first IMP injection in LTS12551 to the last IMP injection plus 2 weeks (up to 96 weeks)

Title

Change From Baseline in Blood Eosinophils Cells Count at Weeks 48 and 96

Description

For this analysis, baseline was defined as respective parent study baseline.

Time Frame

Baseline of parent study, Week 48 and Week 96 of this extension study

Title

Change From Baseline in Morning Peak Expiratory Flow (PEF) at Weeks 48 and 96: Participants From Study DRI12544

Description

Time Frame

Baseline of parent study, Week 48 and Week 96 of this extension study

Title

Change From Baseline in Evening Peak Expiratory Flow (PEF) at Weeks 48 and 96: Participants From Study DRI12544

Description

Time Frame

Baseline of parent study, Week 48 and Week 96 of this extension study

Title

Change From Baseline in Morning Asthma Symptom Scores at Weeks 48 and 96: Participants From Study DRI12544

Description

Time Frame

Baseline of parent study, Week 48 and Week 96 of this extension study

Title

Change From Baseline in Evening Asthma Symptom Scores at Weeks 48 and 96: Participants From Study DRI12544

Description

Time Frame

Baseline of parent study, Week 48, and Week 96 of this extension study

Title

Change From Baseline in Number of Inhalations Per Day of Salbutamol/Albuterol or Levosalbutamol/Levalbuterol for Symptom Relief at Weeks 48 and 96: Participants From Study DRI12544

Description

Time Frame

Baseline of parent study, Week 48, and Week 96 of this extension study

Title

Change From Baseline in Number of Nocturnal Awakenings at Weeks 48 and 96: Participants From Study DRI12544

Description

Time Frame

Baseline of parent study, Week 48 and Week 96 of this extension study

Title

Percent Change From Baseline in Oral Corticosteroid (OCS) Dose at Weeks 48, and 96: Participants From Study EFC13691

Description

OCS was allowed as background controller medication for the participants from study EFC13691 only. For this analysis, baseline was defined as parent study EFC13691 baseline.

Time Frame

Baseline of parent study, Weeks 48 and 96 of this extension study

Title

Percentage of Participants Achieving a Reduction of 50% or Greater (≥ 50% ) in OCS Dose Over Time at Weeks 48 and 96: Participants From Study EFC13691

Description

OCS was allowed as background controller medication for the participants from study EFC13691 only. Percentage of participants who achieved a reduction of ≥ 50% in OCS dose were reported.

Time Frame

Weeks 48 and 96 of this extension study

Title

Percentage of Participants With Background OCS Completely Tapered Off Over Time at Weeks 48 and 96: Participants From Study EFC13691

Description

Time Frame

Weeks 48, and 96 of this extension study

Title

Change From Baseline in European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L) Index Scores at Weeks 48 and 96: Participants From Study DRI12544

Description

Time Frame

Baseline of parent study, Week 48 and Week 96 of this extension study

Title

Change From Baseline in EQ-5D-3L VAS Scores at Weeks 48 and 96: Participants From Study DRI12544

Description

Time Frame

Baseline of parent study, Week 48 and Week 96 of this extension study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: - Participants with asthma who completed the treatment period in a previous dupilumab asthma clinical study (i.e., PDY14192, EFC13579 or EFC13691) or participants with asthma who completed the treatment and follow-up periods in previous dupilumab asthma Study DRI12544. Exclusion criteria: - Participants who experienced any hypersensitivity reactions to Investigational Medicinal Product (IMP) in the previous dupilumab asthma study, which, in the opinion of the Investigator, could indicate that continued treatment with dupilumab, may present an unreasonable risk for the participant. The above information was 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

Birmingham

State/Province

Alabama

ZIP/Postal Code

35209

Country

United States

Facility Name

Investigational Site Number 840099

City

Gilbert

State/Province

Arizona

ZIP/Postal Code

85234

Country

United States

Facility Name

Investigational Site Number 840087

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85251

Country

United States

Facility Name

Investigational Site Number 840402

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85724

Country

United States

Facility Name

Investigational Site Number 840132

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72209

Country

United States

Facility Name

Investigational Site Number 840109

City

Bakersfield

State/Province

California

ZIP/Postal Code

93301

Country

United States

Facility Name

Investigational Site Number 840045

City

Long Beach

State/Province

California

ZIP/Postal Code

90720

Country

United States

Facility Name

Investigational Site Number 840019

City

Los Angeles

State/Province

California

ZIP/Postal Code

90025

Country

United States

Facility Name

Investigational Site Number 840029

City

Los Angeles

State/Province

California

ZIP/Postal Code

90025

Country

United States

Facility Name

Investigational Site Number 840022

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Facility Name

Investigational Site Number 840044

City

Newport Beach

State/Province

California

ZIP/Postal Code

92663

Country

United States

Facility Name

Investigational Site Number 840041

City

North Hollywood

State/Province

California

ZIP/Postal Code

91606

Country

United States

Facility Name

Investigational Site Number 840014

City

Rolling Hills Estates

State/Province

California

ZIP/Postal Code

90274

Country

United States

Facility Name

Investigational Site Number 840121

City

San Jose

State/Province

California

ZIP/Postal Code

95117

Country

United States

Facility Name

Investigational Site Number 840040

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80907

Country

United States

Facility Name

Investigational Site Number 840403

City

Denver

State/Province

Colorado

ZIP/Postal Code

80206

Country

United States

Facility Name

Investigational Site Number 840006

City

Denver

State/Province

Colorado

ZIP/Postal Code

80230

Country

United States

Facility Name

Investigational Site Number 840024

City

Denver

State/Province

Colorado

ZIP/Postal Code

80230

Country

United States

Facility Name

Investigational Site Number 840130

City

Denver

State/Province

Colorado

ZIP/Postal Code

80246

Country

United States

Facility Name

Investigational Site Number 840902

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06510

Country

United States

Facility Name

Investigational Site Number 840137

City

Aventura

State/Province

Florida

ZIP/Postal Code

33180

Country

United States

Facility Name

Investigational Site Number 840071

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32607

Country

United States

Facility Name

Investigational Site Number 840115

City

Ocoee

State/Province

Florida

ZIP/Postal Code

34761

Country

United States

Facility Name

Investigational Site Number 840055

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34239

Country

United States

Facility Name

Investigational Site Number 840079

City

Twin Falls

State/Province

Idaho

ZIP/Postal Code

83301

Country

United States

Facility Name

Investigational Site Number 840101

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

Investigational Site Number 840032

City

Fort Mitchell

State/Province

Kentucky

ZIP/Postal Code

41017

Country

United States

Facility Name

Investigational Site Number 840017

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40223-5440

Country

United States

Facility Name

Investigational Site Number 840030

City

Owensboro

State/Province

Kentucky

ZIP/Postal Code

42301

Country

United States

Facility Name

Investigational Site Number 840064

City

Bangor

State/Province

Maine

ZIP/Postal Code

04401

Country

United States

Facility Name

Investigational Site Number 840052

City

Chevy Chase

State/Province

Maryland

ZIP/Postal Code

20815

Country

United States

Facility Name

Investigational Site Number 840073

City

Gaithersburg

State/Province

Maryland

ZIP/Postal Code

20878

Country

United States

Facility Name

Investigational Site Number 840080

City

Owings Mills

State/Province

Maryland

ZIP/Postal Code

21117

Country

United States

Facility Name

Investigational Site Number 840401

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Investigational Site Number 840018

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55402

Country

United States

Facility Name

Investigational Site Number 840002

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Investigational Site Number 840102

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Investigational Site Number 840093

City

Saint Louis

State/Province

Missouri

Country

United States

Facility Name

Investigational Site Number 840037

City

Missoula

State/Province

Montana

ZIP/Postal Code

59808

Country

United States

Facility Name

Investigational Site Number 840078

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68124

Country

United States

Facility Name

Investigational Site Number 840004

City

Papillion

State/Province

Nebraska

ZIP/Postal Code

27103

Country

United States

Facility Name

Investigational Site Number 840111

City

Brick

State/Province

New Jersey

ZIP/Postal Code

08723

Country

United States

Facility Name

Investigational Site Number 840068

City

Ocean City

State/Province

New Jersey

ZIP/Postal Code

07712

Country

United States

Facility Name

Investigational Site Number 840011

City

Princeton

State/Province

New Jersey

ZIP/Postal Code

08540

Country

United States

Facility Name

Investigational Site Number 840065

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

Investigational Site Number 840126

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28226

Country

United States

Facility Name

Investigational Site Number 840083

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28277

Country

United States

Facility Name

Investigational Site Number 840108

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27705

Country

United States

Facility Name

Investigational Site Number 840107

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27401

Country

United States

Facility Name

Investigational Site Number 840907

City

High Point

State/Province

North Carolina

ZIP/Postal Code

27262

Country

United States

Facility Name

Investigational Site Number 840404

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157-1071

Country

United States

Facility Name

Investigational Site Number 840015

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45236

Country

United States

Facility Name

Investigational Site Number 840146

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45241

Country

United States

Facility Name

Investigational Site Number 840049

City

Middleburg Heights

State/Province

Ohio

ZIP/Postal Code

44130

Country

United States

Facility Name

Investigational Site Number 840942

City

Toledo

State/Province

Ohio

ZIP/Postal Code

43617

Country

United States

Facility Name

Investigational Site Number 840112

City

Edmond

State/Province

Oklahoma

ZIP/Postal Code

73034

Country

United States

Facility Name

Investigational Site Number 840104

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74136

Country

United States

Facility Name

Investigational Site Number 840034

City

Medford

State/Province

Oregon

ZIP/Postal Code

97504

Country

United States

Facility Name

Investigational Site Number 840031

City

Portland

State/Province

Oregon

ZIP/Postal Code

97223

Country

United States

Facility Name

Investigational Site Number 840046

City

Bethlehem

State/Province

Pennsylvania

ZIP/Postal Code

18020

Country

United States

Facility Name

Investigational Site Number 840085

City

Hershey

State/Province

Pennsylvania

ZIP/Postal Code

17033

Country

United States

Facility Name

Investigational Site Number 840067

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19140

Country

United States

Facility Name

Investigational Site Number 840928

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Facility Name

Investigational Site Number 840091

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15241

Country

United States

Facility Name

Investigational Site Number 840082

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29407

Country

United States

Facility Name

Investigational Site Number 840117

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29607

Country

United States

Facility Name

Investigational Site Number 840021

City

Spartanburg

State/Province

South Carolina

ZIP/Postal Code

29303

Country

United States

Facility Name

Investigational Site Number 840062

City

Amarillo

State/Province

Texas

ZIP/Postal Code

79106

Country

United States

Facility Name

Investigational Site Number 840038

City

Boerne

State/Province

Texas

ZIP/Postal Code

78006

Country

United States

Facility Name

Investigational Site Number 840124

City

Cypress

State/Province

Texas

ZIP/Postal Code

77429

Country

United States

Facility Name

Investigational Site Number 840023

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Investigational Site Number 840923

City

El Paso

State/Province

Texas

ZIP/Postal Code

79903

Country

United States

Facility Name

Investigational Site Number 840922

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76109

Country

United States

Facility Name

Investigational Site Number 840027

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76244

Country

United States

Facility Name

Investigational Site Number 840070

City

McKinney

State/Province

Texas

ZIP/Postal Code

75069

Country

United States

Facility Name

Investigational Site Number 840118

City

Plano

State/Province

Texas

ZIP/Postal Code

75093

Country

United States

Facility Name

Investigational Site Number 840008

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Investigational Site Number 840035

City

Draper

State/Province

Utah

ZIP/Postal Code

84020

Country

United States

Facility Name

Investigational Site Number 840077

City

Murray

State/Province

Utah

ZIP/Postal Code

84107

Country

United States

Facility Name

Investigational Site Number 840057

City

South Burlington

State/Province

Vermont

ZIP/Postal Code

05403

Country

United States

Facility Name

Investigational Site Number 840059

City

Fairfax

State/Province

Virginia

ZIP/Postal Code

22030

Country

United States

Facility Name

Investigational Site Number 840951

City

Bellingham

State/Province

Washington

ZIP/Postal Code

98225

Country

United States

Facility Name

Investigational Site Number 032096

City

Bahia Blanca

ZIP/Postal Code

B8000JRB

Country

Argentina

Facility Name

Investigational Site Number 032004

City

Buenos Aires

ZIP/Postal Code

B6500BWQ

Country

Argentina

Facility Name

Investigational Site Number 032003

City

Buenos Aires

ZIP/Postal Code

C1121ABE

Country

Argentina

Facility Name

Investigational Site Number 032011

City

Caba

ZIP/Postal Code

1120

Country

Argentina

Facility Name

Investigational Site Number 032097

City

Caba

ZIP/Postal Code

C1414AIF

Country

Argentina

Facility Name

Investigational Site Number 032001

City

Caba

ZIP/Postal Code

C1425BEN

Country

Argentina

Facility Name

Investigational Site Number 032010

City

Caba

ZIP/Postal Code

C1425FVH

Country

Argentina

Facility Name

Investigational Site Number 032091

City

Caba

ZIP/Postal Code

C1426ABP

Country

Argentina

Facility Name

Investigational Site Number 032095

City

Capital Federal

ZIP/Postal Code

C1425DUC

Country

Argentina

Facility Name

Investigational Site Number 032002

City

La Plata

ZIP/Postal Code

B1900BNN

Country

Argentina

Facility Name

Investigational Site Number 032006

City

Rosario

ZIP/Postal Code

S2000BRH

Country

Argentina

Facility Name

Investigational Site Number 032007

City

Rosario

ZIP/Postal Code

S2000DBS

Country

Argentina

Facility Name

Investigational Site Number 032005

City

Rosario

ZIP/Postal Code

S2000JKR

Country

Argentina

Facility Name

Investigational Site Number 032012

City

San Miguel De Tucuman

ZIP/Postal Code

T4000CHE

Country

Argentina

Facility Name

Investigational Site Number 032009

City

San Miguel De Tucumán

ZIP/Postal Code

T4000IAR

Country

Argentina

Facility Name

Investigational Site Number 036004

City

Adelaide

ZIP/Postal Code

5000

Country

Australia

Facility Name

Investigational Site Number 036005

City

Campbelltown

ZIP/Postal Code

2560

Country

Australia

Facility Name

Investigational Site Number 036001

City

Clayton

ZIP/Postal Code

3168

Country

Australia

Facility Name

Investigational Site Number 036008

City

Frankston

ZIP/Postal Code

3199

Country

Australia

Facility Name

Investigational Site Number 036093

City

Murdoch

ZIP/Postal Code

6150

Country

Australia

Facility Name

Investigational Site Number 036003

City

Nedlands

ZIP/Postal Code

6009

Country

Australia

Facility Name

Investigational Site Number 036094

City

Parkville

ZIP/Postal Code

3050

Country

Australia

Facility Name

Investigational Site Number 036009

City

Prahran

ZIP/Postal Code

3004

Country

Australia

Facility Name

Investigational Site Number 036006

City

Woolloongabba

ZIP/Postal Code

4102

Country

Australia

Facility Name

Investigational Site Number 056002

City

Brussels

ZIP/Postal Code

1020

Country

Belgium

Facility Name

Investigational Site Number 056003

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Investigational Site Number 056001

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Investigational Site Number 076009

City

Florianópolis

ZIP/Postal Code

88040-970

Country

Brazil

Facility Name

Investigational Site Number 076007

City

Porto Alegre

ZIP/Postal Code

90020-090

Country

Brazil

Facility Name

Investigational Site Number 076001

City

Porto Alegre

ZIP/Postal Code

90610-000

Country

Brazil

Facility Name

Investigational Site Number 076003

City

Salvador

ZIP/Postal Code

41940-455

Country

Brazil

Facility Name

Investigational Site Number 076012

City

Sao Paulo

ZIP/Postal Code

04266-010

Country

Brazil

Facility Name

Investigational Site Number 076002

City

Sorocaba

ZIP/Postal Code

18040-425

Country

Brazil

Facility Name

Investigational Site Number 076013

City

São Bernardo Do Campo

ZIP/Postal Code

09715-090

Country

Brazil

Facility Name

Investigational Site Number 076006

City

São Paulo

ZIP/Postal Code

05437-000

Country

Brazil

Facility Name

Investigational Site Number 124019

City

Burlington

ZIP/Postal Code

L7N 3V2

Country

Canada

Facility Name

Investigational Site Number 124009

City

Calgary

ZIP/Postal Code

T2N 4Z6

Country

Canada

Facility Name

Investigational Site Number 124016

City

Hamilton

ZIP/Postal Code

L8N 4A6

Country

Canada

Facility Name

Investigational Site Number 124003

City

Mississauga

ZIP/Postal Code

L5A 3V4

Country

Canada

Facility Name

Investigational Site Number 124001

City

Montreal

ZIP/Postal Code

H2X 3E4

Country

Canada

Facility Name

Investigational Site Number 124012

City

Montreal

ZIP/Postal Code

H4A 3J1

Country

Canada

Facility Name

Investigational Site Number 124010

City

Montreal

ZIP/Postal Code

H4J 1C5

Country

Canada

Facility Name

Investigational Site Number 124013

City

Ottawa

ZIP/Postal Code

K1G 6C6

Country

Canada

Facility Name

Investigational Site Number 124018

City

Quebec

ZIP/Postal Code

G1V 4G5

Country

Canada

Facility Name

Investigational Site Number 124014

City

Quebec

ZIP/Postal Code

G1V 4W2

Country

Canada

Facility Name

Investigational Site Number 124008

City

Sherbrooke

ZIP/Postal Code

J1H 5N4

Country

Canada

Facility Name

Investigational Site Number 124015

City

Toronto

ZIP/Postal Code

M5G 1E2

Country

Canada

Facility Name

Investigational Site Number 124002

City

Toronto

ZIP/Postal Code

M5T 3A9

Country

Canada

Facility Name

Investigational Site Number 124007

City

Trois-Rivieres

ZIP/Postal Code

G8T 7A1

Country

Canada

Facility Name

Investigational Site Number 124006

City

Vancouver

ZIP/Postal Code

V5Z 1M9

Country

Canada

Facility Name

Investigational Site Number 124017

City

Vancouver

ZIP/Postal Code

V6Z 1Y6

Country

Canada

Facility Name

Investigational Site Number 152007

City

Quillota

ZIP/Postal Code

2260877

Country

Chile

Facility Name

Investigational Site Number 152024

City

Santiago

ZIP/Postal Code

7500588

Country

Chile

Facility Name

Investigational Site Number 152005

City

Santiago

ZIP/Postal Code

7500692

Country

Chile

Facility Name

Investigational Site Number 152014

City

Santiago

ZIP/Postal Code

7500698

Country

Chile

Facility Name

Investigational Site Number 152011

City

Santiago

ZIP/Postal Code

7500710

Country

Chile

Facility Name

Investigational Site Number 152018

City

Santiago

ZIP/Postal Code

8207257

Country

Chile

Facility Name

Investigational Site Number 152002

City

Santiago

ZIP/Postal Code

8380456

Country

Chile

Facility Name

Investigational Site Number 152013

City

Santiago

ZIP/Postal Code

8910131

Country

Chile

Facility Name

Investigational Site Number 152023

City

Talcahuano

Country

Chile

Facility Name

Investigational Site Number 152008

City

Talca

ZIP/Postal Code

3460001

Country

Chile

Facility Name

Investigational Site Number 152004

City

Talca

Country

Chile

Facility Name

Investigational Site Number 152010

City

Valdivia

ZIP/Postal Code

5090145

Country

Chile

Facility Name

Investigational Site Number 152003

City

Viña Del Mar

ZIP/Postal Code

2520024

Country

Chile

Facility Name

Investigational Site Number 152021

City

Viña Del Mar

ZIP/Postal Code

2520594

Country

Chile

Facility Name

Investigational Site Number 170001

City

Bogota

ZIP/Postal Code

110121

Country

Colombia

Facility Name

Investigational Site Number 170002

City

Bogotá

ZIP/Postal Code

110231

Country

Colombia

Facility Name

Investigational Site Number 208002

City

Hvidovre

ZIP/Postal Code

2650

Country

Denmark

Facility Name

Investigational Site Number 208001

City

København Nv

ZIP/Postal Code

2400

Country

Denmark

Facility Name

Investigational Site Number 250009

City

Brest

ZIP/Postal Code

29609

Country

France

Facility Name

Investigational Site Number 250004

City

La Tronche

ZIP/Postal Code

38700

Country

France

Facility Name

Investigational Site Number 250010

City

Lille Cedex

ZIP/Postal Code

59037

Country

France

Facility Name

Investigational Site Number 250013

City

Lille Cedex

ZIP/Postal Code

59037

Country

France

Facility Name

Investigational Site Number 250006

City

Lyon

ZIP/Postal Code

69317

Country

France

Facility Name

Investigational Site Number 250001

City

Marseille

ZIP/Postal Code

13015

Country

France

Facility Name

Investigational Site Number 250002

City

Montpellier

ZIP/Postal Code

34295

Country

France

Facility Name

Investigational Site Number 250005

City

Nantes

ZIP/Postal Code

44033

Country

France

Facility Name

Investigational Site Number 250007

City

Nimes Cedex 9

ZIP/Postal Code

30029

Country

France

Facility Name

Investigational Site Number 250008

City

Strasbourg

ZIP/Postal Code

67091

Country

France

Facility Name

Investigational Site Number 250014

City

Vandoeuvre-Les-Nancy Cedex

ZIP/Postal Code

54511

Country

France

Facility Name

Investigational Site Number 276006

City

Berlin

ZIP/Postal Code

10787

Country

Germany

Facility Name

Investigational Site Number 276003

City

Bochum

ZIP/Postal Code

44789

Country

Germany

Facility Name

Investigational Site Number 276010

City

Frankfurt Am Main

ZIP/Postal Code

60596

Country

Germany

Facility Name

Investigational Site Number 276011

City

Großhansdorf

ZIP/Postal Code

22927

Country

Germany

Facility Name

Investigational Site Number 276009

City

Koblenz

ZIP/Postal Code

56068

Country

Germany

Facility Name

Investigational Site Number 276005

City

Rüdersdorf Bei Berlin

ZIP/Postal Code

15562

Country

Germany

Facility Name

Investigational Site Number 348301

City

Balassagyarmat

ZIP/Postal Code

2660

Country

Hungary

Facility Name

Investigational Site Number 348303

City

Edelény

ZIP/Postal Code

3780

Country

Hungary

Facility Name

Investigational Site Number 348003

City

Gödöllö

ZIP/Postal Code

2100

Country

Hungary

Facility Name

Investigational Site Number 376003

City

Haifa

ZIP/Postal Code

34362

Country

Israel

Facility Name

Investigational Site Number 376001

City

Kfar Saba

ZIP/Postal Code

44281

Country

Israel

Facility Name

Investigational Site Number 376005

City

Petah-Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

Investigational Site Number 376002

City

Rehovot

ZIP/Postal Code

76100

Country

Israel

Facility Name

Investigational Site Number 380010

City

Ancona

ZIP/Postal Code

60126

Country

Italy

Facility Name

Investigational Site Number 380009

City

Catania

ZIP/Postal Code

95123

Country

Italy

Facility Name

Investigational Site Number 380004

City

Ferrara

ZIP/Postal Code

44124

Country

Italy

Facility Name

Investigational Site Number 380008

City

Foggia

ZIP/Postal Code

71100

Country

Italy

Facility Name

Investigational Site Number 380002

City

Genova

ZIP/Postal Code

16132

Country

Italy

Facility Name

Investigational Site Number 380003

City

Modena

ZIP/Postal Code

41124

Country

Italy

Facility Name

Investigational Site Number 380007

City

Padova

ZIP/Postal Code

35128

Country

Italy

Facility Name

Investigational Site Number 380099

City

Palermo

ZIP/Postal Code

90146

Country

Italy

Facility Name

Investigational Site Number 380001

City

Pisa

ZIP/Postal Code

56100

Country

Italy

Facility Name

Investigational Site Number 392185

City

Akashi-Shi

Country

Japan

Facility Name

Investigational Site Number 392009

City

Asahi-Shi

Country

Japan

Facility Name

Investigational Site Number 392037

City

Chiyoda-Ku

Country

Japan

Facility Name

Investigational Site Number 392002

City

Chuo-Ku

Country

Japan

Facility Name

Investigational Site Number 392007

City

Chuo-Ku

Country

Japan

Facility Name

Investigational Site Number 392112

City

Chuo-Ku

Country

Japan

Facility Name

Investigational Site Number 392012

City

Edogawa-Ku

Country

Japan

Facility Name

Investigational Site Number 392137

City

Fukuoka-Shi

Country

Japan

Facility Name

Investigational Site Number 392021

City

Fukuyama-Shi

Country

Japan

Facility Name

Investigational Site Number 392030

City

Habikino-Shi

Country

Japan

Facility Name

Investigational Site Number 392004

City

Himeji-Shi

Country

Japan

Facility Name

Investigational Site Number 392032

City

Hirakata-Shi

Country

Japan

Facility Name

Investigational Site Number 392108

City

Hiroshima-Shi

Country

Japan

Facility Name

Investigational Site Number 392158

City

Hiroshima-Shi

Country

Japan

Facility Name

Investigational Site Number 392013

City

Iizuka-Shi

Country

Japan

Facility Name

Investigational Site Number 392042

City

Isesaki-Shi

Country

Japan

Facility Name

Investigational Site Number 392023

City

Kanazawa-Shi

Country

Japan

Facility Name

Investigational Site Number 392142

City

Kasuga-Shi

Country

Japan

Facility Name

Investigational Site Number 392119

City

Kishiwada-Shi

Country

Japan

Facility Name

Investigational Site Number 392025

City

Kobe-Shi

Country

Japan

Facility Name

Investigational Site Number 392162

City

Kobe-Shi

Country

Japan

Facility Name

Investigational Site Number 392040

City

Kodaira-Shi

Country

Japan

Facility Name

Investigational Site Number 392044

City

Kokubunji-Shi

Country

Japan

Facility Name

Investigational Site Number 392131

City

Koushi-Shi

Country

Japan

Facility Name

Investigational Site Number 392010

City

Kurashiki-Shi

Country

Japan

Facility Name

Investigational Site Number 392036

City

Kyoto-Shi

Country

Japan

Facility Name

Investigational Site Number 392153

City

Kyoto-Shi

Country

Japan

Facility Name

Investigational Site Number 392133

City

Machida-Shi

Country

Japan

Facility Name

Investigational Site Number 392135

City

Matsuyama-Shi

Country

Japan

Facility Name

Investigational Site Number 392122

City

Minato-Ku

Country

Japan

Facility Name

Investigational Site Number 392144

City

Minato-Ku

Country

Japan

Facility Name

Investigational Site Number 392106

City

Mizunami-Shi

Country

Japan

Facility Name

Investigational Site Number 392164

City

Muroran-Shi

Country

Japan

Facility Name

Investigational Site Number 392163

City

Nagoya-Shi

Country

Japan

Facility Name

Investigational Site Number 392020

City

Naka-Gun

Country

Japan

Facility Name

Investigational Site Number 392005

City

Naruto-Shi

Country

Japan

Facility Name

Investigational Site Number 392187

City

Obihiro-Shi

Country

Japan

Facility Name

Investigational Site Number 392177

City

Ome-Shi

Country

Japan

Facility Name

Investigational Site Number 392152

City

Osaka Sayama-Shi

Country

Japan

Facility Name

Investigational Site Number 392155

City

Osaka Sayama-Shi

Country

Japan

Facility Name

Investigational Site Number 392170

City

Osaki-Shi

Country

Japan

Facility Name

Investigational Site Number 392127

City

Ota-Ku

Country

Japan

Facility Name

Investigational Site Number 392043

City

Ota-Shi

Country

Japan

Facility Name

Investigational Site Number 392169

City

Sagamihara-Shi

Country

Japan

Facility Name

Investigational Site Number 392024

City

Sakai-Shi

Country

Japan

Facility Name

Investigational Site Number 392011

City

Sakaide-Shi

Country

Japan

Facility Name

Investigational Site Number 392008

City

Sapporo-Shi

Country

Japan

Facility Name

Investigational Site Number 392034

City

Sapporo-Shi

Country

Japan

Facility Name

Investigational Site Number 392038

City

Setagaya-Ku

Country

Japan

Facility Name

Investigational Site Number 392179

City

Seto-Shi

Country

Japan

Facility Name

Investigational Site Number 392186

City

Shibuya-Ku

Country

Japan

Facility Name

Investigational Site Number 392167

City

Shinagawa-Ku

Country

Japan

Facility Name

Investigational Site Number 392130

City

Shinjuku-Ku

Country

Japan

Facility Name

Investigational Site Number 392165

City

Sumida-Ku

Country

Japan

Facility Name

Investigational Site Number 392146

City

Tachikawa-Shi

Country

Japan

Facility Name

Investigational Site Number 392173

City

Tachikawa-Shi

Country

Japan

Facility Name

Investigational Site Number 392006

City

Tomakomai-Shi

Country

Japan

Facility Name

Investigational Site Number 392029

City

Tsu-Shi

Country

Japan

Facility Name

Investigational Site Number 392168

City

Uozu-Shi

Country

Japan

Facility Name

Investigational Site Number 392132

City

Urasoe-Shi

Country

Japan

Facility Name

Investigational Site Number 392045

City

Uruma-Shi

Country

Japan

Facility Name

Investigational Site Number 392014

City

Yokohama-Shi

Country

Japan

Facility Name

Investigational Site Number 410002

City

Bucheon-Si

ZIP/Postal Code

14584

Country

Korea, Republic of

Facility Name

Investigational Site Number 410003

City

Cheongju-Si

ZIP/Postal Code

28644

Country

Korea, Republic of

Facility Name

Investigational Site Number 410013

City

Incheon

ZIP/Postal Code

21565

Country

Korea, Republic of

Facility Name

Investigational Site Number 410006

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

Investigational Site Number 410008

City

Seoul

ZIP/Postal Code

03312

Country

Korea, Republic of

Facility Name

Investigational Site Number 410004

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Facility Name

Investigational Site Number 410012

City

Seoul

ZIP/Postal Code

04763

Country

Korea, Republic of

Facility Name

Investigational Site Number 410005

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

Investigational Site Number 410007

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

Investigational Site Number 410010

City

Seoul

ZIP/Postal Code

06973

Country

Korea, Republic of

Facility Name

Investigational Site Number 410011

City

Seoul

ZIP/Postal Code

08308

Country

Korea, Republic of

Facility Name

Investigational Site Number 410001

City

Suwon

ZIP/Postal Code

16499

Country

Korea, Republic of

Facility Name

Investigational Site Number 484013

City

Chihuahua

ZIP/Postal Code

31020

Country

Mexico

Facility Name

Investigational Site Number 484006

City

Chihuahua

ZIP/Postal Code

31200

Country

Mexico

Facility Name

Investigational Site Number 484014

City

Cuautitlan Izcalli

ZIP/Postal Code

54769

Country

Mexico

Facility Name

Investigational Site Number 484005

City

Distrito Federal

ZIP/Postal Code

07760

Country

Mexico

Facility Name

Investigational Site Number 484008

City

Durango

ZIP/Postal Code

34080

Country

Mexico

Facility Name

Investigational Site Number 484001

City

Guadalajara

ZIP/Postal Code

44100

Country

Mexico

Facility Name

Investigational Site Number 484004

City

Mexico City

ZIP/Postal Code

64718

Country

Mexico

Facility Name

Investigational Site Number 484003

City

Monterrey

ZIP/Postal Code

64460

Country

Mexico

Facility Name

Investigational Site Number 484007

City

Monterrey

ZIP/Postal Code

66465

Country

Mexico

Facility Name

Investigational Site Number 484010

City

México

ZIP/Postal Code

06700

Country

Mexico

Facility Name

Investigational Site Number 484012

City

San Juan Del Rio

ZIP/Postal Code

76800

Country

Mexico

Facility Name

Investigational Site Number 484011

City

Veracruz

ZIP/Postal Code

91910

Country

Mexico

Facility Name

Investigational Site Number 528001

City

Arnhem

ZIP/Postal Code

6815 AD

Country

Netherlands

Facility Name

Investigational Site Number 528002

City

Dordrecht

ZIP/Postal Code

3318 AT

Country

Netherlands

Facility Name

Investigational Site Number 616006

City

Bialystok

ZIP/Postal Code

15-010

Country

Poland

Facility Name

Investigational Site Number 616004

City

Gdansk

ZIP/Postal Code

80-405

Country

Poland

Facility Name

Investigational Site Number 616003

City

Gdansk

ZIP/Postal Code

80-952

Country

Poland

Facility Name

Investigational Site Number 616007

City

Krakow

ZIP/Postal Code

31-159

Country

Poland

Facility Name

Investigational Site Number 616097

City

Krakow

ZIP/Postal Code

31-159

Country

Poland

Facility Name

Investigational Site Number 616001

City

Lodz

ZIP/Postal Code

90-141

Country

Poland

Facility Name

Investigational Site Number 616005

City

Lodz

ZIP/Postal Code

90-153

Country

Poland

Facility Name

Investigational Site Number 616009

City

Lodz

ZIP/Postal Code

90-329

Country

Poland

Facility Name

Investigational Site Number 616096

City

Poznan

ZIP/Postal Code

60-693

Country

Poland

Facility Name

Investigational Site Number 616098

City

Strzelce Opolskie

ZIP/Postal Code

47-100

Country

Poland

Facility Name

Investigational Site Number 616008

City

Warszawa

ZIP/Postal Code

00-013

Country

Poland

Facility Name

Investigational Site Number 616010

City

Warszawa

ZIP/Postal Code

04-141

Country

Poland

Facility Name

Investigational Site Number 616011

City

Znin

ZIP/Postal Code

88-400

Country

Poland

Facility Name

Investigational Site Number 642104

City

Bucharest

ZIP/Postal Code

011461

Country

Romania

Facility Name

Investigational Site Number 642103

City

Bucharest

ZIP/Postal Code

050159

Country

Romania

Facility Name

Investigational Site Number 642102

City

Cluj-Napoca

ZIP/Postal Code

400162

Country

Romania

Facility Name

Investigational Site Number 642107

City

Cluj-Napoca

ZIP/Postal Code

400371

Country

Romania

Facility Name

Investigational Site Number 642105

City

Timisoara

ZIP/Postal Code

300310

Country

Romania

Facility Name

Investigational Site Number 642106

City

Timisoara

ZIP/Postal Code

300310

Country

Romania

Facility Name

Investigational Site Number 643013

City

Ekaterinburg

ZIP/Postal Code

620028

Country

Russian Federation

Facility Name

Investigational Site Number 643096

City

Moscow

ZIP/Postal Code

105077

Country

Russian Federation

Facility Name

Investigational Site Number 643002

City

Moscow

ZIP/Postal Code

109240

Country

Russian Federation

Facility Name

Investigational Site Number 643005

City

Moscow

ZIP/Postal Code

115280

Country

Russian Federation

Facility Name

Investigational Site Number 643007

City

Moscow

ZIP/Postal Code

117574

Country

Russian Federation

Facility Name

Investigational Site Number 643012

City

Moscow

ZIP/Postal Code

123182

Country

Russian Federation

Facility Name

Investigational Site Number 643001

City

Moscow

ZIP/Postal Code

125315

Country

Russian Federation

Facility Name

Investigational Site Number 643006

City

Novosibirsk

ZIP/Postal Code

630091

Country

Russian Federation

Facility Name

Investigational Site Number 643091

City

Ryazan

ZIP/Postal Code

390039

Country

Russian Federation

Facility Name

Investigational Site Number 643011

City

Saint-Petersburg

ZIP/Postal Code

194223

Country

Russian Federation

Facility Name

Investigational Site Number 643010

City

Saint-Petersburg

ZIP/Postal Code

194354

Country

Russian Federation

Facility Name

Investigational Site Number 643099

City

St-Petersburg

ZIP/Postal Code

193231

Country

Russian Federation

Facility Name

Investigational Site Number 643009

City

St-Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

Investigational Site Number 643008

City

Yaroslavl

ZIP/Postal Code

150003

Country

Russian Federation

Facility Name

Investigational Site Number 710009

City

Brandfort

ZIP/Postal Code

9400

Country

South Africa

Facility Name

Investigational Site Number 710011

City

Cape Town

ZIP/Postal Code

7505

Country

South Africa

Facility Name

Investigational Site Number 710001

City

Cape Town

ZIP/Postal Code

7530

Country

South Africa

Facility Name

Investigational Site Number 710091

City

Cape Town

ZIP/Postal Code

7700

Country

South Africa

Facility Name

Investigational Site Number 710092

City

Cape Town

ZIP/Postal Code

7700

Country

South Africa

Facility Name

Investigational Site Number 710002

City

Cape Town

ZIP/Postal Code

7764

Country

South Africa

Facility Name

Investigational Site Number 710003

City

Cape Town

ZIP/Postal Code

8000

Country

South Africa

Facility Name

Investigational Site Number 710006

City

Durban

ZIP/Postal Code

4071

Country

South Africa

Facility Name

Investigational Site Number 710007

City

Pretoria

ZIP/Postal Code

0087

Country

South Africa

Facility Name

Investigational Site Number 724014

City

Barcelona

ZIP/Postal Code

08023

Country

Spain

Facility Name

Investigational Site Number 724002

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Investigational Site Number 724001

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Investigational Site Number 724010

City

Palma De Mallorca

ZIP/Postal Code

07120

Country

Spain

Facility Name

Investigational Site Number 724006

City

Pozuelo De Alarcón

ZIP/Postal Code

28223

Country

Spain

Facility Name

Investigational Site Number 724003

City

Sabadell

ZIP/Postal Code

08208

Country

Spain

Facility Name

Investigational Site Number 724007

City

Sant Boi De Llobregat

ZIP/Postal Code

08830

Country

Spain

Facility Name

Investigational Site Number 724096

City

Santiago De Compostela

ZIP/Postal Code

15706

Country

Spain

Facility Name

Investigational Site Number 724008

City

Sevilla

ZIP/Postal Code

41071

Country

Spain

Facility Name

Investigational Site Number 724097

City

Valencia

ZIP/Postal Code

46017

Country

Spain

Facility Name

Investigational Site Number 158008

City

New Taipei City

ZIP/Postal Code

23561

Country

Taiwan

Facility Name

Investigational Site Number 158007

City

Taichung

ZIP/Postal Code

40447

Country

Taiwan

Facility Name

Investigational Site Number 158009

City

Taipei

ZIP/Postal Code

11031

Country

Taiwan

Facility Name

Investigational Site Number 792002

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Investigational Site Number 792098

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Investigational Site Number 792008

City

Bursa

ZIP/Postal Code

16059

Country

Turkey

Facility Name

Investigational Site Number 792007

City

Istanbul

ZIP/Postal Code

34020

Country

Turkey

Facility Name

Investigational Site Number 792001

City

Istanbul

ZIP/Postal Code

34098

Country

Turkey

Facility Name

Investigational Site Number 792004

City

Istanbul

ZIP/Postal Code

34098

Country

Turkey

Facility Name

Investigational Site Number 792003

City

Istanbul

ZIP/Postal Code

34844

Country

Turkey

Facility Name

Investigational Site Number 792005

City

Izmir

ZIP/Postal Code

35040

Country

Turkey

Facility Name

Investigational Site Number 792090

City

Izmir

ZIP/Postal Code

35110

Country

Turkey

Facility Name

Investigational Site Number 792013

City

Kirikkale

ZIP/Postal Code

71450

Country

Turkey

Facility Name

Investigational Site Number 792006

City

Mersin

ZIP/Postal Code

33070

Country

Turkey

Facility Name

Investigational Site Number 792096

City

Rize

ZIP/Postal Code

53100

Country

Turkey

Facility Name

Investigational Site Number 804007

City

Chernivtsi

ZIP/Postal Code

58001

Country

Ukraine

Facility Name

Investigational Site Number 804023

City

Dnipro

ZIP/Postal Code

49101

Country

Ukraine

Facility Name

Investigational Site Number 804009

City

Ivano-Frankivsk

ZIP/Postal Code

76018

Country

Ukraine

Facility Name

Investigational Site Number 804094

City

Ivano-Frankivsk

ZIP/Postal Code

76018

Country

Ukraine

Facility Name

Investigational Site Number 804005

City

Kharkiv

ZIP/Postal Code

61058

Country

Ukraine

Facility Name

Investigational Site Number 804021

City

Kharkiv

ZIP/Postal Code

61093

Country

Ukraine

Facility Name

Investigational Site Number 804001

City

Kharkiv

ZIP/Postal Code

61124

Country

Ukraine

Facility Name

Investigational Site Number 804004

City

Kyiv

ZIP/Postal Code

03049

Country

Ukraine

Facility Name

Investigational Site Number 804003

City

Kyiv

ZIP/Postal Code

03680

Country

Ukraine

Facility Name

Investigational Site Number 804008

City

Kyiv

ZIP/Postal Code

03680

Country

Ukraine

Facility Name

Investigational Site Number 804017

City

Kyiv

ZIP/Postal Code

03680

Country

Ukraine

Facility Name

Investigational Site Number 804018

City

Kyiv

ZIP/Postal Code

03680

Country

Ukraine

Facility Name

Investigational Site Number 804020

City

Kyiv

ZIP/Postal Code

03680

Country

Ukraine

Facility Name

Investigational Site Number 804016

City

Kyiv

ZIP/Postal Code

04050

Country

Ukraine

Facility Name

Investigational Site Number 804006

City

Odesa

ZIP/Postal Code

65025

Country

Ukraine

Facility Name

Investigational Site Number 804002

City

Poltava

ZIP/Postal Code

36038

Country

Ukraine

Facility Name

Investigational Site Number 804014

City

Ternopil

ZIP/Postal Code

46000

Country

Ukraine

Facility Name

Investigational Site Number 804019

City

Vinnytsya

ZIP/Postal Code

21001

Country

Ukraine

Facility Name

Investigational Site Number 804015

City

Yalta

ZIP/Postal Code

298603

Country

Ukraine

Facility Name

Investigational Site Number 804022

City

Zaporizhzhya

ZIP/Postal Code

69076

Country

Ukraine

Facility Name

Investigational Site Number 804012

City

Zaporizhzhya

ZIP/Postal Code

69118

Country

Ukraine

Facility Name

Investigational Site Number 826001

City

Bradford

ZIP/Postal Code

BD9 6RJ

Country

United Kingdom

Facility Name

Investigational Site Number 826010

City

London

ZIP/Postal Code

W2 1NY

Country

United Kingdom

Facility Name

Investigational Site Number 826009

City

Oxford

ZIP/Postal Code

OX3 7LE

Country

United Kingdom

Facility Name

Investigational Site Number 826007

City

Portsmouth

ZIP/Postal Code

PO6 3LY

Country

United Kingdom

Facility Name

Investigational Site Number 826006

City

South Shields

ZIP/Postal Code

NE34 0PL

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Citations:

PubMed Identifier

36114102

Citation

Tohda Y, Nakamura Y, Fujisawa T, Ebisawa M, Msihid J, Djandji M, Ortiz B, Jacob-Nara JA, Deniz Y, Rowe PJ, Ishida M, Arima K. Efficacy of dupilumab in patients with uncontrolled, moderate-to-severe asthma recruited from Japanese centers in the phase 3 LIBERTY ASTHMA TRAVERSE study. Allergol Int. 2023 Jan;72(1):89-99. doi: 10.1016/j.alit.2022.07.008. Epub 2022 Sep 13.

Results Reference

derived

PubMed Identifier

35809937

Citation

Lugogo N, Mohan A. Are We Poised to Change the Trajectory of Maintenance Oral Corticosteroid Use in Severe Asthma in the Age of Biologics? Chest. 2022 Jul;162(1):4-5. doi: 10.1016/j.chest.2022.04.004. No abstract available.

Results Reference

derived

PubMed Identifier

35636689

Citation

Wechsler ME, Klion AD, Paggiaro P, Nair P, Staumont-Salle D, Radwan A, Johnson RR, Kapoor U, Khokhar FA, Daizadeh N, Chen Z, Laws E, Ortiz B, Jacob-Nara JA, Mannent LP, Rowe PJ, Deniz Y. Effect of Dupilumab on Blood Eosinophil Counts in Patients With Asthma, Chronic Rhinosinusitis With Nasal Polyps, Atopic Dermatitis, or Eosinophilic Esophagitis. J Allergy Clin Immunol Pract. 2022 Oct;10(10):2695-2709. doi: 10.1016/j.jaip.2022.05.019. Epub 2022 May 28.

Results Reference

derived

PubMed Identifier

35217003

Citation

Sher LD, Wechsler ME, Rabe KF, Maspero JF, Daizadeh N, Mao X, Ortiz B, Mannent LP, Laws E, Ruddy M, Pandit-Abid N, Jacob-Nara JA, Gall R, Rowe PJ, Deniz Y, Lederer DJ, Hardin M. Dupilumab Reduces Oral Corticosteroid Use in Patients With Corticosteroid-Dependent Severe Asthma: An Analysis of the Phase 3, Open-Label Extension TRAVERSE Trial. Chest. 2022 Jul;162(1):46-55. doi: 10.1016/j.chest.2022.01.071. Epub 2022 Feb 22.

Results Reference

derived

PubMed Identifier

34597534

Citation

Wechsler ME, Ford LB, Maspero JF, Pavord ID, Papi A, Bourdin A, Watz H, Castro M, Nenasheva NM, Tohda Y, Langton D, Cardona G, Domingo C, Park HS, Chapman KR, Mao X, Zhang Y, Khan AH, Deniz Y, Rowe PJ, Kapoor U, Khokhar FA, Mannent LP, Ruddy M, Laws E, Amin N, Hardin M. Long-term safety and efficacy of dupilumab in patients with moderate-to-severe asthma (TRAVERSE): an open-label extension study. Lancet Respir Med. 2022 Jan;10(1):11-25. doi: 10.1016/S2213-2600(21)00322-2. Epub 2021 Sep 28.

Results Reference

derived

Learn more about this trial

Long-Term Safety Evaluation of Dupilumab in Patients With Asthma (LIBERTY ASTHMA TRAVERSE)

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Long-Term Safety Evaluation of Dupilumab in Patients With Asthma (LIBERTY ASTHMA TRAVERSE)

Asthma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial