Clinical trial NCT02134028: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2014-05-08
Enrollment: 2282
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: From the first IMP injection in LTS12551 to the last IMP injection plus 14 weeks (up to 108 weeks)
Secondary outcomes:
measure: Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period
timeFrame: From the first IMP injection in LTS12551 to the last IMP injection plus 14 weeks (up to 108 weeks)
measure: Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period
timeFrame: From the first IMP injection in LTS12551 to the last IMP injection plus 14 weeks (up to 108 weeks)
measure: Number of Severe Exacerbation Events
timeFrame: From the first IMP injection in LTS12551 to the last IMP injection plus 2 weeks (up to 96 weeks)
measure: Annualized Event Rate Per Participant-Years for Severe Exacerbation
timeFrame: From the first IMP injection in LTS12551 to the last IMP injection plus 2 weeks (up to 96 weeks)
measure: Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Weeks 48 and 96
timeFrame: Baseline of parent study, Week 48 and Week 96 of this extension study
measure: Change From Baseline in Percent Predicted FEV1 at Weeks 48 and 96
timeFrame: Baseline of parent study, Week 48 and Week 96 of this extension study
measure: Change From Baseline in Forced Vital Capacity (FVC) at Weeks 48 and 96
timeFrame: Baseline of parent study, Week 48, and Week 96 of this extension study
measure: Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 48 and 96
timeFrame: Baseline of parent study, Week 48, and Week 96 of this extension study
measure: Change From Baseline in Asthma Control Questionnaire 5-Question Version (ACQ-5) Mean Scores at Weeks 24 and 48
timeFrame: Baseline of parent study, Weeks 24, and 48 of this extension study
measure: Percentage of Participants Achieving ACQ-5 Score Response (ACQ-5 Responders) at Weeks 24 and 48
timeFrame: At Weeks 24, and 48 of this extension study
measure: Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Global Scores at Weeks 24 and 48
timeFrame: Baseline of parent study, Weeks 24, and 48 of this extension study
measure: Percentage of Participants Achieving AQLQ Global Score Response (AQLQ Responders) at Weeks 24 and 48
timeFrame: At Weeks 24, and 48 of this extension study
measure: Serum Concentrations of Dupilumab Over Time Till Week 96
timeFrame: Baseline of parent study, Weeks 0, 4, 12, 24, 48, 72, and 96 of this extension study
measure: Percentage of Participants With Antidrug Antibodies (ADA) Response
timeFrame: From the first IMP injection in LTS12551 to the last IMP injection plus 2 weeks (up to 96 weeks)
measure: Change From Baseline in Blood Eosinophils Cells Count at Weeks 48 and 96
timeFrame: Baseline of parent study, Week 48 and Week 96 of this extension study
measure: Change From Baseline in Morning Peak Expiratory Flow (PEF) at Weeks 48 and 96: Participants From Study DRI12544
timeFrame: Baseline of parent study, Week 48 and Week 96 of this extension study
measure: Change From Baseline in Evening Peak Expiratory Flow (PEF) at Weeks 48 and 96: Participants From Study DRI12544
timeFrame: Baseline of parent study, Week 48 and Week 96 of this extension study
measure: Change From Baseline in Morning Asthma Symptom Scores at Weeks 48 and 96: Participants From Study DRI12544
timeFrame: Baseline of parent study, Week 48 and Week 96 of this extension study
measure: Change From Baseline in Evening Asthma Symptom Scores at Weeks 48 and 96: Participants From Study DRI12544
timeFrame: Baseline of parent study, Week 48, and Week 96 of this extension study
measure: 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
timeFrame: Baseline of parent study, Week 48, and Week 96 of this extension study
measure: Change From Baseline in Number of Nocturnal Awakenings at Weeks 48 and 96: Participants From Study DRI12544
timeFrame: Baseline of parent study, Week 48 and Week 96 of this extension study
measure: Percent Change From Baseline in Oral Corticosteroid (OCS) Dose at Weeks 48, and 96: Participants From Study EFC13691
timeFrame: Baseline of parent study, Weeks 48 and 96 of this extension study
measure: 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
timeFrame: Weeks 48 and 96 of this extension study
measure: Percentage of Participants With Background OCS Completely Tapered Off Over Time at Weeks 48 and 96: Participants From Study EFC13691
timeFrame: Weeks 48, and 96 of this extension study
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
timeFrame: Baseline of parent study, Week 48 and Week 96 of this extension study
measure: Change From Baseline in EQ-5D-3L VAS Scores at Weeks 48 and 96: Participants From Study DRI12544
timeFrame: Baseline of parent study, Week 48 and Week 96 of this extension study
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Investigational Site Number 840047
state: Alabama
city: Gilbert
country: United States
facility: Investigational Site Number 840099
state: Arizona
city: Scottsdale
country: United States
facility: Investigational Site Number 840087
state: Arizona
city: Tucson
country: United States
facility: Investigational Site Number 840402
state: Arizona
city: Little Rock
country: United States
facility: Investigational Site Number 840132
state: Arkansas
city: Bakersfield
country: United States
facility: Investigational Site Number 840109
state: California
city: Long Beach
country: United States
facility: Investigational Site Number 840045
state: California
city: Los Angeles
country: United States
facility: Investigational Site Number 840019
state: California
city: Los Angeles
country: United States
facility: Investigational Site Number 840029
state: California
city: Los Angeles
country: United States
facility: Investigational Site Number 840022
state: California
city: Newport Beach
country: United States
facility: Investigational Site Number 840044
state: California
city: North Hollywood
country: United States
facility: Investigational Site Number 840041
state: California
city: Rolling Hills Estates
country: United States
facility: Investigational Site Number 840014
state: California
city: San Jose
country: United States
facility: Investigational Site Number 840121
state: California
city: Colorado Springs
country: United States
facility: Investigational Site Number 840040
state: Colorado
city: Denver
country: United States
facility: Investigational Site Number 840403
state: Colorado
city: Denver
country: United States
facility: Investigational Site Number 840006
state: Colorado
city: Denver
country: United States
facility: Investigational Site Number 840024
state: Colorado
city: Denver
country: United States
facility: Investigational Site Number 840130
state: Colorado
city: New Haven
country: United States
facility: Investigational Site Number 840902
state: Connecticut
city: Aventura
country: United States
facility: Investigational Site Number 840137
state: Florida
city: Gainesville
country: United States
facility: Investigational Site Number 840071
state: Florida
city: Ocoee
country: United States
facility: Investigational Site Number 840115
state: Florida
city: Sarasota
country: United States
facility: Investigational Site Number 840055
state: Florida
city: Twin Falls
country: United States
facility: Investigational Site Number 840079
state: Idaho
city: Chicago
country: United States
facility: Investigational Site Number 840101
state: Illinois
city: Fort Mitchell
country: United States
facility: Investigational Site Number 840032
state: Kentucky
city: Louisville
country: United States
facility: Investigational Site Number 840017
state: Kentucky
city: Owensboro
country: United States
facility: Investigational Site Number 840030
state: Kentucky
city: Bangor
country: United States
facility: Investigational Site Number 840064
state: Maine
city: Chevy Chase
country: United States
facility: Investigational Site Number 840052
state: Maryland
city: Gaithersburg
country: United States
facility: Investigational Site Number 840073
state: Maryland
city: Owings Mills
country: United States
facility: Investigational Site Number 840080
state: Maryland
city: Boston
country: United States
facility: Investigational Site Number 840401
state: Massachusetts
city: Minneapolis
country: United States
facility: Investigational Site Number 840018
state: Minnesota
city: Saint Louis
country: United States
facility: Investigational Site Number 840002
state: Missouri
city: Saint Louis
country: United States
facility: Investigational Site Number 840102
state: Missouri
city: Saint Louis
country: United States
facility: Investigational Site Number 840093
state: Missouri
city: Missoula
country: United States
facility: Investigational Site Number 840037
state: Montana
city: Omaha
country: United States
facility: Investigational Site Number 840078
state: Nebraska
city: Papillion
country: United States
facility: Investigational Site Number 840004
state: Nebraska
city: Brick
country: United States
facility: Investigational Site Number 840111
state: New Jersey
city: Ocean City
country: United States
facility: Investigational Site Number 840068
state: New Jersey
city: Princeton
country: United States
facility: Investigational Site Number 840011
state: New Jersey
city: New York
country: United States
facility: Investigational Site Number 840065
state: New York
city: Charlotte
country: United States
facility: Investigational Site Number 840126
state: North Carolina
city: Charlotte
country: United States
facility: Investigational Site Number 840083
state: North Carolina
city: Durham
country: United States
facility: Investigational Site Number 840108
state: North Carolina
city: Greensboro
country: United States
facility: Investigational Site Number 840107
state: North Carolina
city: High Point
country: United States
facility: Investigational Site Number 840907
state: North Carolina
city: Winston-Salem
country: United States
facility: Investigational Site Number 840404
state: North Carolina
city: Cincinnati
country: United States
facility: Investigational Site Number 840015
state: Ohio
city: Cincinnati
country: United States
facility: Investigational Site Number 840146
state: Ohio
city: Middleburg Heights
country: United States
facility: Investigational Site Number 840049
state: Ohio
city: Toledo
country: United States
facility: Investigational Site Number 840942
state: Ohio
city: Edmond
country: United States
facility: Investigational Site Number 840112
state: Oklahoma
city: Tulsa
country: United States
facility: Investigational Site Number 840104
state: Oklahoma
city: Medford
country: United States
facility: Investigational Site Number 840034
state: Oregon
city: Portland
country: United States
facility: Investigational Site Number 840031
state: Oregon
city: Bethlehem
country: United States
facility: Investigational Site Number 840046
state: Pennsylvania
city: Hershey
country: United States
facility: Investigational Site Number 840085
state: Pennsylvania
city: Philadelphia
country: United States
facility: Investigational Site Number 840067
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Investigational Site Number 840928
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Investigational Site Number 840091
state: Pennsylvania
city: Charleston
country: United States
facility: Investigational Site Number 840082
state: South Carolina
city: Greenville
country: United States
facility: Investigational Site Number 840117
state: South Carolina
city: Spartanburg
country: United States
facility: Investigational Site Number 840021
state: South Carolina
city: Amarillo
country: United States
facility: Investigational Site Number 840062
state: Texas
city: Boerne
country: United States
facility: Investigational Site Number 840038
state: Texas
city: Cypress
country: United States
facility: Investigational Site Number 840124
state: Texas
city: Dallas
country: United States
facility: Investigational Site Number 840023
state: Texas
city: El Paso
country: United States
facility: Investigational Site Number 840923
state: Texas
city: Fort Worth
country: United States
facility: Investigational Site Number 840922
state: Texas
city: Fort Worth
country: United States
facility: Investigational Site Number 840027
state: Texas
city: McKinney
country: United States
facility: Investigational Site Number 840070
state: Texas
city: Plano
country: United States
facility: Investigational Site Number 840118
state: Texas
city: San Antonio
country: United States
facility: Investigational Site Number 840008
state: Texas
city: Draper
country: United States
facility: Investigational Site Number 840035
state: Utah
city: Murray
country: United States
facility: Investigational Site Number 840077
state: Utah
city: South Burlington
country: United States
facility: Investigational Site Number 840057
state: Vermont
city: Fairfax
country: United States
facility: Investigational Site Number 840059
state: Virginia
city: Bellingham
country: United States
facility: Investigational Site Number 840951
state: Washington
city: Bahia Blanca
country: Argentina
facility: Investigational Site Number 032096
city: Buenos Aires
country: Argentina
facility: Investigational Site Number 032004
city: Buenos Aires
country: Argentina
facility: Investigational Site Number 032003
city: Caba
country: Argentina
facility: Investigational Site Number 032011
city: Caba
country: Argentina
facility: Investigational Site Number 032097
city: Caba
country: Argentina
facility: Investigational Site Number 032001
city: Caba
country: Argentina
facility: Investigational Site Number 032010
city: Caba
country: Argentina
facility: Investigational Site Number 032091
city: Capital Federal
country: Argentina
facility: Investigational Site Number 032095
city: La Plata
country: Argentina
facility: Investigational Site Number 032002
city: Rosario
country: Argentina
facility: Investigational Site Number 032006
city: Rosario
country: Argentina
facility: Investigational Site Number 032007
city: Rosario
country: Argentina
facility: Investigational Site Number 032005
city: San Miguel De Tucuman
country: Argentina
facility: Investigational Site Number 032012
city: San Miguel De Tucumán
country: Argentina
facility: Investigational Site Number 032009
city: Adelaide
country: Australia
facility: Investigational Site Number 036004
city: Campbelltown
country: Australia
facility: Investigational Site Number 036005
city: Clayton
country: Australia
facility: Investigational Site Number 036001
city: Frankston
country: Australia
facility: Investigational Site Number 036008
city: Murdoch
country: Australia
facility: Investigational Site Number 036093
city: Nedlands
country: Australia
facility: Investigational Site Number 036003
city: Parkville
country: Australia
facility: Investigational Site Number 036094
city: Prahran
country: Australia
facility: Investigational Site Number 036009
city: Woolloongabba
country: Australia
facility: Investigational Site Number 036006
city: Brussels
country: Belgium
facility: Investigational Site Number 056002
city: Gent
country: Belgium
facility: Investigational Site Number 056003
city: Leuven
country: Belgium
facility: Investigational Site Number 056001
city: Florianópolis
country: Brazil
facility: Investigational Site Number 076009
city: Porto Alegre
country: Brazil
facility: Investigational Site Number 076007
city: Porto Alegre
country: Brazil
facility: Investigational Site Number 076001
city: Salvador
country: Brazil
facility: Investigational Site Number 076003
city: Sao Paulo
country: Brazil
facility: Investigational Site Number 076012
city: Sorocaba
country: Brazil
facility: Investigational Site Number 076002
city: São Bernardo Do Campo
country: Brazil
facility: Investigational Site Number 076013
city: São Paulo
country: Brazil
facility: Investigational Site Number 076006
city: Burlington
country: Canada
facility: Investigational Site Number 124019
city: Calgary
country: Canada
facility: Investigational Site Number 124009
city: Hamilton
country: Canada
facility: Investigational Site Number 124016
city: Mississauga
country: Canada
facility: Investigational Site Number 124003
city: Montreal
country: Canada
facility: Investigational Site Number 124001
city: Montreal
country: Canada
facility: Investigational Site Number 124012
city: Montreal
country: Canada
facility: Investigational Site Number 124010
city: Ottawa
country: Canada
facility: Investigational Site Number 124013
city: Quebec
country: Canada
facility: Investigational Site Number 124018
city: Quebec
country: Canada
facility: Investigational Site Number 124014
city: Sherbrooke
country: Canada
facility: Investigational Site Number 124008
city: Toronto
country: Canada
facility: Investigational Site Number 124015
city: Toronto
country: Canada
facility: Investigational Site Number 124002
city: Trois-Rivieres
country: Canada
facility: Investigational Site Number 124007
city: Vancouver
country: Canada
facility: Investigational Site Number 124006
city: Vancouver
country: Canada
facility: Investigational Site Number 124017
city: Quillota
country: Chile
facility: Investigational Site Number 152007
city: Santiago
country: Chile
facility: Investigational Site Number 152024
city: Santiago
country: Chile
facility: Investigational Site Number 152005
city: Santiago
country: Chile
facility: Investigational Site Number 152014
city: Santiago
country: Chile
facility: Investigational Site Number 152011
city: Santiago
country: Chile
facility: Investigational Site Number 152018
city: Santiago
country: Chile
facility: Investigational Site Number 152002
city: Santiago
country: Chile
facility: Investigational Site Number 152013
city: Talcahuano
country: Chile
facility: Investigational Site Number 152023
city: Talca
country: Chile
facility: Investigational Site Number 152008
city: Talca
country: Chile
facility: Investigational Site Number 152004
city: Valdivia
country: Chile
facility: Investigational Site Number 152010
city: Viña Del Mar
country: Chile
facility: Investigational Site Number 152003
city: Viña Del Mar
country: Chile
facility: Investigational Site Number 152021
city: Bogota
country: Colombia
facility: Investigational Site Number 170001
city: Bogotá
country: Colombia
facility: Investigational Site Number 170002
city: Hvidovre
country: Denmark
facility: Investigational Site Number 208002
city: København Nv
country: Denmark
facility: Investigational Site Number 208001
city: Brest
country: France
facility: Investigational Site Number 250009
city: La Tronche
country: France
facility: Investigational Site Number 250004
city: Lille Cedex
country: France
facility: Investigational Site Number 250010
city: Lille Cedex
country: France
facility: Investigational Site Number 250013
city: Lyon
country: France
facility: Investigational Site Number 250006
city: Marseille
country: France
facility: Investigational Site Number 250001
city: Montpellier
country: France
facility: Investigational Site Number 250002
city: Nantes
country: France
facility: Investigational Site Number 250005
city: Nimes Cedex 9
country: France
facility: Investigational Site Number 250007
city: Strasbourg
country: France
facility: Investigational Site Number 250008
city: Vandoeuvre-Les-Nancy Cedex
country: France
facility: Investigational Site Number 250014
city: Berlin
country: Germany
facility: Investigational Site Number 276006
city: Bochum
country: Germany
facility: Investigational Site Number 276003
city: Frankfurt Am Main
country: Germany
facility: Investigational Site Number 276010
city: Großhansdorf
country: Germany
facility: Investigational Site Number 276011
city: Koblenz
country: Germany
facility: Investigational Site Number 276009
city: Rüdersdorf Bei Berlin
country: Germany
facility: Investigational Site Number 276005
city: Balassagyarmat
country: Hungary
facility: Investigational Site Number 348301
city: Edelény
country: Hungary
facility: Investigational Site Number 348303
city: Gödöllö
country: Hungary
facility: Investigational Site Number 348003
city: Haifa
country: Israel
facility: Investigational Site Number 376003
city: Kfar Saba
country: Israel
facility: Investigational Site Number 376001
city: Petah-Tikva
country: Israel
facility: Investigational Site Number 376005
city: Rehovot
country: Israel
facility: Investigational Site Number 376002
city: Ancona
country: Italy
facility: Investigational Site Number 380010
city: Catania
country: Italy
facility: Investigational Site Number 380009
city: Ferrara
country: Italy
facility: Investigational Site Number 380004
city: Foggia
country: Italy
facility: Investigational Site Number 380008
city: Genova
country: Italy
facility: Investigational Site Number 380002
city: Modena
country: Italy
facility: Investigational Site Number 380003
city: Padova
country: Italy
facility: Investigational Site Number 380007
city: Palermo
country: Italy
facility: Investigational Site Number 380099
city: Pisa
country: Italy
facility: Investigational Site Number 380001
city: Akashi-Shi
country: Japan
facility: Investigational Site Number 392185
city: Asahi-Shi
country: Japan
facility: Investigational Site Number 392009
city: Chiyoda-Ku
country: Japan
facility: Investigational Site Number 392037
city: Chuo-Ku
country: Japan
facility: Investigational Site Number 392002
city: Chuo-Ku
country: Japan
facility: Investigational Site Number 392007
city: Chuo-Ku
country: Japan
facility: Investigational Site Number 392112
city: Edogawa-Ku
country: Japan
facility: Investigational Site Number 392012
city: Fukuoka-Shi
country: Japan
facility: Investigational Site Number 392137
city: Fukuyama-Shi
country: Japan
facility: Investigational Site Number 392021
city: Habikino-Shi
country: Japan
facility: Investigational Site Number 392030
city: Himeji-Shi
country: Japan
facility: Investigational Site Number 392004
city: Hirakata-Shi
country: Japan
facility: Investigational Site Number 392032
city: Hiroshima-Shi
country: Japan
facility: Investigational Site Number 392108
city: Hiroshima-Shi
country: Japan
facility: Investigational Site Number 392158
city: Iizuka-Shi
country: Japan
facility: Investigational Site Number 392013
city: Isesaki-Shi
country: Japan
facility: Investigational Site Number 392042
city: Kanazawa-Shi
country: Japan
facility: Investigational Site Number 392023
city: Kasuga-Shi
country: Japan
facility: Investigational Site Number 392142
city: Kishiwada-Shi
country: Japan
facility: Investigational Site Number 392119
city: Kobe-Shi
country: Japan
facility: Investigational Site Number 392025
city: Kobe-Shi
country: Japan
facility: Investigational Site Number 392162
city: Kodaira-Shi
country: Japan
facility: Investigational Site Number 392040
city: Kokubunji-Shi
country: Japan
facility: Investigational Site Number 392044
city: Koushi-Shi
country: Japan
facility: Investigational Site Number 392131
city: Kurashiki-Shi
country: Japan
facility: Investigational Site Number 392010
city: Kyoto-Shi
country: Japan
facility: Investigational Site Number 392036
city: Kyoto-Shi
country: Japan
facility: Investigational Site Number 392153
city: Machida-Shi
country: Japan
facility: Investigational Site Number 392133
city: Matsuyama-Shi
country: Japan
facility: Investigational Site Number 392135
city: Minato-Ku
country: Japan
facility: Investigational Site Number 392122
city: Minato-Ku
country: Japan
facility: Investigational Site Number 392144
city: Mizunami-Shi
country: Japan
facility: Investigational Site Number 392106
city: Muroran-Shi
country: Japan
facility: Investigational Site Number 392164
city: Nagoya-Shi
country: Japan
facility: Investigational Site Number 392163
city: Naka-Gun
country: Japan
facility: Investigational Site Number 392020
city: Naruto-Shi
country: Japan
facility: Investigational Site Number 392005
city: Obihiro-Shi
country: Japan
facility: Investigational Site Number 392187
city: Ome-Shi
country: Japan
facility: Investigational Site Number 392177
city: Osaka Sayama-Shi
country: Japan
facility: Investigational Site Number 392152
city: Osaka Sayama-Shi
country: Japan
facility: Investigational Site Number 392155
city: Osaki-Shi
country: Japan
facility: Investigational Site Number 392170
city: Ota-Ku
country: Japan
facility: Investigational Site Number 392127
city: Ota-Shi
country: Japan
facility: Investigational Site Number 392043
city: Sagamihara-Shi
country: Japan
facility: Investigational Site Number 392169
city: Sakai-Shi
country: Japan
facility: Investigational Site Number 392024
city: Sakaide-Shi
country: Japan
facility: Investigational Site Number 392011
city: Sapporo-Shi
country: Japan
facility: Investigational Site Number 392008
city: Sapporo-Shi
country: Japan
facility: Investigational Site Number 392034
city: Setagaya-Ku
country: Japan
facility: Investigational Site Number 392038
city: Seto-Shi
country: Japan
facility: Investigational Site Number 392179
city: Shibuya-Ku
country: Japan
facility: Investigational Site Number 392186
city: Shinagawa-Ku
country: Japan
facility: Investigational Site Number 392167
city: Shinjuku-Ku
country: Japan
facility: Investigational Site Number 392130
city: Sumida-Ku
country: Japan
facility: Investigational Site Number 392165
city: Tachikawa-Shi
country: Japan
facility: Investigational Site Number 392146
city: Tachikawa-Shi
country: Japan
facility: Investigational Site Number 392173
city: Tomakomai-Shi
country: Japan
facility: Investigational Site Number 392006
city: Tsu-Shi
country: Japan
facility: Investigational Site Number 392029
city: Uozu-Shi
country: Japan
facility: Investigational Site Number 392168
city: Urasoe-Shi
country: Japan
facility: Investigational Site Number 392132
city: Uruma-Shi
country: Japan
facility: Investigational Site Number 392045
city: Yokohama-Shi
country: Japan
facility: Investigational Site Number 392014
city: Bucheon-Si
country: Korea, Republic of
facility: Investigational Site Number 410002
city: Cheongju-Si
country: Korea, Republic of
facility: Investigational Site Number 410003
city: Incheon
country: Korea, Republic of
facility: Investigational Site Number 410013
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410006
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410008
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410004
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410012
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410005
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410007
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410010
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410011
city: Suwon
country: Korea, Republic of
facility: Investigational Site Number 410001
city: Chihuahua
country: Mexico
facility: Investigational Site Number 484013
city: Chihuahua
country: Mexico
facility: Investigational Site Number 484006
city: Cuautitlan Izcalli
country: Mexico
facility: Investigational Site Number 484014
city: Distrito Federal
country: Mexico
facility: Investigational Site Number 484005
city: Durango
country: Mexico
facility: Investigational Site Number 484008
city: Guadalajara
country: Mexico
facility: Investigational Site Number 484001
city: Mexico City
country: Mexico
facility: Investigational Site Number 484004
city: Monterrey
country: Mexico
facility: Investigational Site Number 484003
city: Monterrey
country: Mexico
facility: Investigational Site Number 484007
city: México
country: Mexico
facility: Investigational Site Number 484010
city: San Juan Del Rio
country: Mexico
facility: Investigational Site Number 484012
city: Veracruz
country: Mexico
facility: Investigational Site Number 484011
city: Arnhem
country: Netherlands
facility: Investigational Site Number 528001
city: Dordrecht
country: Netherlands
facility: Investigational Site Number 528002
city: Bialystok
country: Poland
facility: Investigational Site Number 616006
city: Gdansk
country: Poland
facility: Investigational Site Number 616004
city: Gdansk
country: Poland
facility: Investigational Site Number 616003
city: Krakow
country: Poland
facility: Investigational Site Number 616007
city: Krakow
country: Poland
facility: Investigational Site Number 616097
city: Lodz
country: Poland
facility: Investigational Site Number 616001
city: Lodz
country: Poland
facility: Investigational Site Number 616005
city: Lodz
country: Poland
facility: Investigational Site Number 616009
city: Poznan
country: Poland
facility: Investigational Site Number 616096
city: Strzelce Opolskie
country: Poland
facility: Investigational Site Number 616098
city: Warszawa
country: Poland
facility: Investigational Site Number 616008
city: Warszawa
country: Poland
facility: Investigational Site Number 616010
city: Znin
country: Poland
facility: Investigational Site Number 616011
city: Bucharest
country: Romania
facility: Investigational Site Number 642104
city: Bucharest
country: Romania
facility: Investigational Site Number 642103
city: Cluj-Napoca
country: Romania
facility: Investigational Site Number 642102
city: Cluj-Napoca
country: Romania
facility: Investigational Site Number 642107
city: Timisoara
country: Romania
facility: Investigational Site Number 642105
city: Timisoara
country: Romania
facility: Investigational Site Number 642106
city: Ekaterinburg
country: Russian Federation
facility: Investigational Site Number 643013
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643096
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643002
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643005
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643007
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643012
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643001
city: Novosibirsk
country: Russian Federation
facility: Investigational Site Number 643006
city: Ryazan
country: Russian Federation
facility: Investigational Site Number 643091
city: Saint-Petersburg
country: Russian Federation
facility: Investigational Site Number 643011
city: Saint-Petersburg
country: Russian Federation
facility: Investigational Site Number 643010
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 643099
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 643009
city: Yaroslavl
country: Russian Federation
facility: Investigational Site Number 643008
city: Brandfort
country: South Africa
facility: Investigational Site Number 710009
city: Cape Town
country: South Africa
facility: Investigational Site Number 710011
city: Cape Town
country: South Africa
facility: Investigational Site Number 710001
city: Cape Town
country: South Africa
facility: Investigational Site Number 710091
city: Cape Town
country: South Africa
facility: Investigational Site Number 710092
city: Cape Town
country: South Africa
facility: Investigational Site Number 710002
city: Cape Town
country: South Africa
facility: Investigational Site Number 710003
city: Durban
country: South Africa
facility: Investigational Site Number 710006
city: Pretoria
country: South Africa
facility: Investigational Site Number 710007
city: Barcelona
country: Spain
facility: Investigational Site Number 724014
city: Barcelona
country: Spain
facility: Investigational Site Number 724002
city: Barcelona
country: Spain
facility: Investigational Site Number 724001
city: Palma De Mallorca
country: Spain
facility: Investigational Site Number 724010
city: Pozuelo De Alarcón
country: Spain
facility: Investigational Site Number 724006
city: Sabadell
country: Spain
facility: Investigational Site Number 724003
city: Sant Boi De Llobregat
country: Spain
facility: Investigational Site Number 724007
city: Santiago De Compostela
country: Spain
facility: Investigational Site Number 724096
city: Sevilla
country: Spain
facility: Investigational Site Number 724008
city: Valencia
country: Spain
facility: Investigational Site Number 724097
city: New Taipei City
country: Taiwan
facility: Investigational Site Number 158008
city: Taichung
country: Taiwan
facility: Investigational Site Number 158007
city: Taipei
country: Taiwan
facility: Investigational Site Number 158009
city: Ankara
country: Turkey
facility: Investigational Site Number 792002
city: Ankara
country: Turkey
facility: Investigational Site Number 792098
city: Bursa
country: Turkey
facility: Investigational Site Number 792008
city: Istanbul
country: Turkey
facility: Investigational Site Number 792007
city: Istanbul
country: Turkey
facility: Investigational Site Number 792001
city: Istanbul
country: Turkey
facility: Investigational Site Number 792004
city: Istanbul
country: Turkey
facility: Investigational Site Number 792003
city: Izmir
country: Turkey
facility: Investigational Site Number 792005
city: Izmir
country: Turkey
facility: Investigational Site Number 792090
city: Kirikkale
country: Turkey
facility: Investigational Site Number 792013
city: Mersin
country: Turkey
facility: Investigational Site Number 792006
city: Rize
country: Turkey
facility: Investigational Site Number 792096
city: Chernivtsi
country: Ukraine
facility: Investigational Site Number 804007
city: Dnipro
country: Ukraine
facility: Investigational Site Number 804023
city: Ivano-Frankivsk
country: Ukraine
facility: Investigational Site Number 804009
city: Ivano-Frankivsk
country: Ukraine
facility: Investigational Site Number 804094
city: Kharkiv
country: Ukraine
facility: Investigational Site Number 804005
city: Kharkiv
country: Ukraine
facility: Investigational Site Number 804021
city: Kharkiv
country: Ukraine
facility: Investigational Site Number 804001
city: Kyiv
country: Ukraine
facility: Investigational Site Number 804004
city: Kyiv
country: Ukraine
facility: Investigational Site Number 804003
city: Kyiv
country: Ukraine
facility: Investigational Site Number 804008
city: Kyiv
country: Ukraine
facility: Investigational Site Number 804017
city: Kyiv
country: Ukraine
facility: Investigational Site Number 804018
city: Kyiv
country: Ukraine
facility: Investigational Site Number 804020
city: Kyiv
country: Ukraine
facility: Investigational Site Number 804016
city: Odesa
country: Ukraine
facility: Investigational Site Number 804006
city: Poltava
country: Ukraine
facility: Investigational Site Number 804002
city: Ternopil
country: Ukraine
facility: Investigational Site Number 804014
city: Vinnytsya
country: Ukraine
facility: Investigational Site Number 804019
city: Yalta
country: Ukraine
facility: Investigational Site Number 804015
city: Zaporizhzhya
country: Ukraine
facility: Investigational Site Number 804022
city: Zaporizhzhya
country: Ukraine
facility: Investigational Site Number 804012
city: Bradford
country: United Kingdom
facility: Investigational Site Number 826001
city: London
country: United Kingdom
facility: Investigational Site Number 826010
city: Oxford
country: United Kingdom
facility: Investigational Site Number 826009
city: Portsmouth
country: United Kingdom
facility: Investigational Site Number 826007
city: South Shields
country: United Kingdom
facility: Investigational Site Number 826006
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.