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

NCT ID: NCT02134028

Last Updated: 2022-03-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2282 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-05

Study Completion Date

2019-10-11

Brief Summary

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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

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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.

Conditions

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Asthma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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dupilumab treatment

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.

Group Type EXPERIMENTAL

Dupilumab

Intervention Type DRUG

Pharmaceutical form: Solution for injection Routes of administration: Subcutaneous

Interventions

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Dupilumab

Pharmaceutical form: Solution for injection Routes of administration: Subcutaneous

Intervention Type DRUG

Other Intervention Names

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SAR231893 REGN668

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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Investigational Site Number 840047

Birmingham, Alabama, United States

Site Status

Investigational Site Number 840099

Gilbert, Arizona, United States

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Investigational Site Number 840087

Scottsdale, Arizona, United States

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Investigational Site Number 840402

Tucson, Arizona, United States

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Investigational Site Number 840132

Little Rock, Arkansas, United States

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Investigational Site Number 840109

Bakersfield, California, United States

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Investigational Site Number 840045

Long Beach, California, United States

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Investigational Site Number 840019

Los Angeles, California, United States

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Investigational Site Number 840029

Los Angeles, California, United States

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Investigational Site Number 840022

Los Angeles, California, United States

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Investigational Site Number 840044

Newport Beach, California, United States

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Investigational Site Number 840041

North Hollywood, California, United States

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Investigational Site Number 840014

Rolling Hills Estates, California, United States

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Investigational Site Number 840121

San Jose, California, United States

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Investigational Site Number 840040

Colorado Springs, Colorado, United States

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Investigational Site Number 840403

Denver, Colorado, United States

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Investigational Site Number 840006

Denver, Colorado, United States

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Investigational Site Number 840024

Denver, Colorado, United States

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Investigational Site Number 840130

Denver, Colorado, United States

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Investigational Site Number 840902

New Haven, Connecticut, United States

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Investigational Site Number 840137

Aventura, Florida, United States

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Investigational Site Number 840071

Gainesville, Florida, United States

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Investigational Site Number 840115

Ocoee, Florida, United States

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Investigational Site Number 840055

Sarasota, Florida, United States

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Investigational Site Number 840079

Twin Falls, Idaho, United States

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Investigational Site Number 840101

Chicago, Illinois, United States

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Investigational Site Number 840032

Fort Mitchell, Kentucky, United States

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Investigational Site Number 840017

Louisville, Kentucky, United States

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Investigational Site Number 840030

Owensboro, Kentucky, United States

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Investigational Site Number 840064

Bangor, Maine, United States

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Investigational Site Number 840052

Chevy Chase, Maryland, United States

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Investigational Site Number 840073

Gaithersburg, Maryland, United States

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Investigational Site Number 840080

Owings Mills, Maryland, United States

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Investigational Site Number 840401

Boston, Massachusetts, United States

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Investigational Site Number 840018

Minneapolis, Minnesota, United States

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Investigational Site Number 840002

St Louis, Missouri, United States

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Investigational Site Number 840102

St Louis, Missouri, United States

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Investigational Site Number 840093

St Louis, Missouri, United States

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Investigational Site Number 840037

Missoula, Montana, United States

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Investigational Site Number 840078

Omaha, Nebraska, United States

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Investigational Site Number 840004

Papillion, Nebraska, United States

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Investigational Site Number 840111

Brick, New Jersey, United States

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Investigational Site Number 840068

Ocean City, New Jersey, United States

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Investigational Site Number 840011

Princeton, New Jersey, United States

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Investigational Site Number 840065

New York, New York, United States

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Investigational Site Number 840126

Charlotte, North Carolina, United States

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Investigational Site Number 840083

Charlotte, North Carolina, United States

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Investigational Site Number 840108

Durham, North Carolina, United States

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Investigational Site Number 840107

Greensboro, North Carolina, United States

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Investigational Site Number 840907

High Point, North Carolina, United States

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Investigational Site Number 840404

Winston-Salem, North Carolina, United States

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Investigational Site Number 840015

Cincinnati, Ohio, United States

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Investigational Site Number 840146

Cincinnati, Ohio, United States

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Investigational Site Number 840049

Middleburg Heights, Ohio, United States

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Investigational Site Number 840942

Toledo, Ohio, United States

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Investigational Site Number 840112

Edmond, Oklahoma, United States

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Investigational Site Number 840104

Tulsa, Oklahoma, United States

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Investigational Site Number 840034

Medford, Oregon, United States

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Investigational Site Number 840031

Portland, Oregon, United States

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Investigational Site Number 840046

Bethlehem, Pennsylvania, United States

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Investigational Site Number 840085

Hershey, Pennsylvania, United States

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Investigational Site Number 840067

Philadelphia, Pennsylvania, United States

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Investigational Site Number 840928

Pittsburgh, Pennsylvania, United States

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Investigational Site Number 840091

Pittsburgh, Pennsylvania, United States

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Investigational Site Number 840082

Charleston, South Carolina, United States

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Investigational Site Number 840117

Greenville, South Carolina, United States

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Investigational Site Number 840021

Spartanburg, South Carolina, United States

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Investigational Site Number 840062

Amarillo, Texas, United States

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Investigational Site Number 840038

Boerne, Texas, United States

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Investigational Site Number 840124

Cypress, Texas, United States

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Investigational Site Number 840023

Dallas, Texas, United States

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Investigational Site Number 840923

El Paso, Texas, United States

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Investigational Site Number 840922

Fort Worth, Texas, United States

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Investigational Site Number 840027

Fort Worth, Texas, United States

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Investigational Site Number 840070

McKinney, Texas, United States

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Investigational Site Number 840118

Plano, Texas, United States

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Investigational Site Number 840008

San Antonio, Texas, United States

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Investigational Site Number 840035

Draper, Utah, United States

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Investigational Site Number 840077

Murray, Utah, United States

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Investigational Site Number 840057

South Burlington, Vermont, United States

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Investigational Site Number 840059

Fairfax, Virginia, United States

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Investigational Site Number 840951

Bellingham, Washington, United States

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Investigational Site Number 032096

Bahía Blanca, , Argentina

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Investigational Site Number 032004

Buenos Aires, , Argentina

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Investigational Site Number 032003

Buenos Aires, , Argentina

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Investigational Site Number 032011

Caba, , Argentina

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Investigational Site Number 032097

Caba, , Argentina

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Investigational Site Number 032001

Caba, , Argentina

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Investigational Site Number 032010

Caba, , Argentina

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Investigational Site Number 032091

Caba, , Argentina

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Investigational Site Number 032095

Capital Federal, , Argentina

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Investigational Site Number 032002

La Plata, , Argentina

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Investigational Site Number 032006

Rosario, , Argentina

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Rosario, , Argentina

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Rosario, , Argentina

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San Miguel de Tucumán, , Argentina

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San Miguel de Tucumán, , Argentina

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Adelaide, , Australia

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Campbelltown, , Australia

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Clayton, , Australia

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Frankston, , Australia

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Murdoch, , Australia

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Nedlands, , Australia

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Parkville, , Australia

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Prahran, , Australia

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Woolloongabba, , Australia

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Investigational Site Number 056002

Brussels, , Belgium

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Investigational Site Number 056003

Ghent, , Belgium

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Investigational Site Number 056001

Leuven, , Belgium

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Investigational Site Number 076009

Florianópolis, , Brazil

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Porto Alegre, , Brazil

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Porto Alegre, , Brazil

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Salvador, , Brazil

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São Bernardo do Campo, , Brazil

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São Paulo, , Brazil

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São Paulo, , Brazil

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Sorocaba, , Brazil

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Investigational Site Number 124019

Burlington, , Canada

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Investigational Site Number 124009

Calgary, , Canada

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Investigational Site Number 124016

Hamilton, , Canada

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Mississauga, , Canada

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Investigational Site Number 124001

Montreal, , Canada

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Montreal, , Canada

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Montreal, , Canada

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Ottawa, , Canada

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Québec, , Canada

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Québec, , Canada

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Sherbrooke, , Canada

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Toronto, , Canada

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Toronto, , Canada

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Trois-Rivières, , Canada

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Vancouver, , Canada

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Vancouver, , Canada

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Investigational Site Number 152007

Quillota, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Talca, , Chile

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Talca, , Chile

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Talcahuano, , Chile

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Valdivia, , Chile

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Viña del Mar, , Chile

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Viña del Mar, , Chile

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Investigational Site Number 170001

Bogotá, , Colombia

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Investigational Site Number 170002

Bogotá, , Colombia

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Investigational Site Number 208002

Hvidovre, , Denmark

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Investigational Site Number 208001

København NV, , Denmark

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Investigational Site Number 250009

Brest, , France

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Investigational Site Number 250004

La Tronche, , France

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Investigational Site Number 250010

Lille, , France

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Investigational Site Number 250013

Lille, , France

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Investigational Site Number 250006

Lyon, , France

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Investigational Site Number 250001

Marseille, , France

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Investigational Site Number 250002

Montpellier, , France

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Investigational Site Number 250005

Nantes, , France

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Investigational Site Number 250007

Nîmes, , France

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Investigational Site Number 250008

Strasbourg, , France

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Investigational Site Number 250014

Vandœuvre-lès-Nancy, , France

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Investigational Site Number 276006

Berlin, , Germany

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Investigational Site Number 276003

Bochum, , Germany

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Investigational Site Number 276010

Frankfurt am Main, , Germany

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Investigational Site Number 276011

Großhansdorf, , Germany

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Investigational Site Number 276009

Koblenz, , Germany

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Investigational Site Number 276005

Rüdersdorf Bei Berlin, , Germany

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Investigational Site Number 348301

Balassagyarmat, , Hungary

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Investigational Site Number 348303

Edelény, , Hungary

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Investigational Site Number 348003

Gödöllö, , Hungary

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Investigational Site Number 376003

Haifa, , Israel

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Investigational Site Number 376001

Kfar Saba, , Israel

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Investigational Site Number 376005

Petah Tikva, , Israel

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Investigational Site Number 376002

Rehovot, , Israel

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Investigational Site Number 380010

Ancona, , Italy

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Investigational Site Number 380009

Catania, , Italy

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Investigational Site Number 380004

Ferrara, , Italy

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Investigational Site Number 380008

Foggia, , Italy

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Investigational Site Number 380002

Genova, , Italy

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Investigational Site Number 380003

Modena, , Italy

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Investigational Site Number 380007

Padua, , Italy

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Investigational Site Number 380099

Palermo, , Italy

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Investigational Site Number 380001

Pisa, , Italy

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Investigational Site Number 392185

Akashi-Shi, , Japan

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Investigational Site Number 392009

Asahi-Shi, , Japan

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Investigational Site Number 392037

Chiyoda-Ku, , Japan

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Investigational Site Number 392002

Chūōku, , Japan

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Investigational Site Number 392007

Chūōku, , Japan

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Investigational Site Number 392112

Chūōku, , Japan

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Investigational Site Number 392012

Edogawa-Ku, , Japan

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Investigational Site Number 392137

Fukuoka, , Japan

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Investigational Site Number 392021

Fukuyama-Shi, , Japan

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Investigational Site Number 392030

Habikino-Shi, , Japan

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Investigational Site Number 392004

Himeji-Shi, , Japan

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Investigational Site Number 392032

Hirakata-Shi, , Japan

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Investigational Site Number 392108

Hiroshima, , Japan

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Investigational Site Number 392158

Hiroshima, , Japan

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Investigational Site Number 392013

Iizuka-Shi, , Japan

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Investigational Site Number 392042

Isesaki-Shi, , Japan

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Investigational Site Number 392023

Kanazawa, , Japan

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Investigational Site Number 392142

Kasuga-Shi, , Japan

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Investigational Site Number 392119

Kishiwada-Shi, , Japan

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Investigational Site Number 392025

Kobe, , Japan

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Investigational Site Number 392162

Kobe, , Japan

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Investigational Site Number 392040

Kodaira-Shi, , Japan

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Investigational Site Number 392044

Kokubunji-Shi, , Japan

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Investigational Site Number 392131

Koushi-Shi, , Japan

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Investigational Site Number 392010

Kurashiki-Shi, , Japan

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Investigational Site Number 392036

Kyoto, , Japan

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Investigational Site Number 392153

Kyoto, , Japan

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Investigational Site Number 392133

Machida-Shi, , Japan

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Investigational Site Number 392135

Matsuyama, , Japan

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Investigational Site Number 392122

Minatoku, , Japan

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Investigational Site Number 392144

Minatoku, , Japan

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Investigational Site Number 392106

Mizunami-Shi, , Japan

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Investigational Site Number 392164

Muroran-Shi, , Japan

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Investigational Site Number 392163

Nagoya, , Japan

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Investigational Site Number 392020

Naka-Gun, , Japan

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Investigational Site Number 392005

Naruto-Shi, , Japan

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Investigational Site Number 392187

Obihiro-Shi, , Japan

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Investigational Site Number 392177

Ome-Shi, , Japan

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Investigational Site Number 392152

Osaka Sayama-Shi, , Japan

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Investigational Site Number 392155

Osaka Sayama-Shi, , Japan

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Investigational Site Number 392170

Osaki-Shi, , Japan

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Investigational Site Number 392043

Ota-Shi, , Japan

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Investigational Site Number 392127

Ōta-ku, , Japan

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Investigational Site Number 392169

Sagamihara-Shi, , Japan

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Investigational Site Number 392011

Sakaide-Shi, , Japan

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Investigational Site Number 392024

Sakaishi, , Japan

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Investigational Site Number 392008

Sapporo, , Japan

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Investigational Site Number 392034

Sapporo, , Japan

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Setagaya-Ku, , Japan

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Investigational Site Number 392179

Seto-Shi, , Japan

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Investigational Site Number 392186

Shibuya-Ku, , Japan

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Investigational Site Number 392167

Shinagawa-Ku, , Japan

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Investigational Site Number 392130

Shinjuku-Ku, , Japan

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Investigational Site Number 392165

Sumida-Ku, , Japan

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Investigational Site Number 392146

Tachikawa-Shi, , Japan

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Investigational Site Number 392173

Tachikawa-Shi, , Japan

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Investigational Site Number 392006

Tomakomai-Shi, , Japan

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Investigational Site Number 392029

Tsu, , Japan

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Investigational Site Number 392168

Uozu-Shi, , Japan

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Investigational Site Number 392132

Urasoe-Shi, , Japan

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Investigational Site Number 392045

Uruma, , Japan

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Investigational Site Number 392014

Yokohama, , Japan

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Investigational Site Number 484013

Chihuahua City, , Mexico

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Investigational Site Number 484006

Chihuahua City, , Mexico

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Investigational Site Number 484014

Cuautitlán Izcalli, , Mexico

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Investigational Site Number 484005

Distrito Federal, , Mexico

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Investigational Site Number 484008

Durango, , Mexico

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Investigational Site Number 484001

Guadalajara, , Mexico

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Investigational Site Number 484004

Mexico City, , Mexico

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Investigational Site Number 484010

México, , Mexico

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Investigational Site Number 484003

Monterrey, , Mexico

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Investigational Site Number 484007

Monterrey, , Mexico

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Investigational Site Number 484012

San Juan del Río, , Mexico

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Investigational Site Number 484011

Veracruz, , Mexico

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Investigational Site Number 528001

Arnhem, , Netherlands

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Investigational Site Number 528002

Dordrecht, , Netherlands

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Investigational Site Number 616006

Bialystok, , Poland

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Investigational Site Number 616004

Gdansk, , Poland

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Investigational Site Number 616003

Gdansk, , Poland

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Investigational Site Number 616007

Krakow, , Poland

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Investigational Site Number 616097

Krakow, , Poland

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Investigational Site Number 616001

Lodz, , Poland

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Investigational Site Number 616005

Lodz, , Poland

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Investigational Site Number 616009

Lodz, , Poland

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Investigational Site Number 616096

Poznan, , Poland

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Investigational Site Number 616098

Strzelce Opolskie, , Poland

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Investigational Site Number 616008

Warsaw, , Poland

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Investigational Site Number 616010

Warsaw, , Poland

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Investigational Site Number 616011

Żnin, , Poland

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Investigational Site Number 642104

Bucharest, , Romania

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Investigational Site Number 642103

Bucharest, , Romania

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Investigational Site Number 642102

Cluj-Napoca, , Romania

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Investigational Site Number 642107

Cluj-Napoca, , Romania

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Investigational Site Number 642105

Timișoara, , Romania

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Investigational Site Number 642106

Timișoara, , Romania

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Investigational Site Number 643096

Moscow, , Russia

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Investigational Site Number 643002

Moscow, , Russia

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Investigational Site Number 643005

Moscow, , Russia

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Investigational Site Number 643007

Moscow, , Russia

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Investigational Site Number 643012

Moscow, , Russia

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Investigational Site Number 643001

Moscow, , Russia

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Investigational Site Number 643006

Novosibirsk, , Russia

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Investigational Site Number 643091

Ryazan, , Russia

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Saint Petersburg, , Russia

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Investigational Site Number 643011

Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Investigational Site Number 643008

Yaroslavl, , Russia

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Yekaterinburg, , Russia

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Investigational Site Number 710011

Cape Town, , South Africa

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Investigational Site Number 710001

Cape Town, , South Africa

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Investigational Site Number 710091

Cape Town, , South Africa

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Cape Town, , South Africa

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Investigational Site Number 710002

Cape Town, , South Africa

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Cape Town, , South Africa

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Durban, , South Africa

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Pretoria, , South Africa

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Winnie Mandela, , South Africa

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Investigational Site Number 410002

Bucheon-si, , South Korea

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Cheongju-si, , South Korea

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Investigational Site Number 410013

Incheon, , South Korea

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Investigational Site Number 410006

Seoul, , South Korea

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Investigational Site Number 410008

Seoul, , South Korea

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Seoul, , South Korea

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Investigational Site Number 410012

Seoul, , South Korea

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Investigational Site Number 410005

Seoul, , South Korea

Site Status

Investigational Site Number 410007

Seoul, , South Korea

Site Status

Investigational Site Number 410010

Seoul, , South Korea

Site Status

Investigational Site Number 410011

Seoul, , South Korea

Site Status

Investigational Site Number 410001

Suwon, , South Korea

Site Status

Investigational Site Number 724014

Barcelona, , Spain

Site Status

Investigational Site Number 724002

Barcelona, , Spain

Site Status

Investigational Site Number 724001

Barcelona, , Spain

Site Status

Investigational Site Number 724010

Palma de Mallorca, , Spain

Site Status

Investigational Site Number 724006

Pozuelo de Alarcón, , Spain

Site Status

Investigational Site Number 724003

Sabadell, , Spain

Site Status

Investigational Site Number 724007

Sant Boi de Llobregat, , Spain

Site Status

Investigational Site Number 724096

Santiago de Compostela, , Spain

Site Status

Investigational Site Number 724008

Seville, , Spain

Site Status

Investigational Site Number 724097

Valencia, , Spain

Site Status

Investigational Site Number 158008

New Taipei City, , Taiwan

Site Status

Investigational Site Number 158007

Taichung, , Taiwan

Site Status

Investigational Site Number 158009

Taipei, , Taiwan

Site Status

Investigational Site Number 792002

Ankara, , Turkey (Türkiye)

Site Status

Investigational Site Number 792098

Ankara, , Turkey (Türkiye)

Site Status

Investigational Site Number 792008

Bursa, , Turkey (Türkiye)

Site Status

Investigational Site Number 792007

Istanbul, , Turkey (Türkiye)

Site Status

Investigational Site Number 792001

Istanbul, , Turkey (Türkiye)

Site Status

Investigational Site Number 792004

Istanbul, , Turkey (Türkiye)

Site Status

Investigational Site Number 792003

Istanbul, , Turkey (Türkiye)

Site Status

Investigational Site Number 792005

Izmir, , Turkey (Türkiye)

Site Status

Investigational Site Number 792090

Izmir, , Turkey (Türkiye)

Site Status

Investigational Site Number 792013

Kırıkkale, , Turkey (Türkiye)

Site Status

Investigational Site Number 792006

Mersin, , Turkey (Türkiye)

Site Status

Investigational Site Number 792096

Rize, , Turkey (Türkiye)

Site Status

Investigational Site Number 804007

Chernivtsi, , Ukraine

Site Status

Investigational Site Number 804023

Dnipro, , Ukraine

Site Status

Investigational Site Number 804009

Ivano-Frankivsk, , Ukraine

Site Status

Investigational Site Number 804094

Ivano-Frankivsk, , Ukraine

Site Status

Investigational Site Number 804005

Kharkiv, , Ukraine

Site Status

Investigational Site Number 804021

Kharkiv, , Ukraine

Site Status

Investigational Site Number 804001

Kharkiv, , Ukraine

Site Status

Investigational Site Number 804004

Kyiv, , Ukraine

Site Status

Investigational Site Number 804003

Kyiv, , Ukraine

Site Status

Investigational Site Number 804008

Kyiv, , Ukraine

Site Status

Investigational Site Number 804017

Kyiv, , Ukraine

Site Status

Investigational Site Number 804018

Kyiv, , Ukraine

Site Status

Investigational Site Number 804020

Kyiv, , Ukraine

Site Status

Investigational Site Number 804016

Kyiv, , Ukraine

Site Status

Investigational Site Number 804006

Odesa, , Ukraine

Site Status

Investigational Site Number 804002

Poltava, , Ukraine

Site Status

Investigational Site Number 804014

Ternopil, , Ukraine

Site Status

Investigational Site Number 804019

Vinnytsia, , Ukraine

Site Status

Investigational Site Number 804015

Yalta, , Ukraine

Site Status

Investigational Site Number 804022

Zaporizhzhya, , Ukraine

Site Status

Investigational Site Number 804012

Zaporizhzhya, , Ukraine

Site Status

Investigational Site Number 826001

Bradford, , United Kingdom

Site Status

Investigational Site Number 826010

London, , United Kingdom

Site Status

Investigational Site Number 826009

Oxford, , United Kingdom

Site Status

Investigational Site Number 826007

Portsmouth, , United Kingdom

Site Status

Investigational Site Number 826006

South Shields, , United Kingdom

Site Status

Countries

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United States Argentina Australia Belgium Brazil Canada Chile Colombia Denmark France Germany Hungary Israel Italy Japan Mexico Netherlands Poland Romania Russia South Africa South Korea Spain Taiwan Turkey (Türkiye) Ukraine United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

Pavord ID, Wechsler ME, Busse WW, Domingo C, Xia C, Gall R, Pandit-Abid N, Jacob-Nara JA, Radwan A, Rowe PJ, Deniz Y. Dupilumab efficacy in patients with type 2 asthma and early Feno level reductions. J Allergy Clin Immunol Glob. 2025 Apr 15;4(3):100474. doi: 10.1016/j.jacig.2025.100474. eCollection 2025 Aug.

Reference Type DERIVED
PMID: 40458676 (View on PubMed)

Rhee CK, Park JW, Park HW, Noh H, Msihid J, Cho YS. Long-term Safety and Efficacy of Dupilumab in Patients With Uncontrolled, Moderate-to-Severe Asthma Recruited From Korean Centers: A Subgroup Analysis of the Phase 3 LIBERTY ASTHMA TRAVERSE Trial. Allergy Asthma Immunol Res. 2024 Jul;16(4):372-386. doi: 10.4168/aair.2024.16.4.372.

Reference Type DERIVED
PMID: 39155737 (View on PubMed)

Maspero JF, Peters AT, Chapman KR, Domingo C, Stewart J, Hardin M, Maroni J, Tawo K, Khokhar FA, Mortensen E, Laws E, Radwan A, Jacob-Nara JA, Deniz Y, Rowe PJ. Long-Term Safety of Dupilumab in Patients With Moderate-to-Severe Asthma: TRAVERSE Continuation Study. J Allergy Clin Immunol Pract. 2024 Apr;12(4):991-997.e6. doi: 10.1016/j.jaip.2023.12.043. Epub 2023 Dec 30.

Reference Type DERIVED
PMID: 38163585 (View on PubMed)

Peters AT, Sagara H, Corren J, Domingo C, Altincatal A, Soler X, Pandit-Abid N, Crikelair N, Rowe PJ, Jacob-Nara JA, Deniz Y. Impact of dupilumab across seasons in patients with type 2, uncontrolled, moderate-to-severe asthma. Ann Allergy Asthma Immunol. 2024 Apr;132(4):477-484.e4. doi: 10.1016/j.anai.2023.11.021. Epub 2023 Nov 25.

Reference Type DERIVED
PMID: 38013139 (View on PubMed)

Wechsler ME, Souza-Machado A, Xu C, Mao X, Kapoor U, Khokhar FA, O'Malley JT, Petro CD, Casullo VM, Mannent LP, Rowe PJ, Jacob-Nara JA, Ruddy M, Laws E, Purcell LA, Hardin M. Preclinical and clinical experience with dupilumab on the correlates of live attenuated vaccines. J Allergy Clin Immunol Glob. 2021 Dec 8;1(1):9-15. doi: 10.1016/j.jacig.2021.12.003. eCollection 2022 Feb.

Reference Type DERIVED
PMID: 37780074 (View on PubMed)

Corren J, Hanania NA, Busse WW, Sher LD, Altincatal A, Hardin M, Mannent LP, Amin N, Lederer DJ, Soler X, Jacob-Nara JA, Rowe PJ, Deniz Y. Efficacy of dupilumab in patients with uncontrolled, moderate-to-severe asthma with fungal sensitization. Clin Exp Allergy. 2023 Oct;53(10):1020-1030. doi: 10.1111/cea.14389. Epub 2023 Sep 26.

Reference Type DERIVED
PMID: 37752621 (View on PubMed)

Pavord ID, Bourdin A, Papi A, Domingo C, Corren J, Altincatal A, Radwan A, Pandit-Abid N, Jacob-Nara JA, Deniz Y, Rowe PJ, Laws E, Lederer DJ, Hardin M. Dupilumab sustains efficacy in patients with moderate-to-severe type 2 asthma regardless of inhaled corticosteroids dose. Allergy. 2023 Nov;78(11):2921-2932. doi: 10.1111/all.15792. Epub 2023 Jul 11.

Reference Type DERIVED
PMID: 37431558 (View on PubMed)

Rabe KF, Pavord ID, Busse WW, Chupp GL, Izuhara K, Altincatal A, Gall R, Pandit-Abid N, Deniz Y, Rowe PJ, Jacob-Nara JA, Radwan A. Dupilumab improves long-term outcomes in patients with uncontrolled, moderate-to-severe GINA-based type 2 asthma, irrespective of allergic status. Allergy. 2023 Aug;78(8):2148-2156. doi: 10.1111/all.15747. Epub 2023 May 21.

Reference Type DERIVED
PMID: 37073882 (View on PubMed)

Sher LD, Corren J, Pavord ID, Daizadeh N, Altincatal A, Soler X, Djandji M, Radwan A, Jacob-Nara JA, Deniz Y, Rowe PJ. Dupilumab long-term efficacy in patients with non-OCS-dependent asthma with and without evidence of allergic asthma. J Asthma. 2023 Sep;60(9):1767-1774. doi: 10.1080/02770903.2023.2185895. Epub 2023 May 31.

Reference Type DERIVED
PMID: 36876957 (View on PubMed)

Sher LD, Passalacqua G, Taille C, Cohn L, Daizadeh N, Pandit-Abid N, Soler X, Khodzhayev A, Jacob-Nara JA, Deniz Y, Rowe PJ, Nag A, Zhang Y. The long-term effect of dupilumab on dyspnea, sleep, and activity in oral corticosteroid-dependent severe asthma. Ann Allergy Asthma Immunol. 2023 Mar;130(3):298-304. doi: 10.1016/j.anai.2022.12.002. Epub 2022 Dec 9.

Reference Type DERIVED
PMID: 36509407 (View on PubMed)

Berger P, Menzies-Gow A, Peters AT, Kuna P, Rabe KF, Altincatal A, Soler X, Pandit-Abid N, Siddiqui S, Jacob-Nara JA, Deniz Y, Rowe PJ. Long-term efficacy of dupilumab in asthma with or without chronic rhinosinusitis and nasal polyps. Ann Allergy Asthma Immunol. 2023 Feb;130(2):215-224. doi: 10.1016/j.anai.2022.11.006. Epub 2022 Nov 7.

Reference Type DERIVED
PMID: 36356712 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36114102 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35809937 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35636689 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35217003 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34597534 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2013-003856-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1117-6745

Identifier Type: OTHER

Identifier Source: secondary_id

LTS12551

Identifier Type: -

Identifier Source: org_study_id

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