Long-Term Safety Evaluation of Dupilumab in Patients With Asthma (LIBERTY ASTHMA TRAVERSE)
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
3 other identifiers
interventional
2,282
27 countries
365
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 asthma
Started Aug 2014
Longer than P75 for phase_3 asthma
365 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2014
CompletedFirst Posted
Study publicly available on registry
May 8, 2014
CompletedStudy Start
First participant enrolled
August 5, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 11, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 11, 2019
CompletedResults Posted
Study results publicly available
November 2, 2020
CompletedMarch 28, 2022
March 1, 2022
5.2 years
April 30, 2014
October 5, 2020
March 21, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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.
From the first IMP injection in LTS12551 to the last IMP injection plus 14 weeks (up to 108 weeks)
Secondary Outcomes (26)
Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period
From the first IMP injection in LTS12551 to the last IMP injection plus 14 weeks (up to 108 weeks)
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period
From the first IMP injection in LTS12551 to the last IMP injection plus 14 weeks (up to 108 weeks)
Number of Severe Exacerbation Events
From the first IMP injection in LTS12551 to the last IMP injection plus 2 weeks (up to 96 weeks)
Annualized Event Rate Per Participant-Years for Severe Exacerbation
From the first IMP injection in LTS12551 to the last IMP injection plus 2 weeks (up to 96 weeks)
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Weeks 48 and 96
Baseline of parent study, Week 48 and Week 96 of this extension study
- +21 more secondary outcomes
Study Arms (1)
dupilumab treatment
EXPERIMENTALFor 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.
Interventions
Pharmaceutical form: Solution for injection Routes of administration: Subcutaneous
Eligibility Criteria
You may qualify if:
- \- 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.
You may not qualify if:
- \- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
- Regeneron Pharmaceuticalscollaborator
Study Sites (365)
Investigational Site Number 840047
Birmingham, Alabama, 35209, United States
Investigational Site Number 840099
Gilbert, Arizona, 85234, United States
Investigational Site Number 840087
Scottsdale, Arizona, 85251, United States
Investigational Site Number 840402
Tucson, Arizona, 85724, United States
Investigational Site Number 840132
Little Rock, Arkansas, 72209, United States
Investigational Site Number 840109
Bakersfield, California, 93301, United States
Investigational Site Number 840045
Long Beach, California, 90720, United States
Investigational Site Number 840019
Los Angeles, California, 90025, United States
Investigational Site Number 840029
Los Angeles, California, 90025, United States
Investigational Site Number 840022
Los Angeles, California, 90048, United States
Investigational Site Number 840044
Newport Beach, California, 92663, United States
Investigational Site Number 840041
North Hollywood, California, 91606, United States
Investigational Site Number 840014
Rolling Hills Estates, California, 90274, United States
Investigational Site Number 840121
San Jose, California, 95117, United States
Investigational Site Number 840040
Colorado Springs, Colorado, 80907, United States
Investigational Site Number 840403
Denver, Colorado, 80206, United States
Investigational Site Number 840006
Denver, Colorado, 80230, United States
Investigational Site Number 840024
Denver, Colorado, 80230, United States
Investigational Site Number 840130
Denver, Colorado, 80246, United States
Investigational Site Number 840902
New Haven, Connecticut, 06510, United States
Investigational Site Number 840137
Aventura, Florida, 33180, United States
Investigational Site Number 840071
Gainesville, Florida, 32607, United States
Investigational Site Number 840115
Ocoee, Florida, 34761, United States
Investigational Site Number 840055
Sarasota, Florida, 34239, United States
Investigational Site Number 840079
Twin Falls, Idaho, 83301, United States
Investigational Site Number 840101
Chicago, Illinois, 60611, United States
Investigational Site Number 840032
Fort Mitchell, Kentucky, 41017, United States
Investigational Site Number 840017
Louisville, Kentucky, 40223-5440, United States
Investigational Site Number 840030
Owensboro, Kentucky, 42301, United States
Investigational Site Number 840064
Bangor, Maine, 04401, United States
Investigational Site Number 840052
Chevy Chase, Maryland, 20815, United States
Investigational Site Number 840073
Gaithersburg, Maryland, 20878, United States
Investigational Site Number 840080
Owings Mills, Maryland, 21117, United States
Investigational Site Number 840401
Boston, Massachusetts, 02115, United States
Investigational Site Number 840018
Minneapolis, Minnesota, 55402, United States
Investigational Site Number 840002
St Louis, Missouri, 63110, United States
Investigational Site Number 840102
St Louis, Missouri, 63141, United States
Investigational Site Number 840093
St Louis, Missouri, United States
Investigational Site Number 840037
Missoula, Montana, 59808, United States
Investigational Site Number 840078
Omaha, Nebraska, 68124, United States
Investigational Site Number 840004
Papillion, Nebraska, 27103, United States
Investigational Site Number 840111
Brick, New Jersey, 08723, United States
Investigational Site Number 840068
Ocean City, New Jersey, 07712, United States
Investigational Site Number 840011
Princeton, New Jersey, 08540, United States
Investigational Site Number 840065
New York, New York, 10029, United States
Investigational Site Number 840126
Charlotte, North Carolina, 28226, United States
Investigational Site Number 840083
Charlotte, North Carolina, 28277, United States
Investigational Site Number 840108
Durham, North Carolina, 27705, United States
Investigational Site Number 840107
Greensboro, North Carolina, 27401, United States
Investigational Site Number 840907
High Point, North Carolina, 27262, United States
Investigational Site Number 840404
Winston-Salem, North Carolina, 27157-1071, United States
Investigational Site Number 840015
Cincinnati, Ohio, 45236, United States
Investigational Site Number 840146
Cincinnati, Ohio, 45241, United States
Investigational Site Number 840049
Middleburg Heights, Ohio, 44130, United States
Investigational Site Number 840942
Toledo, Ohio, 43617, United States
Investigational Site Number 840112
Edmond, Oklahoma, 73034, United States
Investigational Site Number 840104
Tulsa, Oklahoma, 74136, United States
Investigational Site Number 840034
Medford, Oregon, 97504, United States
Investigational Site Number 840031
Portland, Oregon, 97223, United States
Investigational Site Number 840046
Bethlehem, Pennsylvania, 18020, United States
Investigational Site Number 840085
Hershey, Pennsylvania, 17033, United States
Investigational Site Number 840067
Philadelphia, Pennsylvania, 19140, United States
Investigational Site Number 840928
Pittsburgh, Pennsylvania, 15213, United States
Investigational Site Number 840091
Pittsburgh, Pennsylvania, 15241, United States
Investigational Site Number 840082
Charleston, South Carolina, 29407, United States
Investigational Site Number 840117
Greenville, South Carolina, 29607, United States
Investigational Site Number 840021
Spartanburg, South Carolina, 29303, United States
Investigational Site Number 840062
Amarillo, Texas, 79106, United States
Investigational Site Number 840038
Boerne, Texas, 78006, United States
Investigational Site Number 840124
Cypress, Texas, 77429, United States
Investigational Site Number 840023
Dallas, Texas, 75231, United States
Investigational Site Number 840923
El Paso, Texas, 79903, United States
Investigational Site Number 840922
Fort Worth, Texas, 76109, United States
Investigational Site Number 840027
Fort Worth, Texas, 76244, United States
Investigational Site Number 840070
McKinney, Texas, 75069, United States
Investigational Site Number 840118
Plano, Texas, 75093, United States
Investigational Site Number 840008
San Antonio, Texas, 78229, United States
Investigational Site Number 840035
Draper, Utah, 84020, United States
Investigational Site Number 840077
Murray, Utah, 84107, United States
Investigational Site Number 840057
South Burlington, Vermont, 05403, United States
Investigational Site Number 840059
Fairfax, Virginia, 22030, United States
Investigational Site Number 840951
Bellingham, Washington, 98225, United States
Investigational Site Number 032096
Bahía Blanca, B8000JRB, Argentina
Investigational Site Number 032004
Buenos Aires, B6500BWQ, Argentina
Investigational Site Number 032003
Buenos Aires, C1121ABE, Argentina
Investigational Site Number 032011
Caba, 1120, Argentina
Investigational Site Number 032097
Caba, C1414AIF, Argentina
Investigational Site Number 032001
Caba, C1425BEN, Argentina
Investigational Site Number 032010
Caba, C1425FVH, Argentina
Investigational Site Number 032091
Caba, C1426ABP, Argentina
Investigational Site Number 032095
Capital Federal, C1425DUC, Argentina
Investigational Site Number 032002
La Plata, B1900BNN, Argentina
Investigational Site Number 032006
Rosario, S2000BRH, Argentina
Investigational Site Number 032007
Rosario, S2000DBS, Argentina
Investigational Site Number 032005
Rosario, S2000JKR, Argentina
Investigational Site Number 032012
San Miguel de Tucumán, T4000CHE, Argentina
Investigational Site Number 032009
San Miguel de Tucumán, T4000IAR, Argentina
Investigational Site Number 036004
Adelaide, 5000, Australia
Investigational Site Number 036005
Campbelltown, 2560, Australia
Investigational Site Number 036001
Clayton, 3168, Australia
Investigational Site Number 036008
Frankston, 3199, Australia
Investigational Site Number 036093
Murdoch, 6150, Australia
Investigational Site Number 036003
Nedlands, 6009, Australia
Investigational Site Number 036094
Parkville, 3050, Australia
Investigational Site Number 036009
Prahran, 3004, Australia
Investigational Site Number 036006
Woolloongabba, 4102, Australia
Investigational Site Number 056002
Brussels, 1020, Belgium
Investigational Site Number 056003
Ghent, 9000, Belgium
Investigational Site Number 056001
Leuven, 3000, Belgium
Investigational Site Number 076009
Florianópolis, 88040-970, Brazil
Investigational Site Number 076007
Porto Alegre, 90020-090, Brazil
Investigational Site Number 076001
Porto Alegre, 90610-000, Brazil
Investigational Site Number 076003
Salvador, 41940-455, Brazil
Investigational Site Number 076013
São Bernardo do Campo, 09715-090, Brazil
Investigational Site Number 076012
São Paulo, 04266-010, Brazil
Investigational Site Number 076006
São Paulo, 05437-000, Brazil
Investigational Site Number 076002
Sorocaba, 18040-425, Brazil
Investigational Site Number 124019
Burlington, L7N 3V2, Canada
Investigational Site Number 124009
Calgary, T2N 4Z6, Canada
Investigational Site Number 124016
Hamilton, L8N 4A6, Canada
Investigational Site Number 124003
Mississauga, L5A 3V4, Canada
Investigational Site Number 124001
Montreal, H2X 3E4, Canada
Investigational Site Number 124012
Montreal, H4A 3J1, Canada
Investigational Site Number 124010
Montreal, H4J 1C5, Canada
Investigational Site Number 124013
Ottawa, K1G 6C6, Canada
Investigational Site Number 124018
Québec, G1V 4G5, Canada
Investigational Site Number 124014
Québec, G1V 4W2, Canada
Investigational Site Number 124008
Sherbrooke, J1H 5N4, Canada
Investigational Site Number 124015
Toronto, M5G 1E2, Canada
Investigational Site Number 124002
Toronto, M5T 3A9, Canada
Investigational Site Number 124007
Trois-Rivières, G8T 7A1, Canada
Investigational Site Number 124006
Vancouver, V5Z 1M9, Canada
Investigational Site Number 124017
Vancouver, V6Z 1Y6, Canada
Investigational Site Number 152007
Quillota, 2260877, Chile
Investigational Site Number 152024
Santiago, 7500588, Chile
Investigational Site Number 152005
Santiago, 7500692, Chile
Investigational Site Number 152014
Santiago, 7500698, Chile
Investigational Site Number 152011
Santiago, 7500710, Chile
Investigational Site Number 152018
Santiago, 8207257, Chile
Investigational Site Number 152002
Santiago, 8380456, Chile
Investigational Site Number 152013
Santiago, 8910131, Chile
Investigational Site Number 152008
Talca, 3460001, Chile
Investigational Site Number 152004
Talca, Chile
Investigational Site Number 152023
Talcahuano, Chile
Investigational Site Number 152010
Valdivia, 5090145, Chile
Investigational Site Number 152003
Viña del Mar, 2520024, Chile
Investigational Site Number 152021
Viña del Mar, 2520594, Chile
Investigational Site Number 170001
Bogotá, 110121, Colombia
Investigational Site Number 170002
Bogotá, 110231, Colombia
Investigational Site Number 208002
Hvidovre, 2650, Denmark
Investigational Site Number 208001
København NV, 2400, Denmark
Investigational Site Number 250009
Brest, 29609, France
Investigational Site Number 250004
La Tronche, 38700, France
Investigational Site Number 250010
Lille, 59037, France
Investigational Site Number 250013
Lille, 59037, France
Investigational Site Number 250006
Lyon, 69317, France
Investigational Site Number 250001
Marseille, 13015, France
Investigational Site Number 250002
Montpellier, 34295, France
Investigational Site Number 250005
Nantes, 44033, France
Investigational Site Number 250007
Nîmes, 30029, France
Investigational Site Number 250008
Strasbourg, 67091, France
Investigational Site Number 250014
Vandœuvre-lès-Nancy, 54511, France
Investigational Site Number 276006
Berlin, 10787, Germany
Investigational Site Number 276003
Bochum, 44789, Germany
Investigational Site Number 276010
Frankfurt am Main, 60596, Germany
Investigational Site Number 276011
Großhansdorf, 22927, Germany
Investigational Site Number 276009
Koblenz, 56068, Germany
Investigational Site Number 276005
Rüdersdorf Bei Berlin, 15562, Germany
Investigational Site Number 348301
Balassagyarmat, 2660, Hungary
Investigational Site Number 348303
Edelény, 3780, Hungary
Investigational Site Number 348003
Gödöllö, 2100, Hungary
Investigational Site Number 376003
Haifa, 34362, Israel
Investigational Site Number 376001
Kfar Saba, 44281, Israel
Investigational Site Number 376005
Petah Tikva, 49100, Israel
Investigational Site Number 376002
Rehovot, 76100, Israel
Investigational Site Number 380010
Ancona, 60126, Italy
Investigational Site Number 380009
Catania, 95123, Italy
Investigational Site Number 380004
Ferrara, 44124, Italy
Investigational Site Number 380008
Foggia, 71100, Italy
Investigational Site Number 380002
Genova, 16132, Italy
Investigational Site Number 380003
Modena, 41124, Italy
Investigational Site Number 380007
Padua, 35128, Italy
Investigational Site Number 380099
Palermo, 90146, Italy
Investigational Site Number 380001
Pisa, 56100, Italy
Investigational Site Number 392185
Akashi-Shi, Japan
Investigational Site Number 392009
Asahi-Shi, Japan
Investigational Site Number 392037
Chiyoda-Ku, Japan
Investigational Site Number 392002
Chūōku, Japan
Investigational Site Number 392007
Chūōku, Japan
Investigational Site Number 392112
Chūōku, Japan
Investigational Site Number 392012
Edogawa-Ku, Japan
Investigational Site Number 392137
Fukuoka, Japan
Investigational Site Number 392021
Fukuyama-Shi, Japan
Investigational Site Number 392030
Habikino-Shi, Japan
Investigational Site Number 392004
Himeji-Shi, Japan
Investigational Site Number 392032
Hirakata-Shi, Japan
Investigational Site Number 392108
Hiroshima, Japan
Investigational Site Number 392158
Hiroshima, Japan
Investigational Site Number 392013
Iizuka-Shi, Japan
Investigational Site Number 392042
Isesaki-Shi, Japan
Investigational Site Number 392023
Kanazawa, Japan
Investigational Site Number 392142
Kasuga-Shi, Japan
Investigational Site Number 392119
Kishiwada-Shi, Japan
Investigational Site Number 392025
Kobe, Japan
Investigational Site Number 392162
Kobe, Japan
Investigational Site Number 392040
Kodaira-Shi, Japan
Investigational Site Number 392044
Kokubunji-Shi, Japan
Investigational Site Number 392131
Koushi-Shi, Japan
Investigational Site Number 392010
Kurashiki-Shi, Japan
Investigational Site Number 392036
Kyoto, Japan
Investigational Site Number 392153
Kyoto, Japan
Investigational Site Number 392133
Machida-Shi, Japan
Investigational Site Number 392135
Matsuyama, Japan
Investigational Site Number 392122
Minatoku, Japan
Investigational Site Number 392144
Minatoku, Japan
Investigational Site Number 392106
Mizunami-Shi, Japan
Investigational Site Number 392164
Muroran-Shi, Japan
Investigational Site Number 392163
Nagoya, Japan
Investigational Site Number 392020
Naka-Gun, Japan
Investigational Site Number 392005
Naruto-Shi, Japan
Investigational Site Number 392187
Obihiro-Shi, Japan
Investigational Site Number 392177
Ome-Shi, Japan
Investigational Site Number 392152
Osaka Sayama-Shi, Japan
Investigational Site Number 392155
Osaka Sayama-Shi, Japan
Investigational Site Number 392170
Osaki-Shi, Japan
Investigational Site Number 392043
Ota-Shi, Japan
Investigational Site Number 392127
Ōta-ku, Japan
Investigational Site Number 392169
Sagamihara-Shi, Japan
Investigational Site Number 392011
Sakaide-Shi, Japan
Investigational Site Number 392024
Sakaishi, Japan
Investigational Site Number 392008
Sapporo, Japan
Investigational Site Number 392034
Sapporo, Japan
Investigational Site Number 392038
Setagaya-Ku, Japan
Investigational Site Number 392179
Seto-Shi, Japan
Investigational Site Number 392186
Shibuya-Ku, Japan
Investigational Site Number 392167
Shinagawa-Ku, Japan
Investigational Site Number 392130
Shinjuku-Ku, Japan
Investigational Site Number 392165
Sumida-Ku, Japan
Investigational Site Number 392146
Tachikawa-Shi, Japan
Investigational Site Number 392173
Tachikawa-Shi, Japan
Investigational Site Number 392006
Tomakomai-Shi, Japan
Investigational Site Number 392029
Tsu, Japan
Investigational Site Number 392168
Uozu-Shi, Japan
Investigational Site Number 392132
Urasoe-Shi, Japan
Investigational Site Number 392045
Uruma, Japan
Investigational Site Number 392014
Yokohama, Japan
Investigational Site Number 484013
Chihuahua City, 31020, Mexico
Investigational Site Number 484006
Chihuahua City, 31200, Mexico
Investigational Site Number 484014
Cuautitlán Izcalli, 54769, Mexico
Investigational Site Number 484005
Distrito Federal, 07760, Mexico
Investigational Site Number 484008
Durango, 34080, Mexico
Investigational Site Number 484001
Guadalajara, 44100, Mexico
Investigational Site Number 484004
Mexico City, 64718, Mexico
Investigational Site Number 484010
México, 06700, Mexico
Investigational Site Number 484003
Monterrey, 64460, Mexico
Investigational Site Number 484007
Monterrey, 66465, Mexico
Investigational Site Number 484012
San Juan del Río, 76800, Mexico
Investigational Site Number 484011
Veracruz, 91910, Mexico
Investigational Site Number 528001
Arnhem, 6815 AD, Netherlands
Investigational Site Number 528002
Dordrecht, 3318 AT, Netherlands
Investigational Site Number 616006
Bialystok, 15-010, Poland
Investigational Site Number 616004
Gdansk, 80-405, Poland
Investigational Site Number 616003
Gdansk, 80-952, Poland
Investigational Site Number 616007
Krakow, 31-159, Poland
Investigational Site Number 616097
Krakow, 31-159, Poland
Investigational Site Number 616001
Lodz, 90-141, Poland
Investigational Site Number 616005
Lodz, 90-153, Poland
Investigational Site Number 616009
Lodz, 90-329, Poland
Investigational Site Number 616096
Poznan, 60-693, Poland
Investigational Site Number 616098
Strzelce Opolskie, 47-100, Poland
Investigational Site Number 616008
Warsaw, 00-013, Poland
Investigational Site Number 616010
Warsaw, 04-141, Poland
Investigational Site Number 616011
Żnin, 88-400, Poland
Investigational Site Number 642104
Bucharest, 011461, Romania
Investigational Site Number 642103
Bucharest, 050159, Romania
Investigational Site Number 642102
Cluj-Napoca, 400162, Romania
Investigational Site Number 642107
Cluj-Napoca, 400371, Romania
Investigational Site Number 642105
Timișoara, 300310, Romania
Investigational Site Number 642106
Timișoara, 300310, Romania
Investigational Site Number 643096
Moscow, 105077, Russia
Investigational Site Number 643002
Moscow, 109240, Russia
Investigational Site Number 643005
Moscow, 115280, Russia
Investigational Site Number 643007
Moscow, 117574, Russia
Investigational Site Number 643012
Moscow, 123182, Russia
Investigational Site Number 643001
Moscow, 125315, Russia
Investigational Site Number 643006
Novosibirsk, 630091, Russia
Investigational Site Number 643091
Ryazan, 390039, Russia
Investigational Site Number 643099
Saint Petersburg, 193231, Russia
Investigational Site Number 643011
Saint Petersburg, 194223, Russia
Investigational Site Number 643010
Saint Petersburg, 194354, Russia
Investigational Site Number 643009
Saint Petersburg, 197022, Russia
Investigational Site Number 643008
Yaroslavl, 150003, Russia
Investigational Site Number 643013
Yekaterinburg, 620028, Russia
Investigational Site Number 710011
Cape Town, 7505, South Africa
Investigational Site Number 710001
Cape Town, 7530, South Africa
Investigational Site Number 710091
Cape Town, 7700, South Africa
Investigational Site Number 710092
Cape Town, 7700, South Africa
Investigational Site Number 710002
Cape Town, 7764, South Africa
Investigational Site Number 710003
Cape Town, 8000, South Africa
Investigational Site Number 710006
Durban, 4071, South Africa
Investigational Site Number 710007
Pretoria, 0087, South Africa
Investigational Site Number 710009
Winnie Mandela, 9400, South Africa
Investigational Site Number 410002
Bucheon-si, 14584, South Korea
Investigational Site Number 410003
Cheongju-si, 28644, South Korea
Investigational Site Number 410013
Incheon, 21565, South Korea
Investigational Site Number 410006
Seoul, 03080, South Korea
Investigational Site Number 410008
Seoul, 03312, South Korea
Investigational Site Number 410004
Seoul, 03722, South Korea
Investigational Site Number 410012
Seoul, 04763, South Korea
Investigational Site Number 410005
Seoul, 05505, South Korea
Investigational Site Number 410007
Seoul, 06351, South Korea
Investigational Site Number 410010
Seoul, 06973, South Korea
Investigational Site Number 410011
Seoul, 08308, South Korea
Investigational Site Number 410001
Suwon, 16499, South Korea
Investigational Site Number 724014
Barcelona, 08023, Spain
Investigational Site Number 724002
Barcelona, 08035, Spain
Investigational Site Number 724001
Barcelona, 08036, Spain
Investigational Site Number 724010
Palma de Mallorca, 07120, Spain
Investigational Site Number 724006
Pozuelo de Alarcón, 28223, Spain
Investigational Site Number 724003
Sabadell, 08208, Spain
Investigational Site Number 724007
Sant Boi de Llobregat, 08830, Spain
Investigational Site Number 724096
Santiago de Compostela, 15706, Spain
Investigational Site Number 724008
Seville, 41071, Spain
Investigational Site Number 724097
Valencia, 46017, Spain
Investigational Site Number 158008
New Taipei City, 23561, Taiwan
Investigational Site Number 158007
Taichung, 40447, Taiwan
Investigational Site Number 158009
Taipei, 11031, Taiwan
Investigational Site Number 792002
Ankara, 06100, Turkey (Türkiye)
Investigational Site Number 792098
Ankara, 06100, Turkey (Türkiye)
Investigational Site Number 792008
Bursa, 16059, Turkey (Türkiye)
Investigational Site Number 792007
Istanbul, 34020, Turkey (Türkiye)
Investigational Site Number 792001
Istanbul, 34098, Turkey (Türkiye)
Investigational Site Number 792004
Istanbul, 34098, Turkey (Türkiye)
Investigational Site Number 792003
Istanbul, 34844, Turkey (Türkiye)
Investigational Site Number 792005
Izmir, 35040, Turkey (Türkiye)
Investigational Site Number 792090
Izmir, 35110, Turkey (Türkiye)
Investigational Site Number 792013
Kırıkkale, 71450, Turkey (Türkiye)
Investigational Site Number 792006
Mersin, 33070, Turkey (Türkiye)
Investigational Site Number 792096
Rize, 53100, Turkey (Türkiye)
Investigational Site Number 804007
Chernivtsi, 58001, Ukraine
Investigational Site Number 804023
Dnipro, 49101, Ukraine
Investigational Site Number 804009
Ivano-Frankivsk, 76018, Ukraine
Investigational Site Number 804094
Ivano-Frankivsk, 76018, Ukraine
Investigational Site Number 804005
Kharkiv, 61058, Ukraine
Investigational Site Number 804021
Kharkiv, 61093, Ukraine
Investigational Site Number 804001
Kharkiv, 61124, Ukraine
Investigational Site Number 804004
Kyiv, 03049, Ukraine
Investigational Site Number 804003
Kyiv, 03680, Ukraine
Investigational Site Number 804008
Kyiv, 03680, Ukraine
Investigational Site Number 804017
Kyiv, 03680, Ukraine
Investigational Site Number 804018
Kyiv, 03680, Ukraine
Investigational Site Number 804020
Kyiv, 03680, Ukraine
Investigational Site Number 804016
Kyiv, 04050, Ukraine
Investigational Site Number 804006
Odesa, 65025, Ukraine
Investigational Site Number 804002
Poltava, 36038, Ukraine
Investigational Site Number 804014
Ternopil, 46000, Ukraine
Investigational Site Number 804019
Vinnytsia, 21001, Ukraine
Investigational Site Number 804015
Yalta, 298603, Ukraine
Investigational Site Number 804022
Zaporizhzhya, 69076, Ukraine
Investigational Site Number 804012
Zaporizhzhya, 69118, Ukraine
Investigational Site Number 826001
Bradford, BD9 6RJ, United Kingdom
Investigational Site Number 826010
London, W2 1NY, United Kingdom
Investigational Site Number 826009
Oxford, OX3 7LE, United Kingdom
Investigational Site Number 826007
Portsmouth, PO6 3LY, United Kingdom
Investigational Site Number 826006
South Shields, NE34 0PL, United Kingdom
Related Publications (16)
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.
PMID: 40458676DERIVEDRhee 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.
PMID: 39155737DERIVEDMaspero 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.
PMID: 38163585DERIVEDPeters 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.
PMID: 38013139DERIVEDWechsler 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.
PMID: 37780074DERIVEDCorren 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.
PMID: 37752621DERIVEDPavord 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.
PMID: 37431558DERIVEDRabe 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.
PMID: 37073882DERIVEDSher 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.
PMID: 36876957DERIVEDSher 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.
PMID: 36509407DERIVEDBerger 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.
PMID: 36356712DERIVEDTohda 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.
PMID: 36114102DERIVEDLugogo 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.
PMID: 35809937DERIVEDWechsler 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.
PMID: 35636689DERIVEDSher 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.
PMID: 35217003DERIVEDWechsler 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.
PMID: 34597534DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Trial Transparency Team
- Organization
- Sanofi
Study Officials
- STUDY DIRECTOR
Clinical Sciences & Operations
Sanofi
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2014
First Posted
May 8, 2014
Study Start
August 5, 2014
Primary Completion
October 11, 2019
Study Completion
October 11, 2019
Last Updated
March 28, 2022
Results First Posted
November 2, 2020
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will share
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