Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02134028
Recruitment Status : Completed
First Posted : May 8, 2014
Last Update Posted : October 17, 2019
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi

Brief Summary:

Primary Objective:

Evaluate the long-term safety and tolerability of dupilumab in patients with asthma who participated in a previous dupilumab asthma study (DRI12544, PDY14192, EFC13579, EFC13691).

Secondary Objectives:

Evaluate the efficacy of dupilumab in patients with asthma who participated in a previous dupilumab asthma clinical study.

Evaluate dupilumab in patients with asthma who participated in a previous dupilumab asthma clinical study, with regards to:

  • Systemic exposure
  • Anti-drug antibodies
  • Biomarkers

Condition or disease Intervention/treatment Phase
Asthma Drug: dupilumab SAR231893 (REGN668) Phase 2 Phase 3

Detailed Description:
A screening period, up to 3 weeks, will apply only for patients coming from DRI12544 study. The total study duration, per patient, is a maximum of 108 weeks (or 111 weeks considering a maximum screening period of 3 weeks for Study DRI12544) for the patients enrolled prior to Amendment 04 approval and a maximum of 60 weeks for the patients enrolled after Amendment 04 approval.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2285 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 21, 2014
Actual Primary Completion Date : October 11, 2019
Actual Study Completion Date : October 11, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Dupilumab

Arm Intervention/treatment
Experimental: dupilumab treatment

For patients coming from the DRI12544 study: dupilumab loading dose sc on Day 1, followed by 1x Dose every 2 weeks added to current controller medications.

For patients coming from other studies: dupilumab 1x Dose sc every 2 weeks added to current controller medications.

Drug: dupilumab SAR231893 (REGN668)

Pharmaceutical form: Solution

Route of administration: Subcutaneous





Primary Outcome Measures :
  1. The primary endpoint of this study is the number (n) and percentage (%) of patients experiencing any treatment-emergent adverse events (TEAE) [ Time Frame: Up to Week 108 (if enrolled before Amendment 4); Up to Week 60 (if enrolled after Amendment 4) ]

Secondary Outcome Measures :
  1. Assessment of safety parameters (laboratory data, electrocardiogram and vital signs) - clinically significant changes from baseline [ Time Frame: At Week 96/Week 108 and/or Week 48/Week 60 ]
  2. Forced expiratory volume in one second - clinically significant changes from baseline [ Time Frame: At Week 96/Week 108 and/or Week 48/Week 60 ]
  3. Asthma control questionnaire (ACQ-5) - clinically significant changes from baseline [ Time Frame: At Week 96 and/or Week 48 ]
  4. Asthma symptom scores - clinically significant changes from baseline [ Time Frame: At Week 96 and/or Week 48 ]
  5. Asthma Quality of Life Questionnaire (AQLQS) - clinically significant changes from baseline [ Time Frame: At Week 96 and/or Week 48 ]
  6. Serum dupilumab concentrations [ Time Frame: At Week 96 and/or Week 48 ]
  7. Anti-drug antibodies - changes from baseline [ Time Frame: At Week 96 and/or Week 48 ]
  8. Biomarkers - changes from baseline [ Time Frame: At Week 96 and/or Week 48 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

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

Exclusion criteria:

- Patients 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 patient.

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02134028


  Hide Study Locations
Locations
Layout table for location information
United States, Alabama
Investigational Site Number 840047
Birmingham, Alabama, United States, 35209
United States, Arizona
Investigational Site Number 840099
Gilbert, Arizona, United States, 85234
Investigational Site Number 840087
Scottsdale, Arizona, United States, 85251
Investigational Site Number 840402
Tucson, Arizona, United States, 85724
United States, Arkansas
Investigational Site Number 840132
Little Rock, Arkansas, United States, 72209
United States, California
Investigational Site Number 840109
Bakersfield, California, United States, 93301
Investigational Site Number 840045
Long Beach, California, United States, 90720
Investigational Site Number 840019
Los Angeles, California, United States, 90025
Investigational Site Number 840029
Los Angeles, California, United States, 90025
Investigational Site Number 840022
Los Angeles, California, United States, 90048
Investigational Site Number 840044
Newport Beach, California, United States, 92663
Investigational Site Number 840041
North Hollywood, California, United States, 91606
Investigational Site Number 840014
Rolling Hills Estates, California, United States, 90274
Investigational Site Number 840121
San Jose, California, United States, 95117
United States, Colorado
Investigational Site Number 840040
Colorado Springs, Colorado, United States, 80907
Investigational Site Number 840403
Denver, Colorado, United States, 80206
Investigational Site Number 840006
Denver, Colorado, United States, 80230
Investigational Site Number 840024
Denver, Colorado, United States, 80230
Investigational Site Number 840130
Denver, Colorado, United States, 80246
United States, Connecticut
Investigational Site Number 840902
New Haven, Connecticut, United States, 06510
United States, Florida
Investigational Site Number 840137
Aventura, Florida, United States, 33180
Investigational Site Number 840071
Gainesville, Florida, United States, 32607
Investigational Site Number 840115
Ocoee, Florida, United States, 34761
Investigational Site Number 840055
Sarasota, Florida, United States, 34239
United States, Idaho
Investigational Site Number 840079
Twin Falls, Idaho, United States, 83301
United States, Illinois
Investigational Site Number 840101
Chicago, Illinois, United States, 60611
United States, Kentucky
Investigational Site Number 840032
Fort Mitchell, Kentucky, United States, 41017
Investigational Site Number 840017
Louisville, Kentucky, United States, 40223-5440
Investigational Site Number 840030
Owensboro, Kentucky, United States, 42301
United States, Maine
Investigational Site Number 840064
Bangor, Maine, United States, 04401
United States, Maryland
Investigational Site Number 840052
Chevy Chase, Maryland, United States, 20815
Investigational Site Number 840073
Gaithersburg, Maryland, United States, 20878
Investigational Site Number 840080
Owings Mills, Maryland, United States, 21117
United States, Massachusetts
Investigational Site Number 840401
Boston, Massachusetts, United States, 02115
United States, Minnesota
Investigational Site Number 840018
Minneapolis, Minnesota, United States, 55402
United States, Missouri
Investigational Site Number 840002
Saint Louis, Missouri, United States, 63110
Investigational Site Number 840102
Saint Louis, Missouri, United States, 63141
Investigational Site Number 840093
Saint Louis, Missouri, United States
United States, Montana
Investigational Site Number 840037
Missoula, Montana, United States, 59808
United States, Nebraska
Investigational Site Number 840078
Omaha, Nebraska, United States, 68124
Investigational Site Number 840004
Papillion, Nebraska, United States, 27103
United States, New Jersey
Investigational Site Number 840111
Brick, New Jersey, United States, 08723
Investigational Site Number 840068
Ocean City, New Jersey, United States, 07712
Investigational Site Number 840011
Princeton, New Jersey, United States, 08540
United States, New York
Investigational Site Number 840065
New York, New York, United States, 10029
United States, North Carolina
Investigational Site Number 840126
Charlotte, North Carolina, United States, 28226
Investigational Site Number 840083
Charlotte, North Carolina, United States, 28277
Investigational Site Number 840108
Durham, North Carolina, United States, 27705
Investigational Site Number 840107
Greensboro, North Carolina, United States, 27401
Investigational Site Number 840907
High Point, North Carolina, United States, 27262
Investigational Site Number 840404
Winston-Salem, North Carolina, United States, 27157-1071
United States, Ohio
Investigational Site Number 840015
Cincinnati, Ohio, United States, 45236
Investigational Site Number 840146
Cincinnati, Ohio, United States, 45241
Investigational Site Number 840049
Middleburg Heights, Ohio, United States, 44130
Investigational Site Number 840942
Toledo, Ohio, United States, 43617
United States, Oklahoma
Investigational Site Number 840112
Edmond, Oklahoma, United States, 73034
Investigational Site Number 840104
Tulsa, Oklahoma, United States, 74136
United States, Oregon
Investigational Site Number 840034
Medford, Oregon, United States, 97504
Investigational Site Number 840031
Portland, Oregon, United States, 97223
United States, Pennsylvania
Investigational Site Number 840046
Bethlehem, Pennsylvania, United States, 18020
Investigational Site Number 840085
Hershey, Pennsylvania, United States, 17033
Investigational Site Number 840067
Philadelphia, Pennsylvania, United States, 19140
Investigational Site Number 840928
Pittsburgh, Pennsylvania, United States, 15213
Investigational Site Number 840091
Pittsburgh, Pennsylvania, United States, 15241
United States, South Carolina
Investigational Site Number 840082
Charleston, South Carolina, United States, 29407
Investigational Site Number 840117
Greenville, South Carolina, United States, 29607
Investigational Site Number 840021
Spartanburg, South Carolina, United States, 29303
United States, Texas
Investigational Site Number 840062
Amarillo, Texas, United States, 79106
Investigational Site Number 840038
Boerne, Texas, United States, 78006
Investigational Site Number 840124
Cypress, Texas, United States, 77429
Investigational Site Number 840023
Dallas, Texas, United States, 75231
Investigational Site Number 840923
El Paso, Texas, United States, 79903
Investigational Site Number 840922
Fort Worth, Texas, United States, 76109
Investigational Site Number 840027
Fort Worth, Texas, United States, 76244
Investigational Site Number 840070
McKinney, Texas, United States, 75069
Investigational Site Number 840118
Plano, Texas, United States, 75093
Investigational Site Number 840008
San Antonio, Texas, United States, 78229
United States, Utah
Investigational Site Number 840035
Draper, Utah, United States, 84020
Investigational Site Number 840077
Murray, Utah, United States, 84107
United States, Vermont
Investigational Site Number 840057
South Burlington, Vermont, United States, 05403
United States, Virginia
Investigational Site Number 840059
Fairfax, Virginia, United States, 22030
United States, Washington
Investigational Site Number 840951
Bellingham, Washington, United States, 98225
Argentina
Investigational Site Number 032096
Bahia Blanca, Argentina, B8000JRB
Investigational Site Number 032004
Buenos Aires, Argentina, B6500BWQ
Investigational Site Number 032003
Buenos Aires, Argentina, C1121ABE
Investigational Site Number 032011
Caba, Argentina, 1120
Investigational Site Number 032097
Caba, Argentina, C1414AIF
Investigational Site Number 032001
Caba, Argentina, C1425BEN
Investigational Site Number 032010
Caba, Argentina, C1425FVH
Investigational Site Number 032091
Caba, Argentina, C1426ABP
Investigational Site Number 032095
Capital Federal, Argentina, C1425DUC
Investigational Site Number 032002
La Plata, Argentina, B1900BNN
Investigational Site Number 032006
Rosario, Argentina, S2000BRH
Investigational Site Number 032007
Rosario, Argentina, S2000DBS
Investigational Site Number 032005
Rosario, Argentina, S2000JKR
Investigational Site Number 032012
San Miguel De Tucuman, Argentina, T4000CHE
Investigational Site Number 032009
San Miguel De Tucumán, Argentina, T4000IAR
Australia
Investigational Site Number 036004
Adelaide, Australia, 5000
Investigational Site Number 036005
Campbelltown, Australia, 2560
Investigational Site Number 036001
Clayton, Australia, 3168
Investigational Site Number 036008
Frankston, Australia, 3199
Investigational Site Number 036093
Murdoch, Australia, 6150
Investigational Site Number 036003
Nedlands, Australia, 6009
Investigational Site Number 036094
Parkville, Australia, 3050
Investigational Site Number 036009
Prahran, Australia, 3004
Investigational Site Number 036006
Woolloongabba, Australia, 4102
Belgium
Investigational Site Number 056002
Brussels, Belgium, 1020
Investigational Site Number 056003
Gent, Belgium, 9000
Investigational Site Number 056001
Leuven, Belgium, 3000
Brazil
Investigational Site Number 076009
Florianópolis, Brazil, 88040-970
Investigational Site Number 076007
Porto Alegre, Brazil, 90020-090
Investigational Site Number 076001
Porto Alegre, Brazil, 90610-000
Investigational Site Number 076003
Salvador, Brazil, 41940-455
Investigational Site Number 076012
Sao Paulo, Brazil, 04266-010
Investigational Site Number 076002
Sorocaba, Brazil, 18040-425
Investigational Site Number 076013
São Bernardo Do Campo, Brazil, 09715-090
Investigational Site Number 076006
São Paulo, Brazil, 05437-000
Canada
Investigational Site Number 124019
Burlington, Canada, L7N 3V2
Investigational Site Number 124009
Calgary, Canada, T2N 4Z6
Investigational Site Number 124016
Hamilton, Canada, L8N 4A6
Investigational Site Number 124003
Mississauga, Canada, L5A 3V4
Investigational Site Number 124001
Montreal, Canada, H2X 3E4
Investigational Site Number 124012
Montreal, Canada, H4A 3J1
Investigational Site Number 124010
Montreal, Canada, H4J 1C5
Investigational Site Number 124013
Ottawa, Canada, K1G 6C6
Investigational Site Number 124018
Quebec, Canada, G1V 4G5
Investigational Site Number 124014
Quebec, Canada, G1V 4W2
Investigational Site Number 124008
Sherbrooke, Canada, J1H 5N4
Investigational Site Number 124015
Toronto, Canada, M5G 1E2
Investigational Site Number 124002
Toronto, Canada, M5T 3A9
Investigational Site Number 124007
Trois-Rivieres, Canada, G8T 7A1
Investigational Site Number 124006
Vancouver, Canada, V5Z 1M9
Investigational Site Number 124017
Vancouver, Canada, V6Z 1Y6
Chile
Investigational Site Number 152007
Quillota, Chile, 2260877
Investigational Site Number 152024
Santiago, Chile, 7500588
Investigational Site Number 152005
Santiago, Chile, 7500692
Investigational Site Number 152014
Santiago, Chile, 7500698
Investigational Site Number 152011
Santiago, Chile, 7500710
Investigational Site Number 152018
Santiago, Chile, 8207257
Investigational Site Number 152002
Santiago, Chile, 8380456
Investigational Site Number 152013
Santiago, Chile, 8910131
Investigational Site Number 152023
Talcahuano, Chile
Investigational Site Number 152008
Talca, Chile, 3460001
Investigational Site Number 152004
Talca, Chile
Investigational Site Number 152010
Valdivia, Chile, 5090145
Investigational Site Number 152003
Viña Del Mar, Chile, 2520024
Investigational Site Number 152021
Viña Del Mar, Chile, 2520594
Colombia
Investigational Site Number 170001
Bogota, Colombia, 110121
Investigational Site Number 170002
Bogotá, Colombia, 110231
Denmark
Investigational Site Number 208002
Hvidovre, Denmark, 2650
Investigational Site Number 208001
København Nv, Denmark, 2400
France
Investigational Site Number 250009
Brest, France, 29609
Investigational Site Number 250004
La Tronche, France, 38700
Investigational Site Number 250010
Lille Cedex, France, 59037
Investigational Site Number 250013
Lille Cedex, France, 59037
Investigational Site Number 250006
Lyon, France, 69317
Investigational Site Number 250001
Marseille, France, 13015
Investigational Site Number 250002
Montpellier, France, 34295
Investigational Site Number 250005
Nantes, France, 44033
Investigational Site Number 250007
Nimes Cedex 9, France, 30029
Investigational Site Number 250008
Strasbourg, France, 67091
Investigational Site Number 250014
Vandoeuvre-Les-Nancy Cedex, France, 54511
Germany
Investigational Site Number 276006
Berlin, Germany, 10787
Investigational Site Number 276003
Bochum, Germany, 44789
Investigational Site Number 276010
Frankfurt Am Main, Germany, 60596
Investigational Site Number 276011
Großhansdorf, Germany, 22927
Investigational Site Number 276009
Koblenz, Germany, 56068
Investigational Site Number 276005
Rüdersdorf Bei Berlin, Germany, 15562
Hungary
Investigational Site Number 348301
Balassagyarmat, Hungary, 2660
Investigational Site Number 348303
Edelény, Hungary, 3780
Investigational Site Number 348003
Gödöllö, Hungary, 2100
Israel
Investigational Site Number 376003
Haifa, Israel, 34362
Investigational Site Number 376001
Kfar Saba, Israel, 44281
Investigational Site Number 376005
Petah-Tikva, Israel, 49100
Investigational Site Number 376002
Rehovot, Israel, 76100
Italy
Investigational Site Number 380010
Ancona, Italy, 60126
Investigational Site Number 380009
Catania, Italy, 95123
Investigational Site Number 380004
Ferrara, Italy, 44124
Investigational Site Number 380008
Foggia, Italy, 71100
Investigational Site Number 380002
Genova, Italy, 16132
Investigational Site Number 380003
Modena, Italy, 41124
Investigational Site Number 380007
Padova, Italy, 35128
Investigational Site Number 380099
Palermo, Italy, 90146
Investigational Site Number 380001
Pisa, Italy, 56100
Japan
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
Chuo-Ku, Japan
Investigational Site Number 392007
Chuo-Ku, Japan
Investigational Site Number 392112
Chuo-Ku, Japan
Investigational Site Number 392012
Edogawa-Ku, Japan
Investigational Site Number 392137
Fukuoka-Shi, 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-Shi, Japan
Investigational Site Number 392158
Hiroshima-Shi, Japan
Investigational Site Number 392013
Iizuka-Shi, Japan
Investigational Site Number 392042
Isesaki-Shi, Japan
Investigational Site Number 392023
Kanazawa-Shi, Japan
Investigational Site Number 392142
Kasuga-Shi, Japan
Investigational Site Number 392119
Kishiwada-Shi, Japan
Investigational Site Number 392025
Kobe-Shi, Japan
Investigational Site Number 392162
Kobe-Shi, 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-Shi, Japan
Investigational Site Number 392153
Kyoto-Shi, Japan
Investigational Site Number 392133
Machida-Shi, Japan
Investigational Site Number 392135
Matsuyama-Shi, Japan
Investigational Site Number 392122
Minato-Ku, Japan
Investigational Site Number 392144
Minato-Ku, Japan
Investigational Site Number 392106
Mizunami-Shi, Japan
Investigational Site Number 392164
Muroran-Shi, Japan
Investigational Site Number 392163
Nagoya-Shi, 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 392127
Ota-Ku, Japan
Investigational Site Number 392043
Ota-Shi, Japan
Investigational Site Number 392169
Sagamihara-Shi, Japan
Investigational Site Number 392024
Sakai-Shi, Japan
Investigational Site Number 392011
Sakaide-Shi, Japan
Investigational Site Number 392008
Sapporo-Shi, Japan
Investigational Site Number 392034
Sapporo-Shi, 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-Shi, Japan
Investigational Site Number 392168
Uozu-Shi, Japan
Investigational Site Number 392132
Urasoe-Shi, Japan
Investigational Site Number 392045
Uruma-Shi, Japan
Investigational Site Number 392014
Yokohama-Shi, Japan
Korea, Republic of
Investigational Site Number 410002
Bucheon-Si, Korea, Republic of, 14584
Investigational Site Number 410003
Cheongju-Si, Korea, Republic of, 28644
Investigational Site Number 410013
Incheon, Korea, Republic of, 21565
Investigational Site Number 410006
Seoul, Korea, Republic of, 03080
Investigational Site Number 410008
Seoul, Korea, Republic of, 03312
Investigational Site Number 410004
Seoul, Korea, Republic of, 03722
Investigational Site Number 410012
Seoul, Korea, Republic of, 04763
Investigational Site Number 410005
Seoul, Korea, Republic of, 05505
Investigational Site Number 410007
Seoul, Korea, Republic of, 06351
Investigational Site Number 410010
Seoul, Korea, Republic of, 06973
Investigational Site Number 410011
Seoul, Korea, Republic of, 08308
Investigational Site Number 410001
Suwon, Korea, Republic of, 16499
Mexico
Investigational Site Number 484013
Chihuahua, Mexico, 31020
Investigational Site Number 484006
Chihuahua, Mexico, 31200
Investigational Site Number 484014
Cuautitlan Izcalli, Mexico, 54769
Investigational Site Number 484005
Distrito Federal, Mexico, 07760
Investigational Site Number 484008
Durango, Mexico, 34080
Investigational Site Number 484001
Guadalajara, Mexico, 44100
Investigational Site Number 484004
Mexico City, Mexico, 64718
Investigational Site Number 484003
Monterrey, Mexico, 64460
Investigational Site Number 484007
Monterrey, Mexico, 66465
Investigational Site Number 484010
México, Mexico, 06700
Investigational Site Number 484012
San Juan Del Rio, Mexico, 76800
Investigational Site Number 484011
Veracruz, Mexico, 91910
Netherlands
Investigational Site Number 528001
Arnhem, Netherlands, 6815 AD
Investigational Site Number 528002
Dordrecht, Netherlands, 3318 AT
Poland
Investigational Site Number 616006
Bialystok, Poland, 15-010
Investigational Site Number 616004
Gdansk, Poland, 80-405
Investigational Site Number 616003
Gdansk, Poland, 80-952
Investigational Site Number 616007
Krakow, Poland, 31-159
Investigational Site Number 616097
Krakow, Poland, 31-159
Investigational Site Number 616001
Lodz, Poland, 90-141
Investigational Site Number 616005
Lodz, Poland, 90-153
Investigational Site Number 616009
Lodz, Poland, 90-329
Investigational Site Number 616096
Poznan, Poland, 60-693
Investigational Site Number 616098
Strzelce Opolskie, Poland, 47-100
Investigational Site Number 616008
Warszawa, Poland, 00-013
Investigational Site Number 616010
Warszawa, Poland, 04-141
Investigational Site Number 616011
Znin, Poland, 88-400
Romania
Investigational Site Number 642104
Bucharest, Romania, 011461
Investigational Site Number 642103
Bucharest, Romania, 050159
Investigational Site Number 642102
Cluj-Napoca, Romania, 400162
Investigational Site Number 642107
Cluj-Napoca, Romania, 400371
Investigational Site Number 642105
Timisoara, Romania, 300310
Investigational Site Number 642106
Timisoara, Romania, 300310
Russian Federation
Investigational Site Number 643013
Ekaterinburg, Russian Federation, 620028
Investigational Site Number 643096
Moscow, Russian Federation, 105077
Investigational Site Number 643002
Moscow, Russian Federation, 109240
Investigational Site Number 643005
Moscow, Russian Federation, 115280
Investigational Site Number 643007
Moscow, Russian Federation, 117574
Investigational Site Number 643012
Moscow, Russian Federation, 123182
Investigational Site Number 643001
Moscow, Russian Federation, 125315
Investigational Site Number 643006
Novosibirsk, Russian Federation, 630091
Investigational Site Number 643091
Ryazan, Russian Federation, 390039
Investigational Site Number 643011
Saint-Petersburg, Russian Federation, 194223
Investigational Site Number 643010
Saint-Petersburg, Russian Federation, 194354
Investigational Site Number 643099
St-Petersburg, Russian Federation, 193231
Investigational Site Number 643009
St-Petersburg, Russian Federation, 197022
Investigational Site Number 643008
Yaroslavl, Russian Federation, 150003
South Africa
Investigational Site Number 710009
Brandfort, South Africa, 9400
Investigational Site Number 710011
Cape Town, South Africa, 7505
Investigational Site Number 710001
Cape Town, South Africa, 7530
Investigational Site Number 710091
Cape Town, South Africa, 7700
Investigational Site Number 710092
Cape Town, South Africa, 7700
Investigational Site Number 710002
Cape Town, South Africa, 7764
Investigational Site Number 710003
Cape Town, South Africa, 8000
Investigational Site Number 710006
Durban, South Africa, 4071
Investigational Site Number 710007
Pretoria, South Africa, 0087
Spain
Investigational Site Number 724014
Barcelona, Spain, 08023
Investigational Site Number 724002
Barcelona, Spain, 08035
Investigational Site Number 724001
Barcelona, Spain, 08036
Investigational Site Number 724010
Palma De Mallorca, Spain, 07120
Investigational Site Number 724006
Pozuelo De Alarcón, Spain, 28223
Investigational Site Number 724003
Sabadell, Spain, 08208
Investigational Site Number 724007
Sant Boi De Llobregat, Spain, 08830
Investigational Site Number 724096
Santiago De Compostela, Spain, 15706
Investigational Site Number 724008
Sevilla, Spain, 41071
Investigational Site Number 724097
Valencia, Spain, 46017
Taiwan
Investigational Site Number 158008
New Taipei City, Taiwan, 23561
Investigational Site Number 158007
Taichung, Taiwan, 40447
Investigational Site Number 158009
Taipei, Taiwan, 11031
Turkey
Investigational Site Number 792002
Ankara, Turkey, 06100
Investigational Site Number 792098
Ankara, Turkey, 06100
Investigational Site Number 792008
Bursa, Turkey, 16059
Investigational Site Number 792007
Istanbul, Turkey, 34020
Investigational Site Number 792001
Istanbul, Turkey, 34098
Investigational Site Number 792004
Istanbul, Turkey, 34098
Investigational Site Number 792003
Istanbul, Turkey, 34844
Investigational Site Number 792005
Izmir, Turkey, 35040
Investigational Site Number 792090
Izmir, Turkey, 35110
Investigational Site Number 792013
Kirikkale, Turkey, 71450
Investigational Site Number 792006
Mersin, Turkey, 33070
Investigational Site Number 792096
Rize, Turkey, 53100
Ukraine
Investigational Site Number 804007
Chernivtsi, Ukraine, 58001
Investigational Site Number 804023
Dnipro, Ukraine, 49101
Investigational Site Number 804009
Ivano-Frankivsk, Ukraine, 76018
Investigational Site Number 804094
Ivano-Frankivsk, Ukraine, 76018
Investigational Site Number 804005
Kharkiv, Ukraine, 61058
Investigational Site Number 804021
Kharkiv, Ukraine, 61093
Investigational Site Number 804001
Kharkiv, Ukraine, 61124
Investigational Site Number 804004
Kyiv, Ukraine, 03049
Investigational Site Number 804003
Kyiv, Ukraine, 03680
Investigational Site Number 804008
Kyiv, Ukraine, 03680
Investigational Site Number 804017
Kyiv, Ukraine, 03680
Investigational Site Number 804018
Kyiv, Ukraine, 03680
Investigational Site Number 804020
Kyiv, Ukraine, 03680
Investigational Site Number 804016
Kyiv, Ukraine, 04050
Investigational Site Number 804006
Odesa, Ukraine, 65025
Investigational Site Number 804002
Poltava, Ukraine, 36038
Investigational Site Number 804014
Ternopil, Ukraine, 46000
Investigational Site Number 804019
Vinnytsya, Ukraine, 21001
Investigational Site Number 804015
Yalta, Ukraine, 298603
Investigational Site Number 804022
Zaporizhzhya, Ukraine, 69076
Investigational Site Number 804012
Zaporizhzhya, Ukraine, 69118
United Kingdom
Investigational Site Number 826001
Bradford, United Kingdom, BD9 6RJ
Investigational Site Number 826010
London, United Kingdom, W2 1NY
Investigational Site Number 826009
Oxford, United Kingdom, OX3 7LE
Investigational Site Number 826007
Portsmouth, United Kingdom, PO6 3LY
Investigational Site Number 826006
South Shields, United Kingdom, NE34 0PL
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
Layout table for investigator information
Study Director: Clinical Sciences & Operations Sanofi

Layout table for additonal information
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02134028     History of Changes
Other Study ID Numbers: LTS12551
2013-003856-19 ( EudraCT Number )
U1111-1117-6745 ( Other Identifier: UTN )
First Posted: May 8, 2014    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs