AzTrials
AzTrials

AsthmaPhase 3NCT02134028

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

A Phase 3 study testing Dupilumab in people with Asthma, run by Sanofi at 365 sites in 27 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Asthma
What is being tested?
Dupilumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,282 participants
Where
365 sitesin 27 countries
Study dates
5 Aug 2014to 11 Oct 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

365 sites in 27 countries.

365 sites in 27 countries

United States82 sites

  • Investigational Site Number 840062

    Amarillo, Texas, 79106

  • Investigational Site Number 840137

    Aventura, Florida, 33180

  • Investigational Site Number 840109

    Bakersfield, California, 93301

  • Investigational Site Number 840064

    Bangor, Maine, 04401

  • Investigational Site Number 840951

    Bellingham, Washington, 98225

  • Investigational Site Number 840046

    Bethlehem, Pennsylvania, 18020

  • Investigational Site Number 840047

    Birmingham, Alabama, 35209

  • Investigational Site Number 840038

    Boerne, Texas, 78006

  • Investigational Site Number 840401

    Boston, Massachusetts, 02115

  • Investigational Site Number 840111

    Brick, New Jersey, 08723

  • Investigational Site Number 840082

    Charleston, South Carolina, 29407

  • Investigational Site Number 840126

    Charlotte, North Carolina, 28226

  • Investigational Site Number 840083

    Charlotte, North Carolina, 28277

  • Investigational Site Number 840052

    Chevy Chase, Maryland, 20815

  • Investigational Site Number 840101

    Chicago, Illinois, 60611

  • Investigational Site Number 840015

    Cincinnati, Ohio, 45236

  • Investigational Site Number 840146

    Cincinnati, Ohio, 45241

  • Investigational Site Number 840040

    Colorado Springs, Colorado, 80907

  • Investigational Site Number 840124

    Cypress, Texas, 77429

  • Investigational Site Number 840023

    Dallas, Texas, 75231

  • Investigational Site Number 840403

    Denver, Colorado, 80206

  • Investigational Site Number 840006

    Denver, Colorado, 80230

  • Investigational Site Number 840024

    Denver, Colorado, 80230

  • Investigational Site Number 840130

    Denver, Colorado, 80246

  • Investigational Site Number 840035

    Draper, Utah, 84020

  • Investigational Site Number 840108

    Durham, North Carolina, 27705

  • Investigational Site Number 840112

    Edmond, Oklahoma, 73034

  • Investigational Site Number 840923

    El Paso, Texas, 79903

  • Investigational Site Number 840059

    Fairfax, Virginia, 22030

  • Investigational Site Number 840032

    Fort Mitchell, Kentucky, 41017

  • Investigational Site Number 840922

    Fort Worth, Texas, 76109

  • Investigational Site Number 840027

    Fort Worth, Texas, 76244

  • Investigational Site Number 840071

    Gainesville, Florida, 32607

  • Investigational Site Number 840073

    Gaithersburg, Maryland, 20878

  • Investigational Site Number 840099

    Gilbert, Arizona, 85234

  • Investigational Site Number 840107

    Greensboro, North Carolina, 27401

  • Investigational Site Number 840117

    Greenville, South Carolina, 29607

  • Investigational Site Number 840085

    Hershey, Pennsylvania, 17033

  • Investigational Site Number 840907

    High Point, North Carolina, 27262

  • Investigational Site Number 840132

    Little Rock, Arkansas, 72209

  • Investigational Site Number 840045

    Long Beach, California, 90720

  • Investigational Site Number 840019

    Los Angeles, California, 90025

  • Investigational Site Number 840029

    Los Angeles, California, 90025

  • Investigational Site Number 840022

    Los Angeles, California, 90048

  • Investigational Site Number 840017

    Louisville, Kentucky, 40223-5440

  • Investigational Site Number 840070

    McKinney, Texas, 75069

  • Investigational Site Number 840034

    Medford, Oregon, 97504

  • Investigational Site Number 840049

    Middleburg Heights, Ohio, 44130

  • Investigational Site Number 840018

    Minneapolis, Minnesota, 55402

  • Investigational Site Number 840037

    Missoula, Montana, 59808

  • Investigational Site Number 840077

    Murray, Utah, 84107

  • Investigational Site Number 840902

    New Haven, Connecticut, 06510

  • Investigational Site Number 840065

    New York, New York, 10029

  • Investigational Site Number 840044

    Newport Beach, California, 92663

  • Investigational Site Number 840041

    North Hollywood, California, 91606

  • Investigational Site Number 840068

    Ocean City, New Jersey, 07712

  • Investigational Site Number 840115

    Ocoee, Florida, 34761

  • Investigational Site Number 840078

    Omaha, Nebraska, 68124

  • Investigational Site Number 840030

    Owensboro, Kentucky, 42301

  • Investigational Site Number 840080

    Owings Mills, Maryland, 21117

  • Investigational Site Number 840004

    Papillion, Nebraska, 27103

  • Investigational Site Number 840067

    Philadelphia, Pennsylvania, 19140

  • Investigational Site Number 840928

    Pittsburgh, Pennsylvania, 15213

  • Investigational Site Number 840091

    Pittsburgh, Pennsylvania, 15241

  • Investigational Site Number 840118

    Plano, Texas, 75093

  • Investigational Site Number 840031

    Portland, Oregon, 97223

  • Investigational Site Number 840011

    Princeton, New Jersey, 08540

  • Investigational Site Number 840014

    Rolling Hills Estates, California, 90274

  • Investigational Site Number 840008

    San Antonio, Texas, 78229

  • Investigational Site Number 840121

    San Jose, California, 95117

  • Investigational Site Number 840055

    Sarasota, Florida, 34239

  • Investigational Site Number 840087

    Scottsdale, Arizona, 85251

  • Investigational Site Number 840057

    South Burlington, Vermont, 05403

  • Investigational Site Number 840021

    Spartanburg, South Carolina, 29303

  • Investigational Site Number 840002

    St Louis, Missouri, 63110

  • Investigational Site Number 840102

    St Louis, Missouri, 63141

  • Investigational Site Number 840093

    St Louis, Missouri

  • Investigational Site Number 840942

    Toledo, Ohio, 43617

  • Investigational Site Number 840402

    Tucson, Arizona, 85724

  • Investigational Site Number 840104

    Tulsa, Oklahoma, 74136

  • Investigational Site Number 840079

    Twin Falls, Idaho, 83301

  • Investigational Site Number 840404

    Winston-Salem, North Carolina, 27157-1071

Other trials in United States

Japan62 sites

  • Investigational Site Number 392185

    Akashi-Shi

  • Investigational Site Number 392009

    Asahi-Shi

  • Investigational Site Number 392037

    Chiyoda-Ku

  • Investigational Site Number 392002

    Chūōku

  • Investigational Site Number 392007

    Chūōku

  • Investigational Site Number 392112

    Chūōku

  • Investigational Site Number 392012

    Edogawa-Ku

  • Investigational Site Number 392137

    Fukuoka

  • Investigational Site Number 392021

    Fukuyama-Shi

  • Investigational Site Number 392030

    Habikino-Shi

  • Investigational Site Number 392004

    Himeji-Shi

  • Investigational Site Number 392032

    Hirakata-Shi

  • Investigational Site Number 392108

    Hiroshima

  • Investigational Site Number 392158

    Hiroshima

  • Investigational Site Number 392013

    Iizuka-Shi

  • Investigational Site Number 392042

    Isesaki-Shi

  • Investigational Site Number 392023

    Kanazawa

  • Investigational Site Number 392142

    Kasuga-Shi

  • Investigational Site Number 392119

    Kishiwada-Shi

  • Investigational Site Number 392025

    Kobe

  • Investigational Site Number 392162

    Kobe

  • Investigational Site Number 392040

    Kodaira-Shi

  • Investigational Site Number 392044

    Kokubunji-Shi

  • Investigational Site Number 392131

    Koushi-Shi

  • Investigational Site Number 392010

    Kurashiki-Shi

  • Investigational Site Number 392036

    Kyoto

  • Investigational Site Number 392153

    Kyoto

  • Investigational Site Number 392133

    Machida-Shi

  • Investigational Site Number 392135

    Matsuyama

  • Investigational Site Number 392122

    Minatoku

  • Investigational Site Number 392144

    Minatoku

  • Investigational Site Number 392106

    Mizunami-Shi

  • Investigational Site Number 392164

    Muroran-Shi

  • Investigational Site Number 392163

    Nagoya

  • Investigational Site Number 392020

    Naka-Gun

  • Investigational Site Number 392005

    Naruto-Shi

  • Investigational Site Number 392187

    Obihiro-Shi

  • Investigational Site Number 392177

    Ome-Shi

  • Investigational Site Number 392152

    Osaka Sayama-Shi

  • Investigational Site Number 392155

    Osaka Sayama-Shi

  • Investigational Site Number 392170

    Osaki-Shi

  • Investigational Site Number 392127

    Ōta-ku

  • Investigational Site Number 392043

    Ota-Shi

  • Investigational Site Number 392169

    Sagamihara-Shi

  • Investigational Site Number 392011

    Sakaide-Shi

  • Investigational Site Number 392024

    Sakaishi

  • Investigational Site Number 392008

    Sapporo

  • Investigational Site Number 392034

    Sapporo

  • Investigational Site Number 392038

    Setagaya-Ku

  • Investigational Site Number 392179

    Seto-Shi

  • Investigational Site Number 392186

    Shibuya-Ku

  • Investigational Site Number 392167

    Shinagawa-Ku

  • Investigational Site Number 392130

    Shinjuku-Ku

  • Investigational Site Number 392165

    Sumida-Ku

  • Investigational Site Number 392146

    Tachikawa-Shi

  • Investigational Site Number 392173

    Tachikawa-Shi

  • Investigational Site Number 392006

    Tomakomai-Shi

  • Investigational Site Number 392029

    Tsu

  • Investigational Site Number 392168

    Uozu-Shi

  • Investigational Site Number 392132

    Urasoe-Shi

  • Investigational Site Number 392045

    Uruma

  • Investigational Site Number 392014

    Yokohama

Other trials in Japan

Ukraine21 sites

  • Investigational Site Number 804007

    Chernivtsi, 58001

  • Investigational Site Number 804023

    Dnipro, 49101

  • Investigational Site Number 804009

    Ivano-Frankivsk, 76018

  • Investigational Site Number 804094

    Ivano-Frankivsk, 76018

  • Investigational Site Number 804005

    Kharkiv, 61058

  • Investigational Site Number 804021

    Kharkiv, 61093

  • Investigational Site Number 804001

    Kharkiv, 61124

  • Investigational Site Number 804004

    Kyiv, 03049

  • Investigational Site Number 804003

    Kyiv, 03680

  • Investigational Site Number 804008

    Kyiv, 03680

  • Investigational Site Number 804017

    Kyiv, 03680

  • Investigational Site Number 804018

    Kyiv, 03680

  • Investigational Site Number 804020

    Kyiv, 03680

  • Investigational Site Number 804016

    Kyiv, 04050

  • Investigational Site Number 804006

    Odesa, 65025

  • Investigational Site Number 804002

    Poltava, 36038

  • Investigational Site Number 804014

    Ternopil, 46000

  • Investigational Site Number 804019

    Vinnytsia, 21001

  • Investigational Site Number 804015

    Yalta, 298603

  • Investigational Site Number 804022

    Zaporizhzhya, 69076

  • Investigational Site Number 804012

    Zaporizhzhya, 69118

Other trials in Ukraine

Canada16 sites

  • Investigational Site Number 124019

    Burlington, L7N 3V2

  • Investigational Site Number 124009

    Calgary, T2N 4Z6

  • Investigational Site Number 124016

    Hamilton, L8N 4A6

  • Investigational Site Number 124003

    Mississauga, L5A 3V4

  • Investigational Site Number 124001

    Montreal, H2X 3E4

  • Investigational Site Number 124012

    Montreal, H4A 3J1

  • Investigational Site Number 124010

    Montreal, H4J 1C5

  • Investigational Site Number 124013

    Ottawa, K1G 6C6

  • Investigational Site Number 124018

    Québec, G1V 4G5

  • Investigational Site Number 124014

    Québec, G1V 4W2

  • Investigational Site Number 124008

    Sherbrooke, J1H 5N4

  • Investigational Site Number 124015

    Toronto, M5G 1E2

  • Investigational Site Number 124002

    Toronto, M5T 3A9

  • Investigational Site Number 124007

    Trois-Rivières, G8T 7A1

  • Investigational Site Number 124006

    Vancouver, V5Z 1M9

  • Investigational Site Number 124017

    Vancouver, V6Z 1Y6

Other trials in Canada

Argentina15 sites

  • Investigational Site Number 032096

    Bahía Blanca, B8000JRB

  • Investigational Site Number 032004

    Buenos Aires, B6500BWQ

  • Investigational Site Number 032003

    Buenos Aires, C1121ABE

  • Investigational Site Number 032011

    Caba, 1120

  • Investigational Site Number 032097

    Caba, C1414AIF

  • Investigational Site Number 032001

    Caba, C1425BEN

  • Investigational Site Number 032010

    Caba, C1425FVH

  • Investigational Site Number 032091

    Caba, C1426ABP

  • Investigational Site Number 032095

    Capital Federal, C1425DUC

  • Investigational Site Number 032002

    La Plata, B1900BNN

  • Investigational Site Number 032006

    Rosario, S2000BRH

  • Investigational Site Number 032007

    Rosario, S2000DBS

  • Investigational Site Number 032005

    Rosario, S2000JKR

  • Investigational Site Number 032012

    San Miguel de Tucumán, T4000CHE

  • Investigational Site Number 032009

    San Miguel de Tucumán, T4000IAR

Other trials in Argentina

Chile14 sites

  • Investigational Site Number 152007

    Quillota, 2260877

  • Investigational Site Number 152024

    Santiago, 7500588

  • Investigational Site Number 152005

    Santiago, 7500692

  • Investigational Site Number 152014

    Santiago, 7500698

  • Investigational Site Number 152011

    Santiago, 7500710

  • Investigational Site Number 152018

    Santiago, 8207257

  • Investigational Site Number 152002

    Santiago, 8380456

  • Investigational Site Number 152013

    Santiago, 8910131

  • Investigational Site Number 152008

    Talca, 3460001

  • Investigational Site Number 152004

    Talca

  • Investigational Site Number 152023

    Talcahuano

  • Investigational Site Number 152010

    Valdivia, 5090145

  • Investigational Site Number 152003

    Viña del Mar, 2520024

  • Investigational Site Number 152021

    Viña del Mar, 2520594

Other trials in Chile

Russia14 sites

  • Investigational Site Number 643096

    Moscow, 105077

  • Investigational Site Number 643002

    Moscow, 109240

  • Investigational Site Number 643005

    Moscow, 115280

  • Investigational Site Number 643007

    Moscow, 117574

  • Investigational Site Number 643012

    Moscow, 123182

  • Investigational Site Number 643001

    Moscow, 125315

  • Investigational Site Number 643006

    Novosibirsk, 630091

  • Investigational Site Number 643091

    Ryazan, 390039

  • Investigational Site Number 643099

    Saint Petersburg, 193231

  • Investigational Site Number 643011

    Saint Petersburg, 194223

  • Investigational Site Number 643010

    Saint Petersburg, 194354

  • Investigational Site Number 643009

    Saint Petersburg, 197022

  • Investigational Site Number 643008

    Yaroslavl, 150003

  • Investigational Site Number 643013

    Yekaterinburg, 620028

Other trials in Russia

Poland13 sites

  • Investigational Site Number 616006

    Bialystok, 15-010

  • Investigational Site Number 616004

    Gdansk, 80-405

  • Investigational Site Number 616003

    Gdansk, 80-952

  • Investigational Site Number 616007

    Krakow, 31-159

  • Investigational Site Number 616097

    Krakow, 31-159

  • Investigational Site Number 616001

    Lodz, 90-141

  • Investigational Site Number 616005

    Lodz, 90-153

  • Investigational Site Number 616009

    Lodz, 90-329

  • Investigational Site Number 616096

    Poznan, 60-693

  • Investigational Site Number 616098

    Strzelce Opolskie, 47-100

  • Investigational Site Number 616008

    Warsaw, 00-013

  • Investigational Site Number 616010

    Warsaw, 04-141

  • Investigational Site Number 616011

    Żnin, 88-400

Other trials in Poland

Mexico12 sites

  • Investigational Site Number 484013

    Chihuahua City, 31020

  • Investigational Site Number 484006

    Chihuahua City, 31200

  • Investigational Site Number 484014

    Cuautitlán Izcalli, 54769

  • Investigational Site Number 484005

    Distrito Federal, 07760

  • Investigational Site Number 484008

    Durango, 34080

  • Investigational Site Number 484001

    Guadalajara, 44100

  • Investigational Site Number 484010

    México, 06700

  • Investigational Site Number 484004

    Mexico City, 64718

  • Investigational Site Number 484003

    Monterrey, 64460

  • Investigational Site Number 484007

    Monterrey, 66465

  • Investigational Site Number 484012

    San Juan del Río, 76800

  • Investigational Site Number 484011

    Veracruz, 91910

Other trials in Mexico

South Korea12 sites

  • Investigational Site Number 410002

    Bucheon-si, 14584

  • Investigational Site Number 410003

    Cheongju-si, 28644

  • Investigational Site Number 410013

    Incheon, 21565

  • Investigational Site Number 410006

    Seoul, 03080

  • Investigational Site Number 410008

    Seoul, 03312

  • Investigational Site Number 410004

    Seoul, 03722

  • Investigational Site Number 410012

    Seoul, 04763

  • Investigational Site Number 410005

    Seoul, 05505

  • Investigational Site Number 410007

    Seoul, 06351

  • Investigational Site Number 410010

    Seoul, 06973

  • Investigational Site Number 410011

    Seoul, 08308

  • Investigational Site Number 410001

    Suwon, 16499

Other trials in South Korea

Turkey (Türkiye)12 sites

  • Investigational Site Number 792002

    Ankara, 06100

  • Investigational Site Number 792098

    Ankara, 06100

  • Investigational Site Number 792008

    Bursa, 16059

  • Investigational Site Number 792007

    Istanbul, 34020

  • Investigational Site Number 792001

    Istanbul, 34098

  • Investigational Site Number 792004

    Istanbul, 34098

  • Investigational Site Number 792003

    Istanbul, 34844

  • Investigational Site Number 792005

    Izmir, 35040

  • Investigational Site Number 792090

    Izmir, 35110

  • Investigational Site Number 792013

    Kirikkale, 71450

  • Investigational Site Number 792006

    Mersin, 33070

  • Investigational Site Number 792096

    Rize, 53100

Other trials in Turkey (Türkiye)

France11 sites

  • Investigational Site Number 250009

    Brest, 29609

  • Investigational Site Number 250004

    La Tronche, 38700

  • Investigational Site Number 250010

    Lille, 59037

  • Investigational Site Number 250013

    Lille, 59037

  • Investigational Site Number 250006

    Lyon, 69317

  • Investigational Site Number 250001

    Marseille, 13015

  • Investigational Site Number 250002

    Montpellier, 34295

  • Investigational Site Number 250005

    Nantes, 44033

  • Investigational Site Number 250007

    Nîmes, 30029

  • Investigational Site Number 250008

    Strasbourg, 67091

  • Investigational Site Number 250014

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Spain10 sites

  • Investigational Site Number 724014

    Barcelona, 08023

  • Investigational Site Number 724002

    Barcelona, 08035

  • Investigational Site Number 724001

    Barcelona, 08036

  • Investigational Site Number 724010

    Palma de Mallorca, 07120

  • Investigational Site Number 724006

    Pozuelo de Alarcón, 28223

  • Investigational Site Number 724003

    Sabadell, 08208

  • Investigational Site Number 724007

    Sant Boi de Llobregat, 08830

  • Investigational Site Number 724096

    Santiago de Compostela, 15706

  • Investigational Site Number 724008

    Seville, 41071

  • Investigational Site Number 724097

    Valencia, 46017

Other trials in Spain

Australia9 sites

  • Investigational Site Number 036004

    Adelaide, 5000

  • Investigational Site Number 036005

    Campbelltown, 2560

  • Investigational Site Number 036001

    Clayton, 3168

  • Investigational Site Number 036008

    Frankston, 3199

  • Investigational Site Number 036093

    Murdoch, 6150

  • Investigational Site Number 036003

    Nedlands, 6009

  • Investigational Site Number 036094

    Parkville, 3050

  • Investigational Site Number 036009

    Prahran, 3004

  • Investigational Site Number 036006

    Woolloongabba, 4102

Other trials in Australia

Italy9 sites

  • Investigational Site Number 380010

    Ancona, 60126

  • Investigational Site Number 380009

    Catania, 95123

  • Investigational Site Number 380004

    Ferrara, 44124

  • Investigational Site Number 380008

    Foggia, 71100

  • Investigational Site Number 380002

    Genova, 16132

  • Investigational Site Number 380003

    Modena, 41124

  • Investigational Site Number 380007

    Padova, 35128

  • Investigational Site Number 380099

    Palermo, 90146

  • Investigational Site Number 380001

    Pisa, 56100

Other trials in Italy

South Africa9 sites

  • Investigational Site Number 710011

    Cape Town, 7505

  • Investigational Site Number 710001

    Cape Town, 7530

  • Investigational Site Number 710091

    Cape Town, 7700

  • Investigational Site Number 710092

    Cape Town, 7700

  • Investigational Site Number 710002

    Cape Town, 7764

  • Investigational Site Number 710003

    Cape Town, 8000

  • Investigational Site Number 710006

    Durban, 4071

  • Investigational Site Number 710007

    Pretoria, 0087

  • Investigational Site Number 710009

    Winnie Mandela, 9400

Other trials in South Africa

Brazil8 sites

  • Investigational Site Number 076009

    Florianópolis, 88040-970

  • Investigational Site Number 076007

    Porto Alegre, 90020-090

  • Investigational Site Number 076001

    Porto Alegre, 90610-000

  • Investigational Site Number 076003

    Salvador, 41940-455

  • Investigational Site Number 076013

    São Bernardo do Campo, 09715-090

  • Investigational Site Number 076012

    São Paulo, 04266-010

  • Investigational Site Number 076006

    São Paulo, 05437-000

  • Investigational Site Number 076002

    Sorocaba, 18040-425

Other trials in Brazil

Germany6 sites

  • Investigational Site Number 276006

    Berlin, 10787

  • Investigational Site Number 276003

    Bochum, 44789

  • Investigational Site Number 276010

    Frankfurt am Main, 60596

  • Investigational Site Number 276011

    Großhansdorf, 22927

  • Investigational Site Number 276009

    Koblenz, 56068

  • Investigational Site Number 276005

    Rüdersdorf Bei Berlin, 15562

Other trials in Germany

Romania6 sites

  • Investigational Site Number 642104

    Bucharest, 011461

  • Investigational Site Number 642103

    Bucharest, 050159

  • Investigational Site Number 642102

    Cluj-Napoca, 400162

  • Investigational Site Number 642107

    Cluj-Napoca, 400371

  • Investigational Site Number 642105

    Timișoara, 300310

  • Investigational Site Number 642106

    Timișoara, 300310

Other trials in Romania

United Kingdom5 sites

  • Investigational Site Number 826001

    Bradford, BD9 6RJ

  • Investigational Site Number 826010

    London, W2 1NY

  • Investigational Site Number 826009

    Oxford, OX3 7LE

  • Investigational Site Number 826007

    Portsmouth, PO6 3LY

  • Investigational Site Number 826006

    South Shields, NE34 0PL

Other trials in United Kingdom

Israel4 sites

  • Investigational Site Number 376003

    Haifa, 34362

  • Investigational Site Number 376001

    Kfar Saba, 44281

  • Investigational Site Number 376005

    Petah Tikva, 49100

  • Investigational Site Number 376002

    Rehovot, 76100

Other trials in Israel

Belgium3 sites

  • Investigational Site Number 056002

    Brussels, 1020

  • Investigational Site Number 056003

    Ghent, 9000

  • Investigational Site Number 056001

    Leuven, 3000

Other trials in Belgium

Hungary3 sites

  • Investigational Site Number 348301

    Balassagyarmat, 2660

  • Investigational Site Number 348303

    Edelény, 3780

  • Investigational Site Number 348003

    Gödöllö, 2100

Other trials in Hungary

Taiwan3 sites

  • Investigational Site Number 158008

    New Taipei City, 23561

  • Investigational Site Number 158007

    Taichung, 40447

  • Investigational Site Number 158009

    Taipei, 11031

Other trials in Taiwan

Colombia2 sites

  • Investigational Site Number 170001

    Bogotá, 110121

  • Investigational Site Number 170002

    Bogotá, 110231

Other trials in Colombia

Denmark2 sites

  • Investigational Site Number 208002

    Hvidovre, 2650

  • Investigational Site Number 208001

    København NV, 2400

Other trials in Denmark

Netherlands2 sites

  • Investigational Site Number 528001

    Arnhem, 6815 AD

  • Investigational Site Number 528002

    Dordrecht, 3318 AT

Other trials in Netherlands

About this study

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

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
Read the detailed description

A screening period, up to 3 weeks, applied only for participants who came from DRI12544 study. The total study duration, per participant, was a maximum of 108 weeks (or 111 weeks considering a maximum screening period of 3 weeks for study DRI12544) for the participants enrolled prior to Amendment 04 approval and a maximum of 60 weeks for the participants enrolled after Amendment 04 approval.

Following amendment 04 (dated 31 Oct 2016) the open-label treatment duration was amended to 48 weeks (1 year); and the 16-week post-treatment period was shortened to 12 weeks.

Conditions
Asthma
Being tested
Dupilumab
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DupilumabDrug

    Also called SAR231893, REGN668

    Pharmaceutical form: Solution for injection Routes of administration: Subcutaneous

Study groups in NCT02134028
Study groupRoleWhat they receive
dupilumab treatmentExperimentalFor 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.
Receives: Drug: Dupilumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (26)

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

    Criteria for potentially clinically significant vital sign abnormalities:

    • Systolic blood pressure (SBP): Less than or equal to (≤) 95 Adults (≤90 Adolescents) millimeters of mercury (mmHg) and decrease from baseline (DFB) greater than or equal to (≥) 20 mmHg; ≥ 160 Adults (≥ 119 Adolescents) mmHg and increase from baseline (IFB) ≥ 20 mmHg.
    • Diastolic blood pressure (DBP): ≤ 45 Adults (≤54 Adolescents) mmHg and DFB ≥ 10 mmHg; ≥ 110 Adults (≥78 Adolescents) mmHg and IFB ≥ 10 mmHg.
    • Heart rate (HR): ≤ 50 beats per minute (bpm) and DFB ≥ 20 bpm; ≥ 120 bpm and IFB ≥ 20 bpm.
    • Respiratory rate: less than (<) 12 breaths/min(b/m); greater than (>) 20 b/m.
    • Weight (kg): ≥ 5 percent (%) DFB; ≥ 5% IFB.
    • Temperature: ≥ 38.0 degree Celsius (°C) rectal/ear/temporal; ≥ 37.5°C oral; ≥ 37.2°C axillary.

    TEAE period was defined as the time from first dose of IMP in LTS12551 up to the last dose of dupilumab plus 14 weeks.

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

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

    Criteria for potentially clinically significant abnormalities:

    • Hemoglobin (Hb): ≤ 115 grams per liter (g/L)(Male [M]), ≤ 95 g/L (Female[ F]) (< 100 g/L Adolescents); ≥ 185 g/L (M), ≥ 165 g/L (F) (≥ 200 g/L Adolescents); DFB ≥ 20 g/L.
    • Hematocrit: ≤ 0.37 volume/volume (v/v) (M); ≤ 0.32 v/v (F) (<0.32 v/v Adolescents); ≥ 0.55 v/v (M); 0.5 v/v (F) (>0.47 v/v Adolescents).
    • RBCs: ≥ 6 Tera/L.
    • Platelets: < 100 Giga(G)/L; ≥ 700 G/L.

    TEAE period was defined as the time from first dose of IMP in LTS12551 up to the last dose of dupilumab plus 14 weeks.

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

  3. Number of Severe Exacerbation Events

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

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

  4. Annualized Event Rate Per Participant-Years for Severe Exacerbation

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    The ACQ-5 had 5 questions, reflecting the top-scoring five asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath and wheeze. Participants were asked to recall how their asthma had been during the previous week and to respond to each of the five symptom questions on a 7-point scale ranged from 0 (no impairment) to 6 (maximum impairment). ACQ-5 total mean score was mean of the scores of all 5 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled), higher scores indicated lower asthma control. For this analysis, baseline was defined as respective parent study baseline.

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

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

    ACQ-5 response was defined as change from baseline in ACQ-5 scores ≥ 0.5. The ACQ-5 had 5 questions, reflecting the top-scoring five asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath and wheeze. Participants were asked to recall how their asthma had been during the previous week and to respond to each of the five symptom questions on a 7-point scale ranged from 0 (no impairment) to 6 (maximum impairment). ACQ-5 mean total score was mean of the scores of all 5 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicated lower asthma control.

    Measured: At Weeks 24, and 48 of this extension study

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

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

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

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

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

    Measured: At Weeks 24, and 48 of this extension study

  13. Serum Concentrations of Dupilumab Over Time Till Week 96

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

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

  14. Percentage of Participants With Antidrug Antibodies (ADA) Response

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

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

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

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

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

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

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

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

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

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

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

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

    Morning asthma symptom score was determined using AM (ante meridiem) symptom scoring system which evaluated participant's overall asthma symptoms experienced during the night. It ranges from 0 to 4 as: 0=no asthma symptoms, slept through the night, 1=slept well, but some complaints in the morning. No nighttime awakenings, 2=woke up once because of asthma (including early awakening), 3=woke up several times because of asthma (including early awakening), 4=bad night, awake most of the night because of asthma; higher scores indicated more severe symptoms. For this analysis, baseline was defined as parent DRI12544 study baseline.

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

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

    Evening asthma symptom score was determined using PM (post meridiem) symptom scoring system which evaluated participant's overall asthma symptoms experienced during the day. It ranged from 0 to 4 as: 0=very well, no asthma symptoms, 1=one episode of wheezing, cough, or breathlessness, 2=more than one episode of wheezing, cough, or breathlessness without interference of normal activities, 3=wheezing, cough, or breathlessness most of the day, which interfered to some extent with normal activities, 4=asthma very bad, unable to carry out daily activities as usual; higher scores indicated more severe symptoms. For this analysis, baseline was defined as parent DRI12544 study baseline.

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

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

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

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

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

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

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

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

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

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

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

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

    Measured: Weeks 48 and 96 of this extension study

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

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

    Measured: Weeks 48, and 96 of this extension study

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

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

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

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

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2014 (estimated)
  2. Study start5 Aug 2014
  3. Primary completion11 Oct 2019
  4. Study completion11 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2,282 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02134028
Sponsor's protocol ID
LTS12551
Other IDs
2013-003856-19, U1111-1117-6745
Status last verified
Mar 2022
First submitted
30 Apr 2014
Last updated
28 Mar 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • Wechsler ME, Pavord ID, Papi A, Chapman KR, Altincatal A, Pandit-Abid N, Jacob-Nara JA, Rowe PJ, Deniz Y, Laws E, Akinlade B, Amin N, Staudinger HW, Lederer DJ, Hardin M. Long-Term Efficacy of Dupilumab in Moderate-to-Severe Asthma Phenotyped by Blood Eosinophils and Exhaled Nitric Oxide. CHEST Pulm. 2024 Jul 4;3(1):100072. doi: 10.1016/j.chpulm.2024.100072. eCollection 2025 Mar.

    PubMed 42548408

  • Busse WW, Kraft M, Domingo C, de Mir-Messa I, Maselli DJ, Soler X, Xia C, Pandit-Abid N, Jacob-Nara JA, Sacks HJ, Rowe PJ, Deniz Y. Impact of asthma age of onset or duration on efficacy of dupilumab in moderate-to-severe type 2 asthma. J Asthma. 2025 Oct;62(10):1678-1689. doi: 10.1080/02770903.2025.2494233. Epub 2025 Aug 6.

    PubMed 40767333

  • 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.

    PubMed 40458676

  • Pavord ID, Rabe KF, Israel E, Szefler SJ, Brusselle G, Pandit-Abid N, Altincatal A, Chen Z, Amin N, Khan AH, Lederer DJ, Zhang Y, Rowe PJ, Deniz Y, Radwan A, Jacob-Nara JA, Busse WW. Dupilumab Induces Long-Term On-Treatment Clinical Remission in Patients With Type 2 Asthma. J Allergy Clin Immunol Pract. 2025 Jan;13(1):132-142. doi: 10.1016/j.jaip.2024.10.009. Epub 2024 Oct 16.

    PubMed 39424189

  • 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.

    PubMed 39155737

  • 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.

    PubMed 38163585

  • 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.

    PubMed 38013139

  • 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.

    PubMed 37780074

  • 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.

    PubMed 37752621

  • 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.

    PubMed 37431558

  • 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.

    PubMed 37073882

  • 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.

    PubMed 36876957

  • 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.

    PubMed 36509407

  • 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.

    PubMed 36356712

  • 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.

    PubMed 36114102

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dupilumab in people with Asthma, run by Sanofi at 365 sites in 27 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 365 sites in United States, Japan, Ukraine, Canada, Argentina and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (time frame: From the first IMP injection in LTS12551 to the last IMP injection plus 14 weeks (up to 108 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02134028, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2022.

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