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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02134028
• Other study ID #: LTS12551
• Secondary ID: 2013-003856-19U1
• Status: Completed
• Phase: Phase 3
• Start date: August 5, 2014
• Est. completion date: October 11, 2019

Study information

• Verified date: March 2022
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2282
• Est. completion date: October 11, 2019
• Est. primary completion date: October 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion criteria:

• Participants with asthma who completed the treatment period in a previous dupilumab asthma clinical study (i.e., PDY14192, EFC13579 or EFC13691) or participants with asthma who completed the treatment and follow-up periods in previous dupilumab asthma Study DRI12544.

Exclusion criteria:

• Participants who experienced any hypersensitivity reactions to Investigational Medicinal Product (IMP) in the previous dupilumab asthma study, which, in the opinion of the Investigator, could indicate that continued treatment with dupilumab, may present an unreasonable risk for the participant.

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Dupilumab
Pharmaceutical form: Solution for injection Routes of administration: Subcutaneous

Locations

Country	Name	City	State
Argentina	Investigational Site Number 032096	Bahia Blanca
Argentina	Investigational Site Number 032003	Buenos Aires
Argentina	Investigational Site Number 032004	Buenos Aires
Argentina	Investigational Site Number 032001	Caba
Argentina	Investigational Site Number 032010	Caba
Argentina	Investigational Site Number 032011	Caba
Argentina	Investigational Site Number 032091	Caba
Argentina	Investigational Site Number 032097	Caba
Argentina	Investigational Site Number 032095	Capital Federal
Argentina	Investigational Site Number 032002	La Plata
Argentina	Investigational Site Number 032005	Rosario
Argentina	Investigational Site Number 032006	Rosario
Argentina	Investigational Site Number 032007	Rosario
Argentina	Investigational Site Number 032012	San Miguel De Tucuman
Argentina	Investigational Site Number 032009	San Miguel De Tucumán
Australia	Investigational Site Number 036004	Adelaide
Australia	Investigational Site Number 036005	Campbelltown
Australia	Investigational Site Number 036001	Clayton
Australia	Investigational Site Number 036008	Frankston
Australia	Investigational Site Number 036093	Murdoch
Australia	Investigational Site Number 036003	Nedlands
Australia	Investigational Site Number 036094	Parkville
Australia	Investigational Site Number 036009	Prahran
Australia	Investigational Site Number 036006	Woolloongabba
Belgium	Investigational Site Number 056002	Brussels
Belgium	Investigational Site Number 056003	Gent
Belgium	Investigational Site Number 056001	Leuven
Brazil	Investigational Site Number 076009	Florianópolis
Brazil	Investigational Site Number 076001	Porto Alegre
Brazil	Investigational Site Number 076007	Porto Alegre
Brazil	Investigational Site Number 076003	Salvador
Brazil	Investigational Site Number 076013	São Bernardo Do Campo
Brazil	Investigational Site Number 076012	Sao Paulo
Brazil	Investigational Site Number 076006	São Paulo
Brazil	Investigational Site Number 076002	Sorocaba
Canada	Investigational Site Number 124019	Burlington
Canada	Investigational Site Number 124009	Calgary
Canada	Investigational Site Number 124016	Hamilton
Canada	Investigational Site Number 124003	Mississauga
Canada	Investigational Site Number 124001	Montreal
Canada	Investigational Site Number 124010	Montreal
Canada	Investigational Site Number 124012	Montreal
Canada	Investigational Site Number 124013	Ottawa
Canada	Investigational Site Number 124014	Quebec
Canada	Investigational Site Number 124018	Quebec
Canada	Investigational Site Number 124008	Sherbrooke
Canada	Investigational Site Number 124002	Toronto
Canada	Investigational Site Number 124015	Toronto
Canada	Investigational Site Number 124007	Trois-Rivieres
Canada	Investigational Site Number 124006	Vancouver
Canada	Investigational Site Number 124017	Vancouver
Chile	Investigational Site Number 152007	Quillota
Chile	Investigational Site Number 152002	Santiago
Chile	Investigational Site Number 152005	Santiago
Chile	Investigational Site Number 152011	Santiago
Chile	Investigational Site Number 152013	Santiago
Chile	Investigational Site Number 152014	Santiago
Chile	Investigational Site Number 152018	Santiago
Chile	Investigational Site Number 152024	Santiago
Chile	Investigational Site Number 152004	Talca
Chile	Investigational Site Number 152008	Talca
Chile	Investigational Site Number 152023	Talcahuano
Chile	Investigational Site Number 152010	Valdivia
Chile	Investigational Site Number 152003	Viña Del Mar
Chile	Investigational Site Number 152021	Viña Del Mar
Colombia	Investigational Site Number 170001	Bogota
Colombia	Investigational Site Number 170002	Bogotá
Denmark	Investigational Site Number 208002	Hvidovre
Denmark	Investigational Site Number 208001	København Nv
France	Investigational Site Number 250009	Brest
France	Investigational Site Number 250004	La Tronche
France	Investigational Site Number 250010	Lille Cedex
France	Investigational Site Number 250013	Lille Cedex
France	Investigational Site Number 250006	Lyon
France	Investigational Site Number 250001	Marseille
France	Investigational Site Number 250002	Montpellier
France	Investigational Site Number 250005	Nantes
France	Investigational Site Number 250007	Nimes Cedex 9
France	Investigational Site Number 250008	Strasbourg
France	Investigational Site Number 250014	Vandoeuvre-Les-Nancy Cedex
Germany	Investigational Site Number 276006	Berlin
Germany	Investigational Site Number 276003	Bochum
Germany	Investigational Site Number 276010	Frankfurt Am Main
Germany	Investigational Site Number 276011	Großhansdorf
Germany	Investigational Site Number 276009	Koblenz
Germany	Investigational Site Number 276005	Rüdersdorf Bei Berlin
Hungary	Investigational Site Number 348301	Balassagyarmat
Hungary	Investigational Site Number 348303	Edelény
Hungary	Investigational Site Number 348003	Gödöllö
Israel	Investigational Site Number 376003	Haifa
Israel	Investigational Site Number 376001	Kfar Saba
Israel	Investigational Site Number 376005	Petah-Tikva
Israel	Investigational Site Number 376002	Rehovot
Italy	Investigational Site Number 380010	Ancona
Italy	Investigational Site Number 380009	Catania
Italy	Investigational Site Number 380004	Ferrara
Italy	Investigational Site Number 380008	Foggia
Italy	Investigational Site Number 380002	Genova
Italy	Investigational Site Number 380003	Modena
Italy	Investigational Site Number 380007	Padova
Italy	Investigational Site Number 380099	Palermo
Italy	Investigational Site Number 380001	Pisa
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
Korea, Republic of	Investigational Site Number 410002	Bucheon-Si
Korea, Republic of	Investigational Site Number 410003	Cheongju-Si
Korea, Republic of	Investigational Site Number 410013	Incheon
Korea, Republic of	Investigational Site Number 410004	Seoul
Korea, Republic of	Investigational Site Number 410005	Seoul
Korea, Republic of	Investigational Site Number 410006	Seoul
Korea, Republic of	Investigational Site Number 410007	Seoul
Korea, Republic of	Investigational Site Number 410008	Seoul
Korea, Republic of	Investigational Site Number 410010	Seoul
Korea, Republic of	Investigational Site Number 410011	Seoul
Korea, Republic of	Investigational Site Number 410012	Seoul
Korea, Republic of	Investigational Site Number 410001	Suwon
Mexico	Investigational Site Number 484006	Chihuahua
Mexico	Investigational Site Number 484013	Chihuahua
Mexico	Investigational Site Number 484014	Cuautitlan Izcalli
Mexico	Investigational Site Number 484005	Distrito Federal
Mexico	Investigational Site Number 484008	Durango
Mexico	Investigational Site Number 484001	Guadalajara
Mexico	Investigational Site Number 484010	México
Mexico	Investigational Site Number 484004	Mexico City
Mexico	Investigational Site Number 484003	Monterrey
Mexico	Investigational Site Number 484007	Monterrey
Mexico	Investigational Site Number 484012	San Juan Del Rio
Mexico	Investigational Site Number 484011	Veracruz
Netherlands	Investigational Site Number 528001	Arnhem
Netherlands	Investigational Site Number 528002	Dordrecht
Poland	Investigational Site Number 616006	Bialystok
Poland	Investigational Site Number 616003	Gdansk
Poland	Investigational Site Number 616004	Gdansk
Poland	Investigational Site Number 616007	Krakow
Poland	Investigational Site Number 616097	Krakow
Poland	Investigational Site Number 616001	Lodz
Poland	Investigational Site Number 616005	Lodz
Poland	Investigational Site Number 616009	Lodz
Poland	Investigational Site Number 616096	Poznan
Poland	Investigational Site Number 616098	Strzelce Opolskie
Poland	Investigational Site Number 616008	Warszawa
Poland	Investigational Site Number 616010	Warszawa
Poland	Investigational Site Number 616011	Znin
Romania	Investigational Site Number 642103	Bucharest
Romania	Investigational Site Number 642104	Bucharest
Romania	Investigational Site Number 642102	Cluj-Napoca
Romania	Investigational Site Number 642107	Cluj-Napoca
Romania	Investigational Site Number 642105	Timisoara
Romania	Investigational Site Number 642106	Timisoara
Russian Federation	Investigational Site Number 643013	Ekaterinburg
Russian Federation	Investigational Site Number 643001	Moscow
Russian Federation	Investigational Site Number 643002	Moscow
Russian Federation	Investigational Site Number 643005	Moscow
Russian Federation	Investigational Site Number 643007	Moscow
Russian Federation	Investigational Site Number 643012	Moscow
Russian Federation	Investigational Site Number 643096	Moscow
Russian Federation	Investigational Site Number 643006	Novosibirsk
Russian Federation	Investigational Site Number 643091	Ryazan
Russian Federation	Investigational Site Number 643010	Saint-Petersburg
Russian Federation	Investigational Site Number 643011	Saint-Petersburg
Russian Federation	Investigational Site Number 643009	St-Petersburg
Russian Federation	Investigational Site Number 643099	St-Petersburg
Russian Federation	Investigational Site Number 643008	Yaroslavl
South Africa	Investigational Site Number 710009	Brandfort
South Africa	Investigational Site Number 710001	Cape Town
South Africa	Investigational Site Number 710002	Cape Town
South Africa	Investigational Site Number 710003	Cape Town
South Africa	Investigational Site Number 710011	Cape Town
South Africa	Investigational Site Number 710091	Cape Town
South Africa	Investigational Site Number 710092	Cape Town
South Africa	Investigational Site Number 710006	Durban
South Africa	Investigational Site Number 710007	Pretoria
Spain	Investigational Site Number 724001	Barcelona
Spain	Investigational Site Number 724002	Barcelona
Spain	Investigational Site Number 724014	Barcelona
Spain	Investigational Site Number 724010	Palma De Mallorca
Spain	Investigational Site Number 724006	Pozuelo De Alarcón
Spain	Investigational Site Number 724003	Sabadell
Spain	Investigational Site Number 724007	Sant Boi De Llobregat
Spain	Investigational Site Number 724096	Santiago De Compostela
Spain	Investigational Site Number 724008	Sevilla
Spain	Investigational Site Number 724097	Valencia
Taiwan	Investigational Site Number 158008	New Taipei City
Taiwan	Investigational Site Number 158007	Taichung
Taiwan	Investigational Site Number 158009	Taipei
Turkey	Investigational Site Number 792002	Ankara
Turkey	Investigational Site Number 792098	Ankara
Turkey	Investigational Site Number 792008	Bursa
Turkey	Investigational Site Number 792001	Istanbul
Turkey	Investigational Site Number 792003	Istanbul
Turkey	Investigational Site Number 792004	Istanbul
Turkey	Investigational Site Number 792007	Istanbul
Turkey	Investigational Site Number 792005	Izmir
Turkey	Investigational Site Number 792090	Izmir
Turkey	Investigational Site Number 792013	Kirikkale
Turkey	Investigational Site Number 792006	Mersin
Turkey	Investigational Site Number 792096	Rize
Ukraine	Investigational Site Number 804007	Chernivtsi
Ukraine	Investigational Site Number 804023	Dnipro
Ukraine	Investigational Site Number 804009	Ivano-Frankivsk
Ukraine	Investigational Site Number 804094	Ivano-Frankivsk
Ukraine	Investigational Site Number 804001	Kharkiv
Ukraine	Investigational Site Number 804005	Kharkiv
Ukraine	Investigational Site Number 804021	Kharkiv
Ukraine	Investigational Site Number 804003	Kyiv
Ukraine	Investigational Site Number 804004	Kyiv
Ukraine	Investigational Site Number 804008	Kyiv
Ukraine	Investigational Site Number 804016	Kyiv
Ukraine	Investigational Site Number 804017	Kyiv
Ukraine	Investigational Site Number 804018	Kyiv
Ukraine	Investigational Site Number 804020	Kyiv
Ukraine	Investigational Site Number 804006	Odesa
Ukraine	Investigational Site Number 804002	Poltava
Ukraine	Investigational Site Number 804014	Ternopil
Ukraine	Investigational Site Number 804019	Vinnytsya
Ukraine	Investigational Site Number 804015	Yalta
Ukraine	Investigational Site Number 804012	Zaporizhzhya
Ukraine	Investigational Site Number 804022	Zaporizhzhya
United Kingdom	Investigational Site Number 826001	Bradford
United Kingdom	Investigational Site Number 826010	London
United Kingdom	Investigational Site Number 826009	Oxford
United Kingdom	Investigational Site Number 826007	Portsmouth
United Kingdom	Investigational Site Number 826006	South Shields
United States	Investigational Site Number 840062	Amarillo	Texas
United States	Investigational Site Number 840137	Aventura	Florida
United States	Investigational Site Number 840109	Bakersfield	California
United States	Investigational Site Number 840064	Bangor	Maine
United States	Investigational Site Number 840951	Bellingham	Washington
United States	Investigational Site Number 840046	Bethlehem	Pennsylvania
United States	Investigational Site Number 840047	Birmingham	Alabama
United States	Investigational Site Number 840038	Boerne	Texas
United States	Investigational Site Number 840401	Boston	Massachusetts
United States	Investigational Site Number 840111	Brick	New Jersey
United States	Investigational Site Number 840082	Charleston	South Carolina
United States	Investigational Site Number 840083	Charlotte	North Carolina
United States	Investigational Site Number 840126	Charlotte	North Carolina
United States	Investigational Site Number 840052	Chevy Chase	Maryland
United States	Investigational Site Number 840101	Chicago	Illinois
United States	Investigational Site Number 840015	Cincinnati	Ohio
United States	Investigational Site Number 840146	Cincinnati	Ohio
United States	Investigational Site Number 840040	Colorado Springs	Colorado
United States	Investigational Site Number 840124	Cypress	Texas
United States	Investigational Site Number 840023	Dallas	Texas
United States	Investigational Site Number 840006	Denver	Colorado
United States	Investigational Site Number 840024	Denver	Colorado
United States	Investigational Site Number 840130	Denver	Colorado
United States	Investigational Site Number 840403	Denver	Colorado
United States	Investigational Site Number 840035	Draper	Utah
United States	Investigational Site Number 840108	Durham	North Carolina
United States	Investigational Site Number 840112	Edmond	Oklahoma
United States	Investigational Site Number 840923	El Paso	Texas
United States	Investigational Site Number 840059	Fairfax	Virginia
United States	Investigational Site Number 840032	Fort Mitchell	Kentucky
United States	Investigational Site Number 840027	Fort Worth	Texas
United States	Investigational Site Number 840922	Fort Worth	Texas
United States	Investigational Site Number 840071	Gainesville	Florida
United States	Investigational Site Number 840073	Gaithersburg	Maryland
United States	Investigational Site Number 840099	Gilbert	Arizona
United States	Investigational Site Number 840107	Greensboro	North Carolina
United States	Investigational Site Number 840117	Greenville	South Carolina
United States	Investigational Site Number 840085	Hershey	Pennsylvania
United States	Investigational Site Number 840907	High Point	North Carolina
United States	Investigational Site Number 840132	Little Rock	Arkansas
United States	Investigational Site Number 840045	Long Beach	California
United States	Investigational Site Number 840019	Los Angeles	California
United States	Investigational Site Number 840022	Los Angeles	California
United States	Investigational Site Number 840029	Los Angeles	California
United States	Investigational Site Number 840017	Louisville	Kentucky
United States	Investigational Site Number 840070	McKinney	Texas
United States	Investigational Site Number 840034	Medford	Oregon
United States	Investigational Site Number 840049	Middleburg Heights	Ohio
United States	Investigational Site Number 840018	Minneapolis	Minnesota
United States	Investigational Site Number 840037	Missoula	Montana
United States	Investigational Site Number 840077	Murray	Utah
United States	Investigational Site Number 840902	New Haven	Connecticut
United States	Investigational Site Number 840065	New York	New York
United States	Investigational Site Number 840044	Newport Beach	California
United States	Investigational Site Number 840041	North Hollywood	California
United States	Investigational Site Number 840068	Ocean City	New Jersey
United States	Investigational Site Number 840115	Ocoee	Florida
United States	Investigational Site Number 840078	Omaha	Nebraska
United States	Investigational Site Number 840030	Owensboro	Kentucky
United States	Investigational Site Number 840080	Owings Mills	Maryland
United States	Investigational Site Number 840004	Papillion	Nebraska
United States	Investigational Site Number 840067	Philadelphia	Pennsylvania
United States	Investigational Site Number 840091	Pittsburgh	Pennsylvania
United States	Investigational Site Number 840928	Pittsburgh	Pennsylvania
United States	Investigational Site Number 840118	Plano	Texas
United States	Investigational Site Number 840031	Portland	Oregon
United States	Investigational Site Number 840011	Princeton	New Jersey
United States	Investigational Site Number 840014	Rolling Hills Estates	California
United States	Investigational Site Number 840002	Saint Louis	Missouri
United States	Investigational Site Number 840093	Saint Louis	Missouri
United States	Investigational Site Number 840102	Saint Louis	Missouri
United States	Investigational Site Number 840008	San Antonio	Texas
United States	Investigational Site Number 840121	San Jose	California
United States	Investigational Site Number 840055	Sarasota	Florida
United States	Investigational Site Number 840087	Scottsdale	Arizona
United States	Investigational Site Number 840057	South Burlington	Vermont
United States	Investigational Site Number 840021	Spartanburg	South Carolina
United States	Investigational Site Number 840942	Toledo	Ohio
United States	Investigational Site Number 840402	Tucson	Arizona
United States	Investigational Site Number 840104	Tulsa	Oklahoma
United States	Investigational Site Number 840079	Twin Falls	Idaho
United States	Investigational Site Number 840404	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Regeneron Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Canada,  Chile,  Colombia,  Denmark,  France,  Germany,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  Poland,  Romania,  Russian Federation,  South Africa,  Spain,  Taiwan,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	From the first IMP injection in LTS12551 to the last IMP injection plus 14 weeks (up to 108 weeks)
Secondary	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.	From the first IMP injection in LTS12551 to the last IMP injection plus 14 weeks (up to 108 weeks)
Secondary	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.	From the first IMP injection in LTS12551 to the last IMP injection plus 2 weeks (up to 96 weeks)
Secondary	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.	From the first IMP injection in LTS12551 to the last IMP injection plus 2 weeks (up to 96 weeks)
Secondary	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.	Baseline of parent study, Week 48 and Week 96 of this extension study
Secondary	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.	Baseline of parent study, Week 48 and Week 96 of this extension study
Secondary	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.	Baseline of parent study, Week 48, and Week 96 of this extension study
Secondary	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.	Baseline of parent study, Week 48, and Week 96 of this extension study
Secondary	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.	Baseline of parent study, Weeks 24, and 48 of this extension study
Secondary	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.	At Weeks 24, and 48 of this extension study
Secondary	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.	Baseline of parent study, Weeks 24, and 48 of this extension study
Secondary	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.	At Weeks 24, and 48 of this extension study
Secondary	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.	Baseline of parent study, Weeks 0, 4, 12, 24, 48, 72, and 96 of this extension study
Secondary	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).	From the first IMP injection in LTS12551 to the last IMP injection plus 2 weeks (up to 96 weeks)
Secondary	Change From Baseline in Blood Eosinophils Cells Count at Weeks 48 and 96	For this analysis, baseline was defined as respective parent study baseline.	Baseline of parent study, Week 48 and Week 96 of this extension study
Secondary	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.	Baseline of parent study, Week 48 and Week 96 of this extension study
Secondary	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.	Baseline of parent study, Week 48 and Week 96 of this extension study
Secondary	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.	Baseline of parent study, Week 48 and Week 96 of this extension study
Secondary	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.	Baseline of parent study, Week 48, and Week 96 of this extension study
Secondary	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.	Baseline of parent study, Week 48, and Week 96 of this extension study
Secondary	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.	Baseline of parent study, Week 48 and Week 96 of this extension study
Secondary	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.	Baseline of parent study, Weeks 48 and 96 of this extension study
Secondary	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.	Weeks 48 and 96 of this extension study
Secondary	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.	Weeks 48, and 96 of this extension study
Secondary	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.	Baseline of parent study, Week 48 and Week 96 of this extension study
Secondary	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.	Baseline of parent study, Week 48 and Week 96 of this extension study