Clinical trial NCT03620747: Continuation of TRAVERSE- LTS12551 Evaluating Dupilumab Safety in Patients With Asthma (Long-Term Follow-Up)
Official title: Open-label, Interventional, Cohort Study to Evaluate Long-term Safety of Dupilumab in Patients With Moderate to Severe Asthma Who Completed the TRAVERSE-LTS12551 Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2018-08-08
Enrollment: 393
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary Objective:

To describe the long-term safety of dupilumab in treatment of participants with moderate to severe asthma who completed the previous asthma clinical trial (TRAVERSE-LTS12551).

Detailed description: Duration per participant was until dupilumab approval for use in asthma and market availability to the participant, or a maximum of 144 weeks (i.e., about 3 years) after the start of treatment (Visit 1), whichever came first.

Eligibility criteria: Inclusion criteria:

* Participants with asthma who completed the treatment period in the previous dupilumab asthma clinical study LTS12551.
* Signed written informed consent.

Exclusion criteria:

* Participants who experienced any systemic hypersensitivity reactions to the investigational medicinal product in the previous dupilumab asthma study LTS12551, which, in the opinion of the Investigator, could indicate that continued treatment with dupilumab might present an unreasonable risk for the participant.
* Clinically significant comorbidity/lung disease other than asthma.
* Participants with active autoimmune disease or participants who, as per Investigator's medical judgment, were suspected of having high risk for developing autoimmune disease.
* History of malignancy within 5 years before enrollment except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin.

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

Primary outcomes:
measure: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: From first dose of IMP up to 12 weeks after last dose of IMP (maximum duration: up to 144 Weeks)
measure: Treatment-emergent Adverse Event Rate (Event Per 100 Participant-years)
timeFrame: From first dose of IMP up to 12 weeks after last dose of IMP (maximum duration: up to 144 Weeks)
Secondary outcomes:
measure: Adverse Events of Special Interest (AESIs) Event Rate (Event Per100 Participant-years)
timeFrame: From first dose of IMP up to 12 weeks after last dose of IMP (maximum duration: up to 144 Weeks)
measure: Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs), Adverse Events of Special Interest (AESIs) and AEs Leading to Study Discontinuation
timeFrame: From first dose of IMP up to 12 weeks after last dose of IMP (maximum duration: up to 144 Weeks)
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Investigational Site Number :840099
state: Arizona
city: Scottsdale
country: United States
facility: Investigational Site Number :840087
state: Arizona
city: Tucson
country: United States
facility: Investigational Site Number :840402
state: Arizona
city: Little Rock
country: United States
facility: Investigational Site Number :840132
state: Arkansas
city: San Jose
country: United States
facility: Investigational Site Number :840121
state: California
city: Denver
country: United States
facility: Investigational Site Number :840403
state: Colorado
city: Denver
country: United States
facility: Investigational Site Number :840130
state: Colorado
city: Ocoee
country: United States
facility: Investigational Site Number :840115
state: Florida
city: Sarasota
country: United States
facility: Investigational Site Number :840055
state: Florida
city: Twin Falls
country: United States
facility: Investigational Site Number :840079
state: Idaho
city: Fort Mitchell
country: United States
facility: Investigational Site Number :840032
state: Kentucky
city: Bangor
country: United States
facility: Investigational Site Number :840064
state: Maine
city: Chevy Chase
country: United States
facility: Investigational Site Number :840052
state: Maryland
city: Gaithersburg
country: United States
facility: Investigational Site Number :840073
state: Maryland
city: Minneapolis
country: United States
facility: Investigational Site Number :840018
state: Minnesota
city: Saint Louis
country: United States
facility: Investigational Site Number :840102
state: Missouri
city: Papillion
country: United States
facility: Investigational Site Number :840004
state: Nebraska
city: West Long Branch
country: United States
facility: Investigational Site Number :840068
state: New Jersey
city: Charlotte
country: United States
facility: Investigational Site Number :840126
state: North Carolina
city: High Point
country: United States
facility: Investigational Site Number :840907
state: North Carolina
city: Toledo
country: United States
facility: Investigational Site Number :840942
state: Ohio
city: Philadelphia
country: United States
facility: Investigational Site Number :840067
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Investigational Site Number :840091
state: Pennsylvania
city: Allen
country: United States
facility: Investigational Site Number :840070
state: Texas
city: Amarillo
country: United States
facility: Investigational Site Number :840062
state: Texas
city: Cypress
country: United States
facility: Investigational Site Number :840124
state: Texas
city: Dallas
country: United States
facility: Investigational Site Number :840023
state: Texas
city: Fort Worth
country: United States
facility: Investigational Site Number :840922
state: Texas
city: Fort Worth
country: United States
facility: Investigational Site Number :840027
state: Texas
city: San Antonio
country: United States
facility: Investigational Site Number :840008
state: Texas
city: Draper
country: United States
facility: Investigational Site Number :840035
state: Utah
city: Murray
country: United States
facility: Investigational Site Number :840077
state: Utah
city: South Burlington
country: United States
facility: Investigational Site Number :840057
state: Vermont
city: Fairfax
country: United States
facility: Investigational Site Number :840059
state: Virginia
city: Bellingham
country: United States
facility: Investigational Site Number :840951
state: Washington
city: Bahia Blanca
country: Argentina
facility: Investigational Site Number :032096
state: Buenos Aires
city: Capital Federal
country: Argentina
facility: Investigational Site Number :032091
state: Buenos Aires
city: La Plata
country: Argentina
facility: Investigational Site Number :032002
state: Buenos Aires
city: Rosario
country: Argentina
facility: Investigational Site Number :032006
state: Santa Fe
city: Rosario
country: Argentina
facility: Investigational Site Number :032005
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Investigational Site Number :032004
city: Ciudad Autonoma Bs As
country: Argentina
facility: Investigational Site Number :032003
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Investigational Site Number :032097
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Investigational Site Number :032010
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Investigational Site Number :032001
city: San Miguel de Tucuman
country: Argentina
facility: Investigational Site Number :032012
city: San Miguel De TucumÃ¡n
country: Argentina
facility: Investigational Site Number :032009
city: Gent
country: Belgium
facility: Investigational Site Number :056003
city: Vancouver
country: Canada
facility: Investigational Site Number :124006
state: British Columbia
city: Vancouver
country: Canada
facility: Investigational Site Number :124017
state: British Columbia
city: Hamilton
country: Canada
facility: Investigational Site Number :124016
state: Ontario
city: Ottawa
country: Canada
facility: Investigational Site Number :124013
state: Ontario
city: Toronto
country: Canada
facility: Investigational Site Number :124002
state: Ontario
city: Montreal
country: Canada
facility: Investigational Site Number :124001
state: Quebec
city: Montreal
country: Canada
facility: Investigational Site Number :124012
state: Quebec
city: MontrÃ©al
country: Canada
facility: Investigational Site Number :124010
state: Quebec
city: QuÃ©bec
country: Canada
facility: Investigational Site Number :124014
state: Quebec
city: Trois-Rivieres
country: Canada
facility: Investigational Site Number :124007
state: Quebec
city: Quebec
country: Canada
facility: Investigational Site Number :124018
city: Brest cedex 2
country: France
facility: Investigational Site Number :250009
city: Lille Cedex
country: France
facility: Investigational Site Number :250010
city: Lyon cedex 04
country: France
facility: Investigational Site Number :250006
city: Marseille
country: France
facility: Investigational Site Number :250001
city: Montpellier cedex 5
country: France
facility: Investigational Site Number :250002
city: Nantes cedex
country: France
facility: Investigational Site Number :250005
city: Strasbourg
country: France
facility: Investigational Site Number :250008
city: Berlin
country: Germany
facility: Investigational Site Number :276006
city: Frankfurt am Main
country: Germany
facility: Investigational Site Number :276010
city: Grosshansdorf
country: Germany
facility: Investigational Site Number :276011
city: Koblenz
country: Germany
facility: Investigational Site Number :276009
city: Ruedersdorf
country: Germany
facility: Investigational Site Number :276005
city: Kfar- Sava
country: Israel
facility: Investigational Site Number :376001
city: Petach-Tikva
country: Israel
facility: Investigational Site Number :376005
city: Rehovot
country: Israel
facility: Investigational Site Number :376002
city: Mizunami-shi
country: Japan
facility: Investigational Site Number :392106
state: Gifu
city: Ota-shi
country: Japan
facility: Investigational Site Number :392043
state: Gunma
city: Fukuyama-shi
country: Japan
facility: Investigational Site Number :392021
state: Hiroshima
city: Hiroshima-shi
country: Japan
facility: Investigational Site Number :392108
state: Hiroshima
city: Muroran-shi
country: Japan
facility: Investigational Site Number :392164
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Investigational Site Number :392008
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Investigational Site Number :392034
state: Hokkaido
city: Tomakomai-shi
country: Japan
facility: Investigational Site Number :392006
state: Hokkaido
city: Kobe-shi
country: Japan
facility: Investigational Site Number :392162
state: Hyogo
city: Naka-gun
country: Japan
facility: Investigational Site Number :392020
state: Ibaraki
city: Sakaide-shi
country: Japan
facility: Investigational Site Number :392011
state: Kagawa
city: Yokohama-shi
country: Japan
facility: Investigational Site Number :392014
state: Kanagawa
city: Kyoto-shi
country: Japan
facility: Investigational Site Number :392153
state: Kyoto
city: Osaki-shi
country: Japan
facility: Investigational Site Number :392170
state: Miyagi
city: Uruma-shi
country: Japan
facility: Investigational Site Number :392045
state: Okinawa
city: Kishiwada-shi
country: Japan
facility: Investigational Site Number :392119
state: Osaka
city: Naruto-shi
country: Japan
facility: Investigational Site Number :392005
state: Tokushima
city: Chuo-ku
country: Japan
facility: Investigational Site Number :392002
state: Tokyo
city: Chuo-ku
country: Japan
facility: Investigational Site Number :392112
state: Tokyo
city: Machida-shi
country: Japan
facility: Investigational Site Number :392133
state: Tokyo
city: Ome-shi
country: Japan
facility: Investigational Site Number :392177
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Investigational Site Number :392038
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Investigational Site Number :392167
state: Tokyo
city: Tachikawa-shi
country: Japan
facility: Investigational Site Number :392173
state: Tokyo
city: Akashi-shi
country: Japan
facility: Investigational Site Number :392185
city: Chuo-Ku
country: Japan
facility: Investigational Site Number :392007
city: Edogawa-ku
country: Japan
facility: Investigational Site Number :392012
city: Habikino-shi
country: Japan
facility: Investigational Site Number :392030
city: Himeji-shi
country: Japan
facility: Investigational Site Number :392004
city: Hiroshima-shi
country: Japan
facility: Investigational Site Number :392158
city: Iizuka-shi
country: Japan
facility: Investigational Site Number :392013
city: Isesaki-shi
country: Japan
facility: Investigational Site Number :392042
city: Kasuga-shi
country: Japan
facility: Investigational Site Number :392142
city: Kodaira-shi
country: Japan
facility: Investigational Site Number :392040
city: Kokubunji-shi
country: Japan
facility: Investigational Site Number :392044
city: Kurashiki-shi
country: Japan
facility: Investigational Site Number :392010
city: Kyoto-shi
country: Japan
facility: Investigational Site Number :392036
city: Minato-ku
country: Japan
facility: Investigational Site Number :392144
city: Minato-ku
country: Japan
facility: Investigational Site Number :392122
city: Nagoya-shi
country: Japan
facility: Investigational Site Number :392163
city: Osakasayama-shi
country: Japan
facility: Investigational Site Number :392155
city: Osakasayama-shi
country: Japan
facility: Investigational Site Number :392152
city: Ota-ku
country: Japan
facility: Investigational Site Number :392127
city: Sagamihara-shi
country: Japan
facility: Investigational Site Number :392169
city: Shinjuku-ku
country: Japan
facility: Investigational Site Number :392130
city: Sumida-ku
country: Japan
facility: Investigational Site Number :392165
city: Tachikawa-shi
country: Japan
facility: Investigational Site Number :392146
city: Tsu-shi
country: Japan
facility: Investigational Site Number :392029
city: Uozu-shi
country: Japan
facility: Investigational Site Number :392168
city: Urasoe-shi
country: Japan
facility: Investigational Site Number :392132
city: Arnhem
country: Netherlands
facility: Investigational Site Number :528001
city: Brandfort
country: South Africa
facility: Investigational Site Number :710009
city: Cape Town
country: South Africa
facility: Investigational Site Number :710011
city: Cape Town
country: South Africa
facility: Investigational Site Number :710001
city: Cape Town
country: South Africa
facility: Investigational Site Number :710091
city: Cape Town
country: South Africa
facility: Investigational Site Number :710092
city: Durban
country: South Africa
facility: Investigational Site Number :710006
city: Pretoria
country: South Africa
facility: Investigational Site Number :710007
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: