Continuation of TRAVERSE- LTS12551 Evaluating Dupilumab Safety in Patients With Asthma (Long-Term Follow-Up)
- Registration Number
- NCT03620747
- Lead Sponsor
- Sanofi
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 393
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dupilumab Dupilumab SAR231893 (REGN668) Participants received subcutaneous (SC) dose of dupilumab 300 milligrams (mg) every 2 weeks (q2w) from Week 0 up to Week 132. Participants who discontinued treatment for greater than or equal to (\>=) 6 weeks after study LTS12551 (NCT02134028), received a 600 mg loading dose of dupilumab on Week 0. Participants were also on background dose of medium or high dose inhaled corticosteroid (ICS) as maintained in study LTS12551 in combination with controllers (and/or oral corticosteroid \[OCS\] for those participants from the original parent study EFC13691 \[NCT02528214\]). Salbutamol/albuterol hydrofluoroalkane pressurized metered dose inhalers (MDI) or levosalbutamol/levalbuterol hydrofluoroalkane pressurized MDI were given as reliever medication as needed during the study.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) From first dose of IMP up to 12 weeks after last dose of IMP (maximum duration: up to 144 Weeks) An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had to have a causal relationship with the treatment. TEAEs were the AEs that developed or worsened or became serious during the TEAE period (defined as the time from the first dose of the investigational medicinal product \[IMP\] up to 12 weeks after the last dose of the IMP).
Treatment-emergent Adverse Event Rate (Event Per 100 Participant-years) From first dose of IMP up to 12 weeks after last dose of IMP (maximum duration: up to 144 Weeks) An AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had to have a causal relationship with the treatment. TEAEs were the AEs that developed or worsened or became serious during the TEAE period (defined as the time from the first dose of the IMP up to 12 weeks after last dose of the IMP). TEAE event rate was defined as the number of TEAE events per 100 participant-years.
- Secondary Outcome Measures
Name Time Method Adverse Events of Special Interest (AESIs) Event Rate (Event Per100 Participant-years) From first dose of IMP up to 12 weeks after last dose of IMP (maximum duration: up to 144 Weeks) An AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had to have a causal relationship with the treatment. AESIs were AE (serious or non-serious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the investigator to the Sponsor was required. AESI event rate was defined as the number of AESI events per 100 participant-years.
Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs), Adverse Events of Special Interest (AESIs) and AEs Leading to Study Discontinuation From first dose of IMP up to 12 weeks after last dose of IMP (maximum duration: up to 144 Weeks) AE: any untoward medical occurrence in participants that received IMP and did not necessarily had to have causal relationship with treatment. TEAEs: AEs developed/worsened in grade/become serious during the TEAE period (from first dose of IMP up to 12 weeks after last dose of IMP).SAE: any untoward medical occurrence at any dose resulted in death, was life-threatening, required inpatient hospitalization, prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect or was medically important event. AESI: AE (serious/non-serious) of scientific and medical concern specific to Sponsor's product/program, for which ongoing monitoring and immediate notification by Investigator to Sponsor required.
Trial Locations
- Locations (132)
Investigational Site Number :032002
🇦🇷La Plata, Buenos Aires, Argentina
Investigational Site Number :032005
🇦🇷Rosario, Santa Fe, Argentina
Investigational Site Number :032003
🇦🇷Ciudad Autonoma Bs As, Argentina
Investigational Site Number :124010
🇨🇦Montréal, Quebec, Canada
Investigational Site Number :032012
🇦🇷San Miguel de Tucuman, Argentina
Investigational Site Number :392013
🇯🇵Iizuka-shi, Japan
Investigational Site Number :392167
🇯🇵Shinagawa-ku, Tokyo, Japan
Investigational Site Number :392122
🇯🇵Minato-ku, Japan
Investigational Site Number :392163
🇯🇵Nagoya-shi, Japan
Investigational Site Number :392152
🇯🇵Osakasayama-shi, Japan
Investigational Site Number :840018
🇺🇸Minneapolis, Minnesota, United States
Investigational Site Number :840008
🇺🇸San Antonio, Texas, United States
Investigational Site Number :840023
🇺🇸Dallas, Texas, United States
Investigational Site Number :840099
🇺🇸Gilbert, Arizona, United States
Investigational Site Number :840403
🇺🇸Denver, Colorado, United States
Investigational Site Number :840130
🇺🇸Denver, Colorado, United States
Investigational Site Number :840055
🇺🇸Sarasota, Florida, United States
Investigational Site Number :392040
🇯🇵Kodaira-shi, Japan
Investigational Site Number :840402
🇺🇸Tucson, Arizona, United States
Investigational Site Number :840087
🇺🇸Scottsdale, Arizona, United States
Investigational Site Number :840115
🇺🇸Ocoee, Florida, United States
Investigational Site Number :840132
🇺🇸Little Rock, Arkansas, United States
Investigational Site Number :840121
🇺🇸San Jose, California, United States
Investigational Site Number :840079
🇺🇸Twin Falls, Idaho, United States
Investigational Site Number :840032
🇺🇸Fort Mitchell, Kentucky, United States
Investigational Site Number :840052
🇺🇸Chevy Chase, Maryland, United States
Investigational Site Number :840064
🇺🇸Bangor, Maine, United States
Investigational Site Number :840126
🇺🇸Charlotte, North Carolina, United States
Investigational Site Number :840907
🇺🇸High Point, North Carolina, United States
Investigational Site Number :840942
🇺🇸Toledo, Ohio, United States
Investigational Site Number :840073
🇺🇸Gaithersburg, Maryland, United States
Investigational Site Number :840102
🇺🇸Saint Louis, Missouri, United States
Investigational Site Number :840004
🇺🇸Papillion, Nebraska, United States
Investigational Site Number :840068
🇺🇸West Long Branch, New Jersey, United States
Investigational Site Number :840067
🇺🇸Philadelphia, Pennsylvania, United States
Investigational Site Number :840091
🇺🇸Pittsburgh, Pennsylvania, United States
Investigational Site Number :840070
🇺🇸Allen, Texas, United States
Investigational Site Number :840124
🇺🇸Cypress, Texas, United States
Investigational Site Number :840062
🇺🇸Amarillo, Texas, United States
Investigational Site Number :840035
🇺🇸Draper, Utah, United States
Investigational Site Number :840922
🇺🇸Fort Worth, Texas, United States
Investigational Site Number :840077
🇺🇸Murray, Utah, United States
Investigational Site Number :840951
🇺🇸Bellingham, Washington, United States
Investigational Site Number :840057
🇺🇸South Burlington, Vermont, United States
Investigational Site Number :840059
🇺🇸Fairfax, Virginia, United States
Investigational Site Number :032006
🇦🇷Rosario, Santa Fe, Argentina
Investigational Site Number :032096
🇦🇷Bahia Blanca, Buenos Aires, Argentina
Investigational Site Number :032091
🇦🇷Capital Federal, Buenos Aires, Argentina
Investigational Site Number :032004
🇦🇷Buenos Aires, Argentina
Investigational Site Number :032097
🇦🇷Ciudad Autonoma Buenos Aires, Argentina
Investigational Site Number :032001
🇦🇷Ciudad Autonoma Buenos Aires, Argentina
Investigational Site Number :032010
🇦🇷Ciudad Autonoma Buenos Aires, Argentina
Investigational Site Number :032009
🇦🇷San Miguel De Tucumán, Argentina
Investigational Site Number :056003
🇧🇪Gent, Belgium
Investigational Site Number :124016
🇨🇦Hamilton, Ontario, Canada
Investigational Site Number :124006
🇨🇦Vancouver, British Columbia, Canada
Investigational Site Number :124017
🇨🇦Vancouver, British Columbia, Canada
Investigational Site Number :124012
🇨🇦Montreal, Quebec, Canada
Investigational Site Number :124013
🇨🇦Ottawa, Ontario, Canada
Investigational Site Number :124002
🇨🇦Toronto, Ontario, Canada
Investigational Site Number :124001
🇨🇦Montreal, Quebec, Canada
Investigational Site Number :124007
🇨🇦Trois-Rivieres, Quebec, Canada
Investigational Site Number :124014
🇨🇦Québec, Quebec, Canada
Investigational Site Number :124018
🇨🇦Quebec, Canada
Investigational Site Number :250009
🇫🇷Brest cedex 2, France
Investigational Site Number :250010
🇫🇷Lille Cedex, France
Investigational Site Number :250006
🇫🇷Lyon cedex 04, France
Investigational Site Number :250001
🇫🇷Marseille, France
Investigational Site Number :250008
🇫🇷Strasbourg, France
Investigational Site Number :276006
🇩🇪Berlin, Germany
Investigational Site Number :250002
🇫🇷Montpellier cedex 5, France
Investigational Site Number :250005
🇫🇷Nantes cedex, France
Investigational Site Number :276010
🇩🇪Frankfurt am Main, Germany
Investigational Site Number :276011
🇩🇪Grosshansdorf, Germany
Investigational Site Number :392021
🇯🇵Fukuyama-shi, Hiroshima, Japan
Investigational Site Number :276009
🇩🇪Koblenz, Germany
Investigational Site Number :376005
🇮🇱Petach-Tikva, Israel
Investigational Site Number :376001
🇮🇱Kfar- Sava, Israel
Investigational Site Number :376002
🇮🇱Rehovot, Israel
Investigational Site Number :276005
🇩🇪Ruedersdorf, Germany
Investigational Site Number :392106
🇯🇵Mizunami-shi, Gifu, Japan
Investigational Site Number :392043
🇯🇵Ota-shi, Gunma, Japan
Investigational Site Number :392164
🇯🇵Muroran-shi, Hokkaido, Japan
Investigational Site Number :392108
🇯🇵Hiroshima-shi, Hiroshima, Japan
Investigational Site Number :392008
🇯🇵Sapporo-shi, Hokkaido, Japan
Investigational Site Number :392034
🇯🇵Sapporo-shi, Hokkaido, Japan
Investigational Site Number :392006
🇯🇵Tomakomai-shi, Hokkaido, Japan
Investigational Site Number :392162
🇯🇵Kobe-shi, Hyogo, Japan
Investigational Site Number :392020
🇯🇵Naka-gun, Ibaraki, Japan
Investigational Site Number :392011
🇯🇵Sakaide-shi, Kagawa, Japan
Investigational Site Number :392014
🇯🇵Yokohama-shi, Kanagawa, Japan
Investigational Site Number :392153
🇯🇵Kyoto-shi, Kyoto, Japan
Investigational Site Number :392170
🇯🇵Osaki-shi, Miyagi, Japan
Investigational Site Number :392045
🇯🇵Uruma-shi, Okinawa, Japan
Investigational Site Number :392119
🇯🇵Kishiwada-shi, Osaka, Japan
Investigational Site Number :392005
🇯🇵Naruto-shi, Tokushima, Japan
Investigational Site Number :392002
🇯🇵Chuo-ku, Tokyo, Japan
Investigational Site Number :392112
🇯🇵Chuo-ku, Tokyo, Japan
Investigational Site Number :392038
🇯🇵Setagaya-ku, Tokyo, Japan
Investigational Site Number :392177
🇯🇵Ome-shi, Tokyo, Japan
Investigational Site Number :392133
🇯🇵Machida-shi, Tokyo, Japan
Investigational Site Number :392173
🇯🇵Tachikawa-shi, Tokyo, Japan
Investigational Site Number :392007
🇯🇵Chuo-Ku, Japan
Investigational Site Number :392185
🇯🇵Akashi-shi, Japan
Investigational Site Number :392012
🇯🇵Edogawa-ku, Japan
Investigational Site Number :392030
🇯🇵Habikino-shi, Japan
Investigational Site Number :392004
🇯🇵Himeji-shi, Japan
Investigational Site Number :392158
🇯🇵Hiroshima-shi, Japan
Investigational Site Number :392042
🇯🇵Isesaki-shi, Japan
Investigational Site Number :392142
🇯🇵Kasuga-shi, Japan
Investigational Site Number :392044
🇯🇵Kokubunji-shi, Japan
Investigational Site Number :392036
🇯🇵Kyoto-shi, Japan
Investigational Site Number :392010
🇯🇵Kurashiki-shi, Japan
Investigational Site Number :392144
🇯🇵Minato-ku, Japan
Investigational Site Number :392155
🇯🇵Osakasayama-shi, Japan
Investigational Site Number :392127
🇯🇵Ota-ku, Japan
Investigational Site Number :392130
🇯🇵Shinjuku-ku, Japan
Investigational Site Number :392169
🇯🇵Sagamihara-shi, Japan
Investigational Site Number :392165
🇯🇵Sumida-ku, Japan
Investigational Site Number :392146
🇯🇵Tachikawa-shi, Japan
Investigational Site Number :392029
🇯🇵Tsu-shi, Japan
Investigational Site Number :392168
🇯🇵Uozu-shi, Japan
Investigational Site Number :710009
🇿🇦Brandfort, South Africa
Investigational Site Number :710001
🇿🇦Cape Town, South Africa
Investigational Site Number :710092
🇿🇦Cape Town, South Africa
Investigational Site Number :528001
🇳🇱Arnhem, Netherlands
Investigational Site Number :710006
🇿🇦Durban, South Africa
Investigational Site Number :392132
🇯🇵Urasoe-shi, Japan
Investigational Site Number :710011
🇿🇦Cape Town, South Africa
Investigational Site Number :710091
🇿🇦Cape Town, South Africa
Investigational Site Number :710007
🇿🇦Pretoria, South Africa
Investigational Site Number :840027
🇺🇸Fort Worth, Texas, United States