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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
393
Pharmaceutical form: prefilled syringes Route of administration: subcutaneous
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
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).
Time frame: From first dose of IMP up to 12 weeks after last dose of IMP (maximum duration: up to 144 Weeks)
Treatment-emergent Adverse Event Rate (Event Per 100 Participant-years)
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.
Time frame: From first dose of IMP up to 12 weeks after last dose of IMP (maximum duration: up to 144 Weeks)
Adverse Events of Special Interest (AESIs) Event Rate (Event Per100 Participant-years)
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.
Time frame: From first dose of IMP up to 12 weeks after last dose of IMP (maximum duration: up to 144 Weeks)
Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs), Adverse Events of Special Interest (AESIs) and AEs Leading to Study Discontinuation
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Investigational Site Number :840099
Gilbert, Arizona, United States
Investigational Site Number :840087
Scottsdale, Arizona, United States
Investigational Site Number :840402
Tucson, Arizona, United States
Investigational Site Number :840132
Little Rock, Arkansas, United States
Investigational Site Number :840121
San Jose, California, United States
Investigational Site Number :840403
Denver, Colorado, United States
Investigational Site Number :840130
Denver, Colorado, United States
Investigational Site Number :840115
Ocoee, Florida, United States
Investigational Site Number :840055
Sarasota, Florida, United States
Investigational Site Number :840079
Twin Falls, Idaho, United States
...and 122 more locations
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.
Time frame: From first dose of IMP up to 12 weeks after last dose of IMP (maximum duration: up to 144 Weeks)