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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03620747
Registration number
NCT03620747
Ethics application status
Date submitted
26/07/2018
Date registered
8/08/2018
Date last updated
16/03/2023
Titles & IDs
Public title
Continuation of TRAVERSE- LTS12551 Evaluating Dupilumab Safety in Patients With Asthma (Long-Term Follow-Up)
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Scientific 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
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Secondary ID [1]
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2017-002134-23
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Secondary ID [2]
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LPS15023
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Asthma
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Condition category
Condition code
Respiratory
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Asthma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Dupilumab SAR231893 (REGN668)
Experimental: Dupilumab - 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.
Treatment: Drugs: Dupilumab SAR231893 (REGN668)
Pharmaceutical form: prefilled syringes
Route of administration: subcutaneous
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
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Assessment method [1]
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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).
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Timepoint [1]
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From first dose of IMP up to 12 weeks after last dose of IMP (maximum duration: up to 144 Weeks)
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Primary outcome [2]
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Treatment-emergent Adverse Event Rate (Event Per 100 Participant-years)
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Assessment method [2]
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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.
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Timepoint [2]
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From first dose of IMP up to 12 weeks after last dose of IMP (maximum duration: up to 144 Weeks)
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Secondary outcome [1]
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Adverse Events of Special Interest (AESIs) Event Rate (Event Per100 Participant-years)
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Assessment method [1]
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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.
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Timepoint [1]
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From first dose of IMP up to 12 weeks after last dose of IMP (maximum duration: up to 144 Weeks)
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Secondary outcome [2]
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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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Assessment method [2]
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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.
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Timepoint [2]
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From first dose of IMP up to 12 weeks after last dose of IMP (maximum duration: up to 144 Weeks)
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Eligibility
Key inclusion criteria
Inclusion criteria:
- Participants with asthma who completed the treatment period in the previous dupilumab
asthma clinical study LTS12551.
- Signed written informed consent.
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Minimum age
12
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/08/2018
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Date of last participant enrolment
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Date of last data collection
Anticipated
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Actual
18/02/2022
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Sample size
Target
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Accrual to date
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Final
393
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Funding & Sponsors
Primary sponsor type
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Name
Sanofi
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Address
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Regeneron Pharmaceuticals
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Ethics approval
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Summary
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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03620747
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
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Sanofi
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03620747
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