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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)
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
Secondary ID [1] 0 0
2017-002134-23
Secondary ID [2] 0 0
LPS15023
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
From first dose of IMP up to 12 weeks after last dose of IMP (maximum duration: up to 144 Weeks)
Primary outcome [2] 0 0
Treatment-emergent Adverse Event Rate (Event Per 100 Participant-years)
Timepoint [2] 0 0
From first dose of IMP up to 12 weeks after last dose of IMP (maximum duration: up to 144 Weeks)
Secondary outcome [1] 0 0
Adverse Events of Special Interest (AESIs) Event Rate (Event Per100 Participant-years)
Timepoint [1] 0 0
From first dose of IMP up to 12 weeks after last dose of IMP (maximum duration: up to 144 Weeks)
Secondary outcome [2] 0 0
Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs), Adverse Events of Special Interest (AESIs) and AEs Leading to Study Discontinuation
Timepoint [2] 0 0
From first dose of IMP up to 12 weeks after last dose of IMP (maximum duration: up to 144 Weeks)

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.
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/08/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/02/2022
Sample size
Target
Accrual to date
Final
393
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
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United States of America
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Arizona
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Vermont
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Washington
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Buenos Aires
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Santa Fe
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Argentina
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Ciudad Autonoma Buenos Aires
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Argentina
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San Miguel de Tucuman
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Argentina
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San Miguel De Tucumán
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Belgium
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Gent
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Israel
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Rehovot
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Isesaki-shi
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Ota-ku
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Uozu-shi
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Urasoe-shi
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Netherlands
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Arnhem
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South Africa
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Brandfort
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South Africa
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Cape Town
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South Africa
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Durban
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South Africa
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Pretoria

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Regeneron Pharmaceuticals
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT03620747
Trial related presentations / publications
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

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries