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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02134028




Registration number
NCT02134028
Ethics application status
Date submitted
30/04/2014
Date registered
8/05/2014
Date last updated
28/03/2022

Titles & IDs
Public title
Long-Term Safety Evaluation of Dupilumab in Patients With Asthma (LIBERTY ASTHMA TRAVERSE)
Scientific title
Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Dupilumab in Patients With Asthma Who Participated in a Previous Dupilumab Asthma Clinical Study
Secondary ID [1] 0 0
2013-003856-19
Secondary ID [2] 0 0
LTS12551
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

Experimental: dupilumab treatment - For participants coming from the DRI12544 study: dupilumab loading dose subcutaneous (SC) on Day 1, followed by 1\* Dose every 2 weeks added to current controller medications.

For participants coming from other studies: dupilumab 1 \* Dose SC every 2 weeks added to current controller medications.


Treatment: Drugs: Dupilumab
Pharmaceutical form: Solution for injection Routes of administration: Subcutaneous
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
From the first IMP injection in LTS12551 to the last IMP injection plus 14 weeks (up to 108 weeks)
Secondary outcome [1] 0 0
Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period
Timepoint [1] 0 0
From the first IMP injection in LTS12551 to the last IMP injection plus 14 weeks (up to 108 weeks)
Secondary outcome [2] 0 0
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period
Timepoint [2] 0 0
From the first IMP injection in LTS12551 to the last IMP injection plus 14 weeks (up to 108 weeks)
Secondary outcome [3] 0 0
Number of Severe Exacerbation Events
Timepoint [3] 0 0
From the first IMP injection in LTS12551 to the last IMP injection plus 2 weeks (up to 96 weeks)
Secondary outcome [4] 0 0
Annualized Event Rate Per Participant-Years for Severe Exacerbation
Timepoint [4] 0 0
From the first IMP injection in LTS12551 to the last IMP injection plus 2 weeks (up to 96 weeks)
Secondary outcome [5] 0 0
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Weeks 48 and 96
Timepoint [5] 0 0
Baseline of parent study, Week 48 and Week 96 of this extension study
Secondary outcome [6] 0 0
Change From Baseline in Percent Predicted FEV1 at Weeks 48 and 96
Timepoint [6] 0 0
Baseline of parent study, Week 48 and Week 96 of this extension study
Secondary outcome [7] 0 0
Change From Baseline in Forced Vital Capacity (FVC) at Weeks 48 and 96
Timepoint [7] 0 0
Baseline of parent study, Week 48, and Week 96 of this extension study
Secondary outcome [8] 0 0
Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 48 and 96
Timepoint [8] 0 0
Baseline of parent study, Week 48, and Week 96 of this extension study
Secondary outcome [9] 0 0
Change From Baseline in Asthma Control Questionnaire 5-Question Version (ACQ-5) Mean Scores at Weeks 24 and 48
Timepoint [9] 0 0
Baseline of parent study, Weeks 24, and 48 of this extension study
Secondary outcome [10] 0 0
Percentage of Participants Achieving ACQ-5 Score Response (ACQ-5 Responders) at Weeks 24 and 48
Timepoint [10] 0 0
At Weeks 24, and 48 of this extension study
Secondary outcome [11] 0 0
Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Global Scores at Weeks 24 and 48
Timepoint [11] 0 0
Baseline of parent study, Weeks 24, and 48 of this extension study
Secondary outcome [12] 0 0
Percentage of Participants Achieving AQLQ Global Score Response (AQLQ Responders) at Weeks 24 and 48
Timepoint [12] 0 0
At Weeks 24, and 48 of this extension study
Secondary outcome [13] 0 0
Serum Concentrations of Dupilumab Over Time Till Week 96
Timepoint [13] 0 0
Baseline of parent study, Weeks 0, 4, 12, 24, 48, 72, and 96 of this extension study
Secondary outcome [14] 0 0
Percentage of Participants With Antidrug Antibodies (ADA) Response
Timepoint [14] 0 0
From the first IMP injection in LTS12551 to the last IMP injection plus 2 weeks (up to 96 weeks)
Secondary outcome [15] 0 0
Change From Baseline in Blood Eosinophils Cells Count at Weeks 48 and 96
Timepoint [15] 0 0
Baseline of parent study, Week 48 and Week 96 of this extension study
Secondary outcome [16] 0 0
Change From Baseline in Morning Peak Expiratory Flow (PEF) at Weeks 48 and 96: Participants From Study DRI12544
Timepoint [16] 0 0
Baseline of parent study, Week 48 and Week 96 of this extension study
Secondary outcome [17] 0 0
Change From Baseline in Evening Peak Expiratory Flow (PEF) at Weeks 48 and 96: Participants From Study DRI12544
Timepoint [17] 0 0
Baseline of parent study, Week 48 and Week 96 of this extension study
Secondary outcome [18] 0 0
Change From Baseline in Morning Asthma Symptom Scores at Weeks 48 and 96: Participants From Study DRI12544
Timepoint [18] 0 0
Baseline of parent study, Week 48 and Week 96 of this extension study
Secondary outcome [19] 0 0
Change From Baseline in Evening Asthma Symptom Scores at Weeks 48 and 96: Participants From Study DRI12544
Timepoint [19] 0 0
Baseline of parent study, Week 48, and Week 96 of this extension study
Secondary outcome [20] 0 0
Change From Baseline in Number of Inhalations Per Day of Salbutamol/Albuterol or Levosalbutamol/Levalbuterol for Symptom Relief at Weeks 48 and 96: Participants From Study DRI12544
Timepoint [20] 0 0
Baseline of parent study, Week 48, and Week 96 of this extension study
Secondary outcome [21] 0 0
Change From Baseline in Number of Nocturnal Awakenings at Weeks 48 and 96: Participants From Study DRI12544
Timepoint [21] 0 0
Baseline of parent study, Week 48 and Week 96 of this extension study
Secondary outcome [22] 0 0
Percent Change From Baseline in Oral Corticosteroid (OCS) Dose at Weeks 48, and 96: Participants From Study EFC13691
Timepoint [22] 0 0
Baseline of parent study, Weeks 48 and 96 of this extension study
Secondary outcome [23] 0 0
Percentage of Participants Achieving a Reduction of 50% or Greater (= 50% ) in OCS Dose Over Time at Weeks 48 and 96: Participants From Study EFC13691
Timepoint [23] 0 0
Weeks 48 and 96 of this extension study
Secondary outcome [24] 0 0
Percentage of Participants With Background OCS Completely Tapered Off Over Time at Weeks 48 and 96: Participants From Study EFC13691
Timepoint [24] 0 0
Weeks 48, and 96 of this extension study
Secondary outcome [25] 0 0
Change From Baseline in European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L) Index Scores at Weeks 48 and 96: Participants From Study DRI12544
Timepoint [25] 0 0
Baseline of parent study, Week 48 and Week 96 of this extension study
Secondary outcome [26] 0 0
Change From Baseline in EQ-5D-3L VAS Scores at Weeks 48 and 96: Participants From Study DRI12544
Timepoint [26] 0 0
Baseline of parent study, Week 48 and Week 96 of this extension study

Eligibility
Key inclusion criteria
Inclusion criteria:

- Participants with asthma who completed the treatment period in a previous dupilumab asthma clinical study (i.e., PDY14192, EFC13579 or EFC13691) or participants with asthma who completed the treatment and follow-up periods in previous dupilumab asthma Study DRI12544.
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 hypersensitivity reactions to Investigational Medicinal Product (IMP) in the previous dupilumab asthma study, which, in the opinion of the Investigator, could indicate that continued treatment with dupilumab, may present an unreasonable risk for the participant.

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
Not applicable
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
5/08/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/10/2019
Sample size
Target
Accrual to date
Final
2282
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigational Site Number 036004 - Adelaide
Recruitment hospital [2] 0 0
Investigational Site Number 036005 - Campbelltown
Recruitment hospital [3] 0 0
Investigational Site Number 036001 - Clayton
Recruitment hospital [4] 0 0
Investigational Site Number 036008 - Frankston
Recruitment hospital [5] 0 0
Investigational Site Number 036093 - Murdoch
Recruitment hospital [6] 0 0
Investigational Site Number 036003 - Nedlands
Recruitment hospital [7] 0 0
Investigational Site Number 036094 - Parkville
Recruitment hospital [8] 0 0
Investigational Site Number 036009 - Prahran
Recruitment hospital [9] 0 0
Investigational Site Number 036006 - Woolloongabba
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
2560 - Campbelltown
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3199 - Frankston
Recruitment postcode(s) [5] 0 0
6150 - Murdoch
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment postcode(s) [7] 0 0
3050 - Parkville
Recruitment postcode(s) [8] 0 0
3004 - Prahran
Recruitment postcode(s) [9] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
Arizona
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United States of America
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Arkansas
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United States of America
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Connecticut
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Florida
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United States of America
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Idaho
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United States of America
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Illinois
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United States of America
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Kentucky
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Missouri
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New York
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Ohio
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Germany
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Koblenz
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Germany
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Rüdersdorf Bei Berlin
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Balassagyarmat
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Hungary
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Edelény
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Hungary
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Gödöllö
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Israel
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Haifa
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Israel
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Kfar Saba
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Israel
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Petah-Tikva
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Israel
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Rehovot
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Italy
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Italy
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Catania
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Italy
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Ferrara
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Italy
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Foggia
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Genova
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Italy
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Modena
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Padova
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Asahi-Shi
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Chiyoda-Ku
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Chuo-Ku
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Edogawa-Ku
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Fukuoka-Shi
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Habikino-Shi
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Hirakata-Shi
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Hiroshima-Shi
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Iizuka-Shi
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Isesaki-Shi
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Kanazawa-Shi
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Japan
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Kasuga-Shi
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Japan
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Kishiwada-Shi
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Japan
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Kobe-Shi
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Japan
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Kodaira-Shi
Country [120] 0 0
Japan
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Kokubunji-Shi
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Japan
State/province [121] 0 0
Koushi-Shi
Country [122] 0 0
Japan
State/province [122] 0 0
Kurashiki-Shi
Country [123] 0 0
Japan
State/province [123] 0 0
Kyoto-Shi
Country [124] 0 0
Japan
State/province [124] 0 0
Machida-Shi
Country [125] 0 0
Japan
State/province [125] 0 0
Matsuyama-Shi
Country [126] 0 0
Japan
State/province [126] 0 0
Minato-Ku
Country [127] 0 0
Japan
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Mizunami-Shi
Country [128] 0 0
Japan
State/province [128] 0 0
Muroran-Shi
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Japan
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Nagoya-Shi
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Japan
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Naka-Gun
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Japan
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Naruto-Shi
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Obihiro-Shi
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Ome-Shi
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Osaka Sayama-Shi
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Osaki-Shi
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Japan
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Ota-Ku
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Ota-Shi
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Sagamihara-Shi
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Sakai-Shi
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Sakaide-Shi
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Sapporo-Shi
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Setagaya-Ku
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Shibuya-Ku
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Incheon
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Durango
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Mexico City
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Monterrey
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San Juan Del Rio
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Veracruz
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Netherlands
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Arnhem
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Netherlands
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Dordrecht
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Poland
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Bialystok
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Gdansk
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Poland
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Krakow
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Poland
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Lodz
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South Shields

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 evaluate the long-term safety and tolerability of dupilumab in participants with asthma who participated in a previous dupilumab asthma study (DRI12544, PDY14192, EFC13579, EFC13691).

Secondary Objectives:

To evaluate the long-term efficacy of dupilumab in participants with asthma who participated in a previous dupilumab asthma clinical study.

To evaluate dupilumab in participants with asthma who participated in a previous dupilumab asthma clinical study, with regards to:

* Systemic exposure
* Anti-drug antibodies
* Biomarkers
Trial website
https://clinicaltrials.gov/study/NCT02134028
Trial related presentations / publications
Tohda Y, Nakamura Y, Fujisawa T, Ebisawa M, Msihid J, Djandji M, Ortiz B, Jacob-Nara JA, Deniz Y, Rowe PJ, Ishida M, Arima K. Efficacy of dupilumab in patients with uncontrolled, moderate-to-severe asthma recruited from Japanese centers in the phase 3 LIBERTY ASTHMA TRAVERSE study. Allergol Int. 2023 Jan;72(1):89-99. doi: 10.1016/j.alit.2022.07.008. Epub 2022 Sep 13.
Lugogo N, Mohan A. Are We Poised to Change the Trajectory of Maintenance Oral Corticosteroid Use in Severe Asthma in the Age of Biologics? Chest. 2022 Jul;162(1):4-5. doi: 10.1016/j.chest.2022.04.004. No abstract available.
Wechsler ME, Klion AD, Paggiaro P, Nair P, Staumont-Salle D, Radwan A, Johnson RR, Kapoor U, Khokhar FA, Daizadeh N, Chen Z, Laws E, Ortiz B, Jacob-Nara JA, Mannent LP, Rowe PJ, Deniz Y. Effect of Dupilumab on Blood Eosinophil Counts in Patients With Asthma, Chronic Rhinosinusitis With Nasal Polyps, Atopic Dermatitis, or Eosinophilic Esophagitis. J Allergy Clin Immunol Pract. 2022 Oct;10(10):2695-2709. doi: 10.1016/j.jaip.2022.05.019. Epub 2022 May 28.
Sher LD, Wechsler ME, Rabe KF, Maspero JF, Daizadeh N, Mao X, Ortiz B, Mannent LP, Laws E, Ruddy M, Pandit-Abid N, Jacob-Nara JA, Gall R, Rowe PJ, Deniz Y, Lederer DJ, Hardin M. Dupilumab Reduces Oral Corticosteroid Use in Patients With Corticosteroid-Dependent Severe Asthma: An Analysis of the Phase 3, Open-Label Extension TRAVERSE Trial. Chest. 2022 Jul;162(1):46-55. doi: 10.1016/j.chest.2022.01.071. Epub 2022 Feb 22.
Wechsler ME, Ford LB, Maspero JF, Pavord ID, Papi A, Bourdin A, Watz H, Castro M, Nenasheva NM, Tohda Y, Langton D, Cardona G, Domingo C, Park HS, Chapman KR, Mao X, Zhang Y, Khan AH, Deniz Y, Rowe PJ, Kapoor U, Khokhar FA, Mannent LP, Ruddy M, Laws E, Amin N, Hardin M. Long-term safety and efficacy of dupilumab in patients with moderate-to-severe asthma (TRAVERSE): an open-label extension study. Lancet Respir Med. 2022 Jan;10(1):11-25. doi: 10.1016/S2213-2600(21)00322-2. Epub 2021 Sep 28.
Public notes

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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02134028