Long-Term Safety Evaluation of Dupilumab in Patients With Asthma (LIBERTY ASTHMA TRAVERSE)

ID: NCT02134028
Status: Recruiting
Phase: Phase 2/Phase 3
Start Date: July 21, 2014
First Submitted: April 30, 2014
Last Updated: February 22, 2018
Results: N/A
Organization: Sanofi
Sponsors & Collaborators: Sanofi, Regeneron Pharmaceuticals
Location: Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, Denmark, France, Germany, Hungary, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Poland, Romania, Russian Federation, South Africa, Spain, Taiwan, Turkey, Ukraine, United Kingdom, United States
Conditions: Asthma
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Study Description

Brief Summary

Primary Objective:

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

Secondary Objectives:

Evaluate the efficacy of dupilumab in patients with asthma who participated in a previous dupilumab asthma clinical study.

Evaluate dupilumab in patients with asthma who participated in a previous dupilumab asthma clinical study, with regards to:

- Systemic exposure

- Anti-drug antibodies

- Biomarkers

Detailed Description

A screening period, up to 3 weeks, will apply only for patients coming from DRI12544 study. The total study duration, per patient, is a maximum of 108 weeks (or 111 weeks considering a maximum screening period of 3 weeks for Study DRI12544) for the patients enrolled prior to Amendment 04 approval and a maximum of 60 weeks for the patients enrolled after Amendment 04 approval.
Condition or disease Intervention/treatment Phase

Asthma

Drug: dupilumab SAR231893 (REGN668)
Other Names
Phase 2/Phase 3

Tracking Information

First Submitted DateApril 30, 2014
Last Update Posted DateFebruary 22, 2018
Start DateJuly 21, 2014
Anticipated Completion DateNovember 01, 2019
Primary Completion DateNovember 01, 2019
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • The primary endpoint of this study is the number (n) and percentage (%) of patients experiencing any treatment-emergent adverse events (TEAE) [Time Frame: Up to Week 108 (if enrolled before Amendment 4); Up to Week 60 (if enrolled after Amendment 4)]

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Assessment of safety parameters (laboratory data, electrocardiogram and vital signs) - clinically significant changes from baseline [Time Frame: At Week 96/Week 108 and/or Week 48/Week 60]

  • Forced expiratory volume in one second - clinically significant changes from baseline [Time Frame: At Week 96/Week 108 and/or Week 48/Week 60]

  • Asthma control questionnaire (ACQ-5) - clinically significant changes from baseline [Time Frame: At Week 96 and/or Week 48]

  • Asthma symptom scores - clinically significant changes from baseline [Time Frame: At Week 96 and/or Week 48]

  • Asthma Quality of Life Questionnaire (AQLQS) - clinically significant changes from baseline [Time Frame: At Week 96 and/or Week 48]

  • Serum dupilumab concentrations [Time Frame: At Week 96 and/or Week 48]

  • Anti-drug antibodies - changes from baseline [Time Frame: At Week 96 and/or Week 48]

  • Biomarkers - changes from baseline [Time Frame: At Week 96 and/or Week 48]

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleLong-Term Safety Evaluation of Dupilumab in Patients With Asthma (LIBERTY ASTHMA TRAVERSE)
Official TitleOpen-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
Brief Summary

Primary Objective:

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

Secondary Objectives:

Evaluate the efficacy of dupilumab in patients with asthma who participated in a previous dupilumab asthma clinical study.

Evaluate dupilumab in patients with asthma who participated in a previous dupilumab asthma clinical study, with regards to:

- Systemic exposure

- Anti-drug antibodies

- Biomarkers

Detailed Description

A screening period, up to 3 weeks, will apply only for patients coming from DRI12544 study. The total study duration, per patient, is a maximum of 108 weeks (or 111 weeks considering a maximum screening period of 3 weeks for Study DRI12544) for the patients enrolled prior to Amendment 04 approval and a maximum of 60 weeks for the patients enrolled after Amendment 04 approval.

Study TypeInterventional
Study PhasePhase 2/Phase 3
Estimated Enrollment
2206
Allocation
Not Available
Interventional Model
Single Group Assignment
Masking
None (Open Label)
Primary Purpose
Treatment
Conditions
Asthma
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: dupilumab SAR231893 (REGN668)

Pharmaceutical form: Solution Route of administration: Subcutaneous

Other Names
Study Groups/Cohorts
dupilumab treatment
For patients coming from the DRI12544 study: dupilumab loading dose sc on Day 1, followed by 1x Dose every 2 weeks added to current controller medications. For patients coming from other studies: dupilumab 1x Dose sc every 2 weeks added to current controller medications.

Study Arms
Experimental dupilumab treatment
For patients coming from the DRI12544 study: dupilumab loading dose sc on Day 1, followed by 1x Dose every 2 weeks added to current controller medications. For patients coming from other studies: dupilumab 1x Dose sc every 2 weeks added to current controller medications.
Drug : dupilumab SAR231893 (REGN668)
Pharmaceutical form: Solution Route of administration: Subcutaneous

Arm Intervention/Treatment
Experimental dupilumab treatment
For patients coming from the DRI12544 study: dupilumab loading dose sc on Day 1, followed by 1x Dose every 2 weeks added to current controller medications. For patients coming from other studies: dupilumab 1x Dose sc every 2 weeks added to current controller medications.
Drug : dupilumab SAR231893 (REGN668)

Recruitment Information

Recruitment Status:Recruiting
Enrollment2206
Completion DateNovember 01, 2019
Eligibility Criteria: Inclusion criteria:
- Patients with asthma who completed the treatment period in a previous dupilumab asthma clinical study (ie, PDY14192, EFC13579 or EFC13691) or patients with asthma who completed the treatment and follow-up periods in previous dupilumab asthma Study DRI12544.
Exclusion criteria:
- Patients 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 patient.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
GenderAll
Age12 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
Argentina
Australia
Belgium
Brazil
Canada
Chile
Colombia
Denmark
France
Germany
Hungary
Israel
Italy
Japan
Korea, Republic of
Mexico
Netherlands
Poland
Romania
Russian Federation
South Africa
Spain
Taiwan
Turkey
Ukraine
United Kingdom
United States

Administrative Information

NCT Number:NCT02134028
Other Study ID Numbers
LTS12551
2013-003856-19
U1111-1117-6745
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Sanofi
Collaborators
Regeneron Pharmaceuticals
Investigators
Study Director
Clinical Sciences & Operations
Sanofi