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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02134028
Recruitment Status : Completed
First Posted : May 8, 2014
Last Update Posted : October 17, 2019
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE April 30, 2014
First Posted Date  ICMJE May 8, 2014
Last Update Posted Date October 17, 2019
Actual Study Start Date  ICMJE July 21, 2014
Actual Primary Completion Date October 11, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 19, 2017)
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  ICMJE
 (submitted: May 6, 2014)
Number of participants with adverse events [ Time Frame: Week 112 ]
Change History Complete list of historical versions of study NCT02134028 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 19, 2017)
  • 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  ICMJE
 (submitted: May 6, 2014)
  • Assessment of safety parameters (laboratory data, electrocardiogram and vital signs) - clinically significant changes from baseline [ Time Frame: Week 112 ]
  • Forced expiratory volume in one second - clinically significant changes from baseline [ Time Frame: Week 112 ]
  • Asthma control questionnaire - clinically significant changes from baseline [ Time Frame: Week 112 ]
  • Asthma symptom scores - clinically significant changes from baseline [ Time Frame: Week 112 ]
  • Asthma Quality of Life Questionnaire (AQLQS) - clinically significant changes from baseline [ Time Frame: Week 112 ]
  • Anti-drug antibodies - changes from baseline [ Time Frame: Week 112 ]
  • Biomarkers - changes from baseline [ Time Frame: Week 96 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Long-Term Safety Evaluation of Dupilumab in Patients With Asthma (LIBERTY ASTHMA TRAVERSE)
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE Drug: dupilumab SAR231893 (REGN668)

Pharmaceutical form: Solution

Route of administration: Subcutaneous

Study Arms  ICMJE 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.

Intervention: Drug: dupilumab SAR231893 (REGN668)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 16, 2019)
2285
Original Estimated Enrollment  ICMJE
 (submitted: May 6, 2014)
560
Actual Study Completion Date  ICMJE October 11, 2019
Actual Primary Completion Date October 11, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Mexico,   Argentina,   Australia,   Belgium,   Brazil,   Chile,   Colombia,   Denmark,   France,   Germany,   Hungary,   Israel,   Italy,   Japan,   Korea, Republic of,   Netherlands,   Poland,   Romania,   Russian Federation,   South Africa,   Spain,   Taiwan,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02134028
Other Study ID Numbers  ICMJE LTS12551
2013-003856-19 ( EudraCT Number )
U1111-1117-6745 ( Other Identifier: UTN )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Regeneron Pharmaceuticals
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP