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

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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

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

Condition or disease Intervention/treatment Phase
Asthma Drug: dupilumab SAR231893 (REGN668) Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2285 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : July 21, 2014
Actual Primary Completion Date : October 11, 2019
Actual Study Completion Date : October 11, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Dupilumab

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)

Pharmaceutical form: Solution

Route of administration: Subcutaneous





Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. 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 ]
  2. Forced expiratory volume in one second - clinically significant changes from baseline [ Time Frame: At Week 96/Week 108 and/or Week 48/Week 60 ]
  3. Asthma control questionnaire (ACQ-5) - clinically significant changes from baseline [ Time Frame: At Week 96 and/or Week 48 ]
  4. Asthma symptom scores - clinically significant changes from baseline [ Time Frame: At Week 96 and/or Week 48 ]
  5. Asthma Quality of Life Questionnaire (AQLQS) - clinically significant changes from baseline [ Time Frame: At Week 96 and/or Week 48 ]
  6. Serum dupilumab concentrations [ Time Frame: At Week 96 and/or Week 48 ]
  7. Anti-drug antibodies - changes from baseline [ Time Frame: At Week 96 and/or Week 48 ]
  8. Biomarkers - changes from baseline [ Time Frame: At Week 96 and/or Week 48 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02134028


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Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02134028     History of Changes
Other Study ID Numbers: LTS12551
2013-003856-19 ( EudraCT Number )
U1111-1117-6745 ( Other Identifier: UTN )
First Posted: May 8, 2014    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs