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

Study Description

Brief Summary

Detailed Description

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

Tracking Information

First Submitted Date	April 30, 2014
Last Update Posted Date	February 22, 2018
Start Date	July 21, 2014
Anticipated Completion Date	November 01, 2019
Primary Completion Date	November 01, 2019
Results First Submitted Date	N/A
Received Results Disposit Date	N/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

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

Study Design

Brief Title	Long-Term Safety Evaluation of Dupilumab in Patients With Asthma (LIBERTY ASTHMA TRAVERSE)
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
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	Interventional
Study Phase	Phase 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 Method	N/A
Study Population	N/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) Pharmaceutical form: Solution Route of administration: Subcutaneous

Recruitment Information

Recruitment Status:	Recruiting
Enrollment	2206
Completion Date	November 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.
Gender	All
Age	12 Years to N/A
Accepts Healthy Volunteers	No
Contacts	For site information, send an email with site number to [email protected]
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 Committee	Yes
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