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

Completed · Phase 3

Conditions studied: Asthma

In brief

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

Key facts

Study ID

NCT02134028

Run by

Sanofi

People needed

2282

Starts

2014-08-05

Expected to finish

2019-10-11

Last updated by the study team

2022-03-28

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Investigational Site Number 840099 — Gilbert, Arizona, United States
• Investigational Site Number 840087 — Scottsdale, Arizona, United States
• Investigational Site Number 840402 — Tucson, Arizona, United States
• Investigational Site Number 840132 — Little Rock, Arkansas, United States
• Investigational Site Number 840109 — Bakersfield, California, United States
• Investigational Site Number 840045 — Long Beach, California, United States
• Investigational Site Number 840019 — Los Angeles, California, United States
• Investigational Site Number 840029 — Los Angeles, California, United States
• Investigational Site Number 840022 — Los Angeles, California, United States
• Investigational Site Number 840044 — Newport Beach, California, United States
• Investigational Site Number 840041 — North Hollywood, California, United States
• Investigational Site Number 840014 — Rolling Hills Estates, California, United States
• Investigational Site Number 840121 — San Jose, California, United States
• Investigational Site Number 840040 — Colorado Springs, Colorado, United States
• Investigational Site Number 840403 — Denver, Colorado, United States
• Investigational Site Number 840006 — Denver, Colorado, United States
• Investigational Site Number 840024 — Denver, Colorado, United States
• Investigational Site Number 840130 — Denver, Colorado, United States
• Investigational Site Number 840902 — New Haven, Connecticut, United States
• Investigational Site Number 840137 — Aventura, Florida, United States
• Investigational Site Number 840071 — Gainesville, Florida, United States
• Investigational Site Number 840115 — Ocoee, Florida, United States
• Investigational Site Number 840055 — Sarasota, Florida, United States
• Investigational Site Number 840079 — Twin Falls, Idaho, United States
• Investigational Site Number 840047 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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