Long-Term Safety Evaluation of Dupilumab in Patients With Asthma (LIBERTY ASTHMA TRAVERSE)
Status: | Active, not recruiting |
---|---|
Conditions: | Asthma |
Therapuetic Areas: | Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 12 - Any |
Updated: | 3/27/2019 |
Start Date: | July 21, 2014 |
End Date: | November 1, 2019 |
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
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
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
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.
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.
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.
We found this trial at
72
sites
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