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

NCT02134028

CompletedPhase 3

Sponsor: Sanofi

Conditions: Asthma

Interventions: Dupilumab

Countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia

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

Eligibility overview

Sex: ALL

Age: 12 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion criteria:

\- 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.

Exclusion criteria:

\- 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.
Locations (365)
  • Birmingham, Alabama, United States
  • Gilbert, Arizona, United States
  • Scottsdale, Arizona, United States
  • Tucson, Arizona, United States
  • Little Rock, Arkansas, United States
  • Bakersfield, California, United States
  • Long Beach, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Newport Beach, California, United States
  • North Hollywood, California, United States
  • Rolling Hills Estates, California, United States
  • San Jose, California, United States
  • Colorado Springs, Colorado, United States
  • Denver, Colorado, United States
  • Denver, Colorado, United States
  • Denver, Colorado, United States
  • Denver, Colorado, United States
  • New Haven, Connecticut, United States
  • Aventura, Florida, United States
  • Gainesville, Florida, United States
  • Ocoee, Florida, United States
  • Sarasota, Florida, United States
  • Twin Falls, Idaho, United States
  • Chicago, Illinois, United States
  • Fort Mitchell, Kentucky, United States
  • Louisville, Kentucky, United States
  • Owensboro, Kentucky, United States
  • Bangor, Maine, United States
  • + 335 more on CT.gov