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Continuation of TRAVERSE- LTS12551 Evaluating Dupilumab Safety in Patients With Asthma (Long-Term Follow-Up)

NCT03620747

CompletedPhase 3

Sponsor: Sanofi

Conditions: Asthma

Interventions: Dupilumab SAR231893 (REGN668)

Countries: United States, Argentina, Belgium, Canada, France, Germany, Israel, Japan

Primary Objective: To describe the long-term safety of dupilumab in treatment of participants with moderate to severe asthma who completed the previous asthma clinical trial (TRAVERSE-LTS12551).

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 the previous dupilumab asthma clinical study LTS12551.
* Signed written informed consent.

Exclusion criteria:

* Participants who experienced any systemic hypersensitivity reactions to the investigational medicinal product in the previous dupilumab asthma study LTS12551, which, in the opinion of the Investigator, could indicate that continued treatment with dupilumab might present an unreasonable risk for the participant.
* Clinically significant comorbidity/lung disease other than asthma.
* Participants with active autoimmune disease or participants who, as per Investigator's medical judgment, were suspected of having high risk for developing autoimmune disease.
* History of malignancy within 5 years before enrollment except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Locations (132)

Gilbert, Arizona, United States
Scottsdale, Arizona, United States
Tucson, Arizona, United States
Little Rock, Arkansas, United States
San Jose, California, United States
Denver, Colorado, United States
Denver, Colorado, United States
Ocoee, Florida, United States
Sarasota, Florida, United States
Twin Falls, Idaho, United States
Fort Mitchell, Kentucky, United States
Bangor, Maine, United States
Chevy Chase, Maryland, United States
Gaithersburg, Maryland, United States
Minneapolis, Minnesota, United States
St Louis, Missouri, United States
Papillion, Nebraska, United States
West Long Branch, New Jersey, United States
Charlotte, North Carolina, United States
High Point, North Carolina, United States
Toledo, Ohio, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Allen, Texas, United States
Amarillo, Texas, United States
Cypress, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Fort Worth, Texas, United States
San Antonio, Texas, United States
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