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

Clinical Trial ID: NCT03620747

Description

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

Duration per participant is until dupilumab approval for use in asthma and market availability to the patient, or a maximum of 144 weeks (ie, about 3 years) after the Start of Treatment (V1), whichever comes first.


Criteria

Inclusion criteria : - Patients with asthma who completed the treatment period in the previous dupilumab asthma clinical study LTS12551. - Signed written informed consent. Exclusion criteria: - Patients who experienced any systemic hypersensitivity reactions to the 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. - Clinically significant comorbidity/lung disease other than asthma. - Patients with active autoimmune disease or patients who, as per Investigator's medical judgment, are 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 nonmetastatic squamous or basal cell carcinoma of the skin. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  • Start Date

    2018-08-30

  • Last Updated

    2019-07-04

  • Sponsor

    Regeneron Pharmaceuticals

  • Condition Name

    Asthma

Learn about this trial.

Check the eligibility requirements, study details, and more.

Related Trials

Different trials target different symptoms, condition types, and patients. Learn more about other emergeing treatments being investigated now.