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

• Status: Active, not recruiting
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Collaborator: Regeneron Pharmaceuticals
• Treatments: Antibodies, Monoclonal

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.