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

About this trial
This is an interventional treatment trial for Asthma
Eligibility 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.
Sites / Locations
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Arms of the Study
Arm 1
Experimental
Dupilumab
Participants received subcutaneous (SC) dose of dupilumab 300 milligrams (mg) every 2 weeks (q2w) from Week 0 up to Week 132. Participants who discontinued treatment for greater than or equal to (>=) 6 weeks after study LTS12551 (NCT02134028), received a 600 mg loading dose of dupilumab on Week 0. Participants were also on background dose of medium or high dose inhaled corticosteroid (ICS) as maintained in study LTS12551 in combination with controllers (and/or oral corticosteroid [OCS] for those participants from the original parent study EFC13691 [NCT02528214]). Salbutamol/albuterol hydrofluoroalkane pressurized metered dose inhalers (MDI) or levosalbutamol/levalbuterol hydrofluoroalkane pressurized MDI were given as reliever medication as needed during the study.