Dupilumab in Allergic Fungal Rhinosinusitis (AFRS) (LIBERTY-AFRS-AI)

Exclusion Criteria

• •Patients with nasal conditions/concomitant nasal diseases making them non-evaluable at Visit 1 or for the primary efficacy
• •Nasal cavity malignant tumor and benign tumors.
• •Known of fungal invasion into sinus tissue.
• •Severe concomitant illness(es) that, in the investigator's judgment, would adversely affect the patient's participation in the study
• •Active tuberculosis or non-tuberculous mycobacterial infection, or a history of incompletely treated tuberculosis unless documented adequately treated.
• •Diagnosed active endoparasitic infections; suspected or high risk of endoparasitic infection
• •Known or suspected immunodeficiency
• •Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals within 2 weeks before the Screening Visit 1 or during the screening period.
• •History of systemic hypersensitivity or anaphylaxis to dupilumab or any of its excipients.
• •Treatment with commercially available dupilumab within 12 months, participation in prior dupilumab clinical trial, or discontinued dupilumab use due to adverse event.
• •Patients who are treated with intranasal corticosteroid drops; intranasal steroid emitting devices/stents; nasal spray using exhalation delivery system, such as Xhance™, during screening period.
• •Patients who are on intranasal corticosteroids (INCS) spray unless they have received stable dose for at least 4 weeks prior to Visit 1.
• •Patients who have undergone sinus intranasal surgery (including polypectomy) within 6 months prior to Visit 1.
• •Patients who have taken:
• •* Biologic therapy/systemic immunosuppressant to treat inflammatory disease or autoimmune disease within 5 half-lives prior to Visit 1
• •* Any investigational mAb within 5 half-lives prior to Visit 1
• •* Anti-IgE therapy (omalizumab) within 4 months prior to Visit 1. - Treatment with a live (attenuated) vaccine within 4 weeks prior to Visit 1
• •Leukotriene antagonists/modifiers unless patient is on a continuous treatment for at least 30 days prior to Visit 1.
• •Initiation of allergen immunotherapy within 3 months prior to Visit 1 or a plan to begin therapy or change its dose during the screening or treatment period. - Patients received SCS during screening period. - Either intravenous immunoglobulin therapy and/or plasmapheresis within 30 days prior to Screening Visit (Visit 1).
• •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.