Controlled Clinical Study of Dupilumab in Patients With Nasal Polyps

Inclusion criteria

• Participants with bilateral sino-nasal polyposis that despite prior treatment with SCS anytime within the past 2 years; and/or had a medical contraindication/intolerance to SCS; and/or had prior surgery for NP at the screening visit, had:
• An endoscopic bilateral NPS at Visit 1 (V1) of at least 5 out of a maximum score of 8 (with a minimum score of 2 in each nasal cavity).
• Ongoing symptoms (for at least 8 weeks before V1) of NC/blockage/obstruction with moderate or severe symptom severity (score 2 or 3) at V1 and a weekly average severity of greater than 1 at time of randomization (V2), and another symptom such as loss of smell, rhinorrhea (anterior/posterior).
• Signed written informed consent.

Exclusion criteria

• Participants <18 years of age.
• Participant who had been previously treated in dupilumab studies.
• Participant who had taken:
• Biologic therapy/ systemic immunosuppressant to treat inflammatory disease or autoimmune disease (eg, rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis, etc.) within 2 months before V1 or 5 half-lives, whichever was longer.
• Any experimental monoclonal antibody within 5 half-lives or within 6 months before V1 if the half-life was unknown.
• Anti-immunoglobulin E therapy (omalizumab) within 130 days prior to V1.
• Participants who received leukotriene antagonists/modifiers at V1 unless they were on a continuous treatment for at least 30 days prior to V1.
• Initiation of allergen immunotherapy within 3 months prior to V1 or a plan to begin therapy or change its dose during the run-in period or the randomized treatment period.
• Participants who underwent any and/or sinus surgery (including polypectomy) within 6 months before V1.
• Participants who had a sino-nasal or sinus surgery changing the lateral wall structure of the nose making impossible the evaluation of NPS.
• Participants with conditions/concomitant diseases making them non evaluable at V1 or for the primary efficacy endpoint such as:
• Antrochoanal polyps,
• Nasal septal deviation that would occlude at least one nostril,
• Acute sinusitis, nasal infection or upper respiratory infection,
• Ongoing rhinitis medicamentosa,
• Allergic granulomatous angiitis (Churg-Strauss syndrome), granulomatosis with polyangiitis (Wegener's granulomatosis),Young's syndrome, Kartagener's syndrome or other dyskinetic ciliary syndromes, concomitant cystic fibrosis,
• Radiologic suspicion, or confirmed invasive or expansive fungal rhinosinusitis.
• Participants with nasal cavity malignant tumor and benign tumors (eg, papilloma, blood boil etc.).
• Participants with forced expiratory volume 50% or less (of predicted normal).
• Participants who received concomitant treatment prohibited in the study.
• Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit.
• Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit.
• History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
• Positive with hepatitis B surface antigen or hepatitis C antibody at the screening visit.
• Active chronic or acute infection requiring systemic treatment within 2 weeks before the baseline visit.
• Known or suspected history of immunosuppression.
• Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
• Women unwilling to use adequate birth control, if of reproductive potential and sexually active.

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