Clinical trial NCT02898454 (phase 3, status: completed)
Conditions: chronic rhinosinusitis phenotype with nasal polyps (crswnp)
ICD codes: Q97.9, Q98.9, Q97.8, Q98.8, J84.170
Drugs: dupilumab sar231893 (regn668), placebo, mometasone furoate nasal spray
SMILES: CCO, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, [H][C@@]12C[C@@H](C)[C@](O)(C(=O)CCl)[C@@]1(C)C[C@H](O)[C@@]1(Cl)[C@@]2([H])CCC2=CC(=O)C=C[C@]12C
Eligibility criteria:

        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.