Clinical trial NCT02912468 (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 50 micrograms
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 sinonasal polyposis that despite prior treatment with
             systemic corticosteroids (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 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 prior to Visit [V] 1) of nasal
             congestion/blockage/obstruction with moderate or severe symptom severity (score 2 or
             3) at V1 and a weekly average severity of greater than 1 at the 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.

          -  Participants who were previously treated in dupilumab studies.

          -  Participants 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 (mAB) within 5 half-lives or within 6 months
             before V1 if the half-life was unknown.

          -  Anti-immunoglobulin E (IgE) 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.

          -  Initiated allergen immunotherapy within 3 months prior to V1 or planned to begin
             therapy or changed its dose during the run-in period or the randomized treatment
             period.

          -  Participants who undergone any intranasal and/or sinus surgery (including polypectomy)
             within 6 months prior to V1.

          -  Participants who had a sinonasal or sinus surgery changing the lateral wall structure
             of the nose making impossible the evaluation of NPS.

          -  Participants with conditions/concomitant diseases making them nonevaluable 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 in 1 second (FEV1) 50% or less (of
             predicted normal).

          -  Participants who received concomitant treatment prohibited in the study.

          -  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 (HBsAg) 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 planned 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.