Dupilumab in Japanese Patients With Chronic Rhinosinusitis With Nasal Polyp (SINUS-M52)
Condition: Chronic Rhinosinusitis With Nasal Polyps
MeSH terms: Sinusitis; Nasal Polyps; Polyps
Intervention: Dupilumab SAR231893
Intervention description: Pharmaceutical form: solution for injection Route of administration: subcutaneous (SC)
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This was a Phase 4, open-label, single-arm, multicenter study to evaluate the efficacy and
      safety of dupilumab subcutaneous (SC) injection monotherapy in Japanese participants aged 18
      or older with CRSwNP that is not adequately controlled with existing therapies.

      Duration of study period (per participant):

        -  Screening Period (2 to 4 weeks)

        -  Intervention Period (up to 52 weeks±3 days)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants ≧18 years of age.

          -  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
                  enrollment (V2), and loss of smell, rhinorrhea (anterior/posterior).

          -  Participant's body weight > 30 kg at V1.

          -  Signed written informed consent.

        Exclusion Criteria:

          -  Participant 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; Eosinophilic granulomatosis
             with polyangiitis (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;

          -  Participant with nasal cavity malignant tumor and benign tumors (eg, papilloma, blood
             boil, etc).

          -  Participant diagnosed with, suspected of, or at high risk of endoparasitic infection,
             and/or use of antiparasitic drug within 2 weeks before V1 or during screening

          -  Undergone any and/or sinus intranasal surgery within 6 months before V1.

          -  Participant who had participated in prior dupilumab clinical study or had been treated
             with commercially available dupilumab

        The above information is not intended to contain all considerations relevant to a patient's
        potential participation in a clinical trial.