An Evaluation of Dupilumab in Patients With Nasal Polyposis And Chronic Symptoms Of Sinusitis
Condition: Nasal Polyps
MeSH terms: Sinusitis; Nasal Polyps
Intervention: Placebo (for dupilumab); Dupilumab; Mometasone furoate nasal spray
Intervention description: Solution for injection; Subcutaneous injection.; Solution for injection; Subcutaneous injection.; Nasal spray, 2 actuations in each nostril twice daily.
Intervention MeSH terms: Mometasone Furoate; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To evaluate the efficacy of dupilumab (SAR231893/REGN668) in the treatment of bilateral Nasal
      Polyposis (NP) by assessment of the endoscopic nasal polyp score (NPS) in comparison to
      placebo.

      Secondary Objectives:

      To evaluate effect of dupilumab with regards to:

        -  symptoms of sinusitis,

        -  sinus computed tomography (CT) scan,

        -  NPS in the sub-group of participants with co-morbid asthma,

        -  Safety and tolerability.
    

Eligibility criteria:

        Inclusion criteria: participants with:

          -  A minimum bilateral nasal polyp score of 5 out of a maximum score of 8 (with a
             unilateral score of at least 2 for each nostril) despite completion of a prior
             intranasal corticosteroid (INCS) treatment for at least 8 weeks before screening.

          -  Presence of at least two of the following symptoms prior to screening: nasal
             blockade/obstruction/congestion or nasal discharge (anterior/posterior nasal drip);
             facial pain/pressure; reduction or loss of smell.

        Exclusion criteria:

          -  Participants <18 or >65 years of age.

          -  Sinonasal outcome test (SNOT-22) <7.

          -  Participants who had taken other investigational drugs or prohibited therapy for this
             study within 2 months before screening or 5 half-lives, whichever was longer:

               -  Burst of systemic corticosteroids within the 2 months before screening or were
                  scheduled to receive systemic corticosteroids during the study period for another
                  condition

               -  INCS drops within 1 month prior to screening

               -  Monoclonal antibody (mAB) and immunosuppressive treatment

               -  Anti-immunoglobulin E (IgE) therapy (omalizumab) within 130 days of Visit 1

               -  Leukotriene antagonists/modifiers unless participant was on a continuous
                  treatment for at least 30 days prior to Visit 1.

          -  Participants who had undergone any nasal surgery (including polypectomy) within 6
             months before screening or have had more than 5 sinonasal surgeries in the past of
             which maximal 2 were surgeries changing the lateral wall structure of the nose.

          -  Participants with asthma having:

               -  Forced Expiratory Volume (FEV1) ≤ 60%, or .Asthma exacerbation requiring systemic
                  (oral and/or parenteral) steroid treatment or hospitalization for >24 hours for
                  treatment of asthma, within 3 months prior to screening or were on a dose of
                  greater than 1000 microgram (mcg) fluticasone or an equivalent INCS.

        The above information is not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.