An Evaluation of Dupilumab in Patients With Nasal Polyposis And Chronic Symptoms Of Sinusitis

Screening period (4 weeks) + Randomized Treatment Period (16 weeks)+ Post-Treatment Period
(16 weeks) = 36 weeks.

To ensure at least 28 patients with co-morbid asthma needed for subgroup analysis,
recruitment of NP patients without co-morbid asthma will stop when approximately 28 patients
without asthma are randomized.

Inclusion criteria:

Patients 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:

- Patients <18 or >65 years of age.

- Sinonasal outcome test (SNOT22) <7.

- Patients who have taken other investigational drugs or prohibited therapy for this
study within 2 months before screening or 5 half-lives, whichever is longer:

- Burst of systemic corticosteroids within the 2 months before screening or are
scheduled to receive systemic corticosteroids during the study period for
another condition;

- Intranasal corticosteroid 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 patient is on a continuous treatment
for at least 30 days prior to Visit 1.

- Patients who have 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.

- Patients with asthma having:

- Forced Expiratory Volume (FEV1) ≤ 60%, or

- an asthma exacerbation requiring systemic (oral and/or parenteral) steroid treatment
or hospitalization for >24h for treatment of asthma, within 3 months prior to
screening or are on a dose of greater than 1000 μg fluticasone or an equivalent
inhaled corticosteroids.

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