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

NCT01920893

CompletedPhase 2

Sponsor: Sanofi

Conditions: Nasal Polyps

Interventions: Placebo (for dupilumab), Dupilumab, Mometasone furoate nasal spray

Countries: United States, Belgium, Spain, Sweden

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 overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (14)

Rolling Hills Estates, California, United States
Denver, Colorado, United States
Boston, Massachusetts, United States
Lake Oswego, Oregon, United States
Pittsburgh, Pennsylvania, United States
Ghent, Belgium
Leuven, Belgium
Barcelona, Spain
Faitanar, Spain
Jerez de la Frontera, Spain
L'Hospitalet de Llobregat, Spain
Madrid, Spain
Stockholm, Sweden
Stockholm, Sweden