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

Phase 2CompletedNCT01920893

Sanofi60 enrolled

Overview

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.

Screening period (4 weeks) + Randomized Treatment Period (16 weeks) + Post-Treatment Period (16 weeks) = 36 weeks. To ensure at least 28 participants with co-morbid asthma needed for subgroup analysis, recruitment of NP participants without co-morbid asthma would stop when approximately 28 participants without asthma were randomized.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Nasal Polyps

Interventions

Placebo (for dupilumab)DRUG

Solution for injection; Subcutaneous injection.

DupilumabDRUG

Solution for injection; Subcutaneous injection.

Mometasone furoate nasal sprayDRUG

Nasal spray, 2 actuations in each nostril twice daily.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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)

Investigational Site Number 840014

Rolling Hills Estates, California, United States

Investigational Site Number 840015

Denver, Colorado, United States

Investigational Site Number 840013

Outcomes

Primary Outcomes

Change From Baseline in Bilateral Endoscopic Nasal Polyp Score (NPS) at Week 16

NPS was the sum of the right and left nostril scores, as evaluated by means of nasal endoscopy. Total score ranges from 0 to 8 (scored 0 \[no polyp\] to 4 \[large polyps\] for each nostril), with a lower score indicating smaller-sized polyps.

Time frame: Baseline, Week 16

Secondary Outcomes

Change From Baseline in Bilateral Endoscopic NPS at Week 16 in Participants With Asthma

Time frame: Baseline, Week 16

Change From Baseline in Participant Reported Symptoms Scores of Sinusitis at Week 16

Morning symptoms of sinusitis (nasal congestion/obstruction, anterior rhinorrhea \[runny nose\], posterior rhinorrhea \[post nasal drip\], and loss of sense of smell) were assessed using a 0 (no symptoms) - 3 (severe symptoms) categorical scale where higher score indicated severe symptoms.

Time frame: Baseline, Week 16

Change From Baseline in Visual Analogue Scale (VAS) for Rhinosinusitis Symptoms Severity at Week 16

Severity of rhinosinusitis symptoms were assessed on a 0 cm (not troublesome) - 10 cm (worst thinkable troublesome) VAS where higher score indicated worst thinkable troublesome.

Time frame: Baseline, Week 16

Change From Baseline in Nasal Peak Inspiratory Flow (NPIF) at Week 16

NPIF evaluation represents a physiologic measure of the air flow through both nasal cavities during forced inspiration and/or expiration expressed in liter per minute.

Time frame: Baseline, Week 16

Data from ClinicalTrials.gov

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