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

A Randomized, Double-Blind, Phase 2, Placebo Controlled, 2 Arm Study To Evaluate Dupilumab In Patients With Bilateral Nasal Polyposis And Chronic Symptoms Of Sinusitis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001803-35-BE

Enrollment

Registered

2013-05-30

Start date

2013-07-31

Completion date

Unknown

Last updated

2015-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasal polyps MedDRA version: 16.1 Level: PT Classification code 10028756 Term: Nasal polyps System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Product Name: Dupilumab Product Code: SAR231893 Pharmaceutical Form: Solution for injection INN or Proposed INN: Dupilumab Current Sponsor code: SAR231893 Other descriptive name: REGN668 Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

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 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 73 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 1

Exclusion criteria

Exclusion criteria: - Patients 65 years of age. - Sinonasal outcome test (SNOT22) 24h for treatment of asthma, within 3 month prior to screening or are on a dose of greater than 1000 µg fluticasone or an equivalent inhaled corticosteroids.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of dupilumab in the treatment of bilateral NP by assessment of the endoscopic nasal polyp score in comparison to placebo;Secondary Objective: To evaluate effect of dupilumab with regards to: - symptoms of sinusitis - sinus CT scan - nasal polyp score in the sub-group of patients with co-morbid asthma - Safety and tolerability;Primary end point(s): Change from baseline in endoscopic Nasal Polyp Score (NPS);Timepoint(s) of evaluation of this end point: 16 weeks	—

Measure

Time frame

Main Objective: To evaluate the efficacy of dupilumab in the treatment of bilateral NP by assessment of the endoscopic nasal polyp score in comparison to placebo;Secondary Objective: To evaluate effect of dupilumab with regards to: - symptoms of sinusitis - sinus CT scan - nasal polyp score in the sub-group of patients with co-morbid asthma - Safety and tolerability;Primary end point(s): Change from baseline in endoscopic Nasal Polyp Score (NPS);Timepoint(s) of evaluation of this end point: 16 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): 1) Change from baseline in NPS in sub-group of co-morbid asthma 2) Change from baseline in patient reported symptoms of sinusitis 3) Change from baseline in nasal peak inspiratory flow 4) Change from baseline in smell test 5) Change from baseline in CT scan 6) Time to first response in NPS;Timepoint(s) of evaluation of this end point: 16 weeks	—

Countries

Belgium, Spain, Sweden, United States

Contacts

Public ContactBrigitte De Witte

Sanofi Belgium

Contact-us@sanofi.com+32(0)2 710 54 00

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026