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

Nasal Polyps Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01920893
• Other study ID #: ACT12340
• Secondary ID: 2013-001803-35U1
• Status: Completed
• Phase: Phase 2
• First received: August 8, 2013
• Last updated: November 3, 2015
• Start date: August 2013
• Est. completion date: November 2014

Study information

• Verified date: November 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHPUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 in comparison to placebo.

Secondary Objectives:

To evaluate effect of dupilumab with regards to:

• symptoms of sinusitis

• sinus Computed Tomography (CT) scan

• nasal polyp score in the sub-group of patients with co-morbid asthma

• Safety and tolerability

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nasal Polyps

Intervention

Drug:
• Dupilumab
Pharmaceutical form: solution in glass vials Route of administration: subcutaneous
• Placebo (for dupilumab)
Pharmaceutical form: solution in glass vials Route of administration: subcutaneous
• Mometasone furoate nasal spray
Pharmaceutical form: suspension in bottle Route of administration: intranasal

Locations

Country	Name	City	State
Belgium	Investigational Site Number 056001	Gent
Belgium	Investigational Site Number 056002	Leuven
Spain	Investigational Site Number 724001	Barcelona
Spain	Investigational Site Number 724003	Faitanar
Spain	Investigational Site Number 724002	Hospitalet De Llobregat
Spain	Investigational Site Number 724005	Jerez De La Frontera
Spain	Investigational Site Number 724004	Madrid
Sweden	Investigational Site Number 752001	Stockholm
Sweden	Investigational Site Number 752002	Stockholm
United States	Investigational Site Number 840013	Boston	Massachusetts
United States	Investigational Site Number 840015	Denver	Colorado
United States	Investigational Site Number 840002	Lake Oswego	Oregon
United States	Investigational Site Number 840009	Pittsburg	Pennsylvania
United States	Investigational Site Number 840014	Rolling Hills Estates	California

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Regeneron Pharmaceuticals

Countries where clinical trial is conducted

United States,  Belgium,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in endoscopic Nasal Polyp Score (NPS)		16 weeks	No
Secondary	Change from baseline in NPS in sub-group of co-morbid asthma		16 weeks	No
Secondary	Change from baseline in patient reported symptoms of sinusitis		16 weeks	No
Secondary	Change from baseline in nasal peak inspiratory flow		16 weeks	No
Secondary	Change from baseline in smell test		16 weeks	No
Secondary	Change from baseline in CT scan		16 weeks	No
Secondary	Time to first response in NPS		16 weeks	No