Nasal Polyps | An Evaluation of Dupilumab in Patients With Nasal Polyposis And Chronic Symptoms Of Sinusitis
Nasal Polyps research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Placebo (for dupilumab)Solution for injection; Subcutaneous injection.
Drug:DupilumabSolution for injection; Subcutaneous injection.
Drug:Mometasone furoate nasal sprayNasal spray, 2 actuations in each nostril twice daily.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
PlaceboPlacebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection every week (QW) from Week 1 to 15 added to Mometasone furoate nasal spray (MFNS).
Dupilumab 300 mg QWDupilumab, 2 Subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection QW from Week 1 to 15 added to MFNS.
Start Date: August 2013
Completed Date: November 2014
Phase: Phase 2
Primary Outcome: Change From Baseline in Bilateral Endoscopic Nasal Polyp Score (NPS) at Week 16
Secondary Outcome: Change From Baseline in Bilateral Endoscopic NPS at Week 16 in Participants With Asthma
Study sponsors, principal investigator, and references
Lead Sponsor: Sanofi
Collaborator: Regeneron Pharmaceuticals
Bachert C, Mannent L, Naclerio RM, Mullol J, Ferguson BJ, Gevaert P, Hellings P, Jiao L, Wang L, Evans RR, Pirozzi G, Graham NM, Swanson B, Hamilton JD, Radin A, Gandhi NA, Stahl N, Yancopoulos GD, Sutherland ER. Effect of Subcutaneous Dupilumab on Nasal Polyp Burden in Patients With Chronic Sinusitis and Nasal Polyposis: A Randomized Clinical Trial. JAMA. 2016 Feb 2;315(5):469-79. doi: 10.1001/jama.2015.19330.