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

Completed · Phase 2 · Has a placebo group

Conditions studied: Nasal Polyps

In brief

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.

Key facts

Study ID

NCT01920893

Run by

Sanofi

People needed

60

Starts

2013-08-01

Expected to finish

2014-11-01

Last updated by the study team

2017-06-26

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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.

Where it is running

• Investigational Site Number 840014 — Rolling Hills Estates, California, United States
• Investigational Site Number 840015 — Denver, Colorado, United States
• Investigational Site Number 840013 — Boston, Massachusetts, United States
• Investigational Site Number 840002 — Lake Oswego, Oregon, United States
• Investigational Site Number 840009 — Pittsburgh, Pennsylvania, United States
• Investigational Site Number 056001 — Ghent, Belgium
• Investigational Site Number 056002 — Leuven, Belgium
• Investigational Site Number 724001 — Barcelona, Spain
• Investigational Site Number 724003 — Faitanar, Spain
• Investigational Site Number 724005 — Jerez de la Frontera, Spain
• Investigational Site Number 724002 — L'Hospitalet de Llobregat, Spain
• Investigational Site Number 724004 — Madrid, Spain
• Investigational Site Number 752001 — Stockholm, Sweden
• Investigational Site Number 752002 — Stockholm, Sweden

Full record on ClinicalTrials.gov

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