bilaterale nasale polyposis nasal polyposis
Conditions
Interventions
Biweekly subcutaneous injections with dupilumab (300 mg) or or placebo for 24
weeks
dupilumab
efficacy
nasal polyposis
Sponsors
Sanofi-aventis
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Patients with bilateral sinonasal polyposis that despite prior treatment with systemic corticosteroids (SCS) anytime within the past 2 years; and/or have a medical contraindication / intolerance to SCS, and/or had prior surgery for NP at the screening visit, have:;-An endoscopic bilateral NPS of at least 5 out of a maximum score of 8 (with a minimum score of 2 in each nasal cavity).;-Ongoing symptoms (for at least 8 weeks prior to V1) of nasal congestion / blockage / obstruction with moderate or severe symptom severity (score 2 or 3) at V1 and a weekly average severity of greater than 1 at the time of randomization (V2), and another symptom such as loss of smell, rhinorrhea (anterior/posterior).;-Signed written informed consent.
Exclusion criteria
Exclusion criteria: -Patients <18 years of age.;-Patient who has previously been treated in dupilumab studies.;-Patient who has taken:;-Biologic therapy/systemic immunosuppressant to treat inflammatory disease or autoimmune disease (eg, rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis, etc.) within 2 months before V1 or 5 half-lives, whichever is longer.;-Any experimental monoclonal antibody (mAB) within 5 half-lives or within 6 months before V1 if the half-life is unknown.;-Anti-immunoglobulin E (IgE) therapy (omalizumab) within 130 days prior to V1.;-Leukotriene antagonists/modifiers unless patient is on a continuous treatment for at least 30 days prior to V1.;-Initiation of allergen immunotherapy within 3 months prior to V1 or a plan to begin therapy or change its dose during the run-in period or the randomized treatment period.;-Patients who have undergone any intranasal and/or sinus surgery (including polypectomy) within 6 months prior to V1.;-Patients who have had a sinonasal or sinus surgery changing the lateral wall structure of the nose making impossible the evaluation of NPS.;-Patients with conditions/concomitant diseases making them nonevaluable at V1 or for the primary efficacy endpoint such as:;-Antrochoanal polyps.;-Nasal septal deviation that would occlude at least one nostril.;-Acute sinusitis, nasal infection or upper respiratory infection.;-Ongoing rhinitis medicamentosa.;-Allergic granulomatous angiitis (Churg-Strauss syndrome), granulomatosis with polyangiitis (Wegener*s granulomatosis), Young*s syndrome, Kartagener*s syndrome or other dyskinetic ciliary syndromes, concomitant cystic fibrosis.;-Radiologic suspicion, or confirmed invasive or expansive fungal rhinosinusitis.;-Patients with nasal cavity malignant tumor and benign tumors (eg, papilloma, blood boil etc).;-Patients with forced expiratory volume in 1 second (FEV1) 50% or less (of predicted normal).;-Patients receiving concomitant treatment prohibited in the study.;-Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit.;-History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.;-Positive with hepatitis B surface antigen (HBsAg) or hepatitis C antibody at the screening visit.;-Active chronic or acute infection requiring systemic treatment within 2 weeks before the baseline visit.;-Known or suspected history of immunosuppression.;-Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.;-Women unwilling to use adequate birth control, if of reproductive potential and sexually active.;Note: The information listed above is not intended to contain all considerations relevant to a;patient's potential participation in this clinical trial therefore not all inclusion/exclusion criteria are;listed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline at Week 24: * Nasal congestion/obstruction (NC) symptom severity score based on the patient daily morning (AM) assessment. * Nasal polyp score, as assessed by central video recordings of nasal endoscopy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy key secondary - Change in following parameters from baseline at week 24 * total symptom score at Week 24: composite severity score consisting of the patient daily AM assessed nasal congestion, decreased/loss of sense of smell, anterior/posterior rhinorrhea. * UPSIT smell test * severity of decreased/loss of smell * opacification of sinuses assessed by CT scans * sino-nasal outcome test (SNOT-22) - Proportion of patients during study treatment receiving oral corticosteroids for nasal polyposis and/or planned to undergo surgery for nasal polyps. | — |
Countries
The Netherlands
Outcome results
None listed