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Sponsor: Sanofi
Conditions: Chronic Rhinosinusitis Without Nasal Polyps, Sinusitis, Chronic Sinusitis, Sinus Disorder, Respiratory Disorder
Interventions: Dupilumab SAR231893, Placebo
Countries: United States, Argentina, Belgium, Canada, Chile, China, Hungary, Portugal
Primary Objective: To evaluate the efficacy of dupilumab as assessed by the reduction at Week 24 in sinus opacification on computerized tomography (CT) scan in the dupilumab group only Secondary Objectives: * To evaluate the efficacy of dupilumab as assessed by the reduction at Week 24 in sinus opacification on CT scan and sinus total symptom score (sTSS) compared to placebo * To evaluate the safety and tolerability of dupilumab in CRSsNP patients compared to placebo * To evaluate the pharmacokinetics (PK) of dupilumab in CRSsNP patients compared to placebo * Assessment of immunogenicity to dupilumab over time compared to placebo
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * Participant must be at least 18 years of age at the time of signing the informed consent form (ICF). * Participants must have bilateral inflammation of paranasal sinuses in CT scan with LMK ≥8 and bilateral ethmoid opacification before randomization. * Participants must have ongoing symptoms of loss of smell and rhinorrhea (anterior/posterior) of any severity, with or without facial pain/pressure for at least 12 consecutive weeks by Visit 1. * Participants must have ongoing symptoms of nasal congestion (NC)/obstruction at least 12 consecutive weeks before Visit 1 and a NC score of ≥ 2 at Visit 1 (day score) and Visit 2 (weekly average score). * Participants must have sTSS (NC, rhinorrhea, facial pain/pressure) ≥5 at Visit 1 (day score) and Visit 2 (weekly average score). * Participants must have one of the 2 following features: * Prior sinonasal surgery (see note at end of section 5.2 for definitions of sinonasal surgery) for CRS, * Treatment with systemic corticosteroids (SCS) therapy for CRS as defined by any dose and duration within the prior 2 years before screening (Visit 1) or intolerance/contraindication to SCS. Exclusion Criteria: * Participants with nasal conditions/concomitant nasal diseases such as nasal polyposis in endoscopy at Visit 1 or with history of nasal polyposis etc., making them non-evaluable at Visit 1 or for the primary efficacy * Nasal cavity malignant tumor and benign tumors. * Forced expiratory volume (FEV1) ≤50% of predicted normal at Visit 1. * Radiologic suspicion or confirmed invasive or expansive fungal rhinosinusitis. * Severe concomitant illness(es) that, in the investigator's judgment, would adversely affect participation in the study * Active tuberculosis or non-tuberculous mycobacterial infection, or a history of incompletely treated tuberculosis unless documented adequately treated. * Diagnosed active endoparasitic infections; suspected or high risk of endoparasitic infection * Known or suspected immunodeficiency * History of malignancy within 5 years before Visit 1, except completely treated in situ carcinoma of the cervix, and completely treated and resolved nonmetastatic squamous or basal cell carcinoma of the skin. * Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals within 2 weeks before the Screening Visit 1 or during the screening period. * History of systemic hypersensitivity or anaphylaxis to dupilumab or any of its excipients. * Participants in prior dupilumab clinical trial or have been treated with commercially available dupilumab within 12 months or who discontinued dupilumab use due to adverse event. * Participants who are treated with intranasal corticosteroid drops; intranasal steroid emitting devices/stents; nasal spray using exhalation delivery system, such as Xhance™, during screening period. * Participants on unstable dose of intranasal corticosteroids (INCS) spray 4 weeks prior to Screening Visit (Visit1) and during screening period. * Participants who have undergone sinus intranasal surgery (including polypectomy) within 6 months prior to Visit 1. * Participants who have taken: * Biologic therapy/systemic immunosuppressant to treat inflammatory disease or autoimmune disease within 5 half-lives prior to Visit 1 * Any investigational mAb within 5 half-lives prior to Visit 1 * Anti-IgE therapy (omalizumab) within 4 months prior to Visit 1. * Treatment with a live (attenuated) vaccine within 4 weeks prior to Visit 1 * Leukotriene antagonists/modifiers unless participant is on a continuous treatment for at least 30 days prior to Visit 1. * Initiation of allergen immunotherapy within 3 months prior to Visit 1 or a plan to begin therapy or change its dose during the screening or treatment period. * Participants received SCS during screening period (between Visit 1 and Visit 2). * Either intravenous immunoglobulin therapy and/or plasmapheresis within 30 days prior to Screening Visit (Visit 1). The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
- Roseville, California, United States
- Stockton, California, United States
- Denver, Colorado, United States
- Columbia, Missouri, United States
- Papillion, Nebraska, United States
- Columbus, Ohio, United States
- Tulsa, Oklahoma, United States
- Tulsa, Oklahoma, United States
- Dallas, Texas, United States
- San Antonio, Texas, United States
- Norfolk, Virginia, United States
- Buenos Aires, Argentina
- Ciudad Autonoma Buenos Aires, Argentina
- Ciudad Autonoma Buenos Aires, Argentina
- Ghent, Belgium
- Leuven, Belgium
- Vancouver, British Columbia, Canada
- Hamilton, Ontario, Canada
- Kingston, Ontario, Canada
- London, Ontario, Canada
- Montreal, Quebec, Canada
- Montreal, Quebec, Canada
- Trois-Rivières, Quebec, Canada
- Québec, Canada
- Québec, Canada
- Santiago, Reg Metropolitana de Santiago, Chile
- Beijing, China
- Changchun, China
- Changsha, China
- Chongqing, China
- + 28 more on CT.gov