A Controlled Clinical Study of Dupilumab in Patients with Nasal Polyps

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 240

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 437
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 43

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.
-Patients who are receiving leukotriene antagonists/modifiers at V1 unless they are 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.