Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Double-blind, 52-week, Placebo Controlled Efficacy and Safety Study of Dupilumab, in Patients With Bilateral Nasal Polyposis on a Background Therapy With Intranasal Corticosteroids
Brief Summary: Primary Objective:

To evaluate the efficacy of dupilumab 300 mg every 2 weeks (q2w) compared to placebo on a background of mometasone furoate nasal spray (MFNS) in reducing nasal congestion (NC)/obstruction severity and endoscopic nasal polyp score (NPS) in participants with bilateral nasal polyps (NP). In addition for Japanese participants, reduction in computed tomography (CT) scan opacification of the sinuses was a co-primary objective.

Secondary Objectives:

* To evaluate the efficacy of dupilumab in improving total symptoms score.
* To evaluate the efficacy of dupilumab in improving sense of smell.
* To evaluate the efficacy of dupilumab in reducing CT scan opacification of the sinuses (primary objective for Japanese participants).
* To evaluate ability of dupilumab in reducing proportion of participants who required treatment with systemic corticosteroids (SCS) or surgery for NP.
* To evaluate the effect of dupilumab on participant reported outcomes and health related quality of life.
* To evaluate the efficacy of dupilumab 300 mg q2w up to Week 52.
* To evaluate the efficacy of dupilumab 300 mg q2w up to Week 24 followed by 300 mg every 4 weeks (q4w) up to Week 52.
* To evaluate the effect of dupilumab in the subgroups of participants with prior surgery and comorbid asthma including non-steroid anti-inflammatory drug exacerbated respiratory disease.
* To evaluate the safety of dupilumab in participants with bilateral NP.
* To evaluate functional dupilumab concentrations (systemic exposure) and incidence of treatment emergent anti-drug antibodies.


Options:
A: Arm Label: Dupilumab 300 mg q2w; Type: EXPERIMENTAL; Interventions: Drug: Dupilumab, Drug: ICS/LABA therapy, Drug: Salbutamol/albuterol, Drug: Levosalbutamol/levalbuterol | Arm Label: Dupilumab 200 mg q2w; Type: EXPERIMENTAL; Interventions: Drug: Dupilumab, Drug: ICS/LABA therapy, Drug: Salbutamol/albuterol, Drug: Levosalbutamol/levalbuterol | Arm Label: Dupilumab 300 mg q4w; Type: EXPERIMENTAL; Interventions: Drug: Dupilumab, Drug: placebo, Drug: ICS/LABA therapy, Drug: Salbutamol/albuterol, Drug: Levosalbutamol/levalbuterol | Arm Label: Dupilumab 200 mg q4w; Type: EXPERIMENTAL; Interventions: Drug: Dupilumab, Drug: placebo, Drug: ICS/LABA therapy, Drug: Salbutamol/albuterol, Drug: Levosalbutamol/levalbuterol | Arm Label: Placebo q2w; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo, Drug: ICS/LABA therapy, Drug: Salbutamol/albuterol, Drug: Levosalbutamol/levalbuterol | Intervention Type: DRUG; Name: Dupilumab; Assigned to Arm(s): Dupilumab 200 mg q2w, Dupilumab 200 mg q4w, Dupilumab 300 mg q2w, Dupilumab 300 mg q4w | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): Dupilumab 200 mg q4w, Dupilumab 300 mg q4w, Placebo q2w | Intervention Type: DRUG; Name: ICS/LABA therapy; Assigned to Arm(s): Dupilumab 200 mg q2w, Dupilumab 200 mg q4w, Dupilumab 300 mg q2w, Dupilumab 300 mg q4w, Placebo q2w | Intervention Type: DRUG; Name: Salbutamol/albuterol; Assigned to Arm(s): Dupilumab 200 mg q2w, Dupilumab 200 mg q4w, Dupilumab 300 mg q2w, Dupilumab 300 mg q4w, Placebo q2w | Intervention Type: DRUG; Name: Levosalbutamol/levalbuterol; Assigned to Arm(s): Dupilumab 200 mg q2w, Dupilumab 200 mg q4w, Dupilumab 300 mg q2w, Dupilumab 300 mg q4w, Placebo q2w
B: Arm Label: Dupilumab 300 mg q2w; Type: EXPERIMENTAL; Interventions: Drug: Dupilumab SAR231893 (REGN668), Drug: Mometasone furoate nasal spray | Arm Label: Dupilumab 300 mg q2w then q4w; Type: EXPERIMENTAL; Interventions: Drug: Dupilumab SAR231893 (REGN668), Drug: Placebo, Drug: Mometasone furoate nasal spray | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Drug: Mometasone furoate nasal spray | Intervention Type: DRUG; Name: Dupilumab SAR231893 (REGN668); Assigned to Arm(s): Dupilumab 300 mg q2w, Dupilumab 300 mg q2w then q4w | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Dupilumab 300 mg q2w then q4w, Placebo | Intervention Type: DRUG; Name: Mometasone furoate nasal spray; Assigned to Arm(s): Dupilumab 300 mg q2w, Dupilumab 300 mg q2w then q4w, Placebo
C: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Reslizumab 3.0 mg/kg; Type: EXPERIMENTAL; Interventions: Drug: Reslizumab | Intervention Type: DRUG; Name: Reslizumab; Assigned to Arm(s): Reslizumab 3.0 mg/kg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
D: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Drug: Mometasone furoate 50 micrograms | Arm Label: Dupilumab 300 mg; Type: EXPERIMENTAL; Interventions: Drug: Dupilumab SAR231893 (REGN668), Drug: Mometasone furoate 50 micrograms | Intervention Type: DRUG; Name: Dupilumab SAR231893 (REGN668); Assigned to Arm(s): Dupilumab 300 mg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: Mometasone furoate 50 micrograms; Assigned to Arm(s): Dupilumab 300 mg, Placebo

Answer: B