Chronic Rhinosinusitis Phenotype With Nasal Polyps (CRSwNP) Clinical Trial
Official 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
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.
The total study duration per participant was up to 68 weeks that consisted of a 4-weeks run-in period, 52-weeks treatment period, and a 12-weeks post treatment period. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02912468 -
A Controlled Clinical Study of Dupilumab in Patients With Bilateral Nasal Polyps
|
Phase 3 |