Chronic Rhinosinusitis Phenotype With Nasal Polyps (CRSwNP) Clinical Trial
Official title:
A Randomized, 24-Week Treatment, Double-blind, Placebo-controlled Efficacy and Safety Study of Dupilumab 300 mg Every Other Week, in Patients With Bilateral Nasal Polyposis on a Background Therapy With Intranasal Corticosteroids
Primary Objective:
To evaluate the efficacy of dupilumab 300 milligram (mg) every 2 weeks (q2w) compared to
placebo on a background of mometasone furoate nasal spray (MFNS) in reducing nasal
congestion/obstruction (NC) severity and endoscopic nasal polyp score (NPS) in participants
with bilateral nasal polyposis (NP). In addition for Japan participants, reduction in
computed tomography (CT) scan opacification of the sinuses was a coprimary objective.
Secondary Objectives:
- To evaluate the efficacy of dupilumab in improving total symptoms score (TSS).
- 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 Japan).
- To evaluate ability of dupilumab in reducing proportion of participants requiring
treatment with systemic corticosteroids or NP surgery.
- To evaluate the effect of dupilumab on participant reported outcomes and health related
quality of life outcome by sinonasal outcome test-22 (SNOT-22).
- To evaluate the effect of dupilumab in the subgroups of participants with prior surgery
and co-morbid asthma (including non-steroid antiinflammatory drug [NSAID] exacerbated
respiratory disease [ERD]).
- To evaluate residual effect in follow up.
- 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 expected to be up to 52 weeks that consisted of a 4-weeks run-in period, 24-weeks treatment period, and a 24-weeks post treatment period. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02898454 -
Controlled Clinical Study of Dupilumab in Patients With Nasal Polyps
|
Phase 3 |