Primary Objective:
Part A and B: To evaluate the efficacy of dupilumab as assessed by the reduction at Week 24
in sinus opacification on computerized tomography (CT) scan and sinus total symptom score
(sTSS) compared to placebo
Secondary Objectives:
Part A
- To evaluate the efficacy of dupilumab as assessed by the reduction at Week 52 in sinus
opacification on CT scan and total symptom score (sTSS) compared to placebo
- To evaluate the efficacy of dupilumab in improving CRSsNP symptoms at Weeks 24 and 52
compared to placebo
- To evaluate the effect of dupilumab on health related quality of life at Weeks 24 and 52
(HRQoL) compared to placebo
- To evaluate the effect of dupilumab on CRSsNP overall disease severity at Weeks 24 and
52 compared to placebo
- To evaluate the effect of dupilumab at Weeks 24 and 52 in the subgroups of participants
with comorbid asthma compared to placebo
- To evaluate the ability of dupilumab to reduce the incidence of participants with CRSsNP
worsening/acute sinusitis who require treatment with antibiotics, systemic
corticosteroids (SCS) or sinus surgery compared to placebo
- To evaluate the effects of dupilumab on transcriptomic signatures associated with CRSsNP
and type 2 inflammation
- To evaluate the effect of dupilumab in the subgroup of participants with screening blood
eosinophils count ≥300 cells/mm3 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
Part B
- To evaluate the efficacy of dupilumab in improving CRSsNP symptoms at Week 24 compared
to placebo in patients
- To evaluate the effect of dupilumab on health related quality of life (HRQoL) compared
to placebo
- To evaluate the effect of dupilumab on CRSsNP overall disease severity compared to
placebo
- To evaluate the effect of dupilumab in the subgroups of participants with comorbid
asthma compared to placebo
- To evaluate the ability of dupilumab to reduce the incidence of participants with CRSsNP
worsening/acute sinusitis who require treatment with antibiotics, SCS, or sinus surgery
compared to placebo
- To evaluate the effects of dupilumab on transcriptomic signatures associated with CRSsNP
and type 2 inflammation
- 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