Dupilumab in CRSsNP

The duration of study for each participant will include 2-4 weeks of screening period, randomized investigational medicinal product (IMP) intervention period (52 weeks in Part A and 24 weeks in Part B) and 12 weeks of follow-up period.

A Randomized, Double-blind, Placebo-controlled, 2-part Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Uncontrolled, Chronic Rhinosinusitis Without Nasal Polyposis (CRSsNP)

Primary Objective: Part A and B: To evaluate the efficacy of dupilumab as assessed by the reduction at Week 24 in sinus opacification on 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 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 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 To evaluate the effects of dupilumab on transcriptomic signatures associated with CRSsNP and type 2 inflammation 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 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 safety and tolerability of dupilumab in CRSsNP patients compared to placebo To evaluate the PK of dupilumab in CRSsNP patients compared to placebo Immunogenicity to dupilumab in patients with CRSsNP, as determined by the incidence, titer, and neutralizing antibody (Nab) status of treatment-emergent anti-drug antibody (ADA) responses over time compared to placebo To evaluate the effects of dupilumab on transcriptomic signatures associated with CRSsNP and type 2 inflammation

Dupilumab in CRSsNP

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