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Clinical Trial Summary

Primary Objective: To evaluate the efficacy of dupilumab as assessed by the reduction at Week 24 in sinus opacification on computerized tomography (CT) scan in the dupilumab group only Secondary Objectives: - 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 - 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


Clinical Trial Description

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


Study Design


Related Conditions & MeSH terms


NCT number NCT04678856
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 2
Start date December 2, 2020
Completion date January 29, 2024

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