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Dupilumab in CRSsNP

NCT04678856 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2025-02-10

Study results available
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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

Conditions

  • Chronic Rhinosinusitis Without Nasal Polyps
  • Sinusitis
  • Chronic Sinusitis
  • Sinus Disorder
  • Respiratory Disorder

Interventions

DRUG

Dupilumab SAR231893

Pharmaceutical form:Injection solution Route of administration: Subcutaneous

DRUG

Placebo

Pharmaceutical form:Injection solution Route of administration: Subcutaneous

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-02
Primary Completion
2023-11-14
Completion
2024-01-29
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belgium
  • Canada
  • Chile
  • China
  • Hungary
  • Portugal
  • Russia
  • South Korea
  • Spain
  • Sweden
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04678856 on ClinicalTrials.gov