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Completed Phase 2 Interventional Results available

Dupilumab in CRSsNP

ClinicalTrials.gov ID: NCT04678856

Public ClinicalTrials.gov record NCT04678856. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 27, 2026, 1:08 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT04678856
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Sanofi
Industry
Enrollment
71 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 2, 2020 (Actual)
Primary completion
Nov 14, 2023 (Actual)
Completion
Jan 29, 2024 (Actual)
Last update posted
Jul 30, 2026

2020 – 2024

United States locations

U.S. sites
11
U.S. states
8
U.S. cities
10
Facility City State ZIP Site status
Sacramento Ear, Nose & Throat Site Number : 8400010 Roseville California 95661 —
Bensch Clinical Research LLC Site Number : 8400015 Stockton California 95207 —
Colorado Allergy and Asthma Centers, PC Site Number : 8400003 Denver Colorado 80230 —
University of Missouri Health System Site Number : 8400016 Columbia Missouri 65212 —
Nebraska Medical Research Institute Site Number : 8400007 Papillion Nebraska 68046 —
Optimed Research, LTD Site Number : 8400017 Columbus Ohio 43235 —
Vital Prospects Clinical Research Institute, P.C. Site Number : 8400004 Tulsa Oklahoma 74136 —
Essential Medical Research, LLC Site Number : 8400014 Tulsa Oklahoma 74137 —
Pharmaceutical Research & Consulting, Inc. Site Number : 8400006 Dallas Texas 75231 —
Alamo ENT Associates Site Number : 8400021 San Antonio Texas 78258 —
Eastern Virginia Medical School (EVMS) Medical Group - Otola Site Number : 8400009 Norfolk Virginia 23507 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 47 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04678856, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 30, 2026 · Synced Oct 27, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04678856 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →