Dupilumab in CRSsNP
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.
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
- Enrollment
- 71 participants
Conditions and interventions
Conditions
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 1, 2020
- Primary completion
- Nov 13, 2023
- Completion
- Jan 28, 2024
- Last update posted
- Jul 29, 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 29, 2026 · Synced Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04678856 live on ClinicalTrials.gov.