← Back to Search

Monoclonal Antibodies

Dupilumab for Chronic Rhinosinusitis

Phase 4
Waitlist Available
Led By Li-Xing Man, MSc, MD, MPA
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with a diagnosis of CRSwNP including at least 2 of the following symptoms on screening: nasal blockade/obstruction/congestion or nasal discharge, facial pain/pressure, reduction or loss of smell
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 weeks
Awards & highlights

Study Summary

This trial aims to understand why patients with sinus problems may feel better shortly after receiving their first injection of Dupilumab, even though the full effects of the treatment may take months to be seen.

Who is the study for?
This trial is for individuals with chronic rhinosinusitis and nasal polyps who have noticed symptoms improve quickly after starting treatment. Participants must meet certain health requirements, which aren't specified here.Check my eligibility
What is being tested?
The study is examining the immediate effects of Dupilumab on patients with nasal polyps and sinusitis. It aims to understand how cytokine changes, microbiome shifts, and airway function contribute to rapid symptom relief.See study design
What are the potential side effects?
Specific side effects are not detailed here, but Dupilumab may commonly cause injection site reactions, eye issues like dryness or irritation, headaches, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have chronic sinusitis with nasal polyps and experience at least two symptoms like nasal blockage, discharge, facial pain, or loss of smell.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean change in concentration of IgE (IU/mL)
Secondary outcome measures
Mean change in active Staph Aureus collected via nasal swabs
Mean change in concentration of markers of mucin type contributing to sinonasal inflammation (ng/mL)
Mean change in concentration of markers of neutrophil activity contributing to sinonasal inflammation (ng/mL)
+1 more
Other outcome measures
Mean change in SNOT-22 score
Mean change in UPSIT score
Mean change in oscillometry AX (area under the reactance curve)
+2 more

Side effects data

From 2021 Phase 4 trial • 188 Patients • NCT04033367
9%
Conjunctivitis
7%
Headache
3%
Dermatitis Atopic
2%
Nasopharyngitis
1%
Accidental Overdose
1%
Drug Hypersensitivity
1%
Polyarthritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
OLE Period: Placebo/Dupilumab
DB Period: Placebo
DB Period: Dupilumab
OLE Period: Dupilumab/Dupilumab

Trial Design

1Treatment groups
Experimental Treatment
Group I: DupilumabExperimental Treatment1 Intervention
Two injections of 300mg dupilumab, subcutaneous 14 days apart
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dupilumab
2017
Completed Phase 4
~12230

Find a Location

Who is running the clinical trial?

University of RochesterLead Sponsor
836 Previous Clinical Trials
518,163 Total Patients Enrolled
Li-Xing Man, MSc, MD, MPAPrincipal InvestigatorUniversity of Rochester
2 Previous Clinical Trials
9 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients currently able to participate in this ongoing research study?

"As per the information available on clinicaltrials.gov, this study is not presently seeking participants. The trial was initially posted on January 1st, 2024 and most recently updated on December 18th, 2023. However, it is worth noting that there are currently 77 other trials actively accepting patients at this time."

Answered by AI

Is the participation in this survey limited to individuals who are younger than 45 years?

"Individuals between the ages of 18 and 80 are eligible to participate in this trial."

Answered by AI

Is it possible for me to participate in this medical study?

"Patients aged between 18 and 80, diagnosed with chronic rhinosinusitis, are eligible to participate in this trial. The study aims to enroll approximately five individuals."

Answered by AI

Has Dupilumab received the official endorsement of the FDA?

"Based on its status as an approved treatment and being in Phase 4, our team at Power rates the safety of Dupilumab as a 3."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Early-onset Dupilumab Effects in CRSwNP
Li-Xing Man 2024. "Early-onset Dupilumab Effects in CRSwNP". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06188871.
~3 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top