An Evaluation of Dupilumab in Patients With Severe Eosinophilic Chronic Sinusitis Without Nasal Polyposis

Who is this study for? Patients with severe eosinophilic chronic sinusitis without nasal polyposis
What treatments are being studied? Dupilumab
Status: Active_not_recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The investigators will investigate the efficacy of dupilumab in patients with severe eosinophilic CRSsNP who are resistant to the conventional treatment with intranasal corticosteroids and have significantly extensive disease involving more than 2 sinuses bilaterally in sinus CT scan and Lund-Mackay sinus (LMK) CT score \>=10 at baseline.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age 18 or older

• LMK-CT score ≥ 10 (out of maximum of 24) at screening.

• Bilateral sinusitis with at least more than 2 sinus involvement despite completion of a prior intranasal corticosteroid (INCS) treatment for at least 8 weeks prior to screening

• Presence of at least two of the following symptoms prior to screening:

• Nasal blockage/obstruction/congestion

• Nasal discharge (anterior/posterior nasal drip)

• Facial pain/pressure

• Reduction or loss of smell

• Must have Eosinophilic CRSsNP (blood eos ≥ 200) within 6 months prior to screening

• Able and willing to undergo regular intervention as well as evaluation per study protocol

• Must agree not to participate in a clinical study involving another investigational drug or device throughout the duration of this study

• Must be competent to understand the information given in IRB approved ICF and must sign the form prior to the initiation of any study procedure

Locations
United States
Florida
University of South Florida Asthma, Allergy and Immunology
Tampa
Time Frame
Start Date: 2020-12-17
Completion Date: 2025-07
Participants
Target number of participants: 30
Treatments
Active_comparator: Active drug
Dupilumab 300 mg every other week for 24 weeks
Placebo_comparator: Placebo
Placebo
Sponsors
Leads: University of South Florida

This content was sourced from clinicaltrials.gov