Efficacy of Dupilumab for Patients With Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)

NCT04362501 | Completed Phase 2 FDA Drug

• 1 other identifier: IRB00229130
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

The overarching objective of this study is to determine the clinical effectiveness of dupilumab for the treatment of CRS that includes several potential disease endotypes with the exclusion of the nasal polyp cluster that has previously been determined. The additional information gained from secondary and exploratory outcomes will help provide important insight for applied research studies and may also provide practical guidance to clinicians on how to select patients for treatment.

Conditions

Chronic Sinusitis

Keywords

sinusitis; chronic; treatment; non-polyposis

Outcome Measures

Primary Outcomes (1)

• SNOT-22

  Sino-Nasal Outcome Test (SNOT-22) survey score after six months treatment (range 0-110). Higher score means worse symptoms.

  Every two weeks for six months

Secondary Outcomes (7)

• Mini-RQLQ

  Every two weeks for six months

• UPSIT

  Every two weeks for six months

• Rescue medication

  Every two weeks for six months

• CT Score

  Once at screening and then at six month final visit

• Rhinoscopy Score

  Once at screening and then at six month final visit

Study Arms (2)

dupilumab treatment group

EXPERIMENTAL

dupilumab treatment group

Biological: dupilumab

placebo group

PLACEBO COMPARATOR

placebo group

Drug: placebo

Interventions

dupilumab BIOLOGICAL

300mg dupixent SC every two weeks for six months

Also known as: Dupixent

dupilumab treatment group

placebo DRUG

placebo SC injection every two weeks for six months

placebo group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 with history of chronic sinusitis without polyps
• SNOT-22 score of at least 30 at baseline
• Bilateral Lund-Mackay CT score 4 or more and/or MLK endoscopy score 4 or more
• Blood eosinophil count of at least 300/ul and/or SPT positive to at least 5/30 allergens, or eosinophil less than 300/ul and SPT negative (Th2 low group).
• Prior oral steroid or antibiotic use is acceptable but not required for entry
• Informed Consent
• Effective birth control (with \<1% failure rate), post menopausal or documented abstinence
• Women ≥50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatment.
• All male subjects who are sexually active must agree to use an acceptable method of contraception (condom or vasectomy) from V1-V16

You may not qualify if:

• Immunosuppression other than oral steroids in the past 3 months
• History of nasal polyps within the past 3 years or noted at screening by CT or endoscopy
• Acute sinusitis at the time of entry
• Acute fungal sinusitis at the time of entry
• Uncontrolled asthma
• Cystic fibrosis
• Primary immune deficiency including CVID
• Other; serious concomitant illness or sinus disease that the investigator determines to disqualify
• A history of known immunodeficiency disorder including HIV
• History of hepatitis B or C
• Primary ciliary dyskinesia (PCD)
• Use of any biologic medication within the last 5 months or 5 half-lives whichever is longer
• Receipt of any investigational non-biologic within 5 half-lives prior to visit 0
• Receipt of immunoglobulin or blood products within 30 days prior to V1
• Scheduled sinus surgery

Sponsors & Collaborators

• Johns Hopkins University: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Sinusitis; Bronchiolitis Obliterans Syndrome

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• Jody Tversky

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: double blind randomized placebo controlled

Study Record Dates

• First Submitted: April 21, 2020
• First Posted: April 27, 2020
• Study Start: October 15, 2020
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: November 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)