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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04362501
Recruitment Status : Not yet recruiting
First Posted : April 27, 2020
Last Update Posted : April 27, 2020
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Chronic Sinusitis Biological: dupilumab Drug: placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: double blind randomized placebo controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Dupilumab for Patients With Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP): a Randomized Double Blind Placebo Controlled Phase II Study
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : June 1, 2023
Estimated Study Completion Date : June 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis
Drug Information available for: Dupilumab

Arm Intervention/treatment
Experimental: dupilumab treatment group
dupilumab treatment group
Biological: dupilumab
300mg dupixent SC every two weeks for six months
Other Name: Dupixent

Placebo Comparator: placebo group
placebo group
Drug: placebo
placebo SC injection every two weeks for six months




Primary Outcome Measures :
  1. SNOT-22 [ Time Frame: Every two weeks for six months ]
    Sino-Nasal Outcome Test (SNOT-22) survey score after six months treatment (range 0-110). Higher score means worse symptoms.


Secondary Outcome Measures :
  1. Mini-RQLQ [ Time Frame: Every two weeks for six months ]
    Mini-RQLQ (Rhinoconjunctivitis Quality of Life) validated survey (0-84). Higher score means worse symptoms.

  2. UPSIT [ Time Frame: Every two weeks for six months ]
    University of Pennsylvania Smell Identification Test (UPSIT) smell test (0-40). Higher score means better sense of smell.

  3. Rescue medication [ Time Frame: Every two weeks for six months ]
    Rescue medication use of corticosteroids. Specifically, prednisone mg use total over six month period.

  4. CT Score [ Time Frame: Once at screening and then at six month final visit ]
    Sinus CT Lund-Mackay (LM) score (0-24). Higher score means larger polyps.

  5. Rhinoscopy Score [ Time Frame: Once at screening and then at six month final visit ]
    Rhinoscopy modified Lund-Kennedy (MLK) score (0-12). Higher score means worse sinus disease.

  6. Drop out rate rate [ Time Frame: Continuous during entire length of study which is three years. ]
    Number of patients who leave the study. Individual participants will be considered to have dropped out if they leave the study for any reason during the six month treatment period. A total count will be collected over the entire study length estimated to be three years. This number will be divided by the total enrollment number to determine the rate of drop out.

  7. Adverse event rate [ Time Frame: Continuous during entire length of study which is three years. ]
    Significant Adverse Reactions (SAE). Individual participants will be monitored for serious adverse events during the six month treatment period. A total count will be collected over the entire study length estimated to be three years. This number will be divided by the total enrollment number to determine the rate of adverse events.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Significant structural abnormalities or severe septal deviation
  • Symptomatic or untreated life threatening cardiopulmonary disorders
  • History of cancer not in remission at least 5 years prior to the date informed consent
  • Subjects who are febrile (≥38°C; ≥100.4°F);
  • Untreated helminth parasitic infection within 24 weeks prior to informed consent
  • Pregnant or nursing
  • Any other medical illness that precludes study involvement
  • History of anaphylaxis to any biologic therapy or vaccine
  • The following medications are excluded:

    • Any type of anti-interleukin therapy (e.g. Omalizumab, benralizumab, dupilumab mepolizumab, reslizumab, lebrikizumab etc.) within the last 5 months or 5 half-lives whichever is longer
    • Receipt of any investigational non-biologic within 30 days or 5 half-lives prior to visit 0, whichever is longer.
    • Immunosuppressive medications such as methotrexate, azathioprine, cyclosporine, tacrolimus
    • Receipt of immunoglobulin or blood products within 30 days prior to the date informed consent is obtained.
    • Daily high dose aspirin greater than 81mg daily
    • Allergen Immunotherapy during build-up phase during the last three months
    • Other medications that could interfere with the action of dupilumab or suppress eosinophils

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04362501


Contacts
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Contact: Jeanne Hoddinott 4105508017 hoddin1@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Jody Tversky Johns Hopkins University
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT04362501    
Other Study ID Numbers: IRB00229130
First Posted: April 27, 2020    Key Record Dates
Last Update Posted: April 27, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Johns Hopkins University:
sinusitis
chronic
treatment
non-polyposis
Additional relevant MeSH terms:
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Sinusitis
Nasal Polyps
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Polyps
Pathological Conditions, Anatomical