Dupilumab Severe Eosinophilic Chronic Sinusitis Without Nasal Polyposis

  • STATUS
    Recruiting
  • End date
    Dec 16, 2022
  • participants needed
    30
  • sponsor
    University of South Florida
Updated on 16 August 2021

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.

Description

The investigators will use high blood eosinophils (>=200) as a biomarker for eosinophilic CRSsNP and 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. In addition, the investigators will have a prespecified enrollment goal of at least 50% of patients with type 2 inflammatory diseases such as asthma, allergic rhinitis, and/or atopic dermatitis on the basis of patient-reported history and will stratify subject numbers between dupilumab treatment and placebo group.

Details
Condition Severe Eosinophilic Chronic Sinusitis Without Nasal Polyposis
Treatment Placebo, Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]
Clinical Study IdentifierNCT04430179
SponsorUniversity of South Florida
Last Modified on16 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Age < 18
With CRS with nasal polyps
Treated in any clinical trial of dupilumab
Has taken
Biologic therapy/systemic immunosuppressant to treat inflammatory disease or autoimmune disease (eg, rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis, etc) within 2 months before screening or 5 half-lives, whichever is longer
An experimental monoclonal antibody within five half-lives or within 6 months before screening if the half-life is unknown
Anti-immunoglobulin E (IgE) therapy (omalizumab) within 130 days prior to screening
Leukotriene antagonists/modifiers unless patient is on a continuous treatment for at least 30 days prior to screening
Initiation of allergen immunotherapy within 3 months prior to screening or a plan to begin therapy or change its dose during the run-in period or the randomized treatment period
Have had a sino-nasal surgery changing the lateral wall structure of the nose making impossible the evaluation of NPS
Patients with conditions/concomitant diseases making them non-evaluable at screening or for the primary efficacy endpoint such as
Antrochoanal polyps
Nasal septal deviation that would occlude at least one nostril
Acute sinusitis, nasal infection or upper respiratory infection at screening
Ongoing rhinitis medicamentosa
Allergic granulomatous angiitis (Churg-Strauss syndrome), granulomatosis with polyangiitis (Wegener's granulomatosis), Young's syndrome, Kartagener's syndrome or other dyskinetic ciliary syndromes, concomitant cystic fibrosis
Radiologic suspicion, or confirmed invasive or expansive fungal rhinosinusitis
With co-morbid asthma are excluded if forced expiratory volume (FEV1) is 50% (of predicted normal) or less
With known active bacterial, viral, fungal, mycobacterial infection, or other infection or any major episode of infection that required hospitalization or treatment with IV antibiotics within 30 days of screening or during screening or oral antibiotics within 14 days prior to screening. Fungal infection of nail beds is allowed
Have human immunodeficiency virus/acquired immune deficiency syndrome
Have acute or chronic hepatitis B/hepatitis C infection
History of an opportunistic infection (eg, pneumocystis carinii, cryptococcal meningitis, progressive multifocal leukoencephalopathy) or serious bacterial, viral, or fungal infections (eg, disseminated herpes simplex, disseminated herpes zoster) and requiring IV medication(s) 3 weeks prior to randomization
History of or currently active primary or secondary immunodeficiency
History of cancer within the last 5 years, including solid tumors and hematological malignancies (except basal cell and in situ squamous cell carcinomas of the skin that have been excised and resolved) or colonic mucosal dysplasia
History of lymphoproliferative disorder, lymphoma, leukemia, myeloproliferative disorder, or multiple myeloma
History of alcohol or drug abuse within 1 year prior to randomization
Receipt of live vaccine within 4 weeks prior to randomization
Pregnant or breastfeeding
Participation in another clinical study or treatment with an investigational drug or device
Serious or active medical or psychiatric condition which, in the opinion of the Investigator, may interfere with treatment, assessment, or compliance with the protocol
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