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

Korábbi kezelés

• Immunosuppression other than oral steroids in the past 3 months
• Other; serious concomitant illness or sinus disease that the investigator determines to disqualify
• 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
• Untreated helminth parasitic infection within 24 weeks prior to informed consent
• 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

Más betegség

• History of nasal polyps within the past 3 years or noted at screening by CT or endoscopy
• A history of known immunodeficiency disorder including HIV
• History of hepatitis B or C
• Symptomatic or untreated life threatening cardiopulmonary disorders
• History of cancer not in remission at least 5 years prior to the date informed consent
• Any other medical illness that precludes study involvement
• History of anaphylaxis to any biologic therapy or vaccine

Egyéb

• Acute sinusitis at the time of entry
• Acute fungal sinusitis at the time of entry
• Uncontrolled asthma
• Cystic fibrosis
• Primary immune deficiency including CVID
• Primary ciliary dyskinesia (PCD)
• Significant structural abnormalities or severe septal deviation
• Subjects who are febrile (≥38°C; ≥100.4°F);
• Pregnant or nursing

• 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