Efficacy of Dupilumab for Patients With Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP): a Randomized Double Blind Placebo Controlled Phase II Study

IRB00229130

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.

2020-10-15

2024-10-15

2024-10-15

Recruiting

Early phase I

50

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'double blind randomized placebo controlled', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}

2023-10-13