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| ID | Type | Description | Link |
|---|---|---|---|
| U19AI095219 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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The overall aim of the study is to determine the clinical efficacy and mechanisms of action of anti-IL-4a (dupilumab) as treatment for patients with Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP) and Aspirin-Exacerbated Respiratory Disease (AERD).
The protocol involves an 8-week study of dupilumab in patients with CRSwNP and/or AERD. Participants will have 4 total doses of dupilumab administered, with each dose administered every 2 weeks. There will be full clinical assessments and biospecimen collections at Baseline (Visit 1), Week 2 (Visit 2), and Week 8 (Visit 3).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dupilumab | Experimental | Subjects will receive dupilumab (300mg every-other-week for 8 weeks). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dupilumab | Drug | 8-week trial of dupilumab (an anti-IL-4a) in patients with AERD. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Nasal fluid levels of LTE4 | The nasal fluid levels of LTE4 will be measured at week 8 and will serve as a surrogate biomarker of respiratory mast cell activation or burden. | At Week 8 (Visit 3) |
| Measure | Description | Time Frame |
|---|---|---|
| Nasal fluid levels of albumin | The nasal fluid levels of albumin will be measured at week 8 and serve as a surrogate biomarker of nasal epithelial cell integrity. | At Week 8 (Visit 3) |
| Sense of smell - University of Pennsylvania Smell Identification Test (UPSIT) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in sense of smell - University of Pennsylvania Smell Identification Test (UPSIT) | Change from Visit 1 to Visit 2 and from Visit 1 to Visit 3 in UPSIT. The UPSIT scale goes from 0 to 40, with 0 being worse (no scents identified) and 40 being best (all scents identified) | 2 weeks (between Visit 1 and Visit 2) and 8 weeks (between Visit 1 and Visit 3) |
Key Inclusion Criteria:
History of AERD, defined as meeting the diagnostic triad with:
Visible nasal polyps bilaterally on otoscope physical exam at the time of screening.
Evidence of sense of smell impairment, with a University of Pennsylvania Smell Identification Test (UPSIT) score of <34.
Stable asthma (no glucocorticoid burst for at least 4 weeks prior to Visit 1, and no hospitalizations or ER visits for asthma for at least the prior 3 months).
Consistent (daily) use of an intranasal steroid for at least 4 weeks prior to Screening.
No current smoking (not more than one instance of smoking in the last 3 months).
For females: Practicing FDA-approved methods of birth control for the duration of the study. Female participants of childbearing potential must have a negative pregnancy test upon study entry.
Key Exclusion Criteria:
Note: Other inclusion and exclusion criteria apply.
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| Name | Affiliation | Role |
|---|---|---|
| Tanya M Laidlaw, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 11, 2023 | Sep 10, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009298 | Nasal Polyps |
| D055963 | Asthma, Aspirin-Induced |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D011127 | Polyps |
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| ID | Term |
|---|---|
| C582203 | dupilumab |
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Patients' sense of smell will be assessed at week 8 using the UPSIT. The UPSIT scale goes from 0 to 40, with 0 being worse (no scents identified) and 40 being best (all scents identified) |
| At Week 8 (Visit 3) |
| Rhinoscopic Total Polyp Score (TPS) | The extent of patients' nasal polyps will be assessed at week 8 using a TPS. The TPS scale goes from 0 (no polyps) to 8 (large polyps bilaterally), with 0 being best and 8 being worst. | At Week 8 (Visit 3) |
| Peak Nasal Inspiratory Flow (PNIF) | Patients' nasal congestion will be assessed at week 8 by a PNIF. PNIF goes from 0 mL (no airflow) to 500 mL of airflow, with 0 being worst. | At Week 8 (Visit 3) |
| Quality of life - 22-Item Sino-Nasal Outcome Test (SNOT-22) | Quality of life will be assessed at week 8 with a SNOT-22. For the SNOT-22, the scores range from 0 (no symptoms, excellent disease control) to 110 (maximum sinus symptoms, poor disease control). | At Week 8 (Visit 3) |
| Lung function - Forced Expiratory Volume 1 (FEV1) | Patients' lung function will be assessed at week 8 with an FEV1. | At Week 8 (Visit 3) |
| Asthma control - Asthma Control Questionnaire-6 (ACQ-6) | Asthma control will be measured at week 8 with an ACQ-6. For the ACQ-6, scores ranging from 0 (well-controlled) to 6 (extremely poorly-controlled). A lower score indicates better asthma control. | At Week 8 (Visit 3) |
| Number of treatment-related adverse events (AEs) and serious adverse events (SAEs) leading to study drug discontinuation | Safety will be measured by the number of treatment-related AEs and SAEs leading to dupilumab discontinuation. | At Week 8 (Visit 3) |
| Change in Rhinoscopic Total Polyp Score (TPS) | Change from Visit 1 to Visit 2 and from Visit 1 to Visit 3 in TPS. The TPS scale goes from 0 (no polyps) to 8 (large polyps bilaterally), with 0 being best and 8 being worst. | 2 weeks (between Visit 1 and Visit 2) and 8 weeks (between Visit 1 and Visit 3) |
| Change in Peak Nasal Inspiratory Flow (PNIF) | Change from Visit 1 to Visit 2 and from Visit 1 to Visit 3 in PNIF. PNIF goes from 0 mL (no airflow) to 500 mL of airflow, with 0 being worst. | 2 weeks (between Visit 1 and Visit 2) and 8 weeks (between Visit 1 and Visit 3) |
| Change in 22-Item Sino-Nasal Outcome Test (SNOT-22) | Change from Visit 1 to Visit 2 and from Visit 1 to Visit 3 in SNOT-22. For the SNOT-22, the scores range from 0 (no symptoms, excellent disease control) to 110 (maximum sinus symptoms, poor disease control). | 2 weeks (between Visit 1 and Visit 2) and 8 weeks (between Visit 1 and Visit 3) |
| Change in lung function - Forced Expiratory Volume 1 (FEV1) | Change from Visit 1 to Visit 2 and from Visit 1 to Visit 3 in FEV1. | 2 weeks (between Visit 1 and Visit 2) and 8 weeks (between Visit 1 and Visit 3) |
| Change in Asthma control - Asthma Control Questionnaire-6 (ACQ-6) | Change from Visit 1 to Visit 2 and from Visit 1 to Visit 3 in ACQ-6. For the ACQ-6, scores ranging from 0 (well-controlled) to 6 (extremely poorly-controlled). A lower score indicates better asthma control. | 2 weeks (between Visit 1 and Visit 2) and 8 weeks (between Visit 1 and Visit 3) |
| Change in Nasal fluid levels of eicosanoids | Change from Visit 1 to Visit 2 and from Visit 1 to Visit 3 in nasal fluid eicosanoid levels. | weeks (between Visit 1 and Visit 2) and 8 weeks (between Visit 1 and Visit 3) |
| Change in Nasal fluid levels of albumin | Change from Visit 1 to Visit 2 and from Visit 1 to Visit 3 in nasal fluid albumin levels. | 2 weeks (between Visit 1 and Visit 2) and 8 weeks (between Visit 1 and Visit 3) |
| Change in urinary levels of eicosanoids | Change from Visit 1 to Visit 2 and from Visit 1 to Visit 3 in urinary eicosanoid levels. | 2 weeks (between Visit 1 and Visit 2) and 8 weeks (between Visit 1 and Visit 3) |
| Change in serum tryptase | Change from Visit 1 to Visit 2 and from Visit 1 to Visit 3 in serum tryptase levels. | 2 weeks (between Visit 1 and Visit 2) and 8 weeks (between Visit 1 and Visit 3) |
| Change in IgE levels | Change from Visit 1 to Visit 2 and from Visit 1 to Visit 3 in nasal fluid and plasma levels of IgE. | 2 weeks (between Visit 1 and Visit 2) and 8 weeks (between Visit 1 and Visit 3) |
| Change in eosinophilic cationic protein (ECP) | Change from Visit 1 to Visit 2 and from Visit 1 to Visit 3 in nasal fluid levels of ECP. | 2 weeks (between Visit 1 and Visit 2) and 8 weeks (between Visit 1 and Visit 3) |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001249 | Asthma |
| D001982 | Bronchial Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D004342 | Drug Hypersensitivity |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |