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The study was terminated due to funding ending.
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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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The purpose of this study is to find a more effective treatment for allergic fungal rhinosinusitis (AFRS). Most people suffering from nasal polyps have elevated levels of white blood cells called eosinophils that are involved in inflammation of the air passages. Despite appropriate treatment with oral/topical corticosteroids, saline irrigations, and surgery, nasal polyps return frequently within months of surgery. Participants will be administered a placebo or dupilumab every two weeks for 52 weeks.
Allergic fungal rhinosinusitis (AFRS) is a severe form of eosinophilic nasal polyposis with critically inadequate treatment options for the 10% of chronic rhinosinusitis subjects affected by the disease. Occlusive eosinophilic mucus and severe nasal polyposis present in early adulthood, with an unrelenting course marked by sinus expansion and pressure-induced dehiscence of the surrounding orbit and skull base. Despite appropriate therapies with oral/topical corticosteroids, saline irrigations, and comprehensive sinus surgery, nasal polyps aggressively recur, frequently within months of surgery. Medical options beyond topical and systemic steroids are limited. Neither antifungal nor allergen immunotherapy is beneficial. Due to persistent sinonasal inflammation, patients with AFRS receive an average of three corticosteroid bursts per year and revision sinus surgery every 42 months.
Certain proteins made by the body, called interleukins, appear to play a major role in the survival and activation of eosinophils. Antibodies are proteins naturally produced by your body that find foreign substances, such as bacteria, fungi, viruses, and other substances that enter your body and make them inactive. Dupilumab is an antibody made in the laboratory that has been made to block specific interleukins from activating the eosinophils. This research is being done to find out if the medication dupilumab is effective and safe when used to treat patients with AFRS following recommended sinus surgery. Dupilumab is already approved for the treatment of atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyposis (CRSwNP); however, it is not approved to treat AFRS.
Patients who meet the eligibility criteria will be enrolled in this randomized, double-blind study and will go through four periods: a run-in period, surgery period, randomized treatment period, and post-treatment period. During the run-in period, patients will perform twice daily saline irrigations followed by intranasal corticosteroid spray (INCS) for 2 to 6 weeks before planned sinus surgery. Saline irrigations/INCS and sinus surgery will be completed by the standard of care (SoC). Patients who continue to meet eligibility criteria following surgery will be randomized to receive a placebo or dupilumab subcutaneously every 2 weeks. Participants will receive 26 doses of the investigational medical product (IMP), via either study personnel or home administration, to maintain a 2-week treatment schedule. Participants will receive IMP directly from the central pharmacy, with compliance assessments via reminder text messages on the day of each scheduled home administration, as well as monthly phone calls and injection device collection at recurring 3-month study visits. Participants will then be monitored on daily saline irrigation and INCS spray for 12 weeks to evaluate potential disease recurrence after discontinuation of IMP. An end-of-study visit will be conducted 12 weeks after the treatment period at Week 64.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dupilumab | Experimental | Participants receiving dupilumab for 52 weeks following surgery for allergic fungal rhinosinusitis (AFRS). |
|
| Placebo | Placebo Comparator | Participants receiving a placebo to match dupilumab for 52 weeks following surgery for allergic fungal rhinosinusitis (AFRS). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dupilumab | Drug | Dupilumab will be administered subcutaneously at a dose of 300 milligrams (mg) in a 2 milliliter (mL) solution every 2 weeks until the end of treatment (EOT) at Week 52. Participants will receive a total of 26 doses. |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Lund-Kennedy (mLK) Score | The efficacy of dupilumab in controlling sinonasal inflammation and preventing nasal polyp recurrence after complete sinus surgery for allergic fungal rhinosinusitis (AFRS) is assessed by using the modified Lund-Kennedy score. The modified Lund-Kennedy score (mLK) is a validated measure of sinonasal inflammation, as evaluated by means of nasal endoscopy. The composite score ranges from 0 to 12, with an increasing score representing worsening inflammation among three separate findings (Nasal polyps, Discharge, Edema). Each finding is rated from 0 (absent) to 2 (severe). A ≥ 2-point increase from baseline total postoperative score represents a clinically significant worsening of sinonasal inflammation. | Baseline and End of Treatment at Week 52 |
| Incidence of Oral/Topical Corticosteroid Utilization Per Participant | The number of participants who, during study treatment and off-treatment follow-up, based on clinical evaluation, present worsening signs and/or symptoms and are started on oral corticosteroids rescue treatment. | Baseline and End of Treatment at Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of Revision Sinus Surgery for Recurrent Nasal Polyps, and Comparison of Survival Curves | Documentation of the number of revision sinus surgery per participant, that are deemed clinically necessary for the treatment of an acute exacerbation of chronic rhinosinusitis (AECRS) | Up to End of Treatment at Week 52 |
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Inclusion Criteria:
Capable of giving signed informed consent
Patients aged >18 years at the time of signing the informed consent form (ICF)
Patients with nasal polyps in the setting of suspected AFRS and electing to undergo comprehensive sinus surgery per established criteria
Suspected AFRS based on Bent and Kuhn criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joshua M Levy, MD, MPH, MSc | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory Hospital Midtown-Otolaryngology | Atlanta | Georgia | 30308 | United States | ||
| Ambulatory Surgery Center - Emory University Hospital |
The investigators plan to share individual participant data that underline the results reported in the article, after de-identification (text, tables, figures, and appendices)
The investigators will share de-identified data beginning 3 months and ending 5 years following article publication.
Proposals should be directed to joshua.levy2@emory.edu. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third-party website.
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Participants were planned for recruitment from three locations in the USA: the University of Texas Health Science Center at Houston, in Houston, Texas, and Emory University Hospital Midtown and Emory University Hospital in Atlanta, Georgia. Participant enrollment began October 26, 2023, and the final study visit occurred July 10, 2024. The University of Texas Health Science Center at Houston was not activated as a site, and all participants were recruited at the Emory site.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dupilumab | Participants receiving dupilumab for 52 weeks following surgery for allergic fungal rhinosinusitis (AFRS). Dupilumab: Dupilumab will be administered subcutaneously at a dose of 300 milligrams (mg) in a 2 milliliter (mL) solution every 2 weeks until the end of treatment (EOT) at Week 52. Participants will receive a total of 26 doses. Intranasal Corticosteroid Sprays (INCS): All participants will undergo standardized background therapy with intranasal corticosteroid sprays (INCS) per standard of care (SoC). This will be continued throughout the entire study. Participants either receive fluticasone propionate or mometasone furoate. |
| FG001 | Placebo | Participants receiving a placebo to match dupilumab for 52 weeks following surgery for allergic fungal rhinosinusitis (AFRS). Placebo: A placebo to match dupilumab will be administered subcutaneously every 2 weeks until the end of treatment (EOT) at Week 52. Participants will receive a total of 26 doses. Intranasal Corticosteroid Sprays (INCS): All participants will undergo standardized background therapy with intranasal corticosteroid sprays (INCS) per standard of care (SoC). This will be continued throughout the entire study. Participants either receive fluticasone propionate or mometasone furoate. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Dupilumab | Participants receiving dupilumab for 52 weeks following surgery for allergic fungal rhinosinusitis (AFRS). Dupilumab: Dupilumab will be administered subcutaneously at a dose of 300 milligrams (mg) in a 2 milliliter (mL) solution every 2 weeks until the end of treatment (EOT) at Week 52. Participants will receive a total of 26 doses. Intranasal Corticosteroid Sprays (INCS): All participants will undergo standardized background therapy with intranasal corticosteroid sprays (INCS) per standard of care (SoC). This will be continued throughout the entire study. Participants either receive fluticasone propionate or mometasone furoate. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Modified Lund-Kennedy (mLK) Score | The efficacy of dupilumab in controlling sinonasal inflammation and preventing nasal polyp recurrence after complete sinus surgery for allergic fungal rhinosinusitis (AFRS) is assessed by using the modified Lund-Kennedy score. The modified Lund-Kennedy score (mLK) is a validated measure of sinonasal inflammation, as evaluated by means of nasal endoscopy. The composite score ranges from 0 to 12, with an increasing score representing worsening inflammation among three separate findings (Nasal polyps, Discharge, Edema). Each finding is rated from 0 (absent) to 2 (severe). A ≥ 2-point increase from baseline total postoperative score represents a clinically significant worsening of sinonasal inflammation. | Data are not available for the calculation of the mLK score as the study was terminated before central reader scoring of the nasal endoscopy. | Posted | Baseline and End of Treatment at Week 52 |
|
Information on adverse events was collected beginning at run-in (Week -6) and continued through the final assessment at Week 24 until the study premature termination.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dupilumab | Participants receiving dupilumab for 52 weeks following surgery for allergic fungal rhinosinusitis (AFRS). Dupilumab: Dupilumab will be administered subcutaneously at a dose of 300 milligrams (mg) in a 2 milliliter (mL) solution every 2 weeks until the end of treatment (EOT) at Week 52. Participants will receive a total of 26 doses. Intranasal Corticosteroid Sprays (INCS): All participants will undergo standardized background therapy with intranasal corticosteroid sprays (INCS) per standard of care (SoC). This will be continued throughout the entire study. Participants either receive fluticasone propionate or mometasone furoate. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas S Edwards, MD Assistant Professor, Rhinology and Skull Base Surgery Division | Emory University | 4045017710 | thomas.edwards@emory.edu |
Not provided
| 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 | Apr 2, 2024 | Apr 16, 2025 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000092562 | Allergic Fungal Sinusitis |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C582203 | dupilumab |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Double-blinded, placebo-controlled, parallel-group
|
| Placebo | Drug | A placebo to match dupilumab will be administered subcutaneously every 2 weeks until the end of treatment (EOT) at Week 52. Participants will receive a total of 26 doses. |
|
| Intranasal Corticosteroid Sprays (INCS) | Drug | All participants will undergo standardized background therapy with intranasal corticosteroid sprays (INCS) per standard of care (SoC). This will continue throughout the entire study. Participants either receive fluticasone propionate or mometasone furoate. |
|
| Endoscopic Nasal Polyp Score (NPS) |
NPS is a physician-reported tool to grade the extent/severity of nasal polyps based on evaluation by nasal endoscopy. Each nostril is scored on a scale of 0 (no polyps visible) to 4 (massive polyposis completely obstructing the nasal cavity), with the total score being the sum of left and right nostril scores (range: 0-8). The total NPS is the sum of scores from the right and left nostrils. |
| Baseline and End of Treatment at Week 52 |
| Percent Predicted Forced Vital Capacity (%FVC) Following Sinus Surgery in the Subgroup of Participants With Asthma (~25%) | Spirometry is a common office test used to assess how well the participant's lungs work by measuring how much air the participant inhales, how much the participant exhales, and how quickly the participant exhales. Forced vital capacity (FVC) refers to the maximal volume of air that can be expired following maximum inspiration. It is the total of tidal volume, inspiratory reserve volume, and expiratory reserve volume. The percent FVC is the FVC compared to a predicted FVC based on age, sex, and height. | Baseline and End of Treatment at Week 52 |
| Forced Expiratory Volume in 1 Second (FEV1) Following Sinus Surgery in the Subgroup of Participants With Asthma (~25%) | Forced expiratory volume in one second (FEV1) is measured during a spirometry test, also known as a pulmonary function test, which involves forcefully breathing out into a mouthpiece connected to a spirometer machine. FEV1 is the amount of air forced from the lungs in one second. | Baseline and End of Treatment at Week 52 |
| Forced Vital Capacity (FVC) Following Sinus Surgery in the Subgroup of Participants With Asthma (~25%) | Forced vital capacity (FVC) is measured during a spirometry test, also known as a pulmonary function test, which involves forcefully breathing out into a mouthpiece connected to a spirometer machine. FVC is the total amount of air exhaled during the FEV test. | Baseline and End of Treatment at Week 52 |
| FEV1/FVC Ratio Following Sinus Surgery in the Subgroup of Participants With Asthma (~25%) | The FEV1/FVC ratio is the ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lungs. The normal value for this ratio is above 0.75-85, though this is age-dependent, values less than 0.70 are suggestive of airflow limitation with an obstructive pattern. | Baseline and End of Treatment at Week 52 |
| Change in the Modified Lund-Kennedy (mLK) Radiologic Score | The mLK Radiologic scoring system assigns a value of 0, 1, or 2 to each of the following sinuses: maxillary, anterior ethmoid, posterior ethmoid, frontal, and sphenoid. Score assignments are 0 if the sinus is totally patent, 1 if the sinus is partially opacified, and 2 if the sinus is completely opacified. The osteomeatal complex is scored either 0 if not occluded or 2 if occluded. The maximum score for each side is thus 12, with a total score determined out of 24. Baseline Lund- MacKay (LM) scores will be counted as zero in accordance with recent sinus surgery. | 52 weeks and 64 weeks |
| Endoscopic Nasal Polyp Score (NPS) | Endoscopic nasal polyp score is determined by the treating Investigator. Unlike prior studies of dupilumab in nasal polyps, researchers will separately record the Nasal Polyp Score for each side, with a maximum unilateral score of 4 (massive polyposis completely obstructing the nasal cavity). This is appropriate for monitoring efficacy in AFRS, as a subgroup of participants may present with unilateral disease. | 52 weeks and 64 weeks |
| The 22-item Sinonasal Outcomes Test (SNOT-22) Score | The SNOT-22 score is a validated disease-specific questionnaire quantifying the quality of life among participants with chronic rhinosinusitis. The individual question scores range from 0 (no problem) to 4 (as bad as it can be) among 22 separate questions. Scoring 0 to 110. Higher scores = more severe symptoms and poorer quality of life. | 52 weeks and 64 weeks |
| Change in Asthma Control Questionnaire (ACQ) Score Among Participants With Asthma | The Asthma Control Questionnaire (ACQ) is a validated, self-administered survey used to assess a participants' perception of disease control over the preceding week using Likert scale responses with a range of 0 (well controlled) to 6 (extremely poorly controlled). The ACQ consists of 7 items surveying the frequency of asthma related symptoms, the need for rescue medications, and perceived control of disease. The items are equally weighted and the ACQ score is the mean of the 7 items. Total scores range from 0 to 6 with lower scores indicating better control of asthma symptoms. A score change of 0.5 on the 7-point scale has previously been defined as the Minimal Important Difference (MID). | 52 weeks and 64 weeks |
| Prevalence of Oral/Topical Corticosteroid Utilization Per Treatment Cohort | The number of participants who, during study treatment and off-treatment follow-up, based on clinical evaluation, have to continue on oral corticosteroid rescue treatment due to worsening signs and/or symptoms. | 52 weeks and 64 weeks |
| Incidence of Oral/Topical Antibiotic Utilization Per Participant | The number of participants who, during study treatment and off-treatment follow-up, based on clinical evaluation, present worsening signs and/or symptoms and are started on oral/topical antibiotic rescue treatment. | 52 weeks and 64 weeks |
| Prevalence of Oral/Topical Antibiotic Utilization Per Treatment Cohort | The number of participants who, during study treatment and off-treatment follow-up, based on clinical evaluation, have to continue on oral/topical antibiotic rescue treatment due to worsening signs and/or symptoms. | 52 weeks and 64 weeks |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| BG001 | Placebo | Participants receiving a placebo to match dupilumab for 52 weeks following surgery for allergic fungal rhinosinusitis (AFRS). Placebo: A placebo to match dupilumab will be administered subcutaneously every 2 weeks until the end of treatment (EOT) at Week 52. Participants will receive a total of 26 doses. Intranasal Corticosteroid Sprays (INCS): All participants will undergo standardized background therapy with intranasal corticosteroid sprays (INCS) per standard of care (SoC). This will be continued throughout the entire study. Participants either receive fluticasone propionate or mometasone furoate. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Participants receiving dupilumab for 52 weeks following surgery for allergic fungal rhinosinusitis (AFRS). Dupilumab: Dupilumab will be administered subcutaneously at a dose of 300 milligrams (mg) in a 2 milliliter (mL) solution every 2 weeks until the end of treatment (EOT) at Week 52. Participants will receive a total of 26 doses. Intranasal Corticosteroid Sprays (INCS): All participants will undergo standardized background therapy with intranasal corticosteroid sprays (INCS) per standard of care (SoC). This will be continued throughout the entire study. Participants either receive fluticasone propionate or mometasone furoate. |
| OG001 | Placebo | Participants receiving a placebo to match dupilumab for 52 weeks following surgery for allergic fungal rhinosinusitis (AFRS). Placebo: A placebo to match dupilumab will be administered subcutaneously every 2 weeks until the end of treatment (EOT) at Week 52. Participants will receive a total of 26 doses. Intranasal Corticosteroid Sprays (INCS): All participants will undergo standardized background therapy with intranasal corticosteroid sprays (INCS) per standard of care (SoC). This will be continued throughout the entire study. Participants either receive fluticasone propionate or mometasone furoate. |
|
| Primary | Incidence of Oral/Topical Corticosteroid Utilization Per Participant | The number of participants who, during study treatment and off-treatment follow-up, based on clinical evaluation, present worsening signs and/or symptoms and are started on oral corticosteroids rescue treatment. | Participants were unable to complete the study visits as scheduled at 52 weeks due to the premature termination of the study. Data is reported up to the time point completed by all participants. | Posted | Count of Participants | Participants | Baseline and End of Treatment at Week 52 |
|
|
|
| Secondary | Prevalence of Revision Sinus Surgery for Recurrent Nasal Polyps, and Comparison of Survival Curves | Documentation of the number of revision sinus surgery per participant, that are deemed clinically necessary for the treatment of an acute exacerbation of chronic rhinosinusitis (AECRS) | Posted | Mean | Standard Deviation | Revision Surgeries per participant | Up to End of Treatment at Week 52 |
|
|
|
| Secondary | Endoscopic Nasal Polyp Score (NPS) | NPS is a physician-reported tool to grade the extent/severity of nasal polyps based on evaluation by nasal endoscopy. Each nostril is scored on a scale of 0 (no polyps visible) to 4 (massive polyposis completely obstructing the nasal cavity), with the total score being the sum of left and right nostril scores (range: 0-8). The total NPS is the sum of scores from the right and left nostrils. | Participants were unable to complete the study visits as scheduled at 52 weeks due to the premature termination of the study. Data is reported up to the time point completed by all participants. | Posted | Mean | Standard Deviation | Score on a scale | Baseline and End of Treatment at Week 52 |
|
|
|
| Secondary | Percent Predicted Forced Vital Capacity (%FVC) Following Sinus Surgery in the Subgroup of Participants With Asthma (~25%) | Spirometry is a common office test used to assess how well the participant's lungs work by measuring how much air the participant inhales, how much the participant exhales, and how quickly the participant exhales. Forced vital capacity (FVC) refers to the maximal volume of air that can be expired following maximum inspiration. It is the total of tidal volume, inspiratory reserve volume, and expiratory reserve volume. The percent FVC is the FVC compared to a predicted FVC based on age, sex, and height. | Participants were unable to complete the study visits as scheduled at 52 weeks due to the premature termination of the study. Data is reported up to the time point completed by all participants. | Posted | Mean | Standard Deviation | %FVC | Baseline and End of Treatment at Week 52 |
|
|
|
| Secondary | Forced Expiratory Volume in 1 Second (FEV1) Following Sinus Surgery in the Subgroup of Participants With Asthma (~25%) | Forced expiratory volume in one second (FEV1) is measured during a spirometry test, also known as a pulmonary function test, which involves forcefully breathing out into a mouthpiece connected to a spirometer machine. FEV1 is the amount of air forced from the lungs in one second. | Participants were unable to complete the study visits as scheduled at 52 weeks due to the premature termination of the study. Data is reported up to the time point completed by all participants. | Posted | Mean | Standard Deviation | Liter | Baseline and End of Treatment at Week 52 |
|
|
|
| Secondary | Forced Vital Capacity (FVC) Following Sinus Surgery in the Subgroup of Participants With Asthma (~25%) | Forced vital capacity (FVC) is measured during a spirometry test, also known as a pulmonary function test, which involves forcefully breathing out into a mouthpiece connected to a spirometer machine. FVC is the total amount of air exhaled during the FEV test. | Participants were unable to complete the study visits as scheduled at 52 weeks due to the premature termination of the study. Data is reported up to the time point completed by all participants. | Posted | Mean | Standard Deviation | liter | Baseline and End of Treatment at Week 52 |
|
|
|
| Secondary | FEV1/FVC Ratio Following Sinus Surgery in the Subgroup of Participants With Asthma (~25%) | The FEV1/FVC ratio is the ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lungs. The normal value for this ratio is above 0.75-85, though this is age-dependent, values less than 0.70 are suggestive of airflow limitation with an obstructive pattern. | Participants were unable to complete the study visits as scheduled at 52 weeks due to the premature termination of the study. Data is reported up to the time point completed by all participants. | Posted | Mean | Standard Deviation | FEV1/FVC | Baseline and End of Treatment at Week 52 |
|
|
|
| Secondary | Change in the Modified Lund-Kennedy (mLK) Radiologic Score | The mLK Radiologic scoring system assigns a value of 0, 1, or 2 to each of the following sinuses: maxillary, anterior ethmoid, posterior ethmoid, frontal, and sphenoid. Score assignments are 0 if the sinus is totally patent, 1 if the sinus is partially opacified, and 2 if the sinus is completely opacified. The osteomeatal complex is scored either 0 if not occluded or 2 if occluded. The maximum score for each side is thus 12, with a total score determined out of 24. Baseline Lund- MacKay (LM) scores will be counted as zero in accordance with recent sinus surgery. | Data for the calculation of the mLK score are not available, as the study was terminated prematurely before participants were able to complete the scheduled study visits at weeks 52 and 64. | Posted | 52 weeks and 64 weeks |
|
|
| Secondary | Endoscopic Nasal Polyp Score (NPS) | Endoscopic nasal polyp score is determined by the treating Investigator. Unlike prior studies of dupilumab in nasal polyps, researchers will separately record the Nasal Polyp Score for each side, with a maximum unilateral score of 4 (massive polyposis completely obstructing the nasal cavity). This is appropriate for monitoring efficacy in AFRS, as a subgroup of participants may present with unilateral disease. | Participants were unable to complete the study visits as scheduled at 52 and 64 weeks due to the premature termination of the study. | Posted | 52 weeks and 64 weeks |
|
|
| Secondary | The 22-item Sinonasal Outcomes Test (SNOT-22) Score | The SNOT-22 score is a validated disease-specific questionnaire quantifying the quality of life among participants with chronic rhinosinusitis. The individual question scores range from 0 (no problem) to 4 (as bad as it can be) among 22 separate questions. Scoring 0 to 110. Higher scores = more severe symptoms and poorer quality of life. | Participants were unable to complete the study visits as scheduled at 52 and 64 weeks due to the premature termination of the study. Data is reported up to the time point completed by all participants. | Posted | Mean | Standard Deviation | score on a scale | 52 weeks and 64 weeks |
|
|
|
| Secondary | Change in Asthma Control Questionnaire (ACQ) Score Among Participants With Asthma | The Asthma Control Questionnaire (ACQ) is a validated, self-administered survey used to assess a participants' perception of disease control over the preceding week using Likert scale responses with a range of 0 (well controlled) to 6 (extremely poorly controlled). The ACQ consists of 7 items surveying the frequency of asthma related symptoms, the need for rescue medications, and perceived control of disease. The items are equally weighted and the ACQ score is the mean of the 7 items. Total scores range from 0 to 6 with lower scores indicating better control of asthma symptoms. A score change of 0.5 on the 7-point scale has previously been defined as the Minimal Important Difference (MID). | Participants were unable to complete the study visits as scheduled at 52 and 64 weeks due to the premature termination of the study. Data is reported up to the time point completed by all participants. | Posted | Mean | Standard Deviation | Score on a scale | 52 weeks and 64 weeks |
|
|
|
| Secondary | Prevalence of Oral/Topical Corticosteroid Utilization Per Treatment Cohort | The number of participants who, during study treatment and off-treatment follow-up, based on clinical evaluation, have to continue on oral corticosteroid rescue treatment due to worsening signs and/or symptoms. | Participants were unable to complete the study visits as scheduled at 52 and 64 weeks due to the premature termination of the study. Data is reported up to the time point completed by all participants. | Posted | Count of Participants | Participants | 52 weeks and 64 weeks |
|
|
|
| Secondary | Incidence of Oral/Topical Antibiotic Utilization Per Participant | The number of participants who, during study treatment and off-treatment follow-up, based on clinical evaluation, present worsening signs and/or symptoms and are started on oral/topical antibiotic rescue treatment. | Participants were unable to complete the study visits as scheduled at 52 and 64 weeks due to the premature termination of the study. Data is reported up to the time point completed by all participants. | Posted | Count of Participants | Participants | 52 weeks and 64 weeks |
|
|
|
| Secondary | Prevalence of Oral/Topical Antibiotic Utilization Per Treatment Cohort | The number of participants who, during study treatment and off-treatment follow-up, based on clinical evaluation, have to continue on oral/topical antibiotic rescue treatment due to worsening signs and/or symptoms. | Participants were unable to complete the study visits as scheduled at 52 and 64 weeks due to the premature termination of the study. Data is reported up to the time point completed by all participants. | Posted | Count of Participants | Participants | 52 weeks and 64 weeks |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 2 |
| 3 |
| EG001 | Placebo | Participants receiving a placebo to match dupilumab for 52 weeks following surgery for allergic fungal rhinosinusitis (AFRS). Placebo: A placebo to match dupilumab will be administered subcutaneously every 2 weeks until the end of treatment (EOT) at Week 52. Participants will receive a total of 26 doses. Intranasal Corticosteroid Sprays (INCS): All participants will undergo standardized background therapy with intranasal corticosteroid sprays (INCS) per standard of care (SoC). This will be continued throughout the entire study. Participants either receive fluticasone propionate or mometasone furoate. | 0 | 2 | 0 | 2 | 2 | 2 |
| Injection Site Reaction | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Joint Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Other | General disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D012852 |
| Sinusitis |
| D010254 | Paranasal Sinus Diseases |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Week 12 |
|
|
| Week 24 |
|
|
| End of Treatment at Week 52 |
|
| Week 12 |
|
|
| Week 24 |
|
|
| End of Treatment at Week 52 |
|
| End of Treatment at Week 52 |
|
| End of Treatment at Week 52 |
|
| End of Treatment at Week 52 |
|
| End of Treatment at Week 52 |
|
| Week 12 |
|
|
| Week 24 |
|
|
| 52 Weeks |
|
| 64 weeks |
|
| 52 weeks |
|
| 64 weeks |
|
| Week 12 |
|
|
| Week 24 |
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| Week 54 |
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| Week 64 |
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| Week 12 |
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| Week 24 |
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| Weeks 54 |
|
| Week 64 |
|
| Week 12 |
|
|
| Week 24 |
|
|
| Week 54 |
|
| Week 64 |
|