Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2019-002619-24 | EudraCT Number |
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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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The primary objective of the study is to evaluate the efficacy of dupilumab on lung function in participants with Allergic Bronchopulmonary Aspergillosis (ABPA).
The secondary objectives of the study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dupilumab | Experimental | Loading subcutaneous (SC) dose on day 1, followed by SC dose, every two weeks (Q2W) |
|
| Placebo | Experimental | Matching dupilumab without active substance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dupilumab | Drug | Single-use prefilled glass syringe administered by subcutaneous (SC) injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) Compared to Placebo | At Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Annualized Rate of ABPA-related Exacerbations | Defined as severe respiratory exacerbations that are associated with a doubling of serum total Immunoglobulin E (IgE) from the prior pre-exacerbation value. Adjusted Rate: Negative Binomial Regression Model Unadjusted Rate: (Number of events)/(number of participant years) | Over the 24 to 52 Week Treatment Period |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined inclusion / exclusion criteria applies.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regeneron Study Site | Birmingham | Alabama | 35209 | United States | ||
| Regeneron Study Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33027187 | Derived | Kao CC, Hanania NA, Parulekar AD. The impact of fungal allergic sensitization on asthma. Curr Opin Pulm Med. 2021 Jan;27(1):3-8. doi: 10.1097/MCP.0000000000000740. |
| Label | URL |
|---|---|
| A Plain Language Summary is available on TrialSummaries.com | View source |
Not provided
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.
Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Matching dupilumab without active substance |
| FG001 | Dupilumab 300 mg Q2W | Subcutaneous (SC) dose every two weeks (Q2W) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 24, 2023 | Jul 25, 2024 |
Not provided
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| Placebo | Drug | Matching placebo |
|
| Annualized Rate of Severe Respiratory Exacerbations | Defined as new onset of symptoms or clinical worsening of respiratory symptoms requiring systemic corticosteroid treatment for ≥3 consecutive days; for participants who are on maintenance systemic corticosteroids, at least double the dose of maintenance systemic corticosteroids for ≥3 consecutive days (with or without antibiotic therapy if indicated) Adjusted Rate: Negative Binomial Regression Model Unadjusted Rate: (Number of events)/(number of participant years) | Over the 24 to 52 Week Treatment Period |
| Annualized Rate of Severe Respiratory Exacerbations Requiring Either Hospitalization or Observation for >24 Hours in an ED/Urgent Care Facility | Annualized rate of severe respiratory exacerbations requiring either hospitalization or observation for >24 hours in an emergency department/urgent care facility (events per person-year) Adjusted Rate: Negative Binomial Regression Model Unadjusted Rate: (Number of events)/(number of participant years) | Over the 24 to 52 Week Treatment Period |
| Change From Baseline in Asthma Control Questionnaire (ACQ)-5 Score | ACQ is completed by patient to measure both the adequacy of asthma control and change in asthma control, which occurs either spontaneously or as a result of treatment. The ACQ-5 score is the mean of the first 5 questions, between 0 (totally controlled) and 6 (severely uncontrolled). A higher score indicates lower asthma control. Participants with a score below 1.0 reflect adequately controlled asthma and participants with scores above 1.0 reflect inadequately controlled asthma. The optimal cut-point score of 1.50 should be used to be confident that a patient has inadequately controlled asthma. | Over the 24 to 52 Week Treatment Period |
| Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score | SGRQ will be completed by the patient to measure and quantify health status in adult participants with chronic airflow limitation. Total score ranges from 0 to 100. Scores by dimension are calculated for three domains: Symptoms, Activity, and Impacts (Psychosocial). Lower score indicates better Quality of Life (QoL). | Over the 24 to 52 Week Treatment Period |
| Percentage of Participants Achieving a Reduction in the SGRQ Total Score of 4 Points or Greater From Baseline | SGRQ will be completed by the patient to measure and quantify health status in adult participants with chronic airflow limitation. Total score ranges from 0 to 100. Scores by dimension are calculated for three domains: Symptoms, Activity, and Impacts (Psychosocial). Lower score indicates better Quality of Life (QoL). | Up to 52 Weeks |
| Percent Change From Baseline in Total IgE in Serum | Over the 24 to 52 Week Treatment Period |
| Percent Change From Baseline in A Fumigatus-specific IgE in Serum | Over the 24 to 52 Week Treatment Period |
| Absolute Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) | Over the 24 to 52 Week Treatment Period |
| Percent Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) | Over the 24 to 52 Week Treatment Period |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) From Baseline | Through the end of the 52 Week Treatment Period |
| Number of Participants With Treatment-emergent Anti-drug Antibody (ADA) Responses and Titer Over Time | Up to 64 Weeks |
| Concentrations of Functional Dupilumab in Serum by Treatment Regimen | Up to 64 Weeks |
| Scottsdale |
| Arizona |
| 85251 |
| United States |
| Regeneron Study Site | Bakersfield | California | 93301 | United States |
| Regeneron Study Site | La Jolla | California | 92093 | United States |
| Regeneron Study Site | Los Angeles | California | 90025 | United States |
| Regeneron Study Site | Riverside | California | 92506 | United States |
| Regeneron Study Site | Boise | Idaho | 83706 | United States |
| Regeneron Study Site | Iowa City | Iowa | 52242 | United States |
| Regeneron Study Site | New York | New York | 10032 | United States |
| Regeneron Study Site | The Bronx | New York | 10461 | United States |
| Regeneron Study Site | Columbus | Ohio | 43235 | United States |
| Regeneron Study Site | DuBois | Pennsylvania | 15801 | United States |
| Regeneron Study Site | Philadelphia | Pennsylvania | 19140 | United States |
| Regeneron Study Site | Haskovo | 6305 | Bulgaria |
| Regeneron Study Site | Razgrad | 7200 | Bulgaria |
| Regeneron Study Site | Smolyan | 4700 | Bulgaria |
| Regeneron Study Site | Sofia | 1142 | Bulgaria |
| Regeneron Study Site | Brest | 29609 | France |
| Regeneron Study Site | Lyon | 69004 | France |
| Regeneron Study Site | Marseille | 13015 | France |
| Regeneron Study Site | Montpellier | 34295 | France |
| Regeneron Study Site | Paris | 75018 | France |
| Regeneron Study Site | Rennes | 35033 | France |
| Regeneron Study Site | Tours | 37044 | France |
| Regeneron Study Site | Leipzig | Saxony | 4357 | Germany |
| Regeneron Study Site | Berlin | 10717 | Germany |
| Regeneron Study Site | Frankfurt am Main | 60389 | Germany |
| Regeneron Study Site | Budapest | 1083 | Hungary |
| Regeneron Study Site | Fukuyama | 7200001 | Japan |
| Regeneron Study Site | Kanagawa | 259-1193 | Japan |
| Regeneron Study Site | Nagoya | 454-8509 | Japan |
| Regeneron Study Site | Naka-gun | 3191113 | Japan |
| Regeneron Study Site | Sakai | 591-8555 | Japan |
| Regeneron Study Site | Yanagawa | 8320059 | Japan |
| Regeneron Study Site | Yokohama | 231-8682 | Japan |
| Regeneron Study Site | Amsterdam | North Holland | 1105AZ | Netherlands |
| Regeneron Study Site | Arnhem | 6815 | Netherlands |
| Regeneron Study Site | Breda | 4818 CK | Netherlands |
| Regeneron Study Site | Eindhoven | 5623 | Netherlands |
| Regeneron Study Site | Zutphen | 7207 | Netherlands |
| Regeneron Study Site | Bialystok | 15-044 | Poland |
| Regeneron Study Site | Gdansk | 80402 | Poland |
| Regeneron Study Site | Oradea | Bihor County | 410169 | Romania |
| Regeneron Study Site | Brasov | 500051 | Romania |
| Regeneron Study Site | Leicester | England | LE39QP | United Kingdom |
| Regeneron Study Site | Liverpool | England | L7 8XP | United Kingdom |
| Regeneron Study Site | London | England | E1 2EF | United Kingdom |
| Regeneron Study Site | London | England | SW3 6NP | United Kingdom |
| Regeneron Study Site | Wythenshawe | England | M23 9LT | United Kingdom |
| Regeneron Study Site | Bradford | West Yorkshire | BD96RJ | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Matching dupilumab without active substance |
| BG001 | Dupilumab 300 mg Q2W | Subcutaneous (SC) dose every two weeks (Q2W) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | 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 | Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) Compared to Placebo | Randomized participants with available data for analysis in the statistical model | Posted | Least Squares Mean | Standard Error | Liters | At Week 24 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Annualized Rate of ABPA-related Exacerbations | Defined as severe respiratory exacerbations that are associated with a doubling of serum total Immunoglobulin E (IgE) from the prior pre-exacerbation value. Adjusted Rate: Negative Binomial Regression Model Unadjusted Rate: (Number of events)/(number of participant years) | The full analysis set (FAS) includes all randomized participants. It is based on the treatment allocated as randomized | Posted | Number | Events per person-year | Over the 24 to 52 Week Treatment Period |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Annualized Rate of Severe Respiratory Exacerbations | Defined as new onset of symptoms or clinical worsening of respiratory symptoms requiring systemic corticosteroid treatment for ≥3 consecutive days; for participants who are on maintenance systemic corticosteroids, at least double the dose of maintenance systemic corticosteroids for ≥3 consecutive days (with or without antibiotic therapy if indicated) Adjusted Rate: Negative Binomial Regression Model Unadjusted Rate: (Number of events)/(number of participant years) | The full analysis set (FAS) includes all randomized participants. It is based on the treatment allocated as randomized | Posted | Number | Events per person year | Over the 24 to 52 Week Treatment Period |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Annualized Rate of Severe Respiratory Exacerbations Requiring Either Hospitalization or Observation for >24 Hours in an ED/Urgent Care Facility | Annualized rate of severe respiratory exacerbations requiring either hospitalization or observation for >24 hours in an emergency department/urgent care facility (events per person-year) Adjusted Rate: Negative Binomial Regression Model Unadjusted Rate: (Number of events)/(number of participant years) | The full analysis set (FAS) includes all randomized participants. It is based on the treatment allocated as randomized | Posted | Number | Events per person year | Over the 24 to 52 Week Treatment Period |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Asthma Control Questionnaire (ACQ)-5 Score | ACQ is completed by patient to measure both the adequacy of asthma control and change in asthma control, which occurs either spontaneously or as a result of treatment. The ACQ-5 score is the mean of the first 5 questions, between 0 (totally controlled) and 6 (severely uncontrolled). A higher score indicates lower asthma control. Participants with a score below 1.0 reflect adequately controlled asthma and participants with scores above 1.0 reflect inadequately controlled asthma. The optimal cut-point score of 1.50 should be used to be confident that a patient has inadequately controlled asthma. | Number of randomized patients with a baseline measurement and at least one post-baseline measurement at the post-baseline time point of interest | Posted | Mean | Standard Deviation | ACQ-5 Score | Over the 24 to 52 Week Treatment Period |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score | SGRQ will be completed by the patient to measure and quantify health status in adult participants with chronic airflow limitation. Total score ranges from 0 to 100. Scores by dimension are calculated for three domains: Symptoms, Activity, and Impacts (Psychosocial). Lower score indicates better Quality of Life (QoL). | Number of randomized patients with a baseline measurement and at least one post-baseline measurement at the post-baseline time point of interest | Posted | Mean | Standard Deviation | SGRQ Total Score | Over the 24 to 52 Week Treatment Period |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving a Reduction in the SGRQ Total Score of 4 Points or Greater From Baseline | SGRQ will be completed by the patient to measure and quantify health status in adult participants with chronic airflow limitation. Total score ranges from 0 to 100. Scores by dimension are calculated for three domains: Symptoms, Activity, and Impacts (Psychosocial). Lower score indicates better Quality of Life (QoL). | Participants must have both the baseline and at least one post-baseline measurement at the given post-baseline time point to be included in the calculation of the proportion at the given post-baseline time point. | Posted | Number | 95% Confidence Interval | Percent | Up to 52 Weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Total IgE in Serum | Number of randomized patients with a baseline measurement and at least one post-baseline measurement at the post-baseline time point of interest | Posted | Mean | Standard Deviation | Percent | Over the 24 to 52 Week Treatment Period |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in A Fumigatus-specific IgE in Serum | Number of randomized patients with a baseline measurement and at least one post-baseline measurement at the post-baseline time point of interest | Posted | Mean | Standard Deviation | Percent | Over the 24 to 52 Week Treatment Period |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Absolute Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) | Number of randomized patients with a baseline measurement and at least one post-baseline measurement at the post-baseline time point of interest | Posted | Mean | Standard Deviation | ppb | Over the 24 to 52 Week Treatment Period |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) | Number of randomized patients with a baseline measurement and at least one post-baseline measurement at the post-baseline time point of interest | Posted | Mean | Standard Deviation | Percent | Over the 24 to 52 Week Treatment Period |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) From Baseline | The safety analysis set (SAF) includes all randomized participants who received any study drug; it is based on the treatment received | Posted | Number | Participants with TEAEs | Through the end of the 52 Week Treatment Period |
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| Secondary | Number of Participants With Treatment-emergent Anti-drug Antibody (ADA) Responses and Titer Over Time | The Pharmacokinetic Analysis Set (PKAS) includes all randomized participants who received any study drug and who had at least one non-missing drug concentration result following the first dose of study drug. The PKAS is based on the treatment received rather than as randomized. | Posted | Count of Participants | Participants | Up to 64 Weeks |
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| Secondary | Concentrations of Functional Dupilumab in Serum by Treatment Regimen | Includes all randomized participants who received dupilumab and who had at least one non-missing dupilumab result following the first dose. The PKAS is based on the treatment received rather than as randomized. | Posted | Mean | Standard Deviation | mg/L | Up to 64 Weeks |
|
|
From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Matching dupilumab without active substance | 1 | 27 | 5 | 27 | 19 | 27 |
| EG001 | Dupilumab 300 mg Q2W | Subcutaneous (SC) dose every two weeks (Q2W) | 1 | 35 | 3 | 35 | 29 | 35 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Influenza | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Bronchopulmonary aspergillosis allergic | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Nephrotic syndrome | Renal and urinary disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Trisomy 16 | Congenital, familial and genetic disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA (26.1) | Systematic Assessment |
| |
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.1) | Systematic Assessment |
| |
| Pancreatic carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.1) | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (26.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Bronchopulmonary aspergillosis allergic | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Respiratory tract infection bacterial | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Blepharitis | Eye disorders | MedDRA (26.1) | Systematic Assessment |
|
The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Administrator | Regeneron Pharmaceuticals, Inc. | 844-734-6643 | clinicaltrials@regeneron.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 5, 2024 | Jul 25, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001229 | Aspergillosis, Allergic Bronchopulmonary |
| ID | Term |
|---|---|
| D055732 | Pulmonary Aspergillosis |
| D001228 | Aspergillosis |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D008172 | Lung Diseases, Fungal |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C582203 | dupilumab |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
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| Unknown or Not Reported |
|
| Asian |
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| Other |
|
| Not Reported |
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| Title | Denominators | Categories |
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| Week 0 |
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| Week 12 |
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| Week 24 |
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| Week 52 |
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| Week 64 |
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