Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001803-35 | EudraCT Number | ||
| U1111-1130-6475 | Other Identifier | UTN |
Not provided
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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
Not provided
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Primary Objective:
To evaluate the efficacy of dupilumab (SAR231893/REGN668) in the treatment of bilateral Nasal Polyposis (NP) by assessment of the endoscopic nasal polyp score (NPS) in comparison to placebo.
Secondary Objectives:
To evaluate effect of dupilumab with regards to:
Screening period (4 weeks) + Randomized Treatment Period (16 weeks) + Post-Treatment Period (16 weeks) = 36 weeks.
To ensure at least 28 participants with co-morbid asthma needed for subgroup analysis, recruitment of NP participants without co-morbid asthma would stop when approximately 28 participants without asthma were randomized.
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection every week (QW) from Week 1 to 15 added to Mometasone furoate nasal spray (MFNS). |
|
| Dupilumab 300 mg QW | Experimental | Dupilumab, 2 Subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection QW from Week 1 to 15 added to MFNS. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo (for dupilumab) | Drug | Solution for injection; Subcutaneous injection. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Bilateral Endoscopic Nasal Polyp Score (NPS) at Week 16 | NPS was the sum of the right and left nostril scores, as evaluated by means of nasal endoscopy. Total score ranges from 0 to 8 (scored 0 [no polyp] to 4 [large polyps] for each nostril), with a lower score indicating smaller-sized polyps. | Baseline, Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Bilateral Endoscopic NPS at Week 16 in Participants With Asthma | NPS was the sum of the right and left nostril scores, as evaluated by means of nasal endoscopy. Total score ranges from 0 to 8 (scored 0 [no polyp] to 4 [large polyps] for each nostril), with a lower score indicating smaller-sized polyps. | Baseline, Week 16 |
Not provided
Inclusion criteria: participants with:
Exclusion criteria:
Participants <18 or >65 years of age.
Sinonasal outcome test (SNOT-22) <7.
Participants who had taken other investigational drugs or prohibited therapy for this study within 2 months before screening or 5 half-lives, whichever was longer:
Participants who had undergone any nasal surgery (including polypectomy) within 6 months before screening or have had more than 5 sinonasal surgeries in the past of which maximal 2 were surgeries changing the lateral wall structure of the nose.
Participants with asthma having:
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 840014 | Rolling Hills Estates | California | 90274 | United States | ||
| Investigational Site Number 840015 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26836729 | Result | Bachert C, Mannent L, Naclerio RM, Mullol J, Ferguson BJ, Gevaert P, Hellings P, Jiao L, Wang L, Evans RR, Pirozzi G, Graham NM, Swanson B, Hamilton JD, Radin A, Gandhi NA, Stahl N, Yancopoulos GD, Sutherland ER. Effect of Subcutaneous Dupilumab on Nasal Polyp Burden in Patients With Chronic Sinusitis and Nasal Polyposis: A Randomized Clinical Trial. JAMA. 2016 Feb 2;315(5):469-79. doi: 10.1001/jama.2015.19330. | |
| 34848949 |
Not provided
Not provided
Randomization was stratified according to medical history of asthma (with/without asthma) and by nasal biopsy (biopsy performed,Yes/No). Assignment was done centrally using Interactive Voice/Web Response System in 1:1 ratio (dupilumab:placebo)after 4-week run-in period on Mometasone furoate nasal spray (MFNS) and confirmation of selection criteria.
The study was conducted at 14 sites in 4 countries. A total of 60 participants were randomized between August 2013 and March 2014.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection every week (QW) from Week 1 to 15 added to MFNS. |
| FG001 | Dupilumab 300 mg QW |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
| Dupilumab |
| Drug |
Solution for injection; Subcutaneous injection. |
|
|
| Mometasone furoate nasal spray | Drug | Nasal spray, 2 actuations in each nostril twice daily. |
|
|
| Change From Baseline in Participant Reported Symptoms Scores of Sinusitis at Week 16 | Morning symptoms of sinusitis (nasal congestion/obstruction, anterior rhinorrhea [runny nose], posterior rhinorrhea [post nasal drip], and loss of sense of smell) were assessed using a 0 (no symptoms) - 3 (severe symptoms) categorical scale where higher score indicated severe symptoms. | Baseline, Week 16 |
| Change From Baseline in Visual Analogue Scale (VAS) for Rhinosinusitis Symptoms Severity at Week 16 | Severity of rhinosinusitis symptoms were assessed on a 0 cm (not troublesome) - 10 cm (worst thinkable troublesome) VAS where higher score indicated worst thinkable troublesome. | Baseline, Week 16 |
| Change From Baseline in Nasal Peak Inspiratory Flow (NPIF) at Week 16 | NPIF evaluation represents a physiologic measure of the air flow through both nasal cavities during forced inspiration and/or expiration expressed in liter per minute. | Baseline, Week 16 |
| Change From Baseline in Smell Test (University of Pennsylvania Smell Identification Test [UPSIT]) Scores at Week 16 | UPSIT was a 40-item test to measure the individual's ability to detect odors. Total score ranges from 0 (anosmia)-40 (normal sense of smell), lower score indicated severe smell loss. | Baseline, Week 16 |
| Change From Baseline in Sinus Computed Tomography (CT) Scan Assessments at Week 16: Lund-Mackay Score | CT scan assessment included Lund-Mackay score and percent of the maxillary sinuses occupied by disease. The Lund-Mackay scoring system rated each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses. The total score ranges from 0 (normal) - 24 (more opacified); higher score indicated worse status. | Baseline, Week 16 |
| Change From Baseline in Sinus Computed Tomography (CT) Scan Assessments at Week 16: Percent Area Occupied by Disease | CT scan assessment included Lund-Mackay score and percentage of the area of maxillary sinuses occupied by disease. | Baseline, Week 16 |
| Time to First Response in NPS: Kaplan-Meier Estimate at Week 16 | The time-to-first response in NPS: time from the date of randomization to the date of first NPS (defined as >=1 point reduction from baseline score); for participants without NPS >=1 point reduction, it was censored at the end of treatment date. The median time to first response was not estimated because the number of responses was too low in the Dupilumab arm. Therefore, alternative Kaplan-Meier statistics, the probability of response at Week 16, are presented as the descriptive measure statistics. | Baseline to Week 16 |
| Change From Baseline in 22-Item Sinonasal Outcome Test (SNOT-22) at Week 16 | The SNOT-22 was a validated questionnaire to assess the impact of chronic rhinosinusitis on quality of life. The total score may range from 0 (no problem)-110 (worst quality of life), higher scores represented worst quality of life; minimal clinically important change ≥ 8.90. | Baseline, Week 16 |
| Denver |
| Colorado |
| 80230 |
| United States |
| Investigational Site Number 840013 | Boston | Massachusetts | 02114 | United States |
| Investigational Site Number 840002 | Lake Oswego | Oregon | 97035 | United States |
| Investigational Site Number 840009 | Pittsburgh | Pennsylvania | 15213 | United States |
| Investigational Site Number 056001 | Ghent | 9000 | Belgium |
| Investigational Site Number 056002 | Leuven | 3500 | Belgium |
| Investigational Site Number 724001 | Barcelona | 08036 | Spain |
| Investigational Site Number 724003 | Faitanar | 46014 | Spain |
| Investigational Site Number 724005 | Jerez de la Frontera | 11407 | Spain |
| Investigational Site Number 724002 | L'Hospitalet de Llobregat | 08907 | Spain |
| Investigational Site Number 724004 | Madrid | 28040 | Spain |
| Investigational Site Number 752001 | Stockholm | 14186 | Sweden |
| Investigational Site Number 752002 | Stockholm | 171 76 | Sweden |
| Derived |
| Khan AH, Abbe A, Falissard B, Carita P, Bachert C, Mullol J, Reaney M, Chao J, Mannent LP, Amin N, Mahajan P, Pirozzi G, Eckert L. Data Mining of Free-Text Responses: An Innovative Approach to Analyzing Patient Perspectives on Treatment for Chronic Rhinosinusitis with Nasal Polyps in a Phase IIa Proof-of-Concept Study for Dupilumab. Patient Prefer Adherence. 2021 Nov 19;15:2577-2586. doi: 10.2147/PPA.S320242. eCollection 2021. |
| 34437720 | Derived | Khan AH, Reaney M, Guillemin I, Nelson L, Qin S, Kamat S, Mannent L, Amin N, Whalley D, Hopkins C. Development of Sinonasal Outcome Test (SNOT-22) Domains in Chronic Rhinosinusitis With Nasal Polyps. Laryngoscope. 2022 May;132(5):933-941. doi: 10.1002/lary.29766. Epub 2021 Aug 26. |
| 33710614 | Derived | Chong LY, Piromchai P, Sharp S, Snidvongs K, Webster KE, Philpott C, Hopkins C, Burton MJ. Biologics for chronic rhinosinusitis. Cochrane Database Syst Rev. 2021 Mar 12;3(3):CD013513. doi: 10.1002/14651858.CD013513.pub3. |
| 32075470 | Derived | Boyle JV, Lam K, Han JK. Dupilumab in the treatment of chronic rhinosinusitis with nasal polyposis. Immunotherapy. 2020 Feb;12(2):111-121. doi: 10.2217/imt-2019-0191. Epub 2020 Feb 20. |
| 31306495 | Derived | Bachert C, Hellings PW, Mullol J, Hamilos DL, Gevaert P, Naclerio RM, Joish VN, Chao J, Mannent LP, Amin N, Abbe A, Taniou C, Fan C, Pirozzi G, Graham NMH, Mahajan P, Staudinger H, Khan A. Dupilumab improves health-related quality of life in patients with chronic rhinosinusitis with nasal polyposis. Allergy. 2020 Jan;75(1):148-157. doi: 10.1111/all.13984. Epub 2019 Oct 23. |
| 30954643 | Derived | Laidlaw TM, Mullol J, Fan C, Zhang D, Amin N, Khan A, Chao J, Mannent LP. Dupilumab improves nasal polyp burden and asthma control in patients with CRSwNP and AERD. J Allergy Clin Immunol Pract. 2019 Sep-Oct;7(7):2462-2465.e1. doi: 10.1016/j.jaip.2019.03.044. Epub 2019 Apr 4. No abstract available. |
| 30488542 | Derived | Jonstam K, Swanson BN, Mannent LP, Cardell LO, Tian N, Wang Y, Zhang D, Fan C, Holtappels G, Hamilton JD, Grabher A, Graham NMH, Pirozzi G, Bachert C. Dupilumab reduces local type 2 pro-inflammatory biomarkers in chronic rhinosinusitis with nasal polyposis. Allergy. 2019 Apr;74(4):743-752. doi: 10.1111/all.13685. Epub 2019 Jan 21. |
Dupilumab, 2 subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection QW from Week 1 to 15 added to MFNS.
| Treated (Safety Population) |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Baseline population included all randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection QW from Week 1 to 15 added to MFNS. |
| BG001 | Dupilumab 300 mg QW | Dupilumab, 2 subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection QW from Week 1 to 15 added to MFNS. |
| 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, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Number of participants with asthma | The diagnosis of asthma was based on participant's history; participants with asthma were required to have a forced expiratory volume in 1 second (FEV1) of more than 60% of predicted use, daily inhaled corticosteroids of no more than 1000 mcg of fluticasone (or equivalent), and could not have had an asthma exacerbation requiring systemic corticosteroids or hospitalization within the prior 3 months. | Count of Participants | 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 Bilateral Endoscopic Nasal Polyp Score (NPS) at Week 16 | NPS was the sum of the right and left nostril scores, as evaluated by means of nasal endoscopy. Total score ranges from 0 to 8 (scored 0 [no polyp] to 4 [large polyps] for each nostril), with a lower score indicating smaller-sized polyps. | Intent-to-treat (ITT) population included all randomized participants analyzed according to the treatment group allocated by randomization. Here, number analyzed = number of participants with available data for specified time points. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 16 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Bilateral Endoscopic NPS at Week 16 in Participants With Asthma | NPS was the sum of the right and left nostril scores, as evaluated by means of nasal endoscopy. Total score ranges from 0 to 8 (scored 0 [no polyp] to 4 [large polyps] for each nostril), with a lower score indicating smaller-sized polyps. | Participants of the ITT population with asthma and with available data at Week 16. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 16 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Participant Reported Symptoms Scores of Sinusitis at Week 16 | Morning symptoms of sinusitis (nasal congestion/obstruction, anterior rhinorrhea [runny nose], posterior rhinorrhea [post nasal drip], and loss of sense of smell) were assessed using a 0 (no symptoms) - 3 (severe symptoms) categorical scale where higher score indicated severe symptoms. | Participants from ITT population with data available for symptom score at Week 16. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 16 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Visual Analogue Scale (VAS) for Rhinosinusitis Symptoms Severity at Week 16 | Severity of rhinosinusitis symptoms were assessed on a 0 cm (not troublesome) - 10 cm (worst thinkable troublesome) VAS where higher score indicated worst thinkable troublesome. | Participants from ITT population with data available for Rhinosinusitis Symptoms Severity VAS at Week 16. | Posted | Mean | Standard Deviation | centimetre (cm) | Baseline, Week 16 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Nasal Peak Inspiratory Flow (NPIF) at Week 16 | NPIF evaluation represents a physiologic measure of the air flow through both nasal cavities during forced inspiration and/or expiration expressed in liter per minute. | Participants from ITT population with data available for NPIF at Week 16. | Posted | Mean | Standard Deviation | liter/minute | Baseline, Week 16 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Smell Test (University of Pennsylvania Smell Identification Test [UPSIT]) Scores at Week 16 | UPSIT was a 40-item test to measure the individual's ability to detect odors. Total score ranges from 0 (anosmia)-40 (normal sense of smell), lower score indicated severe smell loss. | Participants from ITT population with data available for UPSIT at Week 16. | Posted | Mean | Standard Deviation | score on scale | Baseline, Week 16 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Sinus Computed Tomography (CT) Scan Assessments at Week 16: Lund-Mackay Score | CT scan assessment included Lund-Mackay score and percent of the maxillary sinuses occupied by disease. The Lund-Mackay scoring system rated each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses. The total score ranges from 0 (normal) - 24 (more opacified); higher score indicated worse status. | Participants from ITT population with CT scan data available at Week 16. | Posted | Mean | Standard Deviation | score on scale | Baseline, Week 16 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Sinus Computed Tomography (CT) Scan Assessments at Week 16: Percent Area Occupied by Disease | CT scan assessment included Lund-Mackay score and percentage of the area of maxillary sinuses occupied by disease. | Participants from ITT population with CT scan data available at Week 16. | Posted | Mean | Standard Deviation | percent area | Baseline, Week 16 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First Response in NPS: Kaplan-Meier Estimate at Week 16 | The time-to-first response in NPS: time from the date of randomization to the date of first NPS (defined as >=1 point reduction from baseline score); for participants without NPS >=1 point reduction, it was censored at the end of treatment date. The median time to first response was not estimated because the number of responses was too low in the Dupilumab arm. Therefore, alternative Kaplan-Meier statistics, the probability of response at Week 16, are presented as the descriptive measure statistics. | ITT population. | Posted | Number | 95% Confidence Interval | Probability of response | Baseline to Week 16 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in 22-Item Sinonasal Outcome Test (SNOT-22) at Week 16 | The SNOT-22 was a validated questionnaire to assess the impact of chronic rhinosinusitis on quality of life. The total score may range from 0 (no problem)-110 (worst quality of life), higher scores represented worst quality of life; minimal clinically important change ≥ 8.90. | Participants from ITT population with SNOT-22 data available at Week 16. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 16 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Post-Hoc | Change From Baseline in Nasal Total Symptoms Score (nTSS) at Week 16 | nTSS was the sum of participant-assessed nasal symptom scores for nasal congestion/obstruction, decreased/loss of sense of smell, and rhinorrhea (anterior/posterior nasal discharge), each accessed on 0-3 categorical scale. Total score ranges from 0 (no symptoms) to 9 (severe symptoms). Higher score indicated severe symptoms. | Participants from ITT population with nTSS data available at Week 16. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 16 |
|
|
All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 32) regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during the 'treatment emergent period' (from the first dose of the double-blind IMP injection up to the end of the 16 weeks post-treatment period).
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 | Participants exposed to placebo (for dupilumab) added to MFNS (mean exposure of 14 weeks). | 0 | 30 | 4 | 30 | 22 | 30 |
| EG001 | Dupilumab 300 mg QW | Participants exposed to dupilumab added to MFNS (mean exposure of 16 weeks). | 0 | 30 | 2 | 30 | 27 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Herpes zoster | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Mononeuropathy | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Nasal polyps | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Sinus headache | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Nasal polyps | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Rhinalgia | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
|
Limitations of the trial such as small numbers of participants analysed or technical problems leading to unreliable data.
If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi | Contact-US@sanofi.com |
| ID | Term |
|---|---|
| D009298 | Nasal Polyps |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C582203 | dupilumab |
| D000068656 | Mometasone Furoate |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| No |
|
| Week 16 |
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| Change from baseline at Week 16 |
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