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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06834360
Registration number
NCT06834360
Ethics application status
Date submitted
14/02/2025
Date registered
19/02/2025
Date last updated
15/07/2025
Titles & IDs
Public title
A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps
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Scientific title
A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Phase 3 Trial to Investigate the Efficacy, Safety, and Tolerability of Itepekimab in Adult Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps
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Secondary ID [1]
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2024-516815-26
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Secondary ID [2]
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EFC18419
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Universal Trial Number (UTN)
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Trial acronym
CEREN2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Rhinosinusitis With Nasal Polyps
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Condition category
Condition code
Infection
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Other infectious diseases
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Respiratory
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Other respiratory disorders / diseases
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Itepekimab (SAR440340)
Treatment: Drugs - Placebo
Treatment: Drugs - Mometasone furoate nasal spray (MFNS)
Experimental: Itepekimab high dose - Subcutaneous (SC) administration of Itepekimab high dose for 52 weeks
Experimental: Itepekimab low dose - SC administration of Itepekimab low dose for 52 weeks
Placebo comparator: Placebo - SC administration of matching placebo for 52 weeks
Treatment: Drugs: Itepekimab (SAR440340)
Pharmaceutical form: Solution for injection in prefilled syringe. Route of administration: Subcutaneous
Treatment: Drugs: Placebo
Pharmaceutical form: Solution for injection in prefilled syringe. Route of administration: Subcutaneous
Treatment: Drugs: Mometasone furoate nasal spray (MFNS)
Pharmaceutical form: Solution for administration via spray pump. Route of administration: Intranasal spray
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change from baseline in the endoscopic NPS
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Assessment method [1]
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The Nasal Polyp Score (NPS) is the sum of the right and left nostril scores, as evaluated by means of nasal endoscopy. Nasal polyp is graded based on polyp size from 0 to 4 with higher scores indicating larger polyps. The sum of right and left nostril scores ranges from 0 (no polyps) to 8 (large polyps).
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Timepoint [1]
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Baseline to Week 24
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Primary outcome [2]
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Change from baseline in the NCS
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Assessment method [2]
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The Nasal Congestion Score (NCS) is scored using a 0-3 categorical scale where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms. Outcome value is defined as the preceding 28-day average of morning scores recorded in eDiary.
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Timepoint [2]
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Baseline to Week 24
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Secondary outcome [1]
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Change from baseline in endoscopic NPS
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Assessment method [1]
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The NPS is the sum of the right and left nostril scores, as evaluated by means of nasal endoscopy. Nasal polyp is graded based on polyp size from 0 to 4 with higher scores indicating larger polyps. The sum of right and left nostril scores ranges from 0 (no polyps) to 8 (large polyps).
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Timepoint [1]
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Baseline to Week 52
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Secondary outcome [2]
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Change from baseline in NCS
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Assessment method [2]
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The NCS is scored using a 0-3 categorical scale where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms. Outcome value is defined as the preceding 28-day average of morning scores recorded in eDiary.
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Timepoint [2]
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Baseline to Week 52
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Secondary outcome [3]
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Change from baseline in opacification of sinuses assessed by Computed Tomography (CT) scan using the LMK score
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Assessment method [3]
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The Lund-Mackay (LMK) system is based on localization with points given for degree of opacification: 0 = normal, 1 = partial opacification, 2 = total opacification. These points are then applied to the maxillary, anterior ethmoid, posterior ethmoid, sphenoid, frontal sinus on each side. The osteomeatal complex is graded as 0 = not occluded, or 2 = occluded, deriving a maximum score of 12 per side. The total score is the sum of scores from each side and ranges from 0 (normal) to 24 (total opacification).
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Timepoint [3]
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Baseline to Week 24
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Secondary outcome [4]
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Change from baseline in the TSS (nasal congestion/obstruction, anterior/posterior rhinorrhea, and loss of sense of smell)
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Assessment method [4]
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The CRSwNP Total Symptom Score (TSS) is a composite score derived from nasal congestion (NC)/obstruction, anterior/posterior rhinorrhea, and loss of smell. The total score ranges from 0 to 9 with higher scores on TSS indicating greater overall symptom severity.
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Timepoint [4]
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Baseline to Weeks 24 and 52
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Secondary outcome [5]
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Change from baseline in loss of smell severity score using the daily CRSwNP sinonasal symptom eDiary, and UPSIT score
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Assessment method [5]
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The CRSwNP sinonasal symptom diary is designed to assess the severity of chronic rhinosinusitis (CRS) sinonasal symptoms on daily basis. These symptoms include NC/obstruction, anterior rhinorrhea and posterior rhinorrhea, facial pain/pressure, loss of smell, and headache. Each of the individual items of the diary are scored from 0 ("No symptoms") to 3 ("Severe symptoms - symptoms that are hard to tolerate, cause interference with activities or daily living"). Higher scores on the items of the individual symptoms denote greater symptom severity. The University of Pennsylvania Smell Identification Test (UPSIT) test is a rapid and easy-to-administer method to quantitatively assess human olfactory function. The total score ranges from 0 (anosmia) to 40 (normosmia).
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Timepoint [5]
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Baseline to Weeks 24 and 52
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Secondary outcome [6]
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Change from baseline in SNOT-22 total score
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Assessment method [6]
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The Sino-Nasal Outcome Test-22-Items (SNOT-22) is a patient-reported outcome questionnaire designed to assess the impact of CRS on patient's Health-Related Quality of Life (HRQoL). It has 22 items covering five domains: Nasal, Ear/Facial, Sleep, Function, and Emotion. A global score ranging from 0 to 110 with higher score indicating greater rhinosinusitis related health burden.
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Timepoint [6]
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Baseline to Weeks 24 and 52
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Secondary outcome [7]
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Change from baseline in PROMIS SD-SF-8b scores
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Assessment method [7]
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The Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance - Short Form 8b (SD-SF-8b) is a generic 8-item sleep disturbance assessment that evaluates difficulties with falling asleep, staying asleep, and getting enough sleep; and perceptions on the quality and satisfaction of sleep. Scores are calculated with a conversion of the raw score (score range 8 to 40) into a standardized T-score with the mean of the 50 and SD of 10, where higher scores indicate more disturbed sleep.
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Timepoint [7]
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Baseline to Weeks 24 and 52
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Secondary outcome [8]
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Proportion of participants with CRSwNP requiring systemic corticosteroid(s) (SCS) or surgery for CRS
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Assessment method [8]
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Timepoint [8]
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Baseline up to Week 52
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Secondary outcome [9]
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Annualized rate of SCS course or surgery for CRS
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Assessment method [9]
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Timepoint [9]
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Baseline up to Week 52
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Secondary outcome [10]
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Time to first either SCS or surgery for CRS
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Assessment method [10]
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Timepoint [10]
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Baseline through Week 52
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Secondary outcome [11]
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Change from baseline in pre-BD FEV1 (in mL) in participants with co-morbid asthma
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Assessment method [11]
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Pre-BD FEV1: pre-bronchodilator forced expiratory volume in 1 second
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Timepoint [11]
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Baseline to Weeks 24 and 52
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Secondary outcome [12]
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Change from baseline in ACQ-5 score in participants with co-morbid asthma
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Assessment method [12]
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The Asthma Control Questionnaire (ACQ) is a questionnaire that measures the adequacy of asthma control and any changes in asthma control that may occur spontaneously or as a result of treatment. The ACQ-5 has 5 questions on the asthma symptoms. The global score is the mean of the item responses and ranges from 0 and 6 with higher score indicating lower asthma control.
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Timepoint [12]
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Baseline to Weeks 24 and 52
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Secondary outcome [13]
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Change from the baseline in NPS and NCS in the subgroup of patients with aspirin-exacerbated respiratory disease (AERD)
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Assessment method [13]
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Timepoint [13]
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Baseline to Weeks 24 and 52
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Secondary outcome [14]
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Proportion of participants with AERD requiring SCS or surgery for CRS
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Assessment method [14]
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Timepoint [14]
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Baseline up to Week 52
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Secondary outcome [15]
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Annualized rate of SCS course or surgery for CRS in participants with AERD
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Assessment method [15]
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Timepoint [15]
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Baseline up to Week 52
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Secondary outcome [16]
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Time to first either SCS or surgery for CRS in participants with AERD
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Assessment method [16]
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Timepoint [16]
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Baseline through Week 52
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Secondary outcome [17]
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Change from baseline in pre-BD FEV1 (in ml) in participants with AERD
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Assessment method [17]
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Pre-BD FEV1: pre-bronchodilator forced expiratory volume in 1 second
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Timepoint [17]
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Baseline to Weeks 24 and 52
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Secondary outcome [18]
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Proportion of NPS responders (defined as participants with improvement by at least 1 point in NPS)
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Assessment method [18]
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Timepoint [18]
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Weeks 24 and 52
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Secondary outcome [19]
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Proportion of NPS responders (defined as participants with improvement by at least 2 points in NPS)
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Assessment method [19]
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Timepoint [19]
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Weeks 24 and 52
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Secondary outcome [20]
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Incidence of treatment-emergent adverse Events (TEAEs), treatment-emergent serious adverse events (TESAEs), treatment-emergent adverse events of special interest (TEAESIs) and TEAEs leading to treatment discontinuation
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Assessment method [20]
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Timepoint [20]
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Baseline to End of Study (EOS) (Week 72)
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Secondary outcome [21]
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Itepekimab concentration in serum
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Assessment method [21]
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Timepoint [21]
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Baseline to EOS (Week 72)
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Secondary outcome [22]
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Incidence of treatment-emergent anti-itepekimab antibody (ADA) responses
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Assessment method [22]
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Timepoint [22]
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Baseline to EOS (Week 72)
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Eligibility
Key inclusion criteria
* Participants must be 18 years of age or older.
* Participants with a history of chronic rhinosinusitis with nasal polyps (CRSwNP) for at least 1 year prior to screening
* Participants must have at least one of the following features:
* Prior sinonasal surgery for nasal polyps (NP).
* Worsening symptoms of chronic rhinosinusitis (CRS) requiring treatment with systemic corticosteroid(s) (SCS) within the prior 1 year before screening (Visit 1).
* An endoscopic bilateral Nasal Polyp Score (NPS) of at least 5 out of maximum score of 8 (with a minimum score of 2 in each nasal cavity) at screening and randomization.
* Ongoing symptoms (for at least 12 weeks before Visit 1) of:
* Nasal congestion/blockade/obstruction with moderate or severe (symptom severity score 2 or 3) at Visit 1 and a weekly average severity of greater than 1 in the week before randomization (Visit 2), AND
* At least one of the following two symptoms: loss of smell or rhinorrhea (anterior/posterior).
* A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies:
* Is not a women of childbearing potential (WOCBP), OR
* Is a WOCBP and agrees to use a contraceptive method that is highly effective, with a failure rate of <1% during the study (at a minimum until 20 weeks after the last dose of study intervention).
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Participants are excluded from the study if any of the following criteria apply:
* Participants with a history of clinically significant renal, hepatic, metabolic, neurologic, hematologic, ophthalmologic, respiratory (excluding those with asthma and aspirin-exacerbated respiratory disease (AERD) which may be included in the study), gastrointestinal, cardiovascular, cerebrovascular, or other significant medical illness or disorder, which, in the judgment of the Investigator, could interfere with the study or require treatment that might interfere with the study.
* Participants who are currently smoking tobacco and/or vaping, or participants in whom smoking/vaping cessation has occurred <6 months prior to Screening (Visit 1). Nicotine replacement therapy and/or noninhaled tobacco product use are not considered current smoking of tobacco.
* Participants meet any contraindications for mometasone furoate nasal spray (MFNS) such as hypersensitivity to MFNS or any of its components; or participants with uncontrolled opportunistic infections.
* Participants with a history of a severe systemic hypersensitivity reaction to a mAb.
* Participants with conditions/concomitant diseases making them non-evaluable at Visit 1 or for the primary efficacy endpoint.
* Participants with nasal cavity malignant tumor and benign tumors (eg, papilloma, blood boil etc).
* Participants with severe uncontrolled asthma with history of 2 and/or more exacerbations, requiring SCS or 1 hospitalization requiring SCS in the past year.
* History of concomitant lung disease (other than asthma, eg, COPD, interstitial lung disease) which in the opinion of the Investigator could interfere with performance and interpretation of spirometry.
* Participants treated with intranasal corticosteroid(s) (INCS) (MFNS is permitted), intranasal emitting devices/stents, nasal spray using exhalation delivery system such as XhanceTM during the screening period. In Japan and China INCS other than MFNS are permitted.
* Participants who have undergone any sinus intranasal surgery (including polypectomy) within 6 months before Visit 1.
* Participants who received SCS 1 month prior to Screening (Visit 1) or during the screening period (between Visit 1 and Visit 2).
* Known allergy to itepekimab or its excipients, or any drug or other allergy that, in the opinion of the Investigator, contraindicates participation in this study.
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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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
6/02/2025
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
13/12/2027
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Actual
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Sample size
Target
210
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
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Recruitment hospital [1]
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Investigational Site Number : 0360003 - Bella Vista
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Recruitment hospital [2]
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Investigational Site Number : 0360002 - Brisbane
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Recruitment hospital [3]
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Investigational Site Number : 0360001 - Spearwood
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Recruitment postcode(s) [1]
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2153 - Bella Vista
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Recruitment postcode(s) [2]
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4029 - Brisbane
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Recruitment postcode(s) [3]
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6163 - Spearwood
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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United States of America
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Florida
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United States of America
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Kentucky
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United States of America
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Louisiana
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United States of America
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Ohio
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United States of America
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Oklahoma
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United States of America
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South Carolina
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United States of America
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Texas
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Argentina
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Tucumán
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Belgium
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Gesves Namur
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Canada
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Ontario
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Canada
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Quebec
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Chile
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State/province [13]
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Biobío
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Chile
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State/province [14]
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Reg Metropolitana De Santiago
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China
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State/province [15]
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Baotou
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Country [16]
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China
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State/province [16]
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Beijing
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China
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Chengdu
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China
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Hangzhou
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China
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Hefei
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China
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Jinan
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China
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Jingzhou
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China
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Nanning
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China
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Shenyang
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China
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Suzhou
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China
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Taiyuan
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China
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Wuhan
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China
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Yantai
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China
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Zibo
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Czechia
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Hradec Králové
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Czechia
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State/province [30]
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Pardubice
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Czechia
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State/province [31]
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Pilsen
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Czechia
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Prague
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France
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Bordeaux
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France
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Marseille
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France
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Montpellier
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France
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Poitiers
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France
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Pontoise
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Hungary
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Budapest
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Hungary
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Szeged
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Israel
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Jerusalem
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Poland
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State/province [41]
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Lódzkie
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Poland
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Bielsko-Biala
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Poland
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Poznan
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Spain
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Navarra
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Turkey
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Ankara
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United Kingdom
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Lancashire
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United Kingdom
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State/province [47]
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Sanofi
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Address
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Regeneron Pharmaceuticals
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Address [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
EFC18419 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 study with 3 treatment groups. The purpose of the study is to evaluate the efficacy, safety and tolerability of 2 dosing regimens of itepekimab compared to placebo as add-on therapy to intranasal corticosteroids (INCS) in male and female participants with chronic rhinosinusitis with nasal polyps (CRSwNP) aged 18 years of age and older. Study details include: * The study duration per participant (4-week screening, 52-week treatment, 20-week safety follow-up) will be up to 76 weeks. For participants transitioning to the LTS18420 study, the study duration will be 56 weeks. * The treatment duration will be up to 52 weeks. * The number of visits will be 9 site visits and 20 phone/home visits.
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Trial website
https://clinicaltrials.gov/study/NCT06834360
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Clinical Sciences & Operations
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Address
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Sanofi
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Country
0
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Phone
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
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Trial Transparency email recommended (Toll free for US & Canada)
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Address
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Country
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0
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Phone
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800-633-1610
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Fax
0
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Email
0
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Query!
When will data be available (start and end dates)?
Query!
Available to whom?
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06834360
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