An Evaluation of Dupilumab in Patients With Nasal Polyposis And Chronic Symptoms Of Sinusitis
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|ClinicalTrials.gov Identifier: NCT01920893|
Recruitment Status : Completed
First Posted : August 12, 2013
Results First Posted : June 2, 2017
Last Update Posted : June 26, 2017
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.
To evaluate effect of dupilumab with regards to:
- symptoms of sinusitis,
- sinus computed tomography (CT) scan,
- NPS in the sub-group of participants with co-morbid asthma,
- Safety and tolerability.
|Condition or disease||Intervention/treatment||Phase|
|Nasal Polyps||Drug: Placebo (for dupilumab) Drug: Dupilumab Drug: Mometasone furoate nasal spray||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Randomized, Double-Blind, Phase 2, Placebo Controlled, 2 Arm Study To Evaluate Dupilumab In Patients With Bilateral Nasal Polyposis And Chronic Symptoms Of Sinusitis|
|Study Start Date :||August 2013|
|Primary Completion Date :||November 2014|
|Study Completion Date :||November 2014|
Placebo Comparator: 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 Mometasone furoate nasal spray (MFNS).
Drug: Placebo (for dupilumab)
Solution for injection; Subcutaneous injection.Drug: Mometasone furoate nasal spray
Nasal spray, 2 actuations in each nostril twice daily.
Other Name: NASONEX®
Experimental: 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.
Solution for injection; Subcutaneous injection.
Other Names:Drug: Mometasone furoate nasal spray
Nasal spray, 2 actuations in each nostril twice daily.
Other Name: NASONEX®
- Change From Baseline in Bilateral Endoscopic Nasal Polyp Score (NPS) at Week 16 [ Time Frame: Baseline, 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.
- Change From Baseline in Bilateral Endoscopic NPS at Week 16 in Participants With Asthma [ Time Frame: Baseline, 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.
- Change From Baseline in Participant Reported Symptoms Scores of Sinusitis at Week 16 [ Time Frame: Baseline, 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.
- Change From Baseline in Visual Analogue Scale (VAS) for Rhinosinusitis Symptoms Severity at Week 16 [ Time Frame: Baseline, 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.
- Change From Baseline in Nasal Peak Inspiratory Flow (NPIF) at Week 16 [ Time Frame: Baseline, 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.
- Change From Baseline in Smell Test (University of Pennsylvania Smell Identification Test [UPSIT]) Scores at Week 16 [ Time Frame: Baseline, 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.
- Change From Baseline in Sinus Computed Tomography (CT) Scan Assessments at Week 16: Lund-Mackay Score [ Time Frame: Baseline, Week 16 ]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.
- Change From Baseline in Sinus Computed Tomography (CT) Scan Assessments at Week 16: Percent Area Occupied by Disease [ Time Frame: Baseline, Week 16 ]CT scan assessment included Lund-Mackay score and percentage of the area of maxillary sinuses occupied by disease.
- Time to First Response in NPS: Kaplan-Meier Estimate at Week 16 [ Time Frame: Baseline to 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.
- Change From Baseline in 22-Item Sinonasal Outcome Test (SNOT-22) at Week 16 [ Time Frame: Baseline, 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01920893
|United States, California|
|Investigational Site Number 840014|
|Rolling Hills Estates, California, United States, 90274|
|United States, Colorado|
|Investigational Site Number 840015|
|Denver, Colorado, United States, 80230|
|United States, Massachusetts|
|Investigational Site Number 840013|
|Boston, Massachusetts, United States, 02114|
|United States, Oregon|
|Investigational Site Number 840002|
|Lake Oswego, Oregon, United States, 97035|
|United States, Pennsylvania|
|Investigational Site Number 840009|
|Pittsburgh, Pennsylvania, United States, 15213|
|Investigational Site Number 056001|
|Gent, Belgium, 9000|
|Investigational Site Number 056002|
|Leuven, Belgium, 3500|
|Investigational Site Number 724001|
|Barcelona, Spain, 08036|
|Investigational Site Number 724003|
|Faitanar, Spain, 46014|
|Investigational Site Number 724002|
|Hospitalet De Llobregat, Spain, 08907|
|Investigational Site Number 724005|
|Jerez De La Frontera, Spain, 11407|
|Investigational Site Number 724004|
|Madrid, Spain, 28040|
|Investigational Site Number 752001|
|Stockholm, Sweden, 14186|
|Investigational Site Number 752002|
|Stockholm, Sweden, 171 76|
|Study Director:||Clinical Sciences & Operations||Sanofi|