Phase 2
N=60
An Evaluation of Dupilumab in Patients With Nasal Polyposis And Chronic Symptoms Of Sinusitis
Nasal Polyps
Bottom Line
View on ClinicalTrials.gov: NCT01920893 ↗Enrolled (actual)
60
Serious AEs
10.0%
Results posted
Jun 2017
Primary outcome: Primary: Change From Baseline in Bilateral Endoscopic Nasal Polyp Score (NPS) at Week 16 — 5.67; 5.87; 5.39; 3.97 score on a scale — p=0.0009
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (for dupilumab) (Drug); Dupilumab (Drug); Mometasone furoate nasal spray (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sanofi
- Primary completion
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Bilateral Endoscopic Nasal Polyp Score (NPS) at Week 16 |
5.67; 5.87; 5.39; 3.97; -0.26; -1.9 | 0.0009 sig |
| SECONDARY Change From Baseline in Bilateral Endoscopic NPS at Week 16 in Participants With Asthma |
0.27; -2.4 | — |
| SECONDARY Change From Baseline in Participant Reported Symptoms Scores of Sinusitis at Week 16 |
-0.26; -0.95; -0.1; -0.62; -0.15; -0.49 | — |
| SECONDARY Change From Baseline in Visual Analogue Scale (VAS) for Rhinosinusitis Symptoms Severity at Week 16 |
-1.84; -4.32 | — |
| SECONDARY Change From Baseline in Nasal Peak Inspiratory Flow (NPIF) at Week 16 |
28.81; 61.91; 26.65; 61.25 | — |
| SECONDARY Change From Baseline in Smell Test (University of Pennsylvania Smell Identification Test [UPSIT]) Scores at Week 16 |
-0.17; 15.36 | — |
| SECONDARY Change From Baseline in Sinus Computed Tomography (CT) Scan Assessments at Week 16: Lund-Mackay Score |
-0.23; -9.24 | — |
| SECONDARY Change From Baseline in Sinus Computed Tomography (CT) Scan Assessments at Week 16: Percent Area Occupied by Disease |
-3.92; -35.66 | — |
| SECONDARY Time to First Response in NPS: Kaplan-Meier Estimate at Week 16 |
0.44; 0.828 | — |
| SECONDARY Change From Baseline in 22-Item Sinonasal Outcome Test (SNOT-22) at Week 16 |
-8.26; -29.1 | — |
Summary
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:
* symptoms of sinusitis,
* sinus computed tomography (CT) scan,
* NPS in the sub-group of participants with co-morbid asthma,
* Safety and tolerability.
Eligibility Criteria
Inclusion criteria: participants with:
- A minimum bilateral nasal polyp score of 5 out of a maximum score of 8 (with a unilateral score of at least 2 for each nostril) despite completion of a prior intranasal corticosteroid (INCS) treatment for at least 8 weeks before screening.
- Presence of at least two of the following symptoms prior to screening: nasal blockade/obstruction/congestion or nasal discharge (anterior/posterior nasal drip); facial pain/pressure; reduction or loss of smell.
Exclusion criteria
- Participants 65 years of age.
- Sinonasal outcome test (SNOT-22) 24 hours for treatment of asthma, within 3 months prior to screening or were on a dose of greater than 1000 microgram (mcg) fluticasone or an equivalent INCS.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Data sourced from ClinicalTrials.gov (NCT01920893). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.