An Evaluation of Dupilumab in Patients With Nasal Polyposis And Chronic Symptoms Of Sinusitis
NCT ID: NCT01920893
Last Updated: 2017-06-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2013-08-31
2014-11-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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).
Placebo (for dupilumab)
Solution for injection; Subcutaneous injection.
Mometasone furoate nasal spray
Nasal spray, 2 actuations in each nostril twice daily.
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.
Dupilumab
Solution for injection; Subcutaneous injection.
Mometasone furoate nasal spray
Nasal spray, 2 actuations in each nostril twice daily.
Interventions
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Placebo (for dupilumab)
Solution for injection; Subcutaneous injection.
Dupilumab
Solution for injection; Subcutaneous injection.
Mometasone furoate nasal spray
Nasal spray, 2 actuations in each nostril twice daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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:
* Burst of systemic corticosteroids within the 2 months before screening or were scheduled to receive systemic corticosteroids during the study period for another condition
* INCS drops within 1 month prior to screening
* Monoclonal antibody (mAB) and immunosuppressive treatment
* Anti-immunoglobulin E (IgE) therapy (omalizumab) within 130 days of Visit 1
* Leukotriene antagonists/modifiers unless participant was on a continuous treatment for at least 30 days prior to Visit 1.
* 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:
* Forced Expiratory Volume (FEV1) ≤ 60%, or .Asthma exacerbation requiring systemic (oral and/or parenteral) steroid treatment or hospitalization for \>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.
18 Years
65 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Investigational Site Number 840014
Rolling Hills Estates, California, United States
Investigational Site Number 840015
Denver, Colorado, United States
Investigational Site Number 840013
Boston, Massachusetts, United States
Investigational Site Number 840002
Lake Oswego, Oregon, United States
Investigational Site Number 840009
Pittsburgh, Pennsylvania, United States
Investigational Site Number 056001
Ghent, , Belgium
Investigational Site Number 056002
Leuven, , Belgium
Investigational Site Number 724001
Barcelona, , Spain
Investigational Site Number 724003
Faitanar, , Spain
Investigational Site Number 724005
Jerez de la Frontera, , Spain
Investigational Site Number 724002
L'Hospitalet de Llobregat, , Spain
Investigational Site Number 724004
Madrid, , Spain
Investigational Site Number 752001
Stockholm, , Sweden
Investigational Site Number 752002
Stockholm, , Sweden
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2013-001803-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1130-6475
Identifier Type: OTHER
Identifier Source: secondary_id
ACT12340
Identifier Type: -
Identifier Source: org_study_id
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