Controlled Clinical Study of Dupilumab in Patients With Nasal Polyps
NCT ID: NCT02898454
Last Updated: 2019-10-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
448 participants
INTERVENTIONAL
2016-11-28
2018-11-16
Brief Summary
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To evaluate the efficacy of dupilumab 300 mg every 2 weeks (q2w) compared to placebo on a background of mometasone furoate nasal spray (MFNS) in reducing nasal congestion (NC)/obstruction severity and endoscopic nasal polyp score (NPS) in participants with bilateral nasal polyps (NP). In addition for Japanese participants, reduction in computed tomography (CT) scan opacification of the sinuses was a co-primary objective.
Secondary Objectives:
* To evaluate the efficacy of dupilumab in improving total symptoms score.
* To evaluate the efficacy of dupilumab in improving sense of smell.
* To evaluate the efficacy of dupilumab in reducing CT scan opacification of the sinuses (primary objective for Japanese participants).
* To evaluate ability of dupilumab in reducing proportion of participants who required treatment with systemic corticosteroids (SCS) or surgery for NP.
* To evaluate the effect of dupilumab on participant reported outcomes and health related quality of life.
* To evaluate the efficacy of dupilumab 300 mg q2w up to Week 52.
* To evaluate the efficacy of dupilumab 300 mg q2w up to Week 24 followed by 300 mg every 4 weeks (q4w) up to Week 52.
* To evaluate the effect of dupilumab in the subgroups of participants with prior surgery and comorbid asthma including non-steroid anti-inflammatory drug exacerbated respiratory disease.
* To evaluate the safety of dupilumab in participants with bilateral NP.
* To evaluate functional dupilumab concentrations (systemic exposure) and incidence of treatment emergent anti-drug antibodies.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Dupilumab 300 mg q2w
Dupilumab 300 mg subcutaneous (SC) injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Dupilumab SAR231893 (REGN668)
Pharmaceutical form: Solution
Route of administration: Subcutaneous
Mometasone furoate nasal spray
Pharmaceutical form: Suspension
Route of administration: Intranasal
Dupilumab 300 mg q2w then q4w
Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 24 and then 300 mg q4w until Week 52 added to background therapy of intranasal MFNS at stable dose. After Week 24, Dupilumab administration was alternated with matched placebo injection every other week up to Week 50.
Dupilumab SAR231893 (REGN668)
Pharmaceutical form: Solution
Route of administration: Subcutaneous
Placebo
Pharmaceutical form: Solution
Route of administration: Subcutaneous
Mometasone furoate nasal spray
Pharmaceutical form: Suspension
Route of administration: Intranasal
Placebo
Placebo (for dupilumab), 1 SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
Placebo
Pharmaceutical form: Solution
Route of administration: Subcutaneous
Mometasone furoate nasal spray
Pharmaceutical form: Suspension
Route of administration: Intranasal
Interventions
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Dupilumab SAR231893 (REGN668)
Pharmaceutical form: Solution
Route of administration: Subcutaneous
Placebo
Pharmaceutical form: Solution
Route of administration: Subcutaneous
Mometasone furoate nasal spray
Pharmaceutical form: Suspension
Route of administration: Intranasal
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* An endoscopic bilateral NPS at Visit 1 (V1) of at least 5 out of a maximum score of 8 (with a minimum score of 2 in each nasal cavity).
* Ongoing symptoms (for at least 8 weeks before V1) of NC/blockage/obstruction with moderate or severe symptom severity (score 2 or 3) at V1 and a weekly average severity of greater than 1 at time of randomization (V2), and another symptom such as loss of smell, rhinorrhea (anterior/posterior).
* Signed written informed consent.
Exclusion Criteria
* Participant who had been previously treated in dupilumab studies.
* Participant who had taken:
* Biologic therapy/ systemic immunosuppressant to treat inflammatory disease or autoimmune disease (eg, rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis, etc.) within 2 months before V1 or 5 half-lives, whichever was longer.
* Any experimental monoclonal antibody within 5 half-lives or within 6 months before V1 if the half-life was unknown.
* Anti-immunoglobulin E therapy (omalizumab) within 130 days prior to V1.
* Participants who received leukotriene antagonists/modifiers at V1 unless they were on a continuous treatment for at least 30 days prior to V1.
* Initiation of allergen immunotherapy within 3 months prior to V1 or a plan to begin therapy or change its dose during the run-in period or the randomized treatment period.
* Participants who underwent any and/or sinus surgery (including polypectomy) within 6 months before V1.
* Participants who had a sino-nasal or sinus surgery changing the lateral wall structure of the nose making impossible the evaluation of NPS.
* Participants with conditions/concomitant diseases making them non evaluable at V1 or for the primary efficacy endpoint such as:
* Antrochoanal polyps,
* Nasal septal deviation that would occlude at least one nostril,
* Acute sinusitis, nasal infection or upper respiratory infection,
* Ongoing rhinitis medicamentosa,
* Allergic granulomatous angiitis (Churg-Strauss syndrome), granulomatosis with polyangiitis (Wegener's granulomatosis),Young's syndrome, Kartagener's syndrome or other dyskinetic ciliary syndromes, concomitant cystic fibrosis,
* Radiologic suspicion, or confirmed invasive or expansive fungal rhinosinusitis.
* Participants with nasal cavity malignant tumor and benign tumors (eg, papilloma, blood boil etc.).
* Participants with forced expiratory volume 50% or less (of predicted normal).
* Participants who received concomitant treatment prohibited in the study.
* Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit.
* Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit.
* History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
* Positive with hepatitis B surface antigen or hepatitis C antibody at the screening visit.
* Active chronic or acute infection requiring systemic treatment within 2 weeks before the baseline visit.
* Known or suspected history of immunosuppression.
* Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
* Women unwilling to use adequate birth control, if of reproductive potential and sexually active.
The above information was not intended to contain all considerations relevant to a Participant's potential participation in a clinical trial.
18 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 8400019
Birmingham, Alabama, United States
Investigational Site Number 8400011
Fresno, California, United States
Investigational Site Number 8400008
Huntington Beach, California, United States
Investigational Site Number 8400004
Rolling Hills Estates, California, United States
Investigational Site Number 8400012
Walnut Creek, California, United States
Investigational Site Number 8400017
Colorado Springs, Colorado, United States
Investigational Site Number 8400006
Denver, Colorado, United States
Investigational Site Number 8400022
New Haven, Connecticut, United States
Investigational Site Number 8400002
Louisville, Kentucky, United States
Investigational Site Number 8400021
Boston, Massachusetts, United States
Investigational Site Number 8400014
Kansas City, Missouri, United States
Investigational Site Number 8400024
The Bronx, New York, United States
Investigational Site Number 8400016
North Charleston, North Carolina, United States
Investigational Site Number 8400013
Bethlehem, Pennsylvania, United States
Investigational Site Number 8400005
Philadelphia, Pennsylvania, United States
Investigational Site Number 8400003
Pittsburgh, Pennsylvania, United States
Investigational Site Number 8400009
Salt Lake City, Utah, United States
Investigational Site Number 8400010
Bellevue, Washington, United States
Investigational Site Number 8400007
Milwaukee, Wisconsin, United States
Investigational Site Number 0320006
Buenos Aires, , Argentina
Investigational Site Number 0320004
Buenos Aires, , Argentina
Investigational Site Number 0320005
Caba, , Argentina
Investigational Site Number 0320001
Caba, , Argentina
Investigational Site Number 0320007
Caba, , Argentina
Investigational Site Number 0320003
Mendoza, , Argentina
Investigational Site Number 0320008
Rosario, , Argentina
Investigational Site Number 0320002
San Miguel de Tucumán, , Argentina
Investigational Site Number 0360002
Clayton, , Australia
Investigational Site Number 0360004
Herston, , Australia
Investigational Site Number 0360005
Murdoch, , Australia
Investigational Site Number 0360001
Parkville, , Australia
Investigational Site Number 0360003
Prahran, , Australia
Investigational Site Number 0560003
Brussels, , Belgium
Investigational Site Number 0560001
Ghent, , Belgium
Investigational Site Number 0560002
Leuven, , Belgium
Investigational Site Number 1240007
Kingston, , Canada
Investigational Site Number 1240002
Montreal, , Canada
Investigational Site Number 1240006
Montreal, , Canada
Investigational Site Number 1240005
Ottawa, , Canada
Investigational Site Number 1240003
Québec, , Canada
Investigational Site Number 1240004
Québec, , Canada
Investigational Site Number 1240008
Trois-Rivières, , Canada
Investigational Site Number 1240001
Vancouver, , Canada
Investigational Site Number 1520009
Quillota, , Chile
Investigational Site Number 1520010
San Fernando, , Chile
Investigational Site Number 1520005
Santiago, , Chile
Investigational Site Number 1520011
Santiago, , Chile
Investigational Site Number 1520008
Santiago, , Chile
Investigational Site Number 1520006
Santiago, , Chile
Investigational Site Number 1520001
Santiago, , Chile
Investigational Site Number 1520014
Santiago, , Chile
Investigational Site Number 1520003
Talca, , Chile
Investigational Site Number 1520007
Viña del Mar, , Chile
Investigational Site Number 3760001
Hadera, , Israel
Investigational Site Number 3760003
Nahariya, , Israel
Investigational Site Number 3760002
Petah Tikva, , Israel
Investigational Site Number 3760005
Rehovot, , Israel
Investigational Site Number 3760004
Tel Litwinsky, , Israel
Investigational Site Number 3920004
Bunkyō City, , Japan
Investigational Site Number 3920009
Bunkyō City, , Japan
Investigational Site Number 3920026
Bunkyō City, , Japan
Investigational Site Number 3920006
Chiyoda-Ku, , Japan
Investigational Site Number 3920024
Fukuoka, , Japan
Investigational Site Number 3920010
Hirakata-Shi, , Japan
Investigational Site Number 3920011
Hiroshima, , Japan
Investigational Site Number 3920007
Iida-Shi, , Japan
Investigational Site Number 3920015
Inzai-Shi, , Japan
Investigational Site Number 3920012
Itabashi-Ku, , Japan
Investigational Site Number 3920014
Izumisano, , Japan
Investigational Site Number 3920016
Kawasaki-Shi, , Japan
Investigational Site Number 3920020
Kitakyushu-Shi, , Japan
Investigational Site Number 3920027
Kitakyushu-Shi, , Japan
Investigational Site Number 3920002
Kumamoto, , Japan
Investigational Site Number 3920021
Kumamoto, , Japan
Investigational Site Number 3920003
Kyoto, , Japan
Investigational Site Number 3920023
Meguro-Ku, , Japan
Investigational Site Number 3920013
Moriguchi-Shi, , Japan
Investigational Site Number 3920025
Okayama, , Japan
Investigational Site Number 3920018
Osaka, , Japan
Investigational Site Number 3920017
Ōta-ku, , Japan
Investigational Site Number 3920005
Sendai, , Japan
Investigational Site Number 3920022
Sendai, , Japan
Investigational Site Number 3920001
Shimonoseki-Shi, , Japan
Investigational Site Number 3920029
Shinagawa-Ku, , Japan
Investigational Site Number 3920030
Shinjyuku-Ku, , Japan
Investigational Site Number 3920028
Takatsuki-Shi, , Japan
Investigational Site Number 3920019
Yoshida-Gun, , Japan
Investigational Site Number 4840001
Chihuahua City, , Mexico
Investigational Site Number 4840005
Chihuahua City, , Mexico
Investigational Site Number 4840004
Durango, , Mexico
Investigational Site Number 4840002
Guadalajara, , Mexico
Investigational Site Number 4840003
Monterrey, , Mexico
Investigational Site Number 6200004
Aveiro, , Portugal
Investigational Site Number 6200006
Guimarães, , Portugal
Investigational Site Number 6200002
Lisbon, , Portugal
Investigational Site Number 6200007
Matosinhos Municipality, , Portugal
Investigational Site Number 6200001
Porto, , Portugal
Investigational Site Number 6200005
Viana do Castelo, , Portugal
Investigational Site Number 6430006
Moscow, , Russia
Investigational Site Number 6430003
Odintsovo, , Russia
Investigational Site Number 6430002
Saint Petersburg, , Russia
Investigational Site Number 6430005
Stavropol, , Russia
Investigational Site Number 6430001
Yaroslavl, , Russia
Investigational Site Number 7240001
Barcelona, , Spain
Investigational Site Number 7240006
Barcelona, , Spain
Investigational Site Number 7240003
Jerez de la Frontera, , Spain
Investigational Site Number 7240002
Madrid, , Spain
Investigational Site Number 7240007
Seville, , Spain
Investigational Site Number 7240009
Valencia, , Spain
Investigational Site Number 7520002
Lund, , Sweden
Investigational Site Number 7520001
Stockholm, , Sweden
Investigational Site Number 7920004
Ankara, , Turkey (Türkiye)
Investigational Site Number 7920005
Ankara, , Turkey (Türkiye)
Investigational Site Number 7920008
Ankara, , Turkey (Türkiye)
Investigational Site Number 7920013
Bursa, , Turkey (Türkiye)
Investigational Site Number 7920010
Istanbul, , Turkey (Türkiye)
Investigational Site Number 7920009
Istanbul, , Turkey (Türkiye)
Investigational Site Number 7920003
Istanbul, , Turkey (Türkiye)
Investigational Site Number 7920001
Istanbul, , Turkey (Türkiye)
Investigational Site Number 7920002
Istanbul, , Turkey (Türkiye)
Investigational Site Number 7920006
Izmir, , Turkey (Türkiye)
Investigational Site Number 7920007
Izmir, , Turkey (Türkiye)
Investigational Site Number 7920011
Rize, , Turkey (Türkiye)
Countries
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References
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Bachert C, Khan AH, Hopkins C, Han JK, Fokkens WJ, Mannent LP, Msihid J, Borsos K, Kamat S, Nash S, Sacks H, Rowe PJ, Deniz Y, Jacob-Nara JA. Mild and symptom-free months in patients with chronic rhinosinusitis with nasal polyps treated with dupilumab. Ann Allergy Asthma Immunol. 2025 Jan;134(1):61-69.e12. doi: 10.1016/j.anai.2024.09.015. Epub 2024 Sep 28.
Bachert C, Khan AH, Fokkens WJ, Hopkins C, Gevaert P, Han JK, Hellings PW, Lee SE, Msihid J, Nash S, Sacks H, Jacob-Nara JA, Deniz Y, Rowe PJ. Dupilumab response onset, maintenance, and durability in patients with severe CRSwNP. J Allergy Clin Immunol. 2024 Dec;154(6):1442-1449. doi: 10.1016/j.jaci.2024.07.026. Epub 2024 Aug 14.
Fokkens WJ, Bachert C, Hopkins C, Marglani O, Praestgaard A, Nash S, Deniz Y, Rowe PJ, Sacks H, Jacob-Nara JA. Dupilumab improves outcomes in patients with chronic rhinosinusitis with nasal polyps irrespective of gender: results from the SINUS-52 trial. Clin Transl Immunology. 2024 Jun 8;13(6):e1511. doi: 10.1002/cti2.1511. eCollection 2024.
Hopkins C, Mullol J, Khan AH, Lee SE, Wagenmann M, Hellings P, Fokkens W, Msihid J, Nair R, Kamat S, Nash S, Radwan A, Jacob-Nara JA, Deniz Y, Rowe PJ. Impact of Dupilumab on Sinonasal Symptoms and Outcomes in Severe Chronic Rhinosinusitis With Nasal Polyps. Otolaryngol Head Neck Surg. 2024 Apr;170(4):1173-1182. doi: 10.1002/ohn.627. Epub 2023 Dec 29.
Lee SE, Amin N, Mannent LP, Bachert C, Gross G, Cho SH, Praestgaard A, Siddiqui S, Nash S, Kamat S, Khan AH, Jacob Nara JA. The relationship of sinus opacification, olfaction and dupilumab efficacy in patients with CRSwNP. Rhinology. 2023 Dec 1;61(6):531-540. doi: 10.4193/Rhin22.220.
Bachert C, Laidlaw TM, Cho SH, Mullol J, Swanson BN, Naimi S, Classe M, Harel S, Jagerschmidt A, Laws E, Ruddy M, Praestgaard A, Amin N, Mannent LP. Effect of Dupilumab on Type 2 Biomarkers in Chronic Rhinosinusitis With Nasal Polyps: SINUS-52 Study Results. Ann Otol Rhinol Laryngol. 2023 Dec;132(12):1649-1661. doi: 10.1177/00034894231176334. Epub 2023 Jun 15.
Maspero JF, Bachert C, Martinez FJ, Hanania NA, Ortiz B, Patel N, Mannent LP, Praestgaard A, Pandit-Abid N, Siddiqui S, Hardin M. Clinical Efficacy among Patients with Chronic Rhinosinusitis with Nasal Polyps and Clinical Features of Obstructive Lung Disease: Post Hoc Analysis of the Phase III SINUS-24 and SINUS-52 Studies. J Asthma Allergy. 2023 Mar 31;16:333-342. doi: 10.2147/JAA.S357393. eCollection 2023.
Gevaert P, Lee SE, Settipane RA, Wagenmann M, Msihid J, Siddiqui S, Nash S, Jacob-Nara JA, Khan AH, Kamat S, Chuang CC. Dupilumab provides early and durable improvement of symptoms in patients with chronic rhinosinusitis with nasal polyps. Clin Transl Immunology. 2023 Jan 27;12(1):e1433. doi: 10.1002/cti2.1433. eCollection 2023.
Peters AT, Soler ZM, Kern RC, Heffler E, Maspero JF, Crampette L, Fujieda S, Lane AP, Zhang H, Nash S, Khan AH, Siddiqui S, Jacob-Nara JA, Rowe P, Deniz Y. Improvement in patient-reported "taste" and association with smell in dupilumab-treated patients with severe chronic rhinosinusitis with nasal polyps from the SINUS-24 and SINUS-52 trials. Clin Exp Allergy. 2022 Sep;52(9):1105-1109. doi: 10.1111/cea.14194. Epub 2022 Jul 12. No abstract available.
Wechsler ME, Klion AD, Paggiaro P, Nair P, Staumont-Salle D, Radwan A, Johnson RR, Kapoor U, Khokhar FA, Daizadeh N, Chen Z, Laws E, Ortiz B, Jacob-Nara JA, Mannent LP, Rowe PJ, Deniz Y. Effect of Dupilumab on Blood Eosinophil Counts in Patients With Asthma, Chronic Rhinosinusitis With Nasal Polyps, Atopic Dermatitis, or Eosinophilic Esophagitis. J Allergy Clin Immunol Pract. 2022 Oct;10(10):2695-2709. doi: 10.1016/j.jaip.2022.05.019. Epub 2022 May 28.
Bachert C, Peters AT, Heffler E, Han JK, Olze H, Pfaar O, Chuang CC, Rout R, Attre R, Goga L, Jacob-Nara JA, Rowe PJ, Deniz Y, Chen Z, Kamat S, Siddiqui S. Responder analysis to demonstrate the effect of targeting type 2 inflammatory mechanisms with dupilumab across objective and patient-reported endpoints for patients with severe chronic rhinosinusitis with nasal polyps in the SINUS-24 and SINUS-52 studies. Clin Exp Allergy. 2022 Feb;52(2):244-249. doi: 10.1111/cea.14051. No abstract available.
Lee SE, Hopkins C, Mullol J, Msihid J, Guillemin I, Amin N, Mannent LP, Li Y, Siddiqui S, Chuang CC, Kamat S, Khan AH. Dupilumab improves health related quality of life: Results from the phase 3 SINUS studies. Allergy. 2022 Jul;77(7):2211-2221. doi: 10.1111/all.15222. Epub 2022 Feb 1.
Bachert C, Corren J, Lee SE, Zhang H, Harel S, Cunoosamy D, Khan AH, Jacob-Nara JA, Siddiqui S, Nash S, Rowe PJ, Deniz Y. Dupilumab efficacy and biomarkers in chronic rhinosinusitis with nasal polyps: Association between dupilumab treatment effect on nasal polyp score and biomarkers of type 2 inflammation in patients with chronic rhinosinusitis with nasal polyps in the phase 3 SINUS-24 and SINUS-52 trials. Int Forum Allergy Rhinol. 2022 Sep;12(9):1191-1195. doi: 10.1002/alr.22964. Epub 2022 Jan 31. No abstract available.
Geng B, Bachert C, Busse WW, Gevaert P, Lee SE, Niederman MS, Chen Z, Lu X, Khokhar FA, Kapoor U, Pandit-Abid N, Jacob-Nara JA, Rowe PJ, Deniz Y, Ortiz B. Respiratory Infections and Anti-Infective Medication Use From Phase 3 Dupilumab Respiratory Studies. J Allergy Clin Immunol Pract. 2022 Mar;10(3):732-741. doi: 10.1016/j.jaip.2021.12.006. Epub 2021 Dec 22.
Hellings PW, Peters AT, Chaker AM, Heffler E, Zhang H, Praestgaard A, Nash S, Khan AH, Siddiqui S, Jacob-Nara JA, Rowe PJ, Deniz Y. Rapid and sustained effects of dupilumab in severe chronic rhinosinusitis with nasal polyps. Int Forum Allergy Rhinol. 2022 Jul;12(7):958-962. doi: 10.1002/alr.22944. Epub 2022 Jan 23. No abstract available.
Han JK, Bachert C, Lee SE, Hopkins C, Heffler E, Hellings PW, Peters AT, Kamat S, Whalley D, Qin S, Nelson L, Siddiqui S, Khan AH, Li Y, Mannent LP, Guillemin I, Chuang CC. Estimating Clinically Meaningful Change of Efficacy Outcomes in Inadequately Controlled Chronic Rhinosinusitis with Nasal Polyposis. Laryngoscope. 2022 Feb;132(2):265-271. doi: 10.1002/lary.29888. Epub 2021 Dec 1.
Chuang CC, Guillemin I, Bachert C, Lee SE, Hellings PW, Fokkens WJ, Duverger N, Fan C, Daizadeh N, Amin N, Mannent LP, Khan AH, Kamat S. Dupilumab in CRSwNP: Responder Analysis Using Clinically Meaningful Efficacy Outcome Thresholds. Laryngoscope. 2022 Feb;132(2):259-264. doi: 10.1002/lary.29911. Epub 2021 Nov 24.
Mullol J, Laidlaw TM, Bachert C, Mannent LP, Canonica GW, Han JK, Maspero JF, Picado C, Daizadeh N, Ortiz B, Li Y, Ruddy M, Laws E, Amin N. Efficacy and safety of dupilumab in patients with uncontrolled severe chronic rhinosinusitis with nasal polyps and a clinical diagnosis of NSAID-ERD: Results from two randomized placebo-controlled phase 3 trials. Allergy. 2022 Apr;77(4):1231-1244. doi: 10.1111/all.15067. Epub 2021 Oct 1.
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.
Hamilton JD, Harel S, Swanson BN, Brian W, Chen Z, Rice MS, Amin N, Ardeleanu M, Radin A, Shumel B, Ruddy M, Patel N, Pirozzi G, Mannent L, Graham NMH. Dupilumab suppresses type 2 inflammatory biomarkers across multiple atopic, allergic diseases. Clin Exp Allergy. 2021 Jul;51(7):915-931. doi: 10.1111/cea.13954. Epub 2021 Jun 26.
Fujieda S, Matsune S, Takeno S, Ohta N, Asako M, Bachert C, Inoue T, Takahashi Y, Fujita H, Deniz Y, Rowe P, Ortiz B, Li Y, Mannent LP. Dupilumab efficacy in chronic rhinosinusitis with nasal polyps from SINUS-52 is unaffected by eosinophilic status. Allergy. 2022 Jan;77(1):186-196. doi: 10.1111/all.14906. Epub 2021 Jun 4.
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.
Hopkins C, Wagenmann M, Bachert C, Desrosiers M, Han JK, Hellings PW, Lee SE, Msihid J, Radwan A, Rowe P, Amin N, Deniz Y, Ortiz B, Mannent LP, Rout R. Efficacy of dupilumab in patients with a history of prior sinus surgery for chronic rhinosinusitis with nasal polyps. Int Forum Allergy Rhinol. 2021 Jul;11(7):1087-1101. doi: 10.1002/alr.22780. Epub 2021 Feb 21.
Peters AT, Han JK, Hellings P, Heffler E, Gevaert P, Bachert C, Xu Y, Chuang CC, Neupane B, Msihid J, Mannent LP, Guyot P, Kamat S. Indirect Treatment Comparison of Biologics in Chronic Rhinosinusitis with Nasal Polyps. J Allergy Clin Immunol Pract. 2021 Jun;9(6):2461-2471.e5. doi: 10.1016/j.jaip.2021.01.031. Epub 2021 Feb 4.
Laidlaw TM, Bachert C, Amin N, Desrosiers M, Hellings PW, Mullol J, Maspero JF, Gevaert P, Zhang M, Mao X, Khan AH, Kamat S, Patel N, Graham NMH, Ruddy M, Staudinger H, Mannent LP. Dupilumab improves upper and lower airway disease control in chronic rhinosinusitis with nasal polyps and asthma. Ann Allergy Asthma Immunol. 2021 May;126(5):584-592.e1. doi: 10.1016/j.anai.2021.01.012. Epub 2021 Jan 16.
Fujieda S, Matsune S, Takeno S, Asako M, Takeuchi M, Fujita H, Takahashi Y, Amin N, Deniz Y, Rowe P, Mannent L. The Effect of Dupilumab on Intractable Chronic Rhinosinusitis with Nasal Polyps in Japan. Laryngoscope. 2021 Jun;131(6):E1770-E1777. doi: 10.1002/lary.29230. Epub 2020 Nov 23.
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2015-001314-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1170-7180
Identifier Type: OTHER
Identifier Source: secondary_id
EFC14280
Identifier Type: -
Identifier Source: org_study_id
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