Controlled Clinical Study of Dupilumab in Patients With Nasal Polyps

NCT02898454 | Completed Phase 3 Results DMC

• 3 other identifiers: EFC142802015-001314-10U1111-1170-7180
• Study Type: interventional
• Target: 448
• Locations: 14 countries
• Sites: 123

Brief Summary

Primary Objective: 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.

Conditions

Chronic Rhinosinusitis Phenotype With Nasal Polyps (CRSwNP)

Outcome Measures

Primary Outcomes (2)

• Change From Baseline at Week 24 in Nasal Congestion/Obstruction Symptom Severity Score

  NC symptom severity was assessed by the participants on a daily basis from visit 1 and throughout the study using an e-diary on a scale of 0 to 3, where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms, with higher scores indicated more severity. Least squares (LS) means and standard error (SE) were obtained from Analysis of covariance (ANCOVA) model described in Statistical Analysis Overview. All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments.

  Baseline, Week 24

• Change From Baseline at Week 24 in Nasal Polyp Score

  NPS: sum of right, left nostril scores, evaluated by nasal endoscopy. For each nostril, NPS was graded based on polyp size from 0 = no polyps to 4 = large polyps causing complete obstruction of inferior nasal cavity; lower score = smaller sized polyps. Total NPS: sum of right and left nostril scores, ranges from 0 (no polyps) to 8 (large polyps), higher score = more severe disease. NPS was assessed by centralized, blinded, independent review of the nasal endoscopy video recordings. LS means and SE were obtained from ANCOVA model described in Statistical Analysis Overview. All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments.

  Baseline, Week 24

Secondary Outcomes (41)

• Change From Baseline at Week 24 in Opacification of Sinuses Measured by Lund Mackay (LMK) Score

  Baseline, Week 24

• Change From Baseline at Week 24 in Total Symptom Score (TSS)

  Baseline, Week 24

• Change From Baseline at Week 24 in the University of Pennsylvania Smell Identification Test (UPSIT) Score

  Baseline, Week 24

• Change From Baseline at Week 24 in Severity of Decreased/Loss of Smell as Assessed by Participant Daily

  Baseline, Week 24

• Change From Baseline at Week 24 in 22-item Sino-nasal Outcome Test (SNOT-22) Scores

  Baseline, Week 24

Study Arms (3)

Dupilumab 300 mg q2w

EXPERIMENTAL

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.

Drug: Dupilumab SAR231893 (REGN668); Drug: Mometasone furoate nasal spray

Dupilumab 300 mg q2w then q4w

EXPERIMENTAL

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.

Drug: Dupilumab SAR231893 (REGN668); Drug: Placebo; Drug: Mometasone furoate nasal spray

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo; Drug: Mometasone furoate nasal spray

Interventions

Dupilumab SAR231893 (REGN668) DRUG

Pharmaceutical form: Solution Route of administration: Subcutaneous

Dupilumab 300 mg q2w; Dupilumab 300 mg q2w then q4w

Placebo DRUG

Pharmaceutical form: Solution Route of administration: Subcutaneous

Dupilumab 300 mg q2w then q4w; Placebo

Mometasone furoate nasal spray DRUG

Pharmaceutical form: Suspension Route of administration: Intranasal

Also known as: NASONEX®

Dupilumab 300 mg q2w; Dupilumab 300 mg q2w then q4w; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with bilateral sino-nasal polyposis that despite prior treatment with SCS anytime within the past 2 years; and/or had a medical contraindication/intolerance to SCS; and/or had prior surgery for NP at the screening visit, had:
• 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.

You may not qualify if:

• Participants \<18 years of age.
• 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,

Sponsors & Collaborators

• Sanofi: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (123)

Investigational Site Number 8400019

Birmingham, Alabama, 35209, United States

Location

Investigational Site Number 8400011

Fresno, California, 93720, United States

Location

Investigational Site Number 8400008

Huntington Beach, California, 92647, United States

Location

Investigational Site Number 8400004

Rolling Hills Estates, California, 90274, United States

Location

Investigational Site Number 8400012

Walnut Creek, California, 94598, United States

Location

Investigational Site Number 8400017

Colorado Springs, Colorado, 80909, United States

Location

Investigational Site Number 8400006

Denver, Colorado, 80230, United States

Location

Investigational Site Number 8400022

New Haven, Connecticut, 06519, United States

Location

Investigational Site Number 8400002

Louisville, Kentucky, 40207, United States

Location

Investigational Site Number 8400021

Boston, Massachusetts, 02114, United States

Location

Investigational Site Number 8400014

Kansas City, Missouri, 64114, United States

Location

Investigational Site Number 8400024

The Bronx, New York, 10461, United States

Location

Investigational Site Number 8400016

North Charleston, North Carolina, 29420, United States

Location

Investigational Site Number 8400013

Bethlehem, Pennsylvania, 18017, United States

Location

Investigational Site Number 8400005

Philadelphia, Pennsylvania, 19104, United States

Location

Investigational Site Number 8400003

Pittsburgh, Pennsylvania, 15213, United States

Location

Investigational Site Number 8400009

Salt Lake City, Utah, 84132, United States

Location

Investigational Site Number 8400010

Bellevue, Washington, 98225, United States

Location

Investigational Site Number 8400007

Milwaukee, Wisconsin, 53219, United States

Location

Investigational Site Number 0320006

Buenos Aires, B1602DQD, Argentina

Location

Investigational Site Number 0320004

Buenos Aires, C1121ABE, Argentina

Location

Investigational Site Number 0320005

Caba, C1414AIF, Argentina

Location

Investigational Site Number 0320001

Caba, C1425BEN, Argentina

Location

Investigational Site Number 0320007

Caba, C1426ABP, Argentina

Location

Investigational Site Number 0320003

Mendoza, 5500, Argentina

Location

Investigational Site Number 0320008

Rosario, S2000DBS, Argentina

Location

Investigational Site Number 0320002

San Miguel de Tucumán, T4000IAR, Argentina

Location

Investigational Site Number 0360002

Clayton, 3168, Australia

Location

Investigational Site Number 0360004

Herston, 4029, Australia

Location

Investigational Site Number 0360005

Murdoch, 6150, Australia

Location

Investigational Site Number 0360001

Parkville, 3050, Australia

Location

Investigational Site Number 0360003

Prahran, 3004, Australia

Location

Investigational Site Number 0560003

Brussels, 1200, Belgium

Location

Investigational Site Number 0560001

Ghent, 9000, Belgium

Location

Investigational Site Number 0560002

Leuven, 3500, Belgium

Location

Investigational Site Number 1240007

Kingston, K7L 2V7, Canada

Location

Investigational Site Number 1240002

Montreal, H2W 1T8, Canada

Location

Investigational Site Number 1240006

Montreal, H4A 3J1, Canada

Location

Investigational Site Number 1240005

Ottawa, K1G 6C6, Canada

Location

Investigational Site Number 1240003

Québec, G1V 4G5, Canada

Location

Investigational Site Number 1240004

Québec, G1V 4W2, Canada

Location

Investigational Site Number 1240008

Trois-Rivières, G8T 7A1, Canada

Location

Investigational Site Number 1240001

Vancouver, V5Z 1M9, Canada

Location

Investigational Site Number 1520009

Quillota, 2260877, Chile

Location

Investigational Site Number 1520010

San Fernando, Chile

Location

Investigational Site Number 1520005

Santiago, 7500010, Chile

Location

Investigational Site Number 1520011

Santiago, 7500571, Chile

Location

Investigational Site Number 1520008

Santiago, 7500692, Chile

Location

Investigational Site Number 1520006

Santiago, 7980378, Chile

Location

Investigational Site Number 1520001

Santiago, 8207257, Chile

Location

Investigational Site Number 1520014

Santiago, 8910131, Chile

Location

Investigational Site Number 1520003

Talca, Chile

Location

Investigational Site Number 1520007

Viña del Mar, Chile

Location

Investigational Site Number 3760001

Hadera, 38100, Israel

Location

Investigational Site Number 3760003

Nahariya, 22100, Israel

Location

Investigational Site Number 3760002

Petah Tikva, 49100, Israel

Location

Investigational Site Number 3760005

Rehovot, 76100, Israel

Location

Investigational Site Number 3760004

Tel Litwinsky, 52621, Israel

Location

Investigational Site Number 3920004

Bunkyō City, Japan

Location

Investigational Site Number 3920009

Bunkyō City, Japan

Location

Investigational Site Number 3920026

Bunkyō City, Japan

Location

Investigational Site Number 3920006

Chiyoda-Ku, Japan

Location

Investigational Site Number 3920024

Fukuoka, Japan

Location

Investigational Site Number 3920010

Hirakata-Shi, Japan

Location

Investigational Site Number 3920011

Hiroshima, Japan

Location

Investigational Site Number 3920007

Iida-Shi, Japan

Location

Investigational Site Number 3920015

Inzai-Shi, Japan

Location

Investigational Site Number 3920012

Itabashi-Ku, Japan

Location

Investigational Site Number 3920014

Izumisano, Japan

Location

Investigational Site Number 3920016

Kawasaki-Shi, Japan

Location

Investigational Site Number 3920020

Kitakyushu-Shi, Japan

Location

Investigational Site Number 3920027

Kitakyushu-Shi, Japan

Location

Investigational Site Number 3920002

Kumamoto, Japan

Location

Investigational Site Number 3920021

Kumamoto, Japan

Location

Investigational Site Number 3920003

Kyoto, Japan

Location

Investigational Site Number 3920023

Meguro-Ku, Japan

Location

Investigational Site Number 3920013

Moriguchi-Shi, Japan

Location

Investigational Site Number 3920025

Okayama, Japan

Location

Investigational Site Number 3920018

Osaka, Japan

Location

Investigational Site Number 3920017

Ōta-ku, Japan

Location

Investigational Site Number 3920005

Sendai, Japan

Location

Investigational Site Number 3920022

Sendai, Japan

Location

Investigational Site Number 3920001

Shimonoseki-Shi, Japan

Location

Investigational Site Number 3920029

Shinagawa-Ku, Japan

Location

Investigational Site Number 3920030

Shinjyuku-Ku, Japan

Location

Investigational Site Number 3920028

Takatsuki-Shi, Japan

Location

Investigational Site Number 3920019

Yoshida-Gun, Japan

Location

Investigational Site Number 4840001

Chihuahua City, 31000, Mexico

Location

Investigational Site Number 4840005

Chihuahua City, 31200, Mexico

Location

Investigational Site Number 4840004

Durango, 34080, Mexico

Location

Investigational Site Number 4840002

Guadalajara, 44100, Mexico

Location

Investigational Site Number 4840003

Monterrey, 64460, Mexico

Location

Investigational Site Number 6200004

Aveiro, 3810-501, Portugal

Location

Investigational Site Number 6200006

Guimarães, 4810-061, Portugal

Location

Investigational Site Number 6200002

Lisbon, 1349-019, Portugal

Location

Investigational Site Number 6200007

Matosinhos Municipality, 4460-188, Portugal

Location

Investigational Site Number 6200001

Porto, 4099-001, Portugal

Location

Investigational Site Number 6200005

Viana do Castelo, 4901-858, Portugal

Location

Investigational Site Number 6430006

Moscow, 123182, Russia

Location

Investigational Site Number 6430003

Odintsovo, 143005, Russia

Location

Investigational Site Number 6430002

Saint Petersburg, 197022, Russia

Location

Investigational Site Number 6430005

Stavropol, 355030, Russia

Location

Investigational Site Number 6430001

Yaroslavl, 150062, Russia

Location

Investigational Site Number 7240001

Barcelona, 08036, Spain

Location

Investigational Site Number 7240006

Barcelona, 08041, Spain

Location

Investigational Site Number 7240003

Jerez de la Frontera, 11407, Spain

Location

Investigational Site Number 7240002

Madrid, 28040, Spain

Location

Investigational Site Number 7240007

Seville, 41071, Spain

Location

Investigational Site Number 7240009

Valencia, 46026, Spain

Location

Investigational Site Number 7520002

Lund, 221 85, Sweden

Location

Investigational Site Number 7520001

Stockholm, 171 76, Sweden

Location

Investigational Site Number 7920004

Ankara, 06100, Turkey (Türkiye)

Location

Investigational Site Number 7920005

Ankara, 06500, Turkey (Türkiye)

Location

Investigational Site Number 7920008

Ankara, 06520, Turkey (Türkiye)

Location

Investigational Site Number 7920013

Bursa, 16059, Turkey (Türkiye)

Location

Investigational Site Number 7920010

Istanbul, 34010, Turkey (Türkiye)

Location

Investigational Site Number 7920009

Istanbul, 34360, Turkey (Türkiye)

Location

Investigational Site Number 7920003

Istanbul, 34373, Turkey (Türkiye)

Location

Investigational Site Number 7920001

Istanbul, 34390, Turkey (Türkiye)

Location

Investigational Site Number 7920002

Istanbul, 34764, Turkey (Türkiye)

Location

Investigational Site Number 7920006

Izmir, 35100, Turkey (Türkiye)

Location

Investigational Site Number 7920007

Izmir, 35340, Turkey (Türkiye)

Location

Investigational Site Number 7920011

Rize, 53100, Turkey (Türkiye)

Location

Related Publications (27)

• 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.

  PMID: 39343385 DERIVED

• 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.

  PMID: 39151476 DERIVED

• 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.

  PMID: 38854740 DERIVED

• 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.

  PMID: 38156522 DERIVED

• 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.

  PMID: 37453138 DERIVED

• 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.

  PMID: 37322842 DERIVED

• 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.

  PMID: 37026112 DERIVED

• 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.

  PMID: 36721661 DERIVED

• 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.

  PMID: 35775319 DERIVED

• 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.

  PMID: 35636689 DERIVED

• 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.

  PMID: 35092110 DERIVED

• 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.

  PMID: 35034364 DERIVED

• 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.

  PMID: 34970860 DERIVED

• 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.

  PMID: 34954123 DERIVED

• 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.

  PMID: 34911163 DERIVED

• 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.

  PMID: 34850966 DERIVED

• 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.

  PMID: 34817082 DERIVED

• 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.

  PMID: 34459002 DERIVED

• 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.

  PMID: 34437720 DERIVED

• 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.

  PMID: 34037993 DERIVED

• 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.

  PMID: 33993501 DERIVED

• 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.

  PMID: 33710614 DERIVED

• 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.

  PMID: 33611847 DERIVED

• 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.

  PMID: 33548517 DERIVED

• 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.

  PMID: 33465455 DERIVED

• 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.

  PMID: 33226139 DERIVED

• Bachert C, Han JK, Desrosiers M, Hellings PW, Amin N, Lee SE, Mullol J, Greos LS, Bosso JV, Laidlaw TM, Cervin AU, Maspero JF, Hopkins C, Olze H, Canonica GW, Paggiaro P, Cho SH, Fokkens WJ, Fujieda S, Zhang M, Lu X, Fan C, Draikiwicz S, Kamat SA, Khan A, Pirozzi G, Patel N, Graham NMH, Ruddy M, Staudinger H, Weinreich D, Stahl N, Yancopoulos GD, Mannent LP. Efficacy and safety of dupilumab in patients with severe chronic rhinosinusitis with nasal polyps (LIBERTY NP SINUS-24 and LIBERTY NP SINUS-52): results from two multicentre, randomised, double-blind, placebo-controlled, parallel-group phase 3 trials. Lancet. 2019 Nov 2;394(10209):1638-1650. doi: 10.1016/S0140-6736(19)31881-1. Epub 2019 Sep 19.

  PMID: 31543428 DERIVED

MeSH Terms

Interventions

dupilumab; Mometasone Furoate

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi

Contact-US@sanofi.com

800-633-1610

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2016
• First Posted: September 13, 2016
• Study Start: November 28, 2016
• Primary Completion: August 27, 2018
• Study Completion: November 16, 2018
• Last Updated: October 23, 2019
• Results First Posted: October 23, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (12); RU (5); SE (2); CA (8); US (19); CL (10); IL (5); ES (6); AR (8); AU (5); BE (3); PT (6); JP (29); ME (5)