A Controlled Clinical Study of Dupilumab in Patients With Bilateral Nasal Polyps

NCT02912468 | Completed Phase 3 Results DMC

• 3 other identifiers: EFC141462015-003101-42U1111-1178-5390
• Study Type: interventional
• Target: 276
• Locations: 13 countries
• Sites: 76

Brief Summary

Primary Objective: To evaluate the efficacy of dupilumab 300 milligram (mg) every 2 weeks (q2w) compared to placebo on a background of mometasone furoate nasal spray (MFNS) in reducing nasal congestion/obstruction (NC) severity and endoscopic nasal polyp score (NPS) in participants with bilateral nasal polyposis (NP). In addition for Japan participants, reduction in computed tomography (CT) scan opacification of the sinuses was a coprimary objective. Secondary Objectives:

• To evaluate the efficacy of dupilumab in improving total symptoms score (TSS).
• 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 Japan).
• To evaluate ability of dupilumab in reducing proportion of participants requiring treatment with systemic corticosteroids or NP surgery.
• To evaluate the effect of dupilumab on participant reported outcomes and health related quality of life outcome by sinonasal outcome test-22 (SNOT-22).
• To evaluate the effect of dupilumab in the subgroups of participants with prior surgery and co-morbid asthma (including non-steroid antiinflammatory drug \[NSAID\] exacerbated respiratory disease \[ERD\]).
• To evaluate residual effect in follow up.
• 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)

Keywords

Nasal polyposis, Chronic rhinosinusitis, Intranasal corticosteroids, Dupilumab, Human monoclonal antibody

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.

  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.

  Baseline, Week 24

Secondary Outcomes (35)

• 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 (2)

Placebo

PLACEBO COMPARATOR

Placebo (for dupilumab), 1 subcutaneous (SC) injection every 2 weeks (q2w) from Day 1 of Week 0 up to Week 24 added to background therapy of intranasal mometasone furoate nasal spray (MFNS) at stable dose.

Drug: Placebo; Drug: Mometasone furoate 50 micrograms

Dupilumab 300 mg

EXPERIMENTAL

Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 24 added to background therapy of intranasal MFNS at stable dose.

Drug: Dupilumab SAR231893 (REGN668); Drug: Mometasone furoate 50 micrograms

Interventions

Dupilumab SAR231893 (REGN668) DRUG

Pharmaceutical form: Solution Route of administration: Subcutaneous

Dupilumab 300 mg

Placebo DRUG

Pharmaceutical form: Solution Route of administration: Subcutaneous

Placebo

Mometasone furoate 50 micrograms DRUG

Pharmaceutical form: Suspension (Nasal spray) Route of administration: Intranasal

Also known as: NASONEX®

Dupilumab 300 mg; 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 sinonasal polyposis that despite prior treatment with systemic corticosteroids (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 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 prior to Visit \[V\] 1) of nasal congestion/blockage/obstruction with moderate or severe symptom severity (score 2 or 3) at V1 and a weekly average severity of greater than 1 at the 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.
• Participants who were previously treated in dupilumab studies.
• Participants 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 (mAB) within 5 half-lives or within 6 months before V1 if the half-life was unknown.
• Anti-immunoglobulin E (IgE) 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.
• Initiated allergen immunotherapy within 3 months prior to V1 or planned to begin therapy or changed its dose during the run-in period or the randomized treatment period.
• Participants who undergone any intranasal and/or sinus surgery (including polypectomy) within 6 months prior to V1.
• Participants who had a sinonasal or sinus surgery changing the lateral wall structure of the nose making impossible the evaluation of NPS.
• Participants with conditions/concomitant diseases making them nonevaluable 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 (76)

Investigational Site Number 8400009

Long Beach, California, 90720, United States

Location

Investigational Site Number 8400004

Orange, California, 92868, United States

Location

Investigational Site Number 8400014

San Diego, California, 92123, United States

Location

Investigational Site Number 8400002

Stockton, California, 95207, United States

Location

Investigational Site Number 8400016

Centennial, Colorado, 80112, United States

Location

Investigational Site Number 8400013

Tampa, Florida, 33613, United States

Location

Investigational Site Number 8400022

West Des Moines, Iowa, 50265, United States

Location

Investigational Site Number 8400007

Boston, Massachusetts, 02115, United States

Location

Investigational Site Number 8400005

Rochester, Minnesota, 55905, United States

Location

Investigational Site Number 8400021

St Louis, Missouri, 63141, United States

Location

Investigational Site Number 8400008

Winston-Salem, North Carolina, 27103, United States

Location

Investigational Site Number 8400019

Tulsa, Oklahoma, 74136, United States

Location

Investigational Site Number 8400020

Medford, Oregon, 97504, United States

Location

Investigational Site Number 8400018

Charleston, South Carolina, 29425, United States

Location

Investigational Site Number 8400003

Nashville, Tennessee, 37232-8695, United States

Location

Investigational Site Number 8400001

Dallas, Texas, 75231, United States

Location

Investigational Site Number 8400015

Norfolk, Virginia, 23507, United States

Location

Investigational Site Number 8400010

Milwaukee, Wisconsin, 53226, United States

Location

Investigational Site Number 1000003

Plovdiv, 4002, Bulgaria

Location

Investigational Site Number 1000002

Sofia, 1527, Bulgaria

Location

Investigational Site Number 1000001

Sofia, 1606, Bulgaria

Location

Investigational Site Number 2030001

Hradec Králové, 50005, Czechia

Location

Investigational Site Number 2030002

Pardubice, 53203, Czechia

Location

Investigational Site Number 2030004

Prague, 12808, Czechia

Location

Investigational Site Number 2500005

La Roche-sur-Yon, 85925, France

Location

Investigational Site Number 2500007

Lille, 59000, France

Location

Investigational Site Number 2500003

Lyon, 69317, France

Location

Investigational Site Number 2500001

Montpellier, 34000, France

Location

Investigational Site Number 2500006

Nantes, 44035, France

Location

Investigational Site Number 2500002

Toulouse, 31059, France

Location

Investigational Site Number 2500004

Vandœuvre-lès-Nancy, 54511, France

Location

Investigational Site Number 2760001

Berlin, 13353, Germany

Location

Investigational Site Number 2760003

München, 81377, Germany

Location

Investigational Site Number 2760002

Münster, 48149, Germany

Location

Investigational Site Number 3480006

Budapest, 1062, Hungary

Location

Investigational Site Number 3480007

Budapest, 1083, Hungary

Location

Investigational Site Number 3480004

Budapest, 1115, Hungary

Location

Investigational Site Number 3480003

Budapest, 1125, Hungary

Location

Investigational Site Number 3480005

Debrecen, 4032, Hungary

Location

Investigational Site Number 3480002

Pécs, 7621, Hungary

Location

Investigational Site Number 3480001

Szeged, 6725, Hungary

Location

Investigational Site Number 3800007

Bologna, 40139, Italy

Location

Investigational Site Number 3800002

Catania, 95123, Italy

Location

Investigational Site Number 3800004

Milan, 20132, Italy

Location

Investigational Site Number 3800006

Milan, 20142, Italy

Location

Investigational Site Number 3800001

Pisa, 56124, Italy

Location

Investigational Site Number 3800005

Rozzano, 20089, Italy

Location

Investigational Site Number 3800003

Varese, 21100, Italy

Location

Investigational Site Number 5280001

Amsterdam, 1105 AZ, Netherlands

Location

Investigational Site Number 6160002

Katowice, 40-611, Poland

Location

Investigational Site Number 6160001

Lodz, 90-153, Poland

Location

Investigational Site Number 6160003

Warsaw, 04-141, Poland

Location

Investigational Site Number 6420007

Brasov, 500283, Romania

Location

Investigational Site Number 6420013

Brasov, 500283, Romania

Location

Investigational Site Number 6420003

Bucharest, 011172, Romania

Location

Investigational Site Number 6420009

Cluj-Napoca, 400015, Romania

Location

Investigational Site Number 6420008

Craiova, 200642, Romania

Location

Investigational Site Number 6420010

Târgu Mureş, 540098, Romania

Location

Investigational Site Number 6430004

Moscow, 119435, Russia

Location

Investigational Site Number 6430003

Moscow, 129090, Russia

Location

Investigational Site Number 6430002

Saint Petersburg, 190013, Russia

Location

Investigational Site Number 6430001

Saint Petersburg, 195030, Russia

Location

Investigational Site Number 6430007

Saint Petersburg, 197022, Russia

Location

Investigational Site Number 6430006

Yaroslavl, 150003, Russia

Location

Investigational Site Number 8040002

Ivano-Frankivsk, 76000, Ukraine

Location

Investigational Site Number 8040004

Kharkiv, 61166, Ukraine

Location

Investigational Site Number 8040005

Kyiv, 01133, Ukraine

Location

Investigational Site Number 8040006

Kyiv, 03680, Ukraine

Location

Investigational Site Number 8040001

Poltava, 36011, Ukraine

Location

Investigational Site Number 8040008

Ternopil, 46000, Ukraine

Location

Investigational Site Number 8260001

Bradford, BD9 6RJ, United Kingdom

Location

Investigational Site Number 8260002

Dundee, DD1 9SY, United Kingdom

Location

Investigational Site Number 8260007

Great Yarmouth, NR31 6LA, United Kingdom

Location

Investigational Site Number 8260006

London, SE1 7EH, United Kingdom

Location

Investigational Site Number 8260004

Stockport, SK2 7JE, United Kingdom

Location

Investigational Site Number 8260005

Wigan, WN1 2NN, United Kingdom

Location

Related Publications (19)

• Lane AP, Mullol J, Hopkins C, Fokkens WJ, Lee SE, Msihid J, Nash S, Sacks H, Borsos K, Kamat S, Rowe PJ, Deniz Y, Jacob-Nara JA. Dupilumab improves sense of smell and clinical outcomes in patients with severe chronic rhinosinusitis with nasal polyps with anosmia. Curr Med Res Opin. 2025 Jan;41(1):53-59. doi: 10.1080/03007995.2024.2434083. Epub 2024 Dec 14.

  PMID: 39618256 DERIVED

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Conditions

Nasal Polyps

Interventions

dupilumab; Mometasone Furoate

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Dupilumab and placebo were provided in matching 2 milliliter (mL) pre-filled syringes. To protect the blind, each treatment kit was prepared such that the dupilumab dose and its corresponding placebo volume were identical and indistinguishable and were labelled with a treatment kit number.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2016
• First Posted: September 23, 2016
• Study Start: December 5, 2016
• Primary Completion: July 5, 2018
• Study Completion: July 5, 2018
• Last Updated: July 25, 2019
• Results First Posted: July 25, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

UA (6); HU (7); FR (7); DE (3); IT (7); PL (3); GB (6); BU (3); RU (6); US (18); NL (1); CZ (3); RO (6)