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Controlled Clinical Study of Dupilumab in Patients With Nasal Polyps (SINUS-52)

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ClinicalTrials.gov Identifier: NCT02898454
Recruitment Status : Completed
First Posted : September 13, 2016
Last Update Posted : November 26, 2018
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi

Brief Summary:

Primary Objective:

To evaluate the efficacy of dupilumab compared to placebo on a background of mometasone furoate nasal spray (MFNS) in reducing nasal congestion/obstruction (NC) severity and endoscopic nasal polyposis score (NPS) in patients with bilateral nasal polyposis (NP). In addition for Japan, reduction in computed tomography (CT) scan opacification of the sinuses will be also a co-primary 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 patients requiring treatment with oral corticosteroids or NP surgery.
  • To evaluate the effect of dupilumab on patient reported outcomes and health related quality of life outcome by sinonasal outcome test-22 (SNOT-22).
  • To evaluate efficacy with various regimen.
  • To evaluate the effect of dupilumab in the subgroups of patients with prior surgery and co-morbid asthma (including non-steroid antiinflammatory drug [NSAID] exacerbated respiratory disease [NERD]).
  • To evaluate the safety of dupilumab in patients with bilateral NP.
  • To evaluate functional dupilumab concentrations (systemic exposure) and incidence of treatment-emergent anti-drug antibodies (ADA).

Condition or disease Intervention/treatment Phase
Nasal Polyps Drug: Dupilumab SAR231893 (REGN668) Drug: Placebo Drug: Mometasone furoate nasal spray Phase 3

Detailed Description:
The total study duration per patient is expected to be up to 68 weeks that will consist of a 4-week run-in period, 52-week treatment period, and a 12-week posttreatment period.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 448 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, 52-week, Placebo Controlled Efficacy and Safety Study of Dupilumab, in Patients With Bilateral Nasal Polyposis on a Background Therapy With Intranasal Corticosteroids
Actual Study Start Date : November 28, 2016
Actual Primary Completion Date : August 27, 2018
Actual Study Completion Date : November 16, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Dupilumab

Arm Intervention/treatment
Experimental: Dupilumab (Arm A)
A dose of dupilumab will be administered subcutaneously (SC) every 2 weeks (q2w) until Week 52. Patients will use MFNS daily.
Drug: Dupilumab SAR231893 (REGN668)

Pharmaceutical form: Solution

Route of administration: Subcutaneous


Drug: Mometasone furoate nasal spray

Pharmaceutical form: Suspension

Route of administration: Intranasal


Experimental: Dupilumab (Arm B)
A dose of dupilumab will be administered SC every 2 weeks until Week 24, then every 4 weeks (q4w) until Week 52. Patients will use MFNS daily.
Drug: Dupilumab SAR231893 (REGN668)

Pharmaceutical form: Solution

Route of administration: Subcutaneous


Drug: Mometasone furoate nasal spray

Pharmaceutical form: Suspension

Route of administration: Intranasal


Placebo Comparator: Placebo (Arm C)
A matching placebo will be administered SC every 2 weeks (q2w) until Week 52. Patients will use MFNS daily.
Drug: Placebo

Pharmaceutical form: Solution

Route of administration: Subcutaneous


Drug: Mometasone furoate nasal spray

Pharmaceutical form: Suspension

Route of administration: Intranasal





Primary Outcome Measures :
  1. Change from baseline in nasal congestion/obstruction (NC) symptom severity score based on the patient daily morning assessment [ Time Frame: From baseline to Week 24 ]
  2. Change from baseline in nasal polyposis score (NPS) as assessed by nasal endoscopy [ Time Frame: From baseline to Week 24 ]
  3. Change from baseline in sinus opacifications as assessed by CT scans using Lund Mackay Score (For Japan only) [ Time Frame: From baseline to Week 24 ]

Secondary Outcome Measures :
  1. Change from baseline in TSS [ Time Frame: From baseline to Week 24 ]
  2. Change from baseline in University of Pennsylvania Smell Identification Test [ Time Frame: From baseline to Week 24 ]
  3. Change from baseline in severity of decreased/ loss of smell as assessed by the patient [ Time Frame: From baseline to Week 24 ]
  4. Change from baseline in sinus opacifications as assessed by CT scans using Lund Mackay Score (This endpoint will not be assessed as a secondary endpoint for Japan as it is already a co-primary endpoint). [ Time Frame: From baseline to Week 24 ]
  5. Change from baseline in in sinonasal outcome test-22 (SNOT-22) [ Time Frame: From baseline to Week 24 ]
  6. Proportion of patients during study treatment receiving systemic corticosteroid for NP and/or planned to under surgery for nasal polyps [ Time Frame: 52 Weeks ]
  7. Change from baseline in NC for every two weeks (q2w) (Arm A) versus placebo (Arm C) [ Time Frame: From baseline to Week 52 ]
  8. Change from baseline in NPS for q2w (Arm A) versus placebo (Arm C) [ Time Frame: From baseline to Week 52 ]
  9. Change from baseline in NC for q2w/q4w (Arm B) versus placebo (Arm C) [ Time Frame: From baseline to Week 52 ]
  10. Change from baseline in NPS for q2w/q4w (Arm B) versus placebo (Arm C) [ Time Frame: From baseline to Week 52 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

  • Patients with bilateral sinonasal polyposis that despite prior treatment with systemic corticosteroids (SCS) anytime within the past 2 years; and/or have a medical contraindication/intolerance to SCS; and/or had prior surgery for NP at the screening visit, have:
  • 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 before V1) 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 time of randomization (V2), and another symptom such as loss of smell, rhinorrhea (anterior/posterior).
  • Signed written informed consent.

Exclusion criteria:

  • Patients <18 years of age.
  • Patient who has been previously treated in dupilumab studies.
  • Patient who has 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 is longer.
  • Any experimental monoclonal antibody (mAB) within 5 half-lives or within 6 months before V1 if the half-life is unknown.
  • Anti-immunoglobulin E therapy (omalizumab) within 130 days prior to V1.
  • Patients who are receiving leukotriene antagonists/modifiers at V1 unless they are 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.
  • Patients who have undergone any intranasal and/or sinus surgery (including polypectomy) within 6 months before V1.
  • Patients who have had a sinonasal or sinus surgery changing the lateral wall structure of the nose making impossible the evaluation of NPS.
  • Patients 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.
  • Patients with nasal cavity malignant tumor and benign tumors (eg, papilloma, blood boil etc.).
  • Patients with forced expiratory volume (FEV1) 50% or less (of predicted normal).
  • Patients receiving concomitant treatment prohibited in the study.
  • 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 (HBsAg) 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 is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02898454


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Locations
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United States, Alabama
Investigational Site Number 8400019
Birmingham, Alabama, United States, 35209
United States, California
Investigational Site Number 8400011
Fresno, California, United States, 93720
Investigational Site Number 8400008
Huntington Beach, California, United States, 92647
Investigational Site Number 8400004
Rolling Hills Estates, California, United States, 90274
Investigational Site Number 8400012
Walnut Creek, California, United States, 94598
United States, Colorado
Investigational Site Number 8400017
Colorado Springs, Colorado, United States, 80909
Investigational Site Number 8400006
Denver, Colorado, United States, 80230
United States, Connecticut
Investigational Site Number 8400022
New Haven, Connecticut, United States, 06519
United States, Kentucky
Investigational Site Number 8400002
Louisville, Kentucky, United States, 40207
United States, Massachusetts
Investigational Site Number 8400021
Boston, Massachusetts, United States, 02114
United States, Missouri
Investigational Site Number 8400014
Kansas City, Missouri, United States, 64114
United States, New York
Investigational Site Number 8400024
Bronx, New York, United States, 10461
United States, North Carolina
Investigational Site Number 8400016
North Charleston, North Carolina, United States, 29420
United States, Pennsylvania
Investigational Site Number 8400013
Bethlehem, Pennsylvania, United States, 18017
Investigational Site Number 8400005
Philadelphia, Pennsylvania, United States, 19104
Investigational Site Number 8400003
Pittsburgh, Pennsylvania, United States, 15213
United States, Utah
Investigational Site Number 8400009
Salt Lake City, Utah, United States, 84132
United States, Washington
Investigational Site Number 8400010
Bellevue, Washington, United States, 98225
United States, Wisconsin
Investigational Site Number 8400007
Milwaukee, Wisconsin, United States, 53219
Argentina
Investigational Site Number 0320006
Buenos Aires, Argentina, B1602DQD
Investigational Site Number 0320004
Buenos Aires, Argentina, C1121ABE
Investigational Site Number 0320005
Caba, Argentina, C1414AIF
Investigational Site Number 0320001
Caba, Argentina, C1425BEN
Investigational Site Number 0320007
Caba, Argentina, C1426ABP
Investigational Site Number 0320003
Mendoza, Argentina, 5500
Investigational Site Number 0320008
Rosario, Argentina, S2000DBS
Investigational Site Number 0320002
San Miguel De Tucumán, Argentina, T4000IAR
Australia
Investigational Site Number 0360002
Clayton, Australia, 3168
Investigational Site Number 0360004
Herston, Australia, 4029
Investigational Site Number 0360005
Murdoch, Australia, 6150
Investigational Site Number 0360001
Parkville, Australia, 3050
Investigational Site Number 0360003
Prahran, Australia, 3004
Belgium
Investigational Site Number 0560003
Bruxelles, Belgium, 1200
Investigational Site Number 0560001
Gent, Belgium, 9000
Investigational Site Number 0560002
Leuven, Belgium, 3500
Canada
Investigational Site Number 1240007
Kingston, Canada, K7L 2V7
Investigational Site Number 1240002
Montreal, Canada, H2W 1T8
Investigational Site Number 1240006
Montreal, Canada, H4A 3J1
Investigational Site Number 1240005
Ottawa, Canada, K1G 6C6
Investigational Site Number 1240003
Quebec, Canada, G1V 4G5
Investigational Site Number 1240004
Quebec, Canada, G1V 4W2
Investigational Site Number 1240008
Trois-Rivieres, Canada, G8T 7A1
Investigational Site Number 1240001
Vancouver, Canada, V5Z 1M9
Chile
Investigational Site Number 1520009
Quillota, Chile, 2260877
Investigational Site Number 1520010
San Fernando, Chile
Investigational Site Number 1520005
Santiago, Chile, 7500010
Investigational Site Number 1520011
Santiago, Chile, 7500571
Investigational Site Number 1520008
Santiago, Chile, 7500692
Investigational Site Number 1520006
Santiago, Chile, 7980378
Investigational Site Number 1520001
Santiago, Chile, 8207257
Investigational Site Number 1520014
Santiago, Chile, 8910131
Investigational Site Number 1520003
Talca, Chile
Investigational Site Number 1520007
Viña Del Mar, Chile
Israel
Investigational Site Number 3760001
Hadera, Israel, 38100
Investigational Site Number 3760003
Nahariya, Israel, 22100
Investigational Site Number 3760002
Petah-Tikva, Israel, 49100
Investigational Site Number 3760005
Rehovot, Israel, 76100
Investigational Site Number 3760004
Tel Hashomer, Israel, 52621
Japan
Investigational Site Number 3920004
Bunkyo-Ku, Japan
Investigational Site Number 3920009
Bunkyo-Ku, Japan
Investigational Site Number 3920026
Bunkyo-Ku, Japan
Investigational Site Number 3920006
Chiyoda-Ku, Japan
Investigational Site Number 3920024
Fukuoka-Shi, Japan
Investigational Site Number 3920010
Hirakata-Shi, Japan
Investigational Site Number 3920011
Hiroshima-Shi, 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-Shi, 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-Shi, Japan
Investigational Site Number 3920021
Kumamoto-Shi, Japan
Investigational Site Number 3920003
Kyoto-Shi, Japan
Investigational Site Number 3920023
Meguro-Ku, Japan
Investigational Site Number 3920013
Moriguchi-Shi, Japan
Investigational Site Number 3920025
Okayama-Shi, Japan
Investigational Site Number 3920018
Osaka-Shi, Japan
Investigational Site Number 3920017
Ota-Ku, Japan
Investigational Site Number 3920005
Sendai-Shi, Japan
Investigational Site Number 3920022
Sendai-Shi, 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
Mexico
Investigational Site Number 4840001
Chihuahua, Mexico, 31000
Investigational Site Number 4840005
Chihuahua, Mexico, 31200
Investigational Site Number 4840004
Durango, Mexico, 34080
Investigational Site Number 4840002
Guadalajara, Mexico, 44100
Investigational Site Number 4840003
Monterrey, Mexico, 64460
Portugal
Investigational Site Number 6200004
Aveiro, Portugal, 3810-501
Investigational Site Number 6200006
Guimarães, Portugal, 4810-061
Investigational Site Number 6200002
Lisboa, Portugal, 1349-019
Investigational Site Number 6200007
Matosinhos, Portugal, 4460-188
Investigational Site Number 6200001
Porto, Portugal, 4099-001
Investigational Site Number 6200005
Viana Do Castelo, Portugal, 4901-858
Russian Federation
Investigational Site Number 6430006
Moscow, Russian Federation, 123182
Investigational Site Number 6430003
Odintsovo, Russian Federation, 143005
Investigational Site Number 6430002
Saint-Petersburg, Russian Federation, 197022
Investigational Site Number 6430005
Stavropol, Russian Federation, 355030
Investigational Site Number 6430001
Yaroslavl, Russian Federation, 150062
Spain
Investigational Site Number 7240001
Barcelona, Spain, 08036
Investigational Site Number 7240006
Barcelona, Spain, 08041
Investigational Site Number 7240003
Jerez De La Frontera, Spain, 11407
Investigational Site Number 7240002
Madrid, Spain, 28040
Investigational Site Number 7240007
Sevilla, Spain, 41071
Investigational Site Number 7240009
Valencia, Spain, 46026
Sweden
Investigational Site Number 7520002
Lund, Sweden, 221 85
Investigational Site Number 7520001
Stockholm, Sweden, 171 76
Turkey
Investigational Site Number 7920004
Ankara, Turkey, 06100
Investigational Site Number 7920005
Ankara, Turkey, 06500
Investigational Site Number 7920008
Ankara, Turkey, 06520
Investigational Site Number 7920013
Bursa, Turkey, 16059
Investigational Site Number 7920010
Istanbul, Turkey, 34010
Investigational Site Number 7920009
Istanbul, Turkey, 34360
Investigational Site Number 7920003
Istanbul, Turkey, 34373
Investigational Site Number 7920001
Istanbul, Turkey, 34390
Investigational Site Number 7920002
Istanbul, Turkey, 34764
Investigational Site Number 7920006
Izmir, Turkey, 35100
Investigational Site Number 7920007
Izmir, Turkey, 35340
Investigational Site Number 7920011
Rize, Turkey, 53100
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02898454     History of Changes
Other Study ID Numbers: EFC14280
2015-001314-10 ( EudraCT Number )
U1111-1170-7180 ( Other Identifier: UTN )
First Posted: September 13, 2016    Key Record Dates
Last Update Posted: November 26, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not available for request
Additional relevant MeSH terms:
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Nasal Polyps
Polyps
Pathological Conditions, Anatomical
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Mometasone Furoate
Antibodies, Monoclonal
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents
Immunologic Factors
Physiological Effects of Drugs