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An Evaluation of Dupilumab in Patients With Nasal Polyposis And Chronic Symptoms Of Sinusitis

This study has been completed.
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01920893
First received: August 8, 2013
Last updated: November 3, 2015
Last verified: November 2015
  Purpose

Primary Objective:

To evaluate the efficacy of dupilumab (SAR231893 / REGN668) in the treatment of bilateral Nasal Polyposis (NP) by assessment of the endoscopic nasal polyp score in comparison to placebo.

Secondary Objectives:

To evaluate effect of dupilumab with regards to:

  • symptoms of sinusitis
  • sinus Computed Tomography (CT) scan
  • nasal polyp score in the sub-group of patients with co-morbid asthma
  • Safety and tolerability

Condition Intervention Phase
Nasal Polyps
Drug: Dupilumab
Drug: Placebo (for dupilumab)
Drug: Mometasone furoate nasal spray
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Phase 2, Placebo Controlled, 2 Arm Study To Evaluate Dupilumab In Patients With Bilateral Nasal Polyposis And Chronic Symptoms Of Sinusitis

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change from baseline in endoscopic Nasal Polyp Score (NPS) [ Time Frame: 16 weeks ]

Secondary Outcome Measures:
  • Change from baseline in NPS in sub-group of co-morbid asthma [ Time Frame: 16 weeks ]
  • Change from baseline in patient reported symptoms of sinusitis [ Time Frame: 16 weeks ]
  • Change from baseline in nasal peak inspiratory flow [ Time Frame: 16 weeks ]
  • Change from baseline in smell test [ Time Frame: 16 weeks ]
  • Change from baseline in CT scan [ Time Frame: 16 weeks ]
  • Time to first response in NPS [ Time Frame: 16 weeks ]

Enrollment: 60
Study Start Date: August 2013
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dupilumab
Dupilumab loading dose (x2) followed by weekly dose through subcutaneous (SC) injection in combination with mometasone furoate nasal spray for 16 weeks
Drug: Dupilumab

Pharmaceutical form: solution in glass vials

Route of administration: subcutaneous

Other Names:
  • SAR231893
  • REGN668
Drug: Mometasone furoate nasal spray

Pharmaceutical form: suspension in bottle

Route of administration: intranasal

Other Name: Nasonex
Placebo Comparator: Placebo
Placebo (for dupilumab) loading dose (x2) followed by weekly dose through subcutaneous (SC) injection in combination with mometasone furoate nasal spray for 16 weeks
Drug: Placebo (for dupilumab)

Pharmaceutical form: solution in glass vials

Route of administration: subcutaneous

Drug: Mometasone furoate nasal spray

Pharmaceutical form: suspension in bottle

Route of administration: intranasal

Other Name: Nasonex

Detailed Description:

Screening period (4 weeks) + Randomized Treatment Period (16 weeks)+ Post-Treatment Period (16 weeks) = 36 weeks.

To ensure at least 28 patients with co-morbid asthma needed for subgroup analysis, recruitment of NP patients without co-morbid asthma will stop when approximately 28 patients without asthma are randomized.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

Patients with:

  • A minimum bilateral nasal polyp score of 5 out of a maximum score of 8 (with a unilateral score of at least 2 for each nostril) despite completion of a prior intranasal corticosteroid (INCS) treatment for at least 8 weeks before screening.
  • Presence of at least two of the following symptoms prior to screening: nasal blockade/obstruction/congestion or nasal discharge (anterior/posterior nasal drip); facial pain/pressure; reduction or loss of smell.

Exclusion criteria:

  • Patients <18 or >65 years of age.
  • Sinonasal outcome test (SNOT22) <7.
  • Patients who have taken other investigational drugs or prohibited therapy for this study within 2 months before screening or 5 half-lives, whichever is longer:

    • Burst of systemic corticosteroids within the 2 months before screening or are scheduled to receive systemic corticosteroids during the study period for another condition;
    • Intranasal corticosteroid drops within 1 month prior to screening;
    • Monoclonal antibody (mAB) and immunosuppressive treatment;
    • Anti-immunoglobulin E (IgE) therapy (omalizumab) within 130 days of Visit 1; .Leukotriene antagonists / modifiers unless patient is on a continuous treatment for at least 30 days prior to Visit 1.
  • Patients who have undergone any nasal surgery (including polypectomy) within 6 months before screening or have had more than 5 sinonasal surgeries in the past of which maximal 2 were surgeries changing the lateral wall structure of the nose.
  • Patients with asthma having:
  • Forced Expiratory Volume (FEV1) ≤ 60%, or
  • an asthma exacerbation requiring systemic (oral and/or parenteral) steroid treatment or hospitalization for >24h for treatment of asthma, within 3 months prior to screening or are on a dose of greater than 1000 μg fluticasone or an equivalent inhaled corticosteroids.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01920893

Locations
United States, California
Investigational Site Number 840014
Rolling Hills Estates, California, United States, 90274
United States, Colorado
Investigational Site Number 840015
Denver, Colorado, United States, 80230
United States, Massachusetts
Investigational Site Number 840013
Boston, Massachusetts, United States, 02114
United States, Oregon
Investigational Site Number 840002
Lake Oswego, Oregon, United States, 97035
United States, Pennsylvania
Investigational Site Number 840009
Pittsburg, Pennsylvania, United States, 15213
Belgium
Investigational Site Number 056001
Gent, Belgium, 9000
Investigational Site Number 056002
Leuven, Belgium, 3500
Spain
Investigational Site Number 724001
Barcelona, Spain, 08036
Investigational Site Number 724003
Faitanar, Spain, 46014
Investigational Site Number 724002
Hospitalet De Llobregat, Spain, 08907
Investigational Site Number 724005
Jerez De La Frontera, Spain, 11407
Investigational Site Number 724004
Madrid, Spain, 28040
Sweden
Investigational Site Number 752001
Stockholm, Sweden, 14186
Investigational Site Number 752002
Stockholm, Sweden, 171 76
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01920893     History of Changes
Other Study ID Numbers: ACT12340
2013-001803-35 ( EudraCT Number )
U1111-1130-6475 ( Other Identifier: UTN )
Study First Received: August 8, 2013
Last Updated: November 3, 2015

Additional relevant MeSH terms:
Sinusitis
Nasal Polyps
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Polyps
Pathological Conditions, Anatomical
Mometasone Furoate
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on May 25, 2017