Controlled Clinical Study of Dupilumab in Patients With Nasal Polyps

Description

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).

Study Start Date

November, 01 2016

Estimated Completion Date

November 2018

Interventions

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

Study ID

Sanofi -- EFC14280

Status

Recruiting

Trial ID

NCT02898454

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

360

Sponsor

Sanofi

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.
  • Gender

    All

    Ages

    18 Years and older

    Accepts Healthy Volunteers

    No

    Study Locations and Contact Information (89)

    Study Location Distance Name Phone Email
    Investigational Site Number 8400021 - Boston, Massachusetts 2.8 miles None None None
    Investigational Site Number 8400021 - Boston, Massachusetts 2.8 miles None None None
    Investigational Site Number 8400021 - Boston, Massachusetts 2.8 miles None None None
    Investigational Site Number 8400021 - Boston, Massachusetts 2.8 miles None None None
    Investigational Site Number 8400021 - Boston, Massachusetts 2.8 miles None None None
    Investigational Site Number 8400022 - New Haven, Connecticut 120.2 miles None None None
    Investigational Site Number 8400022 - New Haven, Connecticut 120.2 miles None None None
    Investigational Site Number 8400022 - New Haven, Connecticut 120.2 miles None None None
    Investigational Site Number 8400022 - New Haven, Connecticut 120.2 miles None None None
    Investigational Site Number 8400022 - New Haven, Connecticut 120.2 miles None None None
    Investigational Site Number 8400024 - The Bronx, New York 176.6 miles None None None
    Investigational Site Number 8400024 - The Bronx, New York 176.6 miles None None None
    Investigational Site Number 8400024 - The Bronx, New York 176.6 miles None None None
    Investigational Site Number 8400024 - The Bronx, New York 176.6 miles None None None
    Investigational Site Number 8400024 - The Bronx, New York 176.6 miles None None None
    Investigational Site Number 8400013 - Bethlehem, Pennsylvania 249.5 miles None None None
    Investigational Site Number 8400013 - Bethlehem, Pennsylvania 249.5 miles None None None
    Investigational Site Number 8400013 - Bethlehem, Pennsylvania 249.5 miles None None None
    Investigational Site Number 8400013 - Bethlehem, Pennsylvania 249.5 miles None None None
    Investigational Site Number 8400013 - Bethlehem, Pennsylvania 249.5 miles None None None
    Investigational Site Number 8400005 - Philadelphia, Pennsylvania 270.8 miles None None None
    Investigational Site Number 8400005 - Philadelphia, Pennsylvania 270.8 miles None None None
    Investigational Site Number 8400005 - Philadelphia, Pennsylvania 270.8 miles None None None
    Investigational Site Number 8400005 - Philadelphia, Pennsylvania 270.8 miles None None None
    Investigational Site Number 8400005 - Philadelphia, Pennsylvania 270.8 miles None None None
    Investigational Site Number 8400020 - Fairfax, Virginia 408.8 miles None None None
    Investigational Site Number 8400020 - Fairfax, Virginia 408.8 miles None None None
    Investigational Site Number 8400020 - Fairfax, Virginia 408.8 miles None None None
    Investigational Site Number 8400020 - Fairfax, Virginia 408.8 miles None None None
    Investigational Site Number 8400020 - Fairfax, Virginia 408.8 miles None None None
    Investigational Site Number 8400003 - Pittsburgh, Pennsylvania 479.6 miles None None None
    Investigational Site Number 8400003 - Pittsburgh, Pennsylvania 479.6 miles None None None
    Investigational Site Number 8400003 - Pittsburgh, Pennsylvania 479.6 miles None None None
    Investigational Site Number 8400003 - Pittsburgh, Pennsylvania 479.6 miles None None None
    Investigational Site Number 8400003 - Pittsburgh, Pennsylvania 479.6 miles None None None
    Investigational Site Number 8400016 - North Charleston, North Carolina 817.8 miles None None None
    Investigational Site Number 8400016 - North Charleston, North Carolina 817.8 miles None None None
    Investigational Site Number 8400016 - North Charleston, North Carolina 817.8 miles None None None
    Investigational Site Number 8400016 - North Charleston, North Carolina 817.8 miles None None None
    Investigational Site Number 8400016 - North Charleston, North Carolina 817.8 miles None None None
    Investigational Site Number 8400002 - Louisville, Kentucky 818.4 miles None None None
    Investigational Site Number 8400002 - Louisville, Kentucky 818.4 miles None None None
    Investigational Site Number 8400002 - Louisville, Kentucky 818.4 miles None None None
    Investigational Site Number 8400002 - Louisville, Kentucky 818.4 miles None None None
    Investigational Site Number 8400002 - Louisville, Kentucky 818.4 miles None None None
    Investigational Site Number 8400007 - Milwaukee, Wisconsin 859.7 miles None None None
    Investigational Site Number 8400007 - Milwaukee, Wisconsin 859.7 miles None None None
    Investigational Site Number 8400007 - Milwaukee, Wisconsin 859.7 miles None None None
    Investigational Site Number 8400007 - Milwaukee, Wisconsin 859.7 miles None None None
    Investigational Site Number 8400007 - Milwaukee, Wisconsin 859.7 miles None None None
    Investigational Site Number 8400019 - Birmingham, Alabama 1,054.2 miles None None None
    Investigational Site Number 8400019 - Birmingham, Alabama 1,054.2 miles None None None
    Investigational Site Number 8400014 - Kansas City, Missouri 1,249.7 miles None None None
    Investigational Site Number 8400014 - Kansas City, Missouri 1,249.7 miles None None None
    Investigational Site Number 8400014 - Kansas City, Missouri 1,249.7 miles None None None
    Investigational Site Number 8400014 - Kansas City, Missouri 1,249.7 miles None None None
    Investigational Site Number 8400014 - Kansas City, Missouri 1,249.7 miles None None None
    Investigational Site Number 8400006 - Denver, Colorado 1,763.8 miles None None None
    Investigational Site Number 8400006 - Denver, Colorado 1,763.8 miles None None None
    Investigational Site Number 8400006 - Denver, Colorado 1,763.8 miles None None None
    Investigational Site Number 8400006 - Denver, Colorado 1,763.8 miles None None None
    Investigational Site Number 8400006 - Denver, Colorado 1,763.8 miles None None None
    Investigational Site Number 8400017 - Colorado Springs, Colorado 1,774.9 miles None None None
    Investigational Site Number 8400017 - Colorado Springs, Colorado 1,774.9 miles None None None
    Investigational Site Number 8400017 - Colorado Springs, Colorado 1,774.9 miles None None None
    Investigational Site Number 8400017 - Colorado Springs, Colorado 1,774.9 miles None None None
    Investigational Site Number 8400009 - Salt Lake City, Utah 2,094.1 miles None None None
    Investigational Site Number 8400009 - Salt Lake City, Utah 2,094.1 miles None None None
    Investigational Site Number 8400009 - Salt Lake City, Utah 2,094.1 miles None None None
    Investigational Site Number 8400009 - Salt Lake City, Utah 2,094.1 miles None None None
    Investigational Site Number 8400010 - Bellevue, Washington 2,483.1 miles None None None
    Investigational Site Number 8400010 - Bellevue, Washington 2,483.1 miles None None None
    Investigational Site Number 8400010 - Bellevue, Washington 2,483.1 miles None None None
    Investigational Site Number 8400010 - Bellevue, Washington 2,483.1 miles None None None
    Investigational Site Number 8400010 - Bellevue, Washington 2,483.1 miles None None None
    Investigational Site Number 8400011 - Fresno, California 2,589.0 miles None None None
    Investigational Site Number 8400011 - Fresno, California 2,589.0 miles None None None
    Investigational Site Number 8400008 - Huntington Beach, California 2,593.5 miles None None None
    Investigational Site Number 8400008 - Huntington Beach, California 2,593.5 miles None None None
    Investigational Site Number 8400008 - Huntington Beach, California 2,593.5 miles None None None
    Investigational Site Number 8400008 - Huntington Beach, California 2,593.5 miles None None None
    Investigational Site Number 8400004 - Rolling Hills Estates, California 2,610.8 miles None None None
    Investigational Site Number 8400004 - Rolling Hills Estates, California 2,610.8 miles None None None
    Investigational Site Number 8400004 - Rolling Hills Estates, California 2,610.8 miles None None None
    Investigational Site Number 8400004 - Rolling Hills Estates, California 2,610.8 miles None None None
    Investigational Site Number 8400012 - Walnut Creek, California 2,673.8 miles None None None
    Investigational Site Number 8400012 - Walnut Creek, California 2,673.8 miles None None None
    Investigational Site Number 8400012 - Walnut Creek, California 2,673.8 miles None None None
    Investigational Site Number 8400012 - Walnut Creek, California 2,673.8 miles None None None

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