A 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 polyp 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 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 patients requiring treatment with systemic 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 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 residual effect in follow up. - 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.

Study Start Date

December, 01 2016

Estimated Completion Date

July 2018

Interventions

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

Study ID

Sanofi -- EFC14146

Status

Unknown

Trial ID

NCT02912468

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

240

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 prior to 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 the 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 previously been 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 (IgE) 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 prior to 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 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
  • 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 in 1 second (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 (74)

    Study Location Distance Name Phone Email
    Investigational Site Number 8400007 - Boston, Massachusetts 2.6 miles None None None
    Investigational Site Number 8400007 - Boston, Massachusetts 2.6 miles None None None
    Investigational Site Number 8400007 - Boston, Massachusetts 2.6 miles None None None
    Investigational Site Number 8400007 - Boston, Massachusetts 2.6 miles None None None
    Investigational Site Number 8400007 - Boston, Massachusetts 2.6 miles None None None
    Investigational Site Number 8400015 - Norfolk, Virginia 471.1 miles None None None
    Investigational Site Number 8400006 - Dublin, Ohio 643.1 miles None None None
    Investigational Site Number 8400006 - Dublin, Ohio 643.1 miles None None None
    Investigational Site Number 8400006 - Dublin, Ohio 643.1 miles None None None
    Investigational Site Number 8400006 - Dublin, Ohio 643.1 miles None None None
    Investigational Site Number 8400006 - Dublin, Ohio 643.1 miles None None None
    Investigational Site Number 8400008 - Winston-Salem, North Carolina 659.2 miles None None None
    Investigational Site Number 8400008 - Winston-Salem, North Carolina 659.2 miles None None None
    Investigational Site Number 8400008 - Winston-Salem, North Carolina 659.2 miles None None None
    Investigational Site Number 8400008 - Winston-Salem, North Carolina 659.2 miles None None None
    Investigational Site Number 8400008 - Winston-Salem, North Carolina 659.2 miles None None None
    Investigational Site Number 8400018 - Charleston, South Carolina 821.2 miles None None None
    Investigational Site Number 8400018 - Charleston, South Carolina 821.2 miles None None None
    Investigational Site Number 8400018 - Charleston, South Carolina 821.2 miles None None None
    Investigational Site Number 8400018 - Charleston, South Carolina 821.2 miles None None None
    Investigational Site Number 8400018 - Charleston, South Carolina 821.2 miles None None None
    Investigational Site Number 8400010 - Milwaukee, Wisconsin 862.1 miles None None None
    Investigational Site Number 8400010 - Milwaukee, Wisconsin 862.1 miles None None None
    Investigational Site Number 8400010 - Milwaukee, Wisconsin 862.1 miles None None None
    Investigational Site Number 8400010 - Milwaukee, Wisconsin 862.1 miles None None None
    Investigational Site Number 8400010 - Milwaukee, Wisconsin 862.1 miles None None None
    Investigational Site Number 8400003 - Nashville, Tennessee 944.2 miles None None None
    Investigational Site Number 8400003 - Nashville, Tennessee 944.2 miles None None None
    Investigational Site Number 8400003 - Nashville, Tennessee 944.2 miles None None None
    Investigational Site Number 8400003 - Nashville, Tennessee 944.2 miles None None None
    Investigational Site Number 8400003 - Nashville, Tennessee 944.2 miles None None None
    Investigational Site Number 8400021 - Saint Louis, Missouri 1,048.4 miles None None None
    Investigational Site Number 8400021 - Saint Louis, Missouri 1,048.4 miles None None None
    Investigational Site Number 8400021 - Saint Louis, Missouri 1,048.4 miles None None None
    Investigational Site Number 8400021 - Saint Louis, Missouri 1,048.4 miles None None None
    Investigational Site Number 8400021 - Saint Louis, Missouri 1,048.4 miles None None None
    Investigational Site Number 8400005 - Rochester, Minnesota 1,083.1 miles None None None
    Investigational Site Number 8400005 - Rochester, Minnesota 1,083.1 miles None None None
    Investigational Site Number 8400005 - Rochester, Minnesota 1,083.1 miles None None None
    Investigational Site Number 8400005 - Rochester, Minnesota 1,083.1 miles None None None
    Investigational Site Number 8400005 - Rochester, Minnesota 1,083.1 miles None None None
    Investigational Site Number 8400022 - West Des Moines, Iowa 1,143.9 miles None None None
    Investigational Site Number 8400022 - West Des Moines, Iowa 1,143.9 miles None None None
    Investigational Site Number 8400022 - West Des Moines, Iowa 1,143.9 miles None None None
    Investigational Site Number 8400022 - West Des Moines, Iowa 1,143.9 miles None None None
    Investigational Site Number 8400022 - West Des Moines, Iowa 1,143.9 miles None None None
    Investigational Site Number 8400013 - Tampa, Florida 1,178.7 miles None None None
    Investigational Site Number 8400013 - Tampa, Florida 1,178.7 miles None None None
    Investigational Site Number 8400013 - Tampa, Florida 1,178.7 miles None None None
    Investigational Site Number 8400019 - Tulsa, Oklahoma 1,396.7 miles None None None
    Investigational Site Number 8400019 - Tulsa, Oklahoma 1,396.7 miles None None None
    Investigational Site Number 8400019 - Tulsa, Oklahoma 1,396.7 miles None None None
    Investigational Site Number 8400019 - Tulsa, Oklahoma 1,396.7 miles None None None
    Investigational Site Number 8400019 - Tulsa, Oklahoma 1,396.7 miles None None None
    Investigational Site Number 8400001 - Dallas, Texas 1,545.0 miles None None None
    Investigational Site Number 8400001 - Dallas, Texas 1,545.0 miles None None None
    Investigational Site Number 8400001 - Dallas, Texas 1,545.0 miles None None None
    Investigational Site Number 8400001 - Dallas, Texas 1,545.0 miles None None None
    Investigational Site Number 8400016 - Centennial, Colorado 1,764.5 miles None None None
    Investigational Site Number 8400016 - Centennial, Colorado 1,764.5 miles None None None
    Investigational Site Number 8400016 - Centennial, Colorado 1,764.5 miles None None None
    Investigational Site Number 8400014 - San Diego, California 2,579.1 miles None None None
    Investigational Site Number 8400014 - San Diego, California 2,579.1 miles None None None
    Investigational Site Number 8400014 - San Diego, California 2,579.1 miles None None None
    Investigational Site Number 8400004 - Orange, California 2,585.0 miles None None None
    Investigational Site Number 8400009 - Long Beach, California 2,594.1 miles None None None
    Investigational Site Number 8400020 - Medford, Oregon 2,605.9 miles None None None
    Investigational Site Number 8400020 - Medford, Oregon 2,605.9 miles None None None
    Investigational Site Number 8400020 - Medford, Oregon 2,605.9 miles None None None
    Investigational Site Number 8400020 - Medford, Oregon 2,605.9 miles None None None
    Investigational Site Number 8400020 - Medford, Oregon 2,605.9 miles None None None
    Investigational Site Number 8400002 - Stockton, California 2,636.3 miles None None None
    Investigational Site Number 8400002 - Stockton, California 2,636.3 miles None None None
    Investigational Site Number 8400002 - Stockton, California 2,636.3 miles None None None

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