Last updated on August 2018

A Controlled Clinical Study of Dupilumab in Patients With Nasal Polyps


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Nasal Polyps
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other:
    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
    creening visit, have:
    An endoscopic bilateral NPS of at least 5 out of a maximum score of 8 (with a minimum
    core 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.

You may not be eligible for this study if the following are true:

  • 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
    creening.
    Positive with hepatitis B surface antigen (HBsAg) or hepatitis C antibody at the
    creening 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
    exually active.
    The above information is not intended to contain all considerations relevant to a patient's
    potential participation in a clinical trial.

Recruitment Status: Closed


Brief Description Eligibility Contact Research Team


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