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

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

Brief description of study

The purpose of this study is to evaluate the effectiveness of the investigational drug dupilumab, compared to placebo, for the treatment of nasal polyps causing severe nasal congestion. The study drug is given by subcutaneous injection (injection under the skin) every 2 weeks (every 14 days) for 52 weeks (about one year).

Detailed description of study

Participants in this study will be randomly (by chance-similar to drawing straws) assigned to receive one of three treatment regimens during the study: • Dupilumab 300 mg by subcutaneous injection every 2 weeks for 52 weeks • Dupilumab 300 mg by subcutaneous injection every 2 weeks for 24 weeks, followed by placebo by subcutaneous injection every 2 weeks alternating with dupilumab 300 mg by subcutaneous injection every 2 weeks for 28 weeks (until week 52) • Placebo by subcutaneous injection under the skin every 2 weeks for 52 weeks Your chances of receiving dupilumab (as part of one of the first two treatment regimens listed above) are approximately 66% (chance of 2 in 3). Your chances of receiving the placebo (in the third treatment regimen listed above) are approximately 33% (chance of 1 in 3). You will not know if you are receiving potentially active investigational drug (dupilumab) or placebo; the study doctor and/or staff will not know either. During the entire study, irrespective of your study treatment assignment, you will be provided and instructed to use mometasone furoate nasal spray (MFNS) (NASONEX®), an intranasal corticosteroid nasal spray (a nasal polyps controller), as instructed by your study doctor. Protocol Summary: The clinical trial consists of 3 periods: 1) Run-in Period (about 4 weeks)—During this period you will receive Mometasone furoate nasal spray (Nasonex). 2) Randomized Treatment Period (up to 52 weeks)—Patients will be randomly selected for one of the following treatments: a) Dupilumab every 2 weeks until week 52 b) Dupilumab every 2 weeks until week 24, then every 4 weeks until week 52 c) Placebo every 2 weeks until week 52 3) Post-treatment Period (about 12 weeks)—Final evaluations, symptom diary collection, continue mometasone-furoate spray

Eligibility of study

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

  • Conditions:
    Nasal polyps, Nasal Obstruction
  • Age: Between 18 Years - 100 Years
  • Gender: All
Updated on 10 Aug 2017. Study ID: TX4763

Interested in the study

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