Controlled Clinical Study of Dupilumab in Patients With Nasal Polyps

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Rhinosinusitis Phenotype With Nasal Polyps (CRSwNP)

In brief

Primary Objective: To evaluate the efficacy of dupilumab 300 mg every 2 weeks (q2w) compared to placebo on a background of mometasone furoate nasal spray (MFNS) in reducing nasal congestion (NC)/obstruction severity and endoscopic nasal polyp score (NPS) in participants with bilateral nasal polyps (NP). In addition for Japanese participants, reduction in computed tomography (CT) scan opacification of the sinuses was a co-primary objective. Secondary Objectives: * To evaluate the efficacy of dupilumab in improving total symptoms score. * 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 Japanese participants). * To evaluate ability of dupilumab in reducing proportion of participants who required treatment with systemic corticosteroids (SCS) or surgery for NP. * To evaluate the effect of dupilumab on participant reported outcomes and health related quality of life. * To evaluate the efficacy of dupilumab 300 mg q2w up to Week 52. * To evaluate the efficacy of dupilumab 300 mg q2w up to Week 24 followed by 300 mg every 4 weeks (q4w) up to Week 52. * To evaluate the effect of dupilumab in the subgroups of participants with prior surgery and comorbid asthma including non-steroid anti-inflammatory drug exacerbated respiratory disease. * To evaluate the safety of dupilumab in participants with bilateral NP. * To evaluate functional dupilumab concentrations (systemic exposure) and incidence of treatment emergent anti-drug antibodies.

Key facts

Study ID

NCT02898454

Run by

Sanofi

People needed

448

Starts

2016-11-28

Expected to finish

2018-11-16

Last updated by the study team

2019-10-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants with bilateral sino-nasal polyposis that despite prior treatment with SCS anytime within the past 2 years; and/or had a medical contraindication/intolerance to SCS; and/or had prior surgery for NP at the screening visit, had:
• An endoscopic bilateral NPS at Visit 1 (V1) 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 NC/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.

You may not qualify if…

• Participants <18 years of age.
• Participant who had been previously treated in dupilumab studies.
• Participant who had 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 was longer.
• Any experimental monoclonal antibody within 5 half-lives or within 6 months before V1 if the half-life was unknown.
• Anti-immunoglobulin E therapy (omalizumab) within 130 days prior to V1.
• Participants who received leukotriene antagonists/modifiers at V1 unless they were 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.
• Participants who underwent any and/or sinus surgery (including polypectomy) within 6 months before V1.
• Participants who had a sino-nasal or sinus surgery changing the lateral wall structure of the nose making impossible the evaluation of NPS.
• Participants 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.
• Participants with nasal cavity malignant tumor and benign tumors (eg, papilloma, blood boil etc.).
• Participants with forced expiratory volume 50% or less (of predicted normal).
• Participants who received concomitant treatment prohibited in the study.
• Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit.
• 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 or hepatitis C antibody at the screening visit.
• Active chronic or acute infection requiring systemic treatment within 2 weeks before the baseline visit.

Where it is running

• Investigational Site Number 8400011 — Fresno, California, United States
• Investigational Site Number 8400008 — Huntington Beach, California, United States
• Investigational Site Number 8400004 — Rolling Hills Estates, California, United States
• Investigational Site Number 8400012 — Walnut Creek, California, United States
• Investigational Site Number 8400017 — Colorado Springs, Colorado, United States
• Investigational Site Number 8400006 — Denver, Colorado, United States
• Investigational Site Number 8400022 — New Haven, Connecticut, United States
• Investigational Site Number 8400002 — Louisville, Kentucky, United States
• Investigational Site Number 8400021 — Boston, Massachusetts, United States
• Investigational Site Number 8400014 — Kansas City, Missouri, United States
• Investigational Site Number 8400024 — The Bronx, New York, United States
• Investigational Site Number 8400016 — North Charleston, North Carolina, United States
• Investigational Site Number 8400013 — Bethlehem, Pennsylvania, United States
• Investigational Site Number 8400005 — Philadelphia, Pennsylvania, United States
• Investigational Site Number 8400003 — Pittsburgh, Pennsylvania, United States
• Investigational Site Number 8400009 — Salt Lake City, Utah, United States
• Investigational Site Number 8400010 — Bellevue, Washington, United States
• Investigational Site Number 8400007 — Milwaukee, Wisconsin, United States
• Investigational Site Number 0320006 — Buenos Aires, Argentina
• Investigational Site Number 0320004 — Buenos Aires, Argentina
• Investigational Site Number 0320005 — Caba, Argentina
• Investigational Site Number 0320001 — Caba, Argentina
• Investigational Site Number 0320007 — Caba, Argentina
• Investigational Site Number 0320003 — Mendoza, Argentina
• Investigational Site Number 8400019 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.