A Controlled Clinical Study of Dupilumab in Patients With Bilateral 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 milligram (mg) every 2 weeks (q2w) 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 participants with bilateral nasal polyposis (NP). In addition for Japan participants, reduction in computed tomography (CT) scan opacification of the sinuses was 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 participants requiring treatment with systemic corticosteroids or NP surgery. * To evaluate the effect of dupilumab on participant 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 participants with prior surgery and co-morbid asthma (including non-steroid antiinflammatory drug \[NSAID\] exacerbated respiratory disease \[ERD\]). * To evaluate residual effect in follow up. * 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

NCT02912468

Run by

Sanofi

People needed

276

Starts

2016-12-05

Expected to finish

2018-07-05

Last updated by the study team

2019-07-25

Who can join

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

You may qualify if…

• Participants with bilateral sinonasal polyposis that despite prior treatment with systemic corticosteroids (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 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 Visit [V] 1) 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 qualify if…

• Participants <18 years of age.
• Participants who were previously treated in dupilumab studies.
• Participants 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 (mAB) within 5 half-lives or within 6 months before V1 if the half-life was unknown.
• Anti-immunoglobulin E (IgE) 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.
• Initiated allergen immunotherapy within 3 months prior to V1 or planned to begin therapy or changed its dose during the run-in period or the randomized treatment period.
• Participants who undergone any intranasal and/or sinus surgery (including polypectomy) within 6 months prior to V1.
• Participants who had a sinonasal or sinus surgery changing the lateral wall structure of the nose making impossible the evaluation of NPS.
• Participants 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.
• Participants with nasal cavity malignant tumor and benign tumors (eg, papilloma, blood boil, etc).
• Participants with forced expiratory volume in 1 second (FEV1) 50% or less (of predicted normal).
• Participants who received 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.

Where it is running

• Investigational Site Number 8400004 — Orange, California, United States
• Investigational Site Number 8400014 — San Diego, California, United States
• Investigational Site Number 8400002 — Stockton, California, United States
• Investigational Site Number 8400016 — Centennial, Colorado, United States
• Investigational Site Number 8400013 — Tampa, Florida, United States
• Investigational Site Number 8400022 — West Des Moines, Iowa, United States
• Investigational Site Number 8400007 — Boston, Massachusetts, United States
• Investigational Site Number 8400005 — Rochester, Minnesota, United States
• Investigational Site Number 8400021 — St Louis, Missouri, United States
• Investigational Site Number 8400008 — Winston-Salem, North Carolina, United States
• Investigational Site Number 8400019 — Tulsa, Oklahoma, United States
• Investigational Site Number 8400020 — Medford, Oregon, United States
• Investigational Site Number 8400018 — Charleston, South Carolina, United States
• Investigational Site Number 8400003 — Nashville, Tennessee, United States
• Investigational Site Number 8400001 — Dallas, Texas, United States
• Investigational Site Number 8400015 — Norfolk, Virginia, United States
• Investigational Site Number 8400010 — Milwaukee, Wisconsin, United States
• Investigational Site Number 1000003 — Plovdiv, Bulgaria
• Investigational Site Number 1000002 — Sofia, Bulgaria
• Investigational Site Number 1000001 — Sofia, Bulgaria
• Investigational Site Number 2030001 — Hradec Králové, Czechia
• Investigational Site Number 2030002 — Pardubice, Czechia
• Investigational Site Number 2030004 — Prague, Czechia
• Investigational Site Number 2500005 — La Roche-sur-Yon, France
• Investigational Site Number 8400009 — Long Beach, California, United States

Full record on ClinicalTrials.gov

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