A Controlled Clinical Study of Dupilumab in Patients With Bilateral Nasal Polyps

Conditions

• Chronic Rhinosinusitis Phenotype With Nasal Polyps (CRSwNP)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Dupilumab SAR231893 (REGN668) — DRUG
  Pharmaceutical form: Solution Route of administration: Subcutaneous
• Placebo — DRUG
  Pharmaceutical form: Solution Route of administration: Subcutaneous
• Mometasone furoate 50 micrograms — DRUG
  Pharmaceutical form: Suspension (Nasal spray) Route of administration: Intranasal

Study Details

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 Dates

Start date

Dec 5, 2016

Status verified

Jul 2019

Primary completion

Jul 5, 2018

Completion

Jul 5, 2018

Study Design

Enrollment

276 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo
  Placebo (for dupilumab), 1 subcutaneous (SC) injection every 2 weeks (q2w) from Day 1 of Week 0 up to Week 24 added to background therapy of intranasal mometasone furoate nasal spray (MFNS) at stable dose.
• Experimental: Dupilumab 300 mg
  Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 24 added to background therapy of intranasal MFNS at stable dose.

Primary Outcome Measure

Change From Baseline at Week 24 in Nasal Congestion/Obstruction Symptom Severity Score [ Time Frame: Baseline, Week 24 ]

Locations (18)

Find similar trials in Long Beach, CA

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