Controlled Clinical Study of Dupilumab in Patients With 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 nasal spray — DRUG
  Pharmaceutical form: Suspension Route of administration: Intranasal

Study Details

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 Dates

Start date

Nov 28, 2016

Status verified

Oct 2019

Primary completion

Aug 27, 2018

Completion

Nov 16, 2018

Study Design

Enrollment

448 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Dupilumab 300 mg q2w
  Dupilumab 300 mg subcutaneous (SC) injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
• Experimental: Dupilumab 300 mg q2w then q4w
  Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 24 and then 300 mg q4w until Week 52 added to background therapy of intranasal MFNS at stable dose. After Week 24, Dupilumab administration was alternated with matched placebo injection every other week up to Week 50.
• Placebo Comparator: Placebo
  Placebo (for dupilumab), 1 SC injection q2w from Day 1 of Week 0 up to Week 52 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 (19)

Find similar trials in Birmingham, AL

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