An Evaluation of Dupilumab in Patients With Nasal Polyposis And Chronic Symptoms Of Sinusitis

Part of paid clinical trials in Rolling Hills Estates, California.

Sponsor
Sanofi
Study ID
NCT01920893
Phase
PHASE2
Status
Completed

Conditions

  • Nasal Polyps

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Placebo (for dupilumab) — DRUG
    Solution for injection; Subcutaneous injection.
  • Dupilumab — DRUG
    Solution for injection; Subcutaneous injection.
  • Mometasone furoate nasal spray — DRUG
    Nasal spray, 2 actuations in each nostril twice daily.

Study Details

Primary Objective: To evaluate the efficacy of dupilumab (SAR231893/REGN668) in the treatment of bilateral Nasal Polyposis (NP) by assessment of the endoscopic nasal polyp score (NPS) in comparison to placebo. Secondary Objectives: To evaluate effect of dupilumab with regards to: * symptoms of sinusitis, * sinus computed tomography (CT) scan, * NPS in the sub-group of participants with co-morbid asthma, * Safety and tolerability.

Key Dates

Start date
Aug 31, 2013
Status verified
Jun 2017
Primary completion
Nov 30, 2014
Completion
Nov 30, 2014

Study Design

Enrollment
60 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection every week (QW) from Week 1 to 15 added to Mometasone furoate nasal spray (MFNS).
  • Experimental: Dupilumab 300 mg QW
    Dupilumab, 2 Subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection QW from Week 1 to 15 added to MFNS.

Primary Outcome Measure

Change From Baseline in Bilateral Endoscopic Nasal Polyp Score (NPS) at Week 16 [ Time Frame: Baseline, Week 16 ]

Locations (5)

FacilityCityStateZIPSite coordinators
Investigational Site Number 840014Rolling Hills EstatesCalifornia90274-
Investigational Site Number 840015DenverColorado80230-
Investigational Site Number 840013BostonMassachusetts02114-
Investigational Site Number 840002Lake OswegoOregon97035-
Investigational Site Number 840009PittsburghPennsylvania15213-

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