EValuating trEatment RESponses of Dupilumab Versus Omalizumab in Type 2 Patients

Part of paid clinical trials in Los Angeles, California.

Sponsor
Sanofi
Study ID
NCT04998604
Phase
PHASE4
Status
Completed

Conditions

  • Asthma
  • Chronic Rhinosinusitis With Nasal Polyps

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dupilumab — DRUG
    solution for injection subcutaneous
  • Omalizumab — DRUG
    solution for injection subcutaneous
  • Placebo — DRUG
    solution for injection subcutaneous

Study Details

Primary Objective -To evaluate the efficacy of dupilumab compared to omalizumab in reducing the polyp size and improving sense of smell Secondary Objectives * To evaluate the efficacy of dupilumab in improving chronic rhinosinusitis with nasal polyps (CRSwNP) symptoms at Week 24 compared to omalizumab * To evaluate the efficacy of dupilumab in improving CRSwNP total symptom score (TSS) at Week 24 compared to omalizumab * To evaluate the effect of dupilumab on health related quality of life (HRQoL) at week 24 compared to omalizumab * To evaluate the efficacy of dupilumab in improving nasal peak inspiratory flow at Week 24 compared to omalizumab * To evaluate the effect of dupilumab on CRSwNP overall disease severity at Week 24 compared to omalizumab * To evaluate the safety of dupilumab and omalizumab

Key Dates

Start date
Sep 27, 2021
Status verified
Sep 2025
Primary completion
Oct 16, 2024
Completion
Dec 27, 2024

Study Design

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

Arms

  • Experimental: Dupilumab 300 mg Q2W
    Participants received dupilumab 300 milligrams (mg) subcutaneous (SC) injection every 2 weeks (Q2W) for 24 weeks.
  • Experimental: Omalizumab 75 to 600 mg Q2W/Q4W
    Participants received omalizumab 75 to 600 mg SC injection Q2W/every 4 weeks (Q4W) based on their serum immunoglobulin E (IgE) levels and body weight for 24 weeks.

Primary Outcome Measure

Change From Baseline to Week 24 in Nasal Polyp Score [ Time Frame: Baseline (Day 1) and Week 24 ]

Locations (16)

FacilityCityStateZIPSite coordinators
Cedars Sinai Medical Center Site Number : 8400026Los AngelesCalifornia90048-
Asthma Allergy & Immunology Clinical Research Unit Site Number : 8400027TampaFlorida33613-
Northwestern University Site Number : 8400001ChicagoIllinois60611-
University of IllinoisChicagoIllinois60612-
Advanced ENT and Allergy Site Number : 8400013LouisvilleKentucky40220-
University of Missouri Health Care - University Hospital Site Number : 8400016ColumbiaMissouri65212-
Northwell Health Site Number : 8400044Great NeckNew York11021-
University of Rochester Site Number : 8400015RochesterNew York14642-
Cleveland Clinic Foundation Site Number : 8400029ClevelandOhio44195-
Optimed Research, LTD Site Number : 8400014ColumbusOhio43235-
Allergy, Asthma and Clinical Research Center Site Number : 8400037Oklahoma CityOklahoma73120-
Essential Medical Research, LLC Site Number : 8400024TulsaOklahoma74137-
Oregon Health & Science University Site Number : 8400031PortlandOregon97239-
University of Texas Health Science Center- Site Number : 8400019HoustonTexas77030-
Chryaslis Clinical Research Site Number : 8400017St. GeorgeUtah84790-
Eastern Virginia Medical School Site Number : 8400010NorfolkVirginia23507-

Find similar trials in Los Angeles, CA

By condition
Asthma
By specialty
PulmonologyLung disease
By research site
Cedars Sinai Medical Center· Los Angeles, CAAsthma Allergy & Immunology Clinical Research Unit· Tampa, FLNorthwestern University· Chicago, ILUniversity of Illinois· Chicago, ILAdvanced ENT and Allergy· Louisville, KYUniversity of Missouri Health Care - University Hospital· Columbia, MO

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