Dupilumab in CRSsNP

Part of paid clinical trials in Roseville, California.

Sponsor
Sanofi
Study ID
NCT04678856
Phase
PHASE3
Status
Completed

Conditions

  • Chronic Rhinosinusitis Without Nasal Polyps
  • Chronic Sinusitis
  • Respiratory Disorder
  • Sinus Disorder
  • Sinusitis

Eligibility Criteria

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

Interventions

  • Dupilumab SAR231893 — DRUG
    Pharmaceutical form:Injection solution Route of administration: Subcutaneous
  • Placebo — DRUG
    Pharmaceutical form:Injection solution Route of administration: Subcutaneous

Study Details

Primary Objective: To evaluate the efficacy of dupilumab as assessed by the reduction at Week 24 in sinus opacification on computerized tomography (CT) scan in the dupilumab group only Secondary Objectives: * To evaluate the efficacy of dupilumab as assessed by the reduction at Week 24 in sinus opacification on CT scan and sinus total symptom score (sTSS) compared to placebo * To evaluate the safety and tolerability of dupilumab in CRSsNP patients compared to placebo * To evaluate the pharmacokinetics (PK) of dupilumab in CRSsNP patients compared to placebo * Assessment of immunogenicity to dupilumab over time compared to placebo

Key Dates

Start date
Dec 2, 2020
Status verified
Jan 2025
Primary completion
Nov 14, 2023
Completion
Jan 29, 2024

Study Design

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

Arms

  • Experimental: Part A and B: Dupilumab
    Participants received dupilumab 300 milligrams (mg) via SC injection q2w for up to 53.1 weeks.
  • Placebo Comparator: Part A and B: Matching placebo
    Participants received matching placebo via SC injection q2w for up to 53.2 weeks.

Primary Outcome Measure

Change From Baseline to Week 24 in Opacification of Sinuses Assessed by Computed Tomography (CT) Scan Using the Lund Mackay (LMK) Score in Dupilumab Group [ Time Frame: Baseline (Day 1) and Week 24 ]

Locations (11)

FacilityCityStateZIPSite coordinators
Sacramento Ear, Nose & Throat Site Number : 8400010RosevilleCalifornia95661-
Bensch Clinical Research LLC Site Number : 8400015StocktonCalifornia95207-
Colorado Allergy and Asthma Centers, PC Site Number : 8400003DenverColorado80230-
University of Missouri Health System Site Number : 8400016ColumbiaMissouri65212-
Nebraska Medical Research Institute Site Number : 8400007PapillionNebraska68046-
Optimed Research, LTD Site Number : 8400017ColumbusOhio43235-
Essential Medical Research, LLC Site Number : 8400014TulsaOklahoma74137-
Vital Prospects Clinical Research Institute, P.C. Site Number : 8400004TulsaOklahoma74136-
Pharmaceutical Research & Consulting, Inc. Site Number : 8400006DallasTexas75231-
Alamo ENT Associates Site Number : 8400021San AntonioTexas78258-
Eastern Virginia Medical School (EVMS) Medical Group - Otola Site Number : 8400009NorfolkVirginia23507-

Find similar trials in Roseville, CA

By research site
Sacramento Ear, Nose & Throat· Roseville, CABensch Clinical Research LLC· Stockton, CAColorado Allergy and Asthma Centers, PC· Denver, COUniversity of Missouri Health System· Columbia, MONebraska Medical Research Institute· Papillion, NEOptimed Research, LTD· Columbus, OH

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