Dupixent Study for Alternate Administration

Part of paid clinical trials in Tacoma, Washington.

Sponsor
Madigan Army Medical Center
Study ID
NCT06750471
Phase
PHASE4
Status
Active Not Recruiting

Conditions

  • Chronic Disease
  • Nasal Polyps
  • Sinusitis

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Accepted

Interventions

  • Dupilumab — BIOLOGICAL
    Dupilumab is an anti-IL 4-13 biologic therapy that has been recently approved for use in recurrent chronic rhinosinusitis with nasal polyposis.

Study Details

Investigators will investigate an alternate Dupilumab administration schedule in patients with recurrent chronic rhinosinusitis with nasal polyposis, who have a history of full endoscopic sinus surgery and are on appropriate topical medical therapies. Specifically, investigators will investigate if the alternate schedule of drug administration is non-inferior in both subjective and objective outcomes.

Key Dates

Start date
Oct 14, 2021
Status verified
Jan 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A - Regular Adminstration
    Eligible patient will receive 300 mg Subcutaneous Dupilumab every 2 weeks for 28 weeks
  • Experimental: Arm B - Alternate Administration
    Eligible patient will receive 300 mg Subcutaneous Dupilumab every 2 weeks for 8 weeks and then every 4 weeks up until 28 weeks

Primary Outcome Measure

Change in Sinonasal outcome test - 22 over different time intervals [ Time Frame: Baseline, week 4, week 8, week 16 and week 28 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Madigan Army Medical CenterTacomaWashington98431-

Find similar trials in Tacoma, WA

By research site
Madigan Army Medical Center· Tacoma, WA

Related Studies