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Dupixent Study for Alternate Administration

NCT06750471 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-01-17

No results posted yet for this study

Summary

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.

Conditions

Interventions

BIOLOGICAL

Dupilumab

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

Sponsors & Collaborators

  • Tripler Army Medical Center

    collaborator FED

  • Fort Belvoir Community Hospital

    collaborator FED

  • William Beaumont Army Medical Center

    collaborator FED

  • Madigan Army Medical Center

    lead FED

Principal Investigators

  • Renee M Serra, MD · ENT/Audiology Department Chair

  • Roy F Thomas, MD · Rhinologist

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-14
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06750471 on ClinicalTrials.gov