Early-onset Dupilumab Effects in CRSwNP

NCT06188871 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2024-05-09

No results posted yet for this study

Summary

While it is known that Dupilumab has profound effects in patients with CRSwNP, these are often seen months later after treatment initiation; however, in practice, patients often endorse feeling significantly better within days of their first injection. No studies have investigated the molecular basis for such an acute change. This study proposes that specific cytokine changes in phenotype in addition to microbiome and oscillometry effects play a synergistic role in producing this effect.

Conditions

Interventions

DRUG

Dupilumab

Two injections of 300mg dupilumab, subcutaneous 14 days apart

Sponsors & Collaborators

  • University of Rochester

    lead OTHER

Principal Investigators

  • Li-Xing Man, MSc, MD, MPA · University of Rochester

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2026-06-01
Completion
2027-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT06188871 on ClinicalTrials.gov