Early-onset Dupilumab Effects in CRSwNP
NCT06188871 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL
Last updated 2024-05-09
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
-
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
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