CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 21 enrolled
Drug / intervention
Omalizumabbiological
Likely dose
Omalizumab 0.016 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04583501
NCT04583501Early Ph 1Completed
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Preclinical Studies of Omalizumab in Chronic Rhinosinusitis With Nasal Polyposis

Johns Hopkins University·interventional·Posted Oct 12, 2020·Updated Aug 13, 2024

In Brief

A Early Phase 1 clinical trial evaluating Omalizumab for Chronic Rhinosinusitis With Nasal Polyps and Nasal Polyps. Completed, enrolled 21 participants across 2 sites.

Detailed Summary

The goal of this study is to examine the mechanism of action of omalizumab in ex vivo tissue culture of whole human nasal polyps from patients with chronic rhino sinusitis with nasal polyposis (CRSwNP), such that specific molecular markers of inflammation can be identified.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Rhinosinusitis With Nasal Polyps, Nasal Polyps
CountriesUnited States
CollaboratorsGenentech, Inc.

Timeline

Early Ph 1CompletedFinished
202120222023202420252026
First PostedOct 12, 2020
Enrollment StartDec 15, 2020
Primary CompletionJul 12, 2024
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 5.7 years ago

Interventions

Omalizumabbiological

Omalizumab will used as dose comparable to to 0.016 mg/kg/IU in serum.