CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 19 enrolled
Drug / intervention
Omalizumab +1 moredrug
Likely dose
Not stated in 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/NCT01003301
NCT01003301Phase 2Completed
CompareCT.gov

The Effects of Omalizumab on the Late-phase Response to Nasal Allergen Challenge

Johns Hopkins University·interventional·Posted Oct 28, 2009·Updated Apr 7, 2014

In Brief

A Phase 2 clinical trial evaluating Omalizumab and Placebo for Cat Allergy. Completed, enrolled 19 participants across 1 site.

Detailed Summary

This research is being done to study the effects of the drug omalizumab (Xolair) in people with cat allergies. The investigators will use omalizumab to study changes in the cells in the nose, cells in the blood and cells in the skin that cause allergies. The investigators will compare the changes in the nose to changes in the skin and blood cells. Objective: To test the hypothesis that treatment with omalizumab will decrease the nasal allergen challenge late-phase eosinophil count in nasal brushings at the time when blood basophils have become hypo-responsive to in vitro allergen exposure.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCat Allergy
CountriesUnited States
CollaboratorsNational Institute of Allergy and Infectious Diseases (NIAID), Genentech, Inc.

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 28, 2009
Enrollment StartOct 1, 2009
Primary CompletionDec 1, 2012
Study CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 16.7 years ago

Interventions

Omalizumabdrug

Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks.

Placebodrug

Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks.