Clinical Trials Directory

Trials / Completed

CompletedNCT01599637

Mode of Action Study of Omalizumab in Patients With Chronic Idiopathic Urticaria (CIU) Who Fail to Respond to Antihistamine Treatment

A Phase II, Multi-centre, Randomized, Double Blind, Placebo-controlled Study to Determine the Mode of Action of Omalizumab in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic With Antihistamine Treatment (H1)

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
40 (actual)
Sponsor
Novartis Pharmaceuticals · Industry
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

Summary

The study is designed to explore the mode of action for omalizumab therapy in patients with chronic idiopathic urticaria.

Conditions

Interventions

TypeNameDescription
DRUGIGE025Study medication will be supplied as a lyophilized, sterile powder in a single-use, 5-mL vial.
DRUGplaceboStudy medication will be supplied as a lyophilized, sterile powder in a single-use, 5-mL vial.

Timeline

Start date
2012-04-01
Primary completion
2013-09-01
Completion
2013-09-01
First posted
2012-05-16
Last updated
2015-03-31
Results posted
2014-11-03

Locations

4 sites across 1 country: Germany

Source: ClinicalTrials.gov record NCT01599637. Inclusion in this directory is not an endorsement.

Mode of Action Study of Omalizumab in Patients With Chronic Idiopathic Urticaria (CIU) Who Fail to Respond to Antihistam (NCT01599637) · Clinical Trials Directory