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Completed Phase 3 Interventional Results available

Open Label Study to Assess Safety and Immunogenicity of Omalizumab Liquid Formulation.

ClinicalTrials.gov ID: NCT00500539

Public ClinicalTrials.gov record NCT00500539. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 23, 2026, 4:44 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An Open Label, Single Arm Study to Assess the Safety and Immunogenicity of Omalizumab Liquid Administered Subcutaneously to Male and Female Adolescents and Adults With Persistent Allergic Asthma

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The primary objective of this study is to assess the immunogenic potential of the liquid formulation of omalizumab administered over a period of 6 months in moderate to severe persistent allergic asthma patients 12 years of age or older, with no previous exposure to the drug (omalizumab naïve patients). The secondary objective of this study is to assess the safety of the liquid formulation of omalizumab in the same patients.

Study identification

NCT ID
NCT00500539
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Novartis
Industry
Enrollment
155 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
12 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 2007 (Type not available)
Primary completion
Sep 2008 (Actual)
Completion
Sep 2008 (Actual)
Last update posted
Jun 2, 2011

2007 – 2008

United States locations

U.S. sites
26
U.S. states
16
U.S. cities
25
Facility City State ZIP Site status
Allergy & Immunology Associates, Ltd Scottsdale Arizona AZ 85251 —
California Allergy and Asthma Medical Group Palmdale California CA 93551 —
Allergy Associates Medical Group, Inc, San Diego California CA 92120 —
Bensch Research Associates Stockton California CA 95207 —
1st Allergy and Clinical Research Center Centennial Colorado CO 80112 —
Innovative Research of West Florida, Inc. Largo Florida FL 33770 —
Georgia Pollen Albany Georgia GA 31707 —
Kansas City Allergy & Asthma Overland Park Kansas 66210 —
Asthma and Allergy Specialists, PA Minneapolis Minnesota MN 55402 —
: The Clinical Research Center, LLC St Louis Missouri MO 63141 —
Allergy, Asthma and Clinical Immunology Brick New Jersey NJ 08724 —
Asthma & Allergy Research of NJ, Inc. Mount Laurel New Jersey NJ 08054 —
Nassau Chest Pysicians, PC Massapequa New York NY 11758 —
Allergy and Asthma Center of NC, PA High Point North Carolina NC 27262 —
Allergy Center at Brookstone Columbus Ohio OH 31904 —
Toledo Center for Clinical Research Sylvania Ohio OH 43650 —
Asthma and Allergy Center Toledo Ohio OH 43617 —
The Corvallis Clinic, PC Corvallis Oregon OR 97330 —
Allergy, Asthma & Dermatology Research Center Lake Oswego Oregon OR97037 —
Clinical Research Institute of Southern Oregon, PC Medford Oregon OR 97504 —
Allergy & Asthma Specialists, PC Blue Bell Pennsylvania PA 19422 —
Asthma Allergy & Pulmonary Associates, PC Philadelphia Pennsylvania PA 19107 —
AAPRI Clinical Research Institute Providence Rhode Island RI 02906 —
North Texas Institute for Clinical Trials Fort Worth Texas TX 76132 —
Allergy and Asthma Associates Houston Texas TX 77054 —
Clinical Trials of North Houston Houston Texas TX 77070 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00500539, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 2, 2011 · Synced Oct 23, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00500539 live on ClinicalTrials.gov.

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