The Safety and Utility of Skin Testing With Xolair (Omalizumab) and Placebo Omalizumab (Formulation Excipients) - Full Text View

Sponsored by:	Genentech
Information provided by:	Genentech
ClinicalTrials.gov Identifier:	NCT00777764

Purpose

The study will be conducted at up to three investigational sites in the United States in 30 healthy volunteers and 30 patients with atopic asthma, for a total of 60 subjects. The study will examine the tolerability of omalizumab and omalizumab excipients in two successive cohorts of subjects, healthy volunteers and patients with allergic asthma without prior exposure to omalizumab, according to a skin test protocol, consisting of a prick skin test and/or intradermal test.

Condition	Intervention	Phase
Healthy Asthma	Drug: omalizumab	Phase IV

MedlinePlus related topics: Asthma

Drug Information available for: Omalizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment
Official Title:	The Safety and Utility of Skin Testing With Xolair (Omalizumab) and Placebo Omalizumab (Formulation Excipients)

Further study details as provided by Genentech:

Primary Outcome Measures:

Frequency and severity of adverse events following a skin test procedure [ Time Frame: Length of study ] [ Designated as safety issue: No ]
Number of patients who experience a positive skin reaction [ Time Frame: Length of study ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	September 2008
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 (Healthy Subjects): Experimental	Drug: omalizumab Multiple concentrations of omalizumab in the skin prick testing proedure
2 (Allergic Asthma Patients): Experimental	Drug: omalizumab Multiple concentrations of omalizumab in the skin prick testing proedure

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Healthy subjects not taking any regular prescription medication, without history of allergy, and considered healthy by the physician
Patients with atopic asthma diagnosed by a physician with asthma and history of positive skin test(s)
Physical examination findings within normal limits
Body mass index (BMI) between 18 and 30, inclusive

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded from study entry:

Pregnancy and lactation
Current or previous treatment with a biologic agent (e.g., monoclonal antibody)
Concurrent disease or condition that would interfere, or for which the treatment might interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to individuals in this study
History or symptoms of significant psychiatric disease, including but not limited to, depression, schizophrenia, etc.
History of drug abuse
Participation in an investigational drug or device trial within the last 30 days prior to screening

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00777764

Contacts

Contact: Katelyn Dyer

dyer.katelyn@gene.com

Locations

United States, Kansas
Investigational Site	Recruiting
Lenexa, Kansas, United States, 66219
Contact: Joanne Hall 913-410-2911

Sponsors and Collaborators

Genentech

Investigators

Study Director:

Dennis Wong, M.D.

Genentech

More Information

Responsible Party:	Genentech, Inc. ( Clinical Trials Posting Group )
Study ID Numbers:	Q4465g
Study First Received:	October 21, 2008
Last Updated:	October 21, 2008
ClinicalTrials.gov Identifier:	NCT00777764
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genentech:

Xolair
Asthma
Skin Tests

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate

Asthma
Healthy
Omalizumab
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Respiratory System Agents
Immune System Diseases
Bronchial Diseases
Therapeutic Uses

Anti-Asthmatic Agents
Anti-Allergic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009