mRNA Expression as a Biomarker of Omalizumab Response

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Instituto de Investigação em Imunologia.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Instituto de Investigação em Imunologia
ClinicalTrials.gov Identifier:
NCT01584687
First received: April 20, 2012
Last updated: April 24, 2012
Last verified: April 2012
  Purpose

Objectives: 1. Determine if mRNA expression could be use as a biomarker to predict and monitor the response to omalizumab in patients with difficult control asthma 2. Identify which genes are switched on and which are switched off by using Omalizumab.

Methods: This study is an open label clinical trial, with six patients. The patients will receive Omalizumab according to their age and weight (maximum dose: 375 mg every 15 days) for 4 months. There will be a run-in period of one month, when allergic asthma diagnosis will be confirmed and treatment will be optimized. Patients will be evaluated and will have blood sample collected on 3 occasions: in the beginning, 2 months after baseline and at the end of the study. Blood samples will always be collected one week after the last omalizumab dose. Primary outcome will be RNA expression of 20 genes measured by real time-PCR (high-affinity IgE receptor, IL-4, IL-5, IL-13, gama-IFN, quimokines, Fc epsilon, between others). Secondary outcomes will be ACT, ACQ and spirometry.


Condition Intervention Phase
Asthma
Biological: Omalizumab
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: mRNA Expression as a Biomarker of Xolair (Omalizumab) Response

Resource links provided by NLM:


Further study details as provided by Instituto de Investigação em Imunologia:

Primary Outcome Measures:
  • Change of mRNA expression in leukocytes (real time-PCR) [ Time Frame: At the end of the study (4months after baseline) ] [ Designated as safety issue: No ]
    Patients will be evaluated and will have blood sample collected on 3 occasions: in the beginning, 2 months after baseline and at the end of the study. Blood samples will always be collected one week after the last omalizumab dose. Primary outcome will be RNA expression of 30 genes measured by real time-PCR.


Secondary Outcome Measures:
  • Change in the scores of questionnaires of asthma control [ Time Frame: At the end of the study (4 months after baseline) ] [ Designated as safety issue: No ]
    Patients will be evaluated on 3 occasions: in the beginning, 2 months after baseline and at the end of the study. Secondary outcomes will be the scores of Asthma Control Test and Asthma Control Questionnaire.


Estimated Enrollment: 6
Study Start Date: June 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Omalizumab
All patients will receive omalizumab.
Biological: Omalizumab
The patients will receive Omalizumab according to their age and weight for 4 months.
Other Names:
  • Anti-IgE
  • Xolair

Detailed Description:

Study rational: There is not a biomarker that can predict which patients will respond to Omalizumab and those who will not respond. Nowadays, the monitoring of therapeutic response to Omalizumab is based on clinical and spirometric data.

On the other hand, when a medication is administered, it has its main expected effect, but also acts on other targets with various direct and indirect effects. We do not know all the genes that are switched on and those that are switched off by the use of Omalizumab. For example, anti-IgE has been developed to block serum total IgE and thereby improve control of allergic asthma. However, the studies noted that Omalizumab also reduces the receptors FcepsilonRI, which may have implications for the treatment of autoimmune urticaria.

  Eligibility

Ages Eligible for Study:   12 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • over 12 years
  • severe asthma not controlled despite medication
  • IgE between 70 and 1300 IU/ml and evidence of allergy clinical history and/or skin test or blood.

Exclusion Criteria:

  • previous use of omalizumab
  • smoke history
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01584687

Contacts
Contact: Pedro Giavina-Bianchi, PhD,MD (5511) 26616098 pbianchi@usp.br
Contact: Marcelo V Aun, MD (5511) 26616225 marcelovivoloaun@yahoo.com.br

Sponsors and Collaborators
Instituto de Investigação em Imunologia
Investigators
Principal Investigator: Pedro Giavina-Bianchi, MD,PhD University of São Paulo
  More Information

No publications provided

Responsible Party: Instituto de Investigação em Imunologia
ClinicalTrials.gov Identifier: NCT01584687     History of Changes
Other Study ID Numbers: CIGE025ABR03T
Study First Received: April 20, 2012
Last Updated: April 24, 2012
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Instituto de Investigação em Imunologia:
asthma
difficult-to-control asthma
mRNA expression
biomarker
real time PCR
ACT
ACQ

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Omalizumab
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on July 29, 2014