mRNA Expression as a Biomarker of Omalizumab Response

Asthma Clinical Trial

Official title:

mRNA Expression as a Biomarker of Xolair (Omalizumab) Response

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01584687
• Other study ID #: CIGE025ABR03T
• Status: Not yet recruiting
• Phase: Phase 4
• First received: April 20, 2012
• Last updated: April 24, 2012
• Start date: June 2012
• Est. completion date: December 2012

Study information

• Verified date: April 2012
• Source: Instituto de Investigação em Imunologia
• Contact: Pedro Giavina-Bianchi, PhD,MD
• Phone: (5511) 26616098
• Email: pbianchi[@]usp.br
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 6
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 60 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Biological:
• Omalizumab
The patients will receive Omalizumab according to their age and weight for 4 months.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigação em Imunologia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of mRNA expression in leukocytes (real time-PCR)	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.	At the end of the study (4months after baseline)	No
Secondary	Change in the scores of questionnaires of asthma control	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.	At the end of the study (4 months after baseline)	No