mRNA Expression as a Biomarker of Omalizumab Response

NCT ID: NCT01584687

Last Updated: 2012-04-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2012-12-31

Brief 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.

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.

Conditions

Asthma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Omalizumab

All patients will receive omalizumab.

Group Type: EXPERIMENTAL

Omalizumab

Intervention Type: BIOLOGICAL

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

Interventions

Omalizumab

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

Intervention Type: BIOLOGICAL

Other Intervention Names

Anti-IgE; Xolair

Eligibility 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Investigação em Imunologia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pedro Giavina-Bianchi, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Central Contacts

Pedro Giavina-Bianchi, PhD,MD

Role: CONTACT

pbianchi@usp.br

(5511) 26616098

Marcelo V Aun, MD

Role: CONTACT

marcelovivoloaun@yahoo.com.br

(5511) 26616225

Other Identifiers

CIGE025ABR03T

Identifier Type: -

Identifier Source: org_study_id