Safety and Tolerability of Omalizumab in Poorly Controlled Moderate to Severe Asthma Patients

A One Year Open-label Extension Study to Assess Long Term Safety and Tolerability of Omalizumab Treatment in Poorly Controlled Moderate to Severe Allergic Asthma Patients Who Participated in the 52-week CIGE24IA04E1 Study

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00482508

Enrollment

Registered

2007-06-05

Start date

2003-05-31

Completion date

2005-10-31

Last updated

2011-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Asthma, anti immunoglobulin E, omalizumab

Brief summary

This study will assess the safety and tolerability of long-term treatment with omalizumab plus current asthma therapy in patients who participated in and successfully completed the treatment period of study CIGE025IA04E1. Patients who participated in CIGE025IA04E1 were perceived by both the patient and the investigator to have benefited from receiving treatment with omalizumab plus current asthma therapy according to best medical practice

Interventions

DRUGOmalizumab

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to 75 Years

Inclusion criteria

* Patients who completed core study and extension study CIGE24IA05E1 up to and including visit 15, without experiencing any significant drug-related adverse events * Patients who have given written informed consent

Exclusion criteria

* Patients who had not received study medication for greater than 84 days since visit 15 of study CIGE24IA05E1 * Pregnant females or nursing mothers * Patients with know hypersensitivity to any ingredients of Omalizumab or related drugs Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Safety assessed by adverse events, serious adverse events, vital signs and laboratory safety data. A blood sample will be collected at each scheduled visit prior to administration of study medication and analyzed for free and total IgE levels and total	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026