Multi-center, open-label, multiple dose study in mild to moderate asthmatics (with IgE/body weight combinations above that in the SmPC dosing table) to determine safety, tolerability, pharmacokinetics, and pharmacodynamics of omalizumab

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2006-005588-24-DE
• Date of registration: 15/02/2007
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: Multi-center, open-label, multiple dose study in mild to moderate asthmatics (with IgE/body weight combinations above that in the SmPC dosing table) to determine safety, tolerability, pharmacokinetics, and pharmacodynamics of omalizumab
• Scientific title: Multi-center, open-label, multiple dose study in mild to moderate asthmatics (with IgE/body weight combinations above that in the SmPC dosing table) to determine safety, tolerability, pharmacokinetics, and pharmacodynamics of omalizumab
• Date of first enrolment: 08/06/2007
• Target sample size: 33
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-005588-24
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

Germany

Key inclusion & exclusion criteria

Inclusion criteria:
Patients must meet the following criteria during the Screening visit and at Baseline
evaluations in order to be eligible for the study:

• Diagnosis of allergic asthma = 1 year duration at screening and a history consistent with GINA step 2 or 3 clinical features.


• Eligible Baseline serum IgE value and body-weight combinations:

• Body weight (kg) •Baseline serum IgE (IU/mL)
• >40 – 50 • >900 – 2000
• >50 – 60 • >700 – 2000
• >60 – 70 • >600 – 2000
• >70 – 80 • >500 – 2000
• >80 – 90 • >500 – 2000
• >90 – 125 • >300 – 2000
• >125 – 150 • >300 – 2000


• Able to give signed informed consent

• Male or female, 18–55 years old

• For women of childbearing potential, a negative serum pregnancy test within 13 days and a negative urine pregnancy test within 24 hours of study drug administration, and all study drug administrations; women of childbearing potential had to either have been surgically sterilized or, in the opinion of the investigator, be using an effective method of contraception

• Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation

When 11 patients have been included in the 1200 mg group, additional patients to be included into the 1200 mg group have to have IgE levels = 900 IU/mL.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Patients meeting any of the following criteria will be excluded from entry into or continuation in the study unless sponsor approval is obtained:

• Documented medical history of anaphylaxis

• Lung disease other than mild to moderate allergic asthma, e.g. COPD

• Use of inhaled tobacco products within the last 12 months

• History of smoking tobacco products of greater than or equal to “10 pack years”

• History of significant medical illnesses other than mild/moderate allergic asthma, including diabetes mellitus, ischemic heart disease, cardiomyopathies, serious neurologic, gastroenterologic, or dermatologic disease, or chronic bronchitis

• Use of oral corticosteroids 3 months prior to Day 1

• Use of any monoclonal antibody in the 6 months before Day 1

• Use of any investigational small molecule drug in the 3 months before Day 1

• Respiratory tract infection in the 4 weeks before Day 1

• History of asthma attack requiring a visit to an emergency room in the 6 weeks before or during Screening

• History of asthma attack requiring treatment with intubation and mechanical ventilation in the 12 months before Day 1

• Evidence for ischemic heart disease or arrhythmia on Screening electrocardiogram (patients not excluded for occasional premature atrial or ventricular contractions)

• Female subjects of child bearing potential who are pregnant, breast feeding or who are either not surgically sterile or are sexually active and not using an acceptable form of contraception as either an hormonal contraceptive since at least two months or the doublebarrier method, i.e. cervical diaphragm with spermicide and condom for the male partner.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Mild to moderate allergic asthma
MedDRA version: 8.1 Level: LLT Classification code 10003553 Term: Asthma

Intervention(s)

Trade Name: Xolair 150 mg Pulver und Lösungsmittel zur Herstellung einer Injektionslösung
Product Name: Xolair
Product Code: IGE025
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: omalizumab
Current Sponsor code: IGE025
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-

Primary Outcome(s)

Main Objective: To demonstrate safety and tolerability of omalizumab in mild and moderate asthmatics with baseline IgE/body-weight combinations above those defined in the SmPC table.

Primary end point(s): Safety and tolerability of omalizumab

Secondary Objective: - To evaluate the pharmacokinetic/pharmacodynamic profile of multiple administration of omalizumab to mild/moderate allergic asthma patients with baseline IgE/body-weight combinations above those defined in the extended dosing table (Table 1-1)

- To determine the pre-dose specific IgE levels in these patients

Secondary ID(s)

CIGE025A2208