An open label, single arm study to assess the safety and immunogenicity of omalizumab liquid administered subcutaneously in a pre-filled safety syringe (75 mg or 150 mg) over a period of 6 months to male and female adolescents and adults with moderate to severe persistent allergic asthma

• Conditions: moderate to severe persistent allergic asthma; MedDRA version: 9.1Level: LLTClassification code 10003553Term: Asthma

• Registration Number: EUCTR2006-005917-36-DE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-19
• Last Update Posted: 12 June 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. male or female patients (or as appropriate whose legal guardian) informed of the study procedures and medications and have given written informed consent

2. 12 years of age or older

3. body weight = 30 kg and = 150 kg and total serum IgE level = 30 to = 700 IU/ml (consistent with the USPI – dosing table provided in Tables 6-1 and 6-2)

4. patients with a diagnosis of allergic asthma = 1 year duration according to American Thoracic Society [ATS] criteria (14) and at screening a history consistent with clinical features of moderate to severe persistant asthma according to [NHLBI June 2002] guidlines (see Appendix 3)

5. positive skin prick test (diameter of wheal = 3 mm) to at least one perennial allergen (dust mite: dermatophagoides pteronyssinus and dermatophagoides farinae, cat/dog dander, cockroaches - standardized skin prick test supplies to be provided); within the previous 1 year prior to Visit 1 or taken at Visit 1, to which the patient will be exposed on a regular basis (most days) for the duration of the study. A ImmunoCap/RAST test may be performed for patients with a borderline skin prick test result, only after consultation with Novartis Clinical personnel for approval. See Appendix 5 for skin prick testing procedures.

6. patients with no clinically significant asthma exacerbations which require treatment with systemic corticosteroids during the 4 weeks immediatly prior to screening visit (Visit 1) and during screening period (between Visit 1 and 2)

7. demonstrate evidence of inadequate asthma symptom control despite treatment with inhaled corticosteroids according to clinical features of [NHLBI] moderate to severe persitent asthma (Step 3/4). Investigators must confirm these symptoms as outlined in Appendix 3 of the protocol (Figure 3-4a of NHLBI guidlines). Evidence of inadequate symptom control must be documented in the patient source documentation
Are the trial subjects under 18? yes
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. previous exposure to omalizumab as a market formulation or in any other omalizumab study; patients participating in another Xolair trial even assigned to placebo or a control group are not allowed into this trial

2. previous exposure to other humanized proteins or monoclonals

3. known HAHA to other monoclonal antibodies

4. use of other investigational drugs at the time of enrollment, or within 30 days of enrollment or = 5 drug half-lives before enrollment, whichever is longer

5. systemic corticosteroids (oral or IV) for reasons other than asthma maintenance therapy (e.g., asthma exacerbations or other allergic conditions) within 4 weeks prior to Visit 1

6. use of methotrexate, gold salts or cyclosporine within 3 months prior to screening

7. history of hypersensitivity to any of the study drugs or to drugs with similar chemical structures

8. known hypersensitivity to any ingredients, including excipients (arginine hydrochloride, histidine, polysorbate 20) of the study medication or drugs related to omalizumab (e.g. monoclonal antibodies, polyclonal gamma globulin)

9. clinically significant laboratory abnormalities (not associated with moderate to severe asthma) at Visit 1

10. clinically significant abnormalities on 12-lead ECG within one month prior to or at Visit 1

11. pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by investigator or other treating physician with a positive hCG laboratory test (> 5 mIU/ml)

12. Women of child-bearing potential (WOCBP), defined as all women physiologically
capable of becoming pregnant, including women whose career, lifestyle, or sexual
orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy defined by investigator or other means, UNLESS (1) they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/ml, OR (2) have past 6 weeks from surgical bilateral oophorectomy with or without hysterectomy OR (3) are using one or more of the following acceptable methods of contraception: surgical sterilization (e.g., bilateral tubal ligation, vasectomy), hormonal contraception (implantable, patch, oral), and copper coated IUD, any double combination of male or female condom with spermicidal gel, diaphragm, sponge, cervical cap. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Reliable contraception should be maintained throughout all phases of the study and is not provided by Novartis.

13. considered potentially unreliable or where it is envisaged the patient may not consistently attend scheduled study visits

14. history of drug or alcohol abuse or current use of illicit drugs

15. clinically significant uncontrolled disease or a history of such disease (e.g., infection, hematological disease, renal, hepatic, coronary heart disease or other cardiovascular disease, endocrinologic or gastrointestinal disease) within 3 months prior to Visit 1

16. an active lung disease other than allergic asthma (e.g., cystic fibrosis, bronchiestasis)

17. with elevated serum IgE levels for reasons other than allergy (e.g., parasite infections, hyperimmunoglobulin E syndrome, Wiskott-Aldrich Syndrome or allergic bronchopulmonary aspergillosis)

18. invo

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the immunogenic potential of omalizumab liquid when administered over a period of 6 months to omalizumab naïve, moderate to severe persistent allergic asthma patients age 12 years or older.;Secondary Objective: To assess the safety and tolerability of omalizumab liquid when administered over a period of 6 months to omalizumab naïve, moderate to severe persistent allergic asthma patients age 12 years or older.;Primary end point(s): Adverse events (AEs)/serious adverse events (SAEs) and immunogenicity (based on HAHA assay)