A 24 week, open label, multi-center evaluation of pharmacokinetics and pharmacodynamics, efficacy and safety of omalizumab in Japanese children (6-15 years) with inadequately controlled allergic asthma despite current recommended treatment
- Conditions
- Allergic asthma
- Registration Number
- JPRN-jRCT2080221137
- Lead Sponsor
- ovartis Pharma K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 44
Body weights and serum total IgE level within the dosing table range; body weight of 20 to 150 kg and serum total IgE levels of 30 to 1300 IU/mL
Receiving asthma long-term control medications of high dose ICS (>200 micro-g/day FP or equivalent) and two or more controller medications out of LTRA, theophylline, sodium cromoglycate,LABA, or OCSs 12 weeks prior to the run-in period. These medications should be kept stable for 4 weeks prior to the run-in period and during the run-in period (except for management of asthma attacks/exacerbations)
Having 2 or more asthma exacerbations requiring treatment with a doubling of the maintenance ICS dose for at least 3 days and/or systemic (oral or IV) corticosteroids in the past; one of these exacerbations must have occurred in the previous 12 months, which is documented in the medical record
Demonstrating inadequately controlled asthma symptoms during the last 14 day run-in period based on the patient diary
With a history of food or drug related severe anaphylactoid or anaphylactic reaction(s)
With positive skin reaction to the study drug at the run-in period
With known hypersensitivity to any ingredients, including excipients (sucrose, histidine, polysorbate 20) of the study drug or drug related to omalizumab (e.g., monoclonal antibodies, polyclonal gamma globulin)
With platelet level =< 100,000/micro-L at the run-in period
Who are taking intra-muscular depo-steroids within 4 weeks of the run-in period
Who are taking systemic (oral or IV) corticosteroids for reasons other than asthma within 4 weeks of the run-in period (patients with chronic OCSs use for asthma are allowed)
Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To examine whether the geometric mean of serum free IgE level at 24 weeks of the treatment period in Japanese pediatric patients reaches under 25 ng/mL (target level)<br>PK/PD
- Secondary Outcome Measures
Name Time Method To assess PK/PD data by modeling & simulation<br>PK/PD<br><br>To assess the efficacy of omalizumab <br>PEF, pulmonary function, asthma symptom score, asthma rescue medication use and QOL questionnaire score<br>To assess the safety of omalizumab <br>Adverse events, physical examination/medical history, vital signs, safety laboratory evaluations, and anti-omalizumab antibodies