Allergic asthma
Conditions
Interventions
investigational material(s)
Generic name etc : Omalizumab(Genetical Recombination)
INN of investigational material : Omalizumab(Genetical Recombination)
Therapeutic category code : 229 Other agents af
Sponsors
Novartis Pharma K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) PK/PD | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess PK/PD data by modeling & simulation PK/PD To assess the efficacy of omalizumab PEF, pulmonary function, asthma symptom score, asthma rescue medication use and QOL questionnaire score To assess the safety of omalizumab Adverse events, physical examination/medical history, vital signs, safety laboratory evaluations, and anti-omalizumab antibodies | — |
Outcome results
None listed