Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of Omalizumab in Japanese Children (6 - 15 Years)

Allergic Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01155700
• Other study ID #: CIGE025B1301
• Status: Completed
• Phase: Phase 3
• First received: June 30, 2010
• Last updated: November 16, 2016
• Start date: June 2010
• Est. completion date: February 2012

Study information

• Verified date: November 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

The primary purpose of this study is to examine whether the geometric mean of serum free IgE level at 24 weeks of the treatment period in Japanese pediatric patients (6 to 15 years of age) reaches under 25 ng/mL (target level). The investigators will also assess how well PK/PD data of Japanese children fit the global PK-PD modeling built from those of Caucasian adults and children, and assess efficacy and safety data in Japanese pediatric patients which will fulfill the Japanese health authority requirement for approval. Data obtained from the study is intended to be used to support the registration of pediatric indication of omalizumab in Japan.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 15 Years

Eligibility

Inclusion Criteria:

• Body weight 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 µg/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 which meet any of the following:

Asthma symptoms every day; Night-time symptoms in =2 out of the last 14 days (missing data to be treated as a day with no symptoms); Limitation of daily activities in =2 out of the last 14 days (missing data to be treated as a day with no limitations)

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/µL (100 x 109/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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Asthma
• Asthma

Intervention

Drug:
• omalizumab

Locations

Country	Name	City	State
Japan	Novartis Investigative Site	Chiba
Japan	Novartis Investigative Site	Fuchu	Tokyo
Japan	Novartis Investigative Site	Fukuoka
Japan	Novartis Investigative Site	Gifu
Japan	Novartis Investigative Site	Habikino	Osaka
Japan	Novartis Investigative Site	Komae	Tokyo
Japan	Novartis Investigative Site	Ohbu	Aichi
Japan	Novartis Investigative Site	Osaka
Japan	Novartis Investigative Site	Sagamihara	Kanagawa
Japan	Novartis Investigative Site	Setagaya-ku	Tokyo
Japan	Novartis Investigative Site	Setagaya-ku	Tokyo
Japan	Novartis Investigative Site	Shimotsuka-gun	Tochigi
Japan	Novartis Investigative Site	Sumida-ku	Tokyo
Japan	Novartis Investigative Site	Tenri	Nara
Japan	Novartis Investigative Site	Tsu	Mie
Japan	Novartis Investigative Site	Yokohama	Kanagawa
Japan	Novartis Investigative Site	Yokohama	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Odajima H, Ebisawa M, Nagakura T, Fujisawa T, Akasawa A, Ito K, Doi S, Yamaguchi K, Katsunuma T, Kurihara K, Kondo N, Sugai K, Nambu M, Hoshioka A, Yoshihara S, Sato N, Seko N, Nishima S. Omalizumab in Japanese children with severe allergic asthma uncontr — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		24 weeks	No
Secondary	To assess PK/PD data by modeling & simulation		24 weeks	No
Secondary	To assess the efficacy of omalizumab by PEF, pulmonary function, asthma symptom score, asthma rescue medication use and QOL questionnaire score.		24 weeks	No
Secondary	To assess the safety of omalizumab		24 weeks	Yes

External Links

•   Results for CIGE025B1301 from the Novartis Clinical Trials website