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

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

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.

Study Overview

• Status: Completed
• Conditions: Allergic Asthma
• Intervention / Treatment: Drug: omalizumab

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Chiba, Japan, 266-0007
    • Novartis Investigative Site
  • Fukuoka, Japan, 811-1394
    • Novartis Investigative Site
  • Gifu, Japan, 501-1194
    • Novartis Investigative Site
  • Osaka, Japan, 530-0012
    • Novartis Investigative Site
  • Aichi
    • Ohbu, Aichi, Japan, 474-0031
      • Novartis Investigative Site
  • Kanagawa
    • Sagamihara, Kanagawa, Japan, 228-8522
      • Novartis Investigative Site
    • Yokohama, Kanagawa, Japan, 245-8575
      • Novartis Investigative Site
    • Yokohama, Kanagawa, Japan, 232-8555
      • Novartis Investigative Site
  • Mie
    • Tsu, Mie, Japan, 514-0125
      • Novartis Investigative Site
  • Nara
    • Tenri, Nara, Japan, 632-8552
      • Novartis Investigative Site
  • Osaka
    • Habikino, Osaka, Japan, 583-8588
      • Novartis Investigative Site
  • Tochigi
    • Shimotsuka-gun, Tochigi, Japan, 321-0293
      • Novartis Investigative Site
  • Tokyo
    • Fuchu, Tokyo, Japan, 183-8561
      • Novartis Investigative Site
    • Komae, Tokyo, Japan, 201-8601
      • Novartis Investigative Site
    • Setagaya-ku, Tokyo, Japan, 157-8535
      • Novartis Investigative Site
    • Setagaya-ku, Tokyo, Japan, 158-0097
      • Novartis Investigative Site
    • Sumida-ku, Tokyo, Japan, 130-8587
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Omalizumab; Omalizumab treatment	Drug: omalizumab

What is the study measuring?

Primary Outcome Measures

Outcome 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).	24 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
To assess PK/PD data by modeling & simulation	24 weeks
To assess the efficacy of omalizumab by PEF, pulmonary function, asthma symptom score, asthma rescue medication use and QOL questionnaire score.	24 weeks
To assess the safety of omalizumab	24 weeks

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

General Publications

• 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 uncontrolled with standard therapy. Allergol Int. 2015 Oct;64(4):364-70. doi: 10.1016/j.alit.2015.05.006. Epub 2015 Jun 10.

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: June 30, 2010
• First Submitted That Met QC Criteria: July 1, 2010
• First Posted (Estimate): July 2, 2010

Study Record Updates

• Last Update Posted (Estimate): November 18, 2016
• Last Update Submitted That Met QC Criteria: November 16, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: omalizumab; allergic asthma; pediatric patients
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Omalizumab
• Other Study ID Numbers: CIGE025B1301