Long-term Safety, Tolerability and Efficacy of Omalizumab in Japanese Children

An Extension Study to CIGE025B1301 to Evaluate the Long-term Safety, Tolerability and Efficacy of Omalizumab in Japanese Children (6 - 15 Years) With Inadequately Controlled Allergic Asthma Despite Current Recommended Treatment

The purpose of this extension study is to assess the long-term safety and tolerability of omalizumab as an add-on therapy in Japanese pediatric patients (6 to 15 years of age) with inadequately controlled allergic asthma despite current recommended treatment by providing continued treatment with omalizumab to patients who have previously completed the core study.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 38
• 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
  • Aichi
    • Ohbu, Aichi, Japan, 474-0031
      • Novartis Investigative Site
  • Kanagawa
    • Sagamihara-city, 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 city, 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, 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:

• Patients who completed the core study (IGE025B1301) and who in the investigator's clinical judgment could benefit from continuous treatment of the study drug.

Exclusion Criteria:

• Patients who currently have diagnosed cancer, are currently being investigated for possible cancer or have any history of cancer.
• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, UNLESS they are: women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner; women whose partners have been sterilized by vasectomy or other means; using a highly effective method of birth control; or agreeing on total abstinence and the investigator also judges that the age, career lifestyle or sexual orientation of the patient ensures compliance.
• With clinically significant uncontrolled systemic disease (eg: infection, hematological disease, renal, hepatic, coronary heart disease or other cardiovascular disease, cerebro-vascular, endocrinologic or gastrointestinal disease) after the treatment period of the core study.
• Patients with a history of major protocol violations during the core study and who are considered potentially unreliable as judged by the investigator at each site.

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	Drug: Omalizumab; omalizumab lyophilized 150 mg injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To assess the long-term safety and tolerability of omalizumab by measuring AEs, serious AEs, physical examination, medical history, laboratory assessments and vital signs	Every 3 months for approximately 2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
To explore the efficacy of omalizumab by JPAC questionnaire; JPAC is the Japan Pediatric Asthma Control Program (JPAC)	Every 3 months for approximately 2 years
To explore the efficacy of omalizumab by QOL questionnaire score (Quality of life questionnaires for pediatric patients with bronchial asthma and their parents or caregivers (Gifu))	Every 3 months for approximately 2 years
To explore the efficacy of omalizumab by use of asthma long-term control medications	Every 3 months for approximately 2 years
To explore the efficacy of omalizumab by Pulmonary function (FEV1, FVC, V(・)50, V(・)25 and FEF25-75%)	Every 3 months for approximately 2 years
To collect the data on the number of hospitalizations, emergency room (ER) visits due to asthma	Every 3 months for approximately 2 years

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, Teramoto T, Sugai K, Nambu M, Hoshioka A, Yoshihara S, Sato N, Seko N, Nishima S. Long-term safety, efficacy, pharmacokinetics and pharmacodynamics of omalizumab in children with severe uncontrolled asthma. Allergol Int. 2017 Jan;66(1):106-115. doi: 10.1016/j.alit.2016.06.004. Epub 2016 Aug 6.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: April 1, 2011
• First Submitted That Met QC Criteria: April 4, 2011
• First Posted (Estimate): April 5, 2011

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: CIGE025B1301E1