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

NCT01328886 | Completed Phase 3

• 1 other identifier: CIGE025B1301E1
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 15

Brief Summary

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.

Conditions

Allergic Asthma

Keywords

omalizumab; allergic asthma; pediatric patients

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (1)

Omalizumab

EXPERIMENTAL

Drug: Omalizumab

Interventions

Omalizumab DRUG

omalizumab lyophilized 150 mg injection

Omalizumab

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (15)

Novartis Investigative Site

Ohbu, Aichi-ken, 474-0031, Japan

Location

Novartis Investigative Site

Chiba, Chiba, 266-0007, Japan

Location

Novartis Investigative Site

Fukuoka, Fukuoka, 811-1394, Japan

Location

Novartis Investigative Site

Gifu, Gifu, 501-1194, Japan

Location

Novartis Investigative Site

Sagamihara, Kanagawa, 228-8522, Japan

Location

Novartis Investigative Site

Yokohama, Kanagawa, 232-8555, Japan

Location

Novartis Investigative Site

Yokohama, Kanagawa, 245-8575, Japan

Location

Novartis Investigative Site

Tsu, Mie-ken, 514-0125, Japan

Location

Novartis Investigative Site

Tenri, Nara, 632-8552, Japan

Location

Novartis Investigative Site

Habikino, Osaka, 583-8588, Japan

Location

Novartis Investigative Site

Shimotsuka-gun, Tochigi, 321-0293, Japan

Location

Novartis Investigative Site

Fuchū, Tokyo, 183-8561, Japan

Location

Novartis Investigative Site

Komae, Tokyo, 201-8601, Japan

Location

Novartis Investigative Site

Setagaya-ku, Tokyo, 158-0097, Japan

Location

Novartis Investigative Site

Sumida-ku, Tokyo, 130-8587, Japan

Location

Related Publications (1)

• 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.

  PMID: 27507228 DERIVED

MeSH Terms

Interventions

Omalizumab

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2011
• First Posted: April 5, 2011
• Study Start: March 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 18, 2016

Record last verified: 2016-11

Locations

JP (15)