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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01155700
First received: June 30, 2010
Last updated: September 20, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Allergic Asthma
Drug: omalizumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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). [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess PK/PD data by modeling & simulation [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • To assess the efficacy of omalizumab by PEF, pulmonary function, asthma symptom score, asthma rescue medication use and QOL questionnaire score. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • To assess the safety of omalizumab [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 51
Study Start Date: June 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Omalizumab
Omalizumab treatment
Drug: omalizumab

  Eligibility

Ages Eligible for Study:   6 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01155700

Locations
Japan
Novartis Investigative Site
Ohbu, Aichi, Japan, 474-0031
Novartis Investigative Site
Sagamihara, Kanagawa, Japan, 228-8522
Novartis Investigative Site
Yokohama, Kanagawa, Japan, 245-8575
Novartis Investigative Site
Yokohama, Kanagawa, Japan, 232-8555
Novartis Investigative Site
Tsu, Mie, Japan, 514-0125
Novartis Investigative Site
Tenri, Nara, Japan, 632-8552
Novartis Investigative Site
Habikino, Osaka, Japan, 583-8588
Novartis Investigative Site
Shimotsuka-gun, Tochigi, Japan, 321-0293
Novartis Investigative Site
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
Setagaya-ku, Tokyo, Japan, 157-8535
Novartis Investigative Site
Sumida-ku, Tokyo, Japan, 130-8587
Novartis Investigative Site
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
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01155700     History of Changes
Other Study ID Numbers: CIGE025B1301
Study First Received: June 30, 2010
Last Updated: September 20, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Novartis:
omalizumab
allergic asthma
pediatric patients

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Omalizumab
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on September 14, 2014