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

Primary Purpose

Allergic Asthma

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
omalizumab
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Asthma focused on measuring omalizumab, allergic asthma, pediatric patients

Eligibility Criteria

6 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Omalizumab

Arm Description

Omalizumab treatment

Outcomes

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).

Secondary Outcome Measures

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

Full Information

First Posted
June 30, 2010
Last Updated
November 16, 2016
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01155700
Brief Title
Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of Omalizumab in Japanese Children (6 - 15 Years)
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Asthma
Keywords
omalizumab, allergic asthma, pediatric patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Omalizumab
Arm Type
Experimental
Arm Description
Omalizumab treatment
Intervention Type
Drug
Intervention Name(s)
omalizumab
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
To assess PK/PD data by modeling & simulation
Time Frame
24 weeks
Title
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
Title
To assess the safety of omalizumab
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Ohbu
State/Province
Aichi
ZIP/Postal Code
474-0031
Country
Japan
Facility Name
Novartis Investigative Site
City
Sagamihara
State/Province
Kanagawa
ZIP/Postal Code
228-8522
Country
Japan
Facility Name
Novartis Investigative Site
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
232-8555
Country
Japan
Facility Name
Novartis Investigative Site
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
245-8575
Country
Japan
Facility Name
Novartis Investigative Site
City
Tsu
State/Province
Mie
ZIP/Postal Code
514-0125
Country
Japan
Facility Name
Novartis Investigative Site
City
Tenri
State/Province
Nara
ZIP/Postal Code
632-8552
Country
Japan
Facility Name
Novartis Investigative Site
City
Habikino
State/Province
Osaka
ZIP/Postal Code
583-8588
Country
Japan
Facility Name
Novartis Investigative Site
City
Shimotsuka-gun
State/Province
Tochigi
ZIP/Postal Code
321-0293
Country
Japan
Facility Name
Novartis Investigative Site
City
Fuchu
State/Province
Tokyo
ZIP/Postal Code
183-8561
Country
Japan
Facility Name
Novartis Investigative Site
City
Komae
State/Province
Tokyo
ZIP/Postal Code
201-8601
Country
Japan
Facility Name
Novartis Investigative Site
City
Setagaya-ku
State/Province
Tokyo
ZIP/Postal Code
157-8535
Country
Japan
Facility Name
Novartis Investigative Site
City
Setagaya-ku
State/Province
Tokyo
ZIP/Postal Code
158-0097
Country
Japan
Facility Name
Novartis Investigative Site
City
Sumida-ku
State/Province
Tokyo
ZIP/Postal Code
130-8587
Country
Japan
Facility Name
Novartis Investigative Site
City
Chiba
ZIP/Postal Code
266-0007
Country
Japan
Facility Name
Novartis Investigative Site
City
Fukuoka
ZIP/Postal Code
811-1394
Country
Japan
Facility Name
Novartis Investigative Site
City
Gifu
ZIP/Postal Code
501-1194
Country
Japan
Facility Name
Novartis Investigative Site
City
Osaka
ZIP/Postal Code
530-0012
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
26433533
Citation
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.
Results Reference
result

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

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