Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of Omalizumab in Japanese Children (6 - 15 Years)
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
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
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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
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 May 16, 2013