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

NCT01155700 | Completed Phase 3

• 1 other identifier: CIGE025B1301
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 17

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.

Conditions

Allergic Asthma

Keywords

omalizumab; allergic asthma; pediatric patients

Outcome Measures

Primary Outcomes (1)

• 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).

  24 weeks

Secondary Outcomes (3)

• To assess PK/PD data by modeling & simulation

  24 weeks

• To assess the efficacy of omalizumab by PEF, pulmonary function, asthma symptom score, asthma rescue medication use and QOL questionnaire score.

  24 weeks

• To assess the safety of omalizumab

  24 weeks

Study Arms (1)

Omalizumab

EXPERIMENTAL

Omalizumab treatment

Drug: omalizumab

Interventions

omalizumab DRUG

Omalizumab

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (17)

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

Osaka, Osaka, 530-0012, 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, 157-8535, 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, 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.

  PMID: 26433533 RESULT

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: June 30, 2010
• First Posted: July 2, 2010
• Study Start: June 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: November 18, 2016

Record last verified: 2016-11

Locations

JP (17)