Allergic AsthmaPhase 3NCT01155700
Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of Omalizumab in Japanese Children (6 - 15 Years)
A Phase 3 study testing omalizumab in people with Allergic Asthma, run by Novartis Pharmaceuticals at 17 sites in Japan.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Allergic Asthma
- What is being tested?
- omalizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 17 sitesJapan
- Study dates
- Jun 2010to Feb 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Japan17 sites
Novartis Investigative Site
Chiba, Chiba, 266-0007
Novartis Investigative Site
Fuchū, Tokyo, 183-8561
Novartis Investigative Site
Fukuoka, Fukuoka, 811-1394
Novartis Investigative Site
Gifu, Gifu, 501-1194
Novartis Investigative Site
Habikino, Osaka, 583-8588
Novartis Investigative Site
Komae, Tokyo, 201-8601
Novartis Investigative Site
Ohbu, Aichi-ken, 474-0031
Novartis Investigative Site
Osaka, Osaka, 530-0012
Novartis Investigative Site
Sagamihara, Kanagawa, 228-8522
Novartis Investigative Site
Setagaya-ku, Tokyo, 157-8535
Novartis Investigative Site
Setagaya-ku, Tokyo, 158-0097
Novartis Investigative Site
Shimotsuka-gun, Tochigi, 321-0293
Novartis Investigative Site
Sumida-ku, Tokyo, 130-8587
Novartis Investigative Site
Tenri, Nara, 632-8552
Novartis Investigative Site
Tsu, Mie-ken, 514-0125
Novartis Investigative Site
Yokohama, Kanagawa, 232-8555
Novartis Investigative Site
Yokohama, Kanagawa, 245-8575
About this study
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
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
- Being tested
- omalizumab
- Keywords
- omalizumab, allergic asthma, pediatric patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omalizumabDrug
| Study group | Role | What they receive |
|---|---|---|
| Omalizumab | Experimental | Omalizumab treatment Receives: Drug: omalizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 24 weeks
Secondary outcomes (3)
To assess PK/PD data by modeling & simulation
Measured: 24 weeks
To assess the efficacy of omalizumab by PEF, pulmonary function, asthma symptom score, asthma rescue medication use and QOL questionnaire score.
Measured: 24 weeks
To assess the safety of omalizumab
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allergic AsthmaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01155700
- Sponsor's protocol ID
- CIGE025B1301
- Status last verified
- Nov 2016
- First submitted
- 30 Jun 2010
- Last updated
- 18 Nov 2016
- Results posted
- No
Publications
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.
PubMed 26433533
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01155700
- Acronym / sponsor ID
- CIGE025B1301
- Conditions
- Allergic Asthma
- Keywords
- omalizumab, allergic asthma, pediatric patients
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 2 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Omalizumab | Experimental | Drug: omalizumabOmalizumab treatment |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| omalizumab | Drug | Omalizumab |
Primary outcome
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
3 secondary outcomes
To assess PK/PD data by modeling & simulation
Time frame: 24 weeks
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
To assess the safety of omalizumab
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2016.
- Results publication: PubMed 26433533Odajima 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing omalizumab in people with Allergic Asthma, run by Novartis Pharmaceuticals at 17 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01155700, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2016.