Uncontrolled and Suspected Eosinophilic AsthmaPhase 24563-003NCT01412736
A Phase IIa Study of KHK4563
A Phase 2 study testing KHK4563 in people with Uncontrolled and Suspected Eosinophilic Asthma, run by Kyowa Kirin Co., Ltd. at 29 sites in 2 countries.
Trial summary
This is a double-blind, placebo-controlled dose-ranging study of KHK4563 to evaluate the effect of multiple-dose subcutaneous administration of KHK4563 on the annual asthma exacerbation rate in adult subjects with uncontrolled, suspected eosinophilic asthma. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Uncontrolled and Suspected Eosinophilic Asthma
- What is being tested?
- KHK4563
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 29 sitesin 2 countries
- Study dates
- Aug 2011to Oct 2013
- Phase
- Phase 2
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 20 through 75 years at the time of Week -3 visit.
- Written informed consent obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
- Physician prescribed daily use of medium-dose or high-dose ICS plus LABA or any combination of sequential dosing of either medium-dose or high-dose ICS/LABA for at least 12 months prior to Week -3 visit. Dose must be stable for at least 30 days prior to Week -3 visit.
- At least 2, but not more than 6, documented asthma exacerbations in the 12 months prior to Week -3 visit that required use of a systemic corticosteroid burst.
Who cannot join
- Any condition (eg, any eosinophilic lower respiratory disease other than asthma, Churg-Strauss syndrome, hypereosinophilic syndrome, eosinophilic bronchitis, eosinophilic pneumonia, chronic obstructive pulmonary disease (COPD), bronchiectasis or cystic fibrosis (CF)) that, in the opinion of the investigator or Medical Expert, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
- Any clinically relevant abnormal findings in physical examination, vital signs, hematology, clinical chemistry, or urinalysis during screening period, which in the opinion of the investigator, may put the subject at risk because of his/her participation in the study, or may influence the results of the study, or the subject's ability to participate in the study.
- Acute upper or lower respiratory infections requiring antibiotics or antiviral medications within 30 days prior to Week -3 visit or during the screening period.
Trial locations and contacts
29 sites in 2 countries.
29 sites in 2 countries
Japan24 sites
Study site
Fukuoka, Fukuoka
Study site
Himeji-shi, Hyōgo
Study site
Hiroshima, Hiroshima
Study site
Itabashi-ku, Tokyo
Study site
Kamogawa-shi, Chiba
Study site
Kishiwada-shi, Osaka
Study site
Kobe, Hyōgo
Study site
Koshigaya-shi, Saitama
Study site
Kumamoto, Kumamoto
Study site
Kyoto, Kyoto
Study site
Mizunami-shi
Study site
Nagasaki, Nagasaki
Study site
Nagoya, Aichi-ken
Study site
Ogaki-shi, Gifu
Study site
Osakasayama-shi
Study site
Oura-gun
Study site
Sagamihara-shi, Kanagawa
Study site
Sapporo, Hokkaido
Study site
Seto-shi
Study site
Shinagawa-ku, Tokyo
Study site
Shinjuku-ku, Tokyo
Study site
Shizuoka, Shizuoka
Study site
Toyota-shi, Aichi-ken
Study site
Yokohama, Kanagawa
South Korea5 sites
Study site
Chungcheongbuk-do
Study site
Gwangju
Study site
Gyenggi-do
Study site
Seoul
Study site
Suwon
About this study
Official title: A Phase IIa , Double-blind, Placebo-controlled Dose-ranging Study to Evaluate the Efficacy and Safety of KHK4563 in Adults With Uncontrolled, Suspected Eosinophilic Asthma
This is a double-blind, placebo-controlled dose-ranging study of KHK4563 to evaluate the effect of multiple-dose subcutaneous administration of KHK4563 on the annual asthma exacerbation rate in adult subjects with uncontrolled, suspected eosinophilic asthma.
- Being tested
- KHK4563, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KHK4563Drug
every 4 weeks for the first 3 doses on Weeks 0 (Day 1), 4, and 8 and then every 8 weeks thereafter for the last 4 doses on Weeks 16, 24, 32, and 40.
KHK4563Drug
every 4 weeks for the first 3 doses on Weeks 0 (Day 1), 4, and 8 and then every 8 weeks thereafter for the last 4 doses on Weeks 16, 24, 32, and 40.
KHK4563Drug
every 4 weeks for the first 3 doses on Weeks 0 (Day 1), 4, and 8 and then every 8 weeks thereafter for the last 4 doses on Weeks 16, 24, 32, and 40.
PlaceboDrug
every 4 weeks for the first 3 doses on Weeks 0 (Day 1), 4, and 8 and then every 8 weeks thereafter for the last 4 doses on Weeks 16, 24, 32, and 40.
| Study group | Role | What they receive |
|---|---|---|
| 2mg | Experimental | sterile lyophilized formulation, 2mg Receives: Drug: KHK4563 |
| 20mg | Experimental | sterile lyophilized formulation, 20mg Receives: Drug: KHK4563 |
| 100mg | Experimental | sterile lyophilized formulation, 100mg Receives: Drug: KHK4563 |
| Placebo | Placebo comparator | two SC administration on day 1 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of the effect of multiple-dose subcutaneous(SC) administration of benralizumab on the annual asthma exacerbation rate in adult subjects with uncontrolled, suspected eosinophilic asthma.
annual asthma exacerbation rate
Measured: Immediately following the first administration of study drug through Study Week 52.
Secondary outcomes (5)
Pulmonary function as assessed by Forced Expiratory Volume in 1 Second (FEV1) and Peak Expiratory flow (PEF)
Pre-dose/pre-bronchodilator Forced Expiratory Volume in 1 Second ( FEV1 ) at the study centre, morning and evening peak expiratory flow (PEF)
Measured: From first administration of study drug through Study Week 52.
Asthma control as assessed by ASTHMA CONTROL QUESTIONNAIRE6(ACQ6)
ASTHMA CONTROL QUESTIONNAIRE6(ACQ6)
Measured: From first administration of study drug through Study Week 52.
Number of participants with Adverse Events as a Measure of Safety and Tolerability
Adverse Events/Serious Adverse Events (AE/SAE) - Laboratory variables - ECG (Electrocardiogram) - Physical Examination
Measured: From first administration of study drug through Study Week 68.
Time Profiles of Serum Concentration
Serum benralizumab concentration
Measured: From first administration of study drug through Study Week 68
Immunogenicity by serum incidence rate of positive anti-drug antibody
Anti-drug antibodies (ADA)
Measured: From first administration of study drug through Study Week 68
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionJul 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uncontrolled and Suspected Eosinophilic AsthmaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01412736
- Sponsor's protocol ID
- 4563-003
- Acronym
- 4563-003
- Status last verified
- Dec 2014
- First submitted
- 7 Aug 2011
- Last updated
- 23 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa , Double-blind, Placebo-controlled Dose-ranging Study to Evaluate the Efficacy and Safety of KHK4563 in Adults With Uncontrolled, Suspected Eosinophilic Asthma
- ClinicalTrials.gov ID
- NCT01412736
- Acronym / sponsor ID
- 4563-003 / 4563-003
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 9 Aug 2011 (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.
This is a double-blind, placebo-controlled dose-ranging study of KHK4563 to evaluate the effect of multiple-dose subcutaneous administration of KHK4563 on the annual asthma exacerbation rate in adult subjects with uncontrolled, suspected eosinophilic asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 2mg | Experimental | Drug: KHK4563sterile lyophilized formulation, 2mg |
| 20mg | Experimental | Drug: KHK4563sterile lyophilized formulation, 20mg |
| 100mg | Experimental | Drug: KHK4563sterile lyophilized formulation, 100mg |
| Placebo | Placebo comparator | Drug: Placebotwo SC administration on day 1 |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 20 through 75 years at the time of Week -3 visit.
- Written informed consent obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
- Physician prescribed daily use of medium-dose or high-dose ICS plus LABA or any combination of sequential dosing of either medium-dose or high-dose ICS/LABA for at least 12 months prior to Week -3 visit. Dose must be stable for at least 30 days prior to Week -3 visit.
- At least 2, but not more than 6, documented asthma exacerbations in the 12 months prior to Week -3 visit that required use of a systemic corticosteroid burst.
Key exclusion criteria (3 listed)
- Any condition (eg, any eosinophilic lower respiratory disease other than asthma, Churg-Strauss syndrome, hypereosinophilic syndrome, eosinophilic bronchitis, eosinophilic pneumonia, chronic obstructive pulmonary disease (COPD), bronchiectasis or cystic fibrosis (CF)) that, in the opinion of the investigator or Medical Expert, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
- Any clinically relevant abnormal findings in physical examination, vital signs, hematology, clinical chemistry, or urinalysis during screening period, which in the opinion of the investigator, may put the subject at risk because of his/her participation in the study, or may influence the results of the study, or the subject's ability to participate in the study.
- Acute upper or lower respiratory infections requiring antibiotics or antiviral medications within 30 days prior to Week -3 visit or during the screening 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 |
|---|---|---|
| KHK4563every 4 weeks for the first 3 doses on Weeks 0 (Day 1), 4, and 8 and then every 8 weeks thereafter for the last 4 doses on Weeks 16, 24, 32, and 40. | Drug | 2mg |
| KHK4563every 4 weeks for the first 3 doses on Weeks 0 (Day 1), 4, and 8 and then every 8 weeks thereafter for the last 4 doses on Weeks 16, 24, 32, and 40. | Drug | 20mg |
| KHK4563every 4 weeks for the first 3 doses on Weeks 0 (Day 1), 4, and 8 and then every 8 weeks thereafter for the last 4 doses on Weeks 16, 24, 32, and 40. | Drug | 100mg |
| Placeboevery 4 weeks for the first 3 doses on Weeks 0 (Day 1), 4, and 8 and then every 8 weeks thereafter for the last 4 doses on Weeks 16, 24, 32, and 40. | Drug | Placebo |
Primary outcome
evaluation of the effect of multiple-dose subcutaneous(SC) administration of benralizumab on the annual asthma exacerbation rate in adult subjects with uncontrolled, suspected eosinophilic asthma.
Time frame: Immediately following the first administration of study drug through Study Week 52.
annual asthma exacerbation rate
5 secondary outcomes
Pulmonary function as assessed by Forced Expiratory Volume in 1 Second (FEV1) and Peak Expiratory flow (PEF)
Time frame: From first administration of study drug through Study Week 52.
Asthma control as assessed by ASTHMA CONTROL QUESTIONNAIRE6(ACQ6)
Time frame: From first administration of study drug through Study Week 52.
Number of participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: From first administration of study drug through Study Week 68.
Time Profiles of Serum Concentration
Time frame: From first administration of study drug through Study Week 68
Immunogenicity by serum incidence rate of positive anti-drug antibody
Time frame: From first administration of study drug through Study Week 68
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 23 Dec 2014.
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.
The record lists no contact. Use the official record to reach the sponsor.
29 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KHK4563 in people with Uncontrolled and Suspected Eosinophilic Asthma, run by Kyowa Kirin Co., Ltd. at 29 sites in 2 countries.
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 4 inclusion and 3 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 23 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Japan, South Korea. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
evaluation of the effect of multiple-dose subcutaneous(SC) administration of benralizumab on the annual asthma exacerbation rate in adult subjects with uncontrolled, suspected eosinophilic asthma. (time frame: Immediately following the first administration of study drug through Study Week 52.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Dec 2014.