A Phase IIa Study of KHK4563

NCT ID: NCT01412736

Last Updated: 2014-12-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2013-10-31

Brief 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.

Conditions

Uncontrolled and Suspected Eosinophilic Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

2mg

sterile lyophilized formulation, 2mg

Group Type: EXPERIMENTAL

KHK4563

Intervention Type: DRUG

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.

20mg

sterile lyophilized formulation, 20mg

Group Type: EXPERIMENTAL

KHK4563

Intervention Type: DRUG

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.

100mg

sterile lyophilized formulation, 100mg

Group Type: EXPERIMENTAL

KHK4563

Intervention Type: DRUG

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.

Placebo

two SC administration on day 1

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

KHK4563

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.

Intervention Type: DRUG

KHK4563

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.

Intervention Type: DRUG

KHK4563

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.

Intervention Type: DRUG

Placebo

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age 20 through 75 years at the time of Week -3 visit.

2. Written informed consent obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.

3. 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.

4. 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.

Exclusion Criteria

1. 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.

2. 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.

3. Acute upper or lower respiratory infections requiring antibiotics or antiviral medications within 30 days prior to Week -3 visit or during the screening period.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kyowa Kirin Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nagoya, Aichi-ken, Japan

Toyota-shi, Aichi-ken, Japan

Kamogawa-shi, Chiba, Japan

Fukuoka, Fukuoka, Japan

Ogaki-shi, Gifu, Japan

Hiroshima, Hiroshima, Japan

Sapporo, Hokkaido, Japan

Himeji-shi, Hyōgo, Japan

Kobe, Hyōgo, Japan

Sagamihara-shi, Kanagawa, Japan

Yokohama, Kanagawa, Japan

Kumamoto, Kumamoto, Japan

Kyoto, Kyoto, Japan

Nagasaki, Nagasaki, Japan

Kishiwada-shi, Osaka, Japan

Koshigaya-shi, Saitama, Japan

Shizuoka, Shizuoka, Japan

Itabashi-ku, Tokyo, Japan

Shinagawa-ku, Tokyo, Japan

Shinjuku-ku, Tokyo, Japan

Mizunami-shi, , Japan

Osakasayama-shi, , Japan

Oura-gun, , Japan

Seto-shi, , Japan

Chungcheongbuk-do, , South Korea

Gwangju, , South Korea

Gyenggi-do, , South Korea

Seoul, , South Korea

Suwon, , South Korea

Countries

Japan; South Korea

Other Identifiers

4563-003

Identifier Type: -

Identifier Source: org_study_id