A Study in Japanese Participants With Moderate-to-Severe Psoriasis
NCT ID: NCT01624233
Last Updated: 2019-09-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
91 participants
INTERVENTIONAL
2012-06-30
2017-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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80 mg ixekizumab
Administered by two 80 milligram (mg) subcutaneous (SC) injections at Week 0, followed by one 80 mg SC injection per Dosing Regimen 1 up to Week 12. Then administered by one 80 mg SC injection per Dosing Regimen 2 from Week 12 up to Week 52, and for up to 192 weeks following disease relapse occurring during a drug-free period beyond 52 weeks.
80 mg ixekizumab
Administered SC
Interventions
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80 mg ixekizumab
Administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Women must agree to use birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
* Candidates for phototherapy and/or systemic therapy
* Present with chronic psoriasis based on a confirmed psoriasis diagnosis for at least 6 months prior to enrollment
* At least 10% Body Surface Area (BSA) of Psoriasis at screening and at enrollment for participants with plaque psoriasis
* Static Physician Global Assessment (sPGA) score of at least 3 and Psoriasis Area and Severity Index (PASI) score of at least 12 at screening and at enrollment for participants with plaque psoriasis
Exclusion Criteria
* Concurrent or recent use of any biologic agent
* Received systemic psoriasis therapy \[such as psoralen and ultraviolet A (PUVA) light therapy\] or phototherapy within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to enrollment for participants with plaque psoriasis
* Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to enrollment and during the study
* Have participated in any study with interleukin-17(IL-17) antagonists, including ixekizumab
* Serious disorder or illness other than psoriasis
* Serious infection within the last 3 months
* Breastfeeding or nursing (lactating) women
* Clinically significant flare of psoriasis during the 12 weeks prior to enrollment for participants with plaque psoriasis
20 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Ehime, , Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Fukuoka, , Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Gifu, , Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Hokkaido, , Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Hyōgo, , Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Ishikawa, , Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Kanagawa, , Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Kumamoto, , Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Kyoto, , Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Miyazaki, , Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Nagano, , Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Numakunai, , Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Okayama, , Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Osaka, , Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Osaka-Pref, , Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Saitama, , Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Tokyo, , Japan
Countries
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References
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Honma M, Cai Z, Burge R, Zhu B, Yotsukura S, Torisu-Itakura H. Relationship Between Rapid Skin Clearance and Quality of Life Benefit: Post Hoc Analysis of Japanese Patients with Moderate-to-Severe Psoriasis Treated with Ixekizumab (UNCOVER-J). Dermatol Ther (Heidelb). 2020 Dec;10(6):1397-1404. doi: 10.1007/s13555-020-00441-4. Epub 2020 Sep 10.
Saeki H, Nakagawa H, Ishii T, Morisaki Y, Aoki T, Berclaz PY, Heffernan M. Efficacy and safety of open-label ixekizumab treatment in Japanese patients with moderate-to-severe plaque psoriasis, erythrodermic psoriasis and generalized pustular psoriasis. J Eur Acad Dermatol Venereol. 2015 Jun;29(6):1148-55. doi: 10.1111/jdv.12773. Epub 2014 Oct 30.
Other Identifiers
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I1F-JE-RHAT
Identifier Type: OTHER
Identifier Source: secondary_id
13976
Identifier Type: -
Identifier Source: org_study_id
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