A Study of Ixekizumab (LY2439821) in Participants in Japan With Generalized Pustular Psoriasis and Erythrodermic Psoriasis
NCT ID: NCT03942042
Last Updated: 2021-08-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
12 participants
INTERVENTIONAL
2019-07-05
2020-07-22
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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Ixekizumab
Induction Dosing Period:
Participants received 160 milligrams (mg) ixekizumab subcutaneously (SC) as 2 injections at Week 0 followed by 80 mg ixekizumab SC as 1 injection at Week 2, 4, 6, 8 and 10.
Maintenance Dosing Period:
Participants with Global Improvement Score (GIS) = 1 at Week 12 are responders who will complete the study.
Participants who are inadequate responders (GIS ≥2 at Week 12 and based on the investigators' discretion) will be administered 80 mg ixekizumab SC as 1 injection at Week 12, 14, 16, and 18 or until they achieve a GIS score of 1.
Ixekizumab
Administered SC
Interventions
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Ixekizumab
Administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* GPP: Meet the criteria for GPP set by Ministry of Health, Labour and Welfare (MHLW) at screening and baseline regardless of IL-36 mutation status.
* EP: Diagnosed to have BSA ≥80% involvement (with inflammatory erythema) at screening and baseline.
* Candidates for phototherapy and/or systemic therapy
* Men must agree to use a reliable method of birth control during the study
* Women must agree to use birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
Exclusion Criteria
* Concurrent or recent use of any biologic agent
* Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to enrollment and during the study
* Have previously received ixekizumab
* Serious disorder or illness other than psoriasis
* Serious infection within the last 12 weeks
* Breastfeeding or nursing (lactating) women
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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Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Kansai Medical University Hospital
Hirakata, Osaka, Japan
Teikyo University Hospital
Itabashi-ku, Tokyo, Japan
Jikei University School of Medicine
Minato-Ku, Tokyo, Japan
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, Japan
Osaka City University Medical School Hospital
Osaka, , Japan
Countries
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References
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Morita A, Okubo Y, Morisaki Y, Torisu-Itakura H, Umezawa Y. Ixekizumab 80 mg Every 2 Weeks Treatment Beyond Week 12 for Japanese Patients with Generalized Pustular Psoriasis and Erythrodermic Psoriasis. Dermatol Ther (Heidelb). 2022 Feb;12(2):481-494. doi: 10.1007/s13555-021-00666-x. Epub 2021 Dec 29.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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I1F-JE-RHCV
Identifier Type: OTHER
Identifier Source: secondary_id
17154
Identifier Type: -
Identifier Source: org_study_id
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