Clinical trial NCT01624233: A Study in Japanese Participants With Moderate-to-Severe Psoriasis
Official title: A Multicenter, Open-Label, Long-Term Study to Evaluate the Efficacy and Safety of LY2439821 in Japanese Patients With Moderate-to-Severe Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2012-06-20
Enrollment: 91
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will assess the safety and efficacy of ixekizumab in participants with moderate to severe psoriasis in Japan.


Eligibility criteria: Inclusion Criteria:

* 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
* 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:

* History of drug-induced psoriasis
* 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

Primary outcomes:
measure: Percentage of Participants Achieving ≥75% Improvement in Psoriasis Area and Severity Index (PASI) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis. Measure: PASI)
timeFrame: Week (Wk) 12
Secondary outcomes:
measure: Percentage of Participants Achieving ≥75% Improvement in PASI
timeFrame: Wks 24 and 52
measure: Pharmacokinetics (PK): Ctrough at Steady State (Ctrough ss) of Ixekizumab
timeFrame: Pre-dose at Wks 12 (Day 84) and Wks24 (Day 168)
measure: Number of Participants With Anti-Ixekizumab Antibodies
timeFrame: Baseline through Wk 52
measure: Percent of Participants Achieving PASI 90% and 100% Improvement
timeFrame: Wks 12, 24 and 52
measure: Percentage of Participants With Static Physician Global Assessment (sPGA) (0 or 1) or sPGA (0) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis Measure: sPGA)
timeFrame: Wks 12, 24 and 52
measure: Change From Baseline in Percent of Body Surface Area (BSA) Involvement
timeFrame: Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52
measure: Change From Baseline in Nail Psoriasis Severity Index (NAPSI)
timeFrame: Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52
measure: Change From Baseline in Psoriasis Scalp Severity Index (PSSI)
timeFrame: Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52
measure: Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Reported 16 Items (QIDS-SR16) Score [Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)]
timeFrame: Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52
measure: Change From Baseline in Itch Numeric Rating Scale (NRS) Score
timeFrame: Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) Score
timeFrame: Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52
measure: Number of Participants Achieving American College of Rheumatology 20% (ACR20) Improvement [Efficacy of Ixekizumab in Participants With Psoriatic Arthritis (PsA) as Measured by ACR20]
timeFrame: Wks 12, 24 and 52
measure: Change From Baseline in Participants Assessment of Joint Pain Visual Analog Scale (VAS) (Efficacy of Ixekizumab in Participants With PsA Pain VAS)
timeFrame: Baseline, Wk 12; Baseline, Wk 52
measure: Percent of Participants Achieving PASI 75%, 90% and/or 100% Improvement
timeFrame: Wk 100 and Retreatment Wk 192
measure: Percentage of Participants With sPGA (0 or 1) and sPGA (0)
timeFrame: Wk 100 and Retreatment Wk 192
measure: Change From Baseline in Percent of BSA Involvement
timeFrame: Baseline, Wk 100; Baseline, Retreatment Wk 192
measure: Change From Baseline in NAPSI
timeFrame: Baseline, Wk 100; Baseline, Retreatment Wk 192
measure: Change From Baseline in PSSI
timeFrame: Baseline, Wk 100; Baseline, Retreatment Wk 192
measure: Change From Baseline in QIDS-SR16 Score
timeFrame: Baseline, Wk 100; Baseline, Retreatment Wk 192
measure: Change From Baseline in Itch NRS Score
timeFrame: Baseline, Wk 100; Baseline, Retreatment Wk 192
measure: Change From Baseline in DLQI Score
timeFrame: Baseline, Wk 100; Baseline, Retreatment Wk 192
measure: Change From Baseline in Participants Assessment of Joint Pain VAS
timeFrame: Baseline, Wk 100; Baseline, Retreatment Wk 192
measure: Number of Participants Achieving ACR20
timeFrame: Wk 100 and Wk Retreatment Wk 192
Other outcomes:
Locations:
city: Ehime
country: Japan
facility: 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.
city: Fukuoka
country: Japan
facility: 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.
city: Gifu
country: Japan
facility: 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.
city: Hokkaido
country: Japan
facility: 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.
city: Hyogo
country: Japan
facility: 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.
city: Ishikawa
country: Japan
facility: 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.
city: Iwate
country: Japan
facility: 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.
city: Kanagawa
country: Japan
facility: 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.
city: Kumamoto
country: Japan
facility: 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.
city: Kyoto
country: Japan
facility: 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.
city: Miyazaki
country: Japan
facility: 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.
city: Nagano
country: Japan
facility: 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.
city: Okayama
country: Japan
facility: 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.
city: Osaka-Pref
country: Japan
facility: 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.
city: Osaka
country: Japan
facility: 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.
city: Saitama
country: Japan
facility: 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.
city: Tokyo
country: Japan
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: 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
References:
citation: 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.
citation: 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.