臨床研究等提出・公開システム

Date of registration	Aug. 15, 2018
Last modified on	April. 16, 2021
Trial ID	jRCT2080224006

Scientific Title	A Multicenter Randomized Double-Blind Placebo-Controlled Study Comparing the Efficacy and Safety of Mirikizumab to Secukinumab and Placebo in Patients with Moderate-to-Severe Plaque Psoriasis OASIS-2
Public Title	I6T-MC-AMAJ

Completion Date or Terminated date	April. 12, 2021
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD	Yes
Plan description	Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	Eli Lilly Japan K.K.
	Address	-
	Phone Number	+81-120-023-812
	E-mail Address	-

Contact for Public Queries	Name
	Contact Name for Public Queries	Eli Lilly Japan K.K.
	Address	-
	Phone Number	+81-120-023-812
	E-mail Address	-

Recruitment Status	completed

Date of First Enrolment		Aug. 22, 2018
Target Sample Size		120
Study Type		Interventional
Study Design	Study Design	Phase 3, multicenter, randomized, double-blind, placebo- and active-controlled, parallel-group, multi-period study
Study Design	Objective	treatment purpose
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	-Participant must have chronic plaque psoriasis for at least 6 months.
	Exclusion Criteria	-Participant must not be breastfeeding or nursing woman. -Participant must not have had serious, opportunistic, or chronic/recurring infection within 3 months. -Participant must not have received a Bacillus Calmette-Guerin (BCG) vaccination within 12 months or received live vaccine(s) (including attenuated live vaccines) within 12 weeks of baseline or intend to receive either during the study. -Participant must not have any other skin conditions (excluding psoriasis). -Participant must not have previous exposure to Cosentyx and any other biologic therapy targeting IL-17 (including Taltz). -Participant must not have received anti-tumor necrosis factor (TNF) biologics within 8 weeks. -Participant must not have previous exposure to any biologic therapy targeting IL-23 (including Stelara).
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Psoriasis valgaris, Generalized pustular psoriasis, Erythrodermic psoriasis
Intervention(s)		investigational material(s) Generic name etc : LY3074828 INN of investigational material : mirikizumab Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigational material : Administered subcutaneous injection control material(s) Generic name etc : Secukinumab INN of investigational material : secukinumab Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigational material : Administered subcutaneous injection Generic name etc : Placebo INN of investigational material : - Therapeutic category code : --- Other Dosage and Administration for Investigational material : Administered subcutaneous injection
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		efficacy sPGA and PASI
Secondary Outcome		efficacy pharmacokinetics PASI etc., PK parameters

Primary Sponsor	Eli Lilly Japan K.K.
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	Nagoya City University Graduate School of Medical Sciences and Nagoya City University Hospital Institutional Review Board
Address of IRB	1 Kawasumi, Mizuho-Cho, Mizuho-Ku, Nagoya-Shi, Aichi
Phone Number of IRB	-
E-mail Address of IRB	-
Status of IRB Review	approved
Date of Approval by IRB	July. 18, 2018

Secondary ID No.	NCT03535194
Name of Other Registries	ClinicalTrials.gov

Secondary ID No.	JapicCTI-184065
Name of Other Registries

Countries / Regions of Recruitment	Asia except Japan/North America/South America/Europe/Oceania/Japan

History of Changes

No	Publication date
5	April. 16, 2021	(this page)	Changes
4	July. 05, 2019	Detail	Changes
3	Dec. 17, 2018	Detail	Changes
2	Aug. 20, 2018	Detail	Changes
1	Aug. 15, 2018	Detail

List of change history