臨床研究等提出・公開システム

Date of registration	Oct. 12, 2011
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080221614

Scientific Title	Efficacy and Safety of Subcutaneous Secukinumab (AIN457) for Moderate to Severe Chronic Plaque-type Psoriasis Assessing Different Doses and Dose Regimens (SCULPTURE)
Public Title

Completion Date or Terminated date
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
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	Novartis Pharma K.K.
	Address	0120-003-293
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size
Study Type		Interventional
Study Design	Study Design	Randomized, Double-blind, Multicenter
Study Design	Objective
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	Moderate and severe plaque-type psoriasis diagnosed for at least 6 months.
	Exclusion Criteria	-Current forms of psoriasis other than chronic plaque-type psoriasis (for example, pustular, erythrodermic, guttate). -Current drug-induced psoriasis. -Previous use of secukinumab or any drug that targets IL-17 or IL-17 receptor.
	Minimum Age	18age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		psoriasis
Intervention(s)		investigational material(s) Generic name etc : AIN457 INN of investigational material : Secukinumab Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigational material : Subcutaneous Injection
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		PASI 75
Secondary Outcome		PASI 50/75/90/100, IGA

Primary Sponsor	Novartis Pharma K.K.
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name of IRB
Address of IRB
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review
Date of Approval by IRB

Secondary ID No.	JapicCTI-111655
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
9	Dec. 17, 2018	(this page)	Changes
8	June. 11, 2013	Detail	Changes
7	June. 11, 2013	Detail	Changes
6	Sept. 14, 2012	Detail	Changes
5	Sept. 14, 2012	Detail	Changes
4	June. 18, 2012	Detail	Changes
3	June. 18, 2012	Detail	Changes
2	Oct. 12, 2011	Detail	Changes
1	Oct. 12, 2011	Detail

List of change history