UMIN-CTR Clinical Trial

Basic information
Public title	An interventional study to assess patient-reported outcome measures in bradalumab treated patients with moderate to severe plaque psoriasis in Japan
Acronym	PROMs in brodalumab treated patients with psoriasis in Japan
Scientific Title	An interventional study to assess patient-reported outcome measures in bradalumab treated patients with moderate to severe plaque psoriasis in Japan
Scientific Title:Acronym	PROMs in brodalumab treated patients with psoriasis in Japan
Region	Japan

Condition
Condition	psoriasis
Classification by specialty	Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objectives of the study are to evaluate the clinical efficacy of bradalumab for disease severity of psoriasis and to assess the change of patient-reported outcomes in brodalumab treated patients with moderate to severe plaque psoriasis without joint symptoms in Japan.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Mean Change From Baseline on the Psoriasis Area and Severity Index (PASI) and in Percent Body Surface Area (%BSA) [Time Frame: Week 12, 48] Proportion of Participants Achieving PASI 75, 90 and PASI 100 [Time Frame: Week 12, 48] Mean Change From Baseline on EuroQol - 5 Dimension - 5 Level, Dermatology Life Quality Index, Patient Health Questionnaire - 8, Generalized Anxiety Disorder - 7, Itch Numerical Rating Scale, Skin Pain Numerical Rating Scale, Medical Outcomes Study Sleep Scale, Work Productivity and Activity Impairment-Psoriasis and Treatment Satisfaction Questionnaire for Medication-9 [Time Frame: Week 12, 48] Patient Global Assessment [Time Frame: Week 12, 48]
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Administer subcutaneously 210 mg as brodalumab in the first dose, followed by doses at 1 week later, 2 weeks later, and once every 2 weeks thereafter. In this study, the research duration will be 48 weeks
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Patients with plaque psoriasis who aged 18 years or older at the time of informed concent. 2)Patients who have given written informed consect to participate. 3)Patients who are judged to be able to inject oneself with brodalumab by the investigator or subinvestigator at the time of informed concent. 4)Patients who responded inadequately to phototherapies or other existing systemic therapies (except biologics) and who have skin eruptions over 10% or more of the body surface area at enrollment. 5)Patients who were carefully deemed by the investigator or subinvestigator not to continue the treatment protocol with prior biologic(s).
Key exclusion criteria	1)Patients with psoriatic erythroderma, pustular psoriasis and guttate psoriasis at the time of informed concent. 2)Patients with a severe infection or active tuberculosis at the time of informed concent. 3)Patients who are judged by the investigator or subinvestigator to be unsuitable for participation in this study. 4)Patients with joint symptoms at enrollment.
Target sample size	70

Research contact person
Name of lead principal investigator	1st name Shinichi Middle name Last name Imafuku
Organization	Fukuoka University Hospital
Division name	Department of Dermatology
Zip code	814-0180
Address	7-45-1 Nanakuma, Jonan-ku, Fukuoka
TEL	092-801-1011
Email	dermatologist@mac.com

Public contact
Name of contact person	1st name Kenji Middle name Last name Kaneko
Organization	Kyowa Hakko Kirin Co., Ltd
Division name	Medical Affairs
Zip code	100-0004
Address	1-9-2 Otemachi, Chiyoda-ku, Tokyo
TEL	03-5205-7200
Homepage URL
Email	ma.cre@kyowa-kirin.co.jp

Sponsor
Institute	Kyowa Hakko Kirin Co., Ltd
Institute
Department

Funding Source
Organization	Kyowa Hakko Kirin Co., Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Board of Nippon Medical School Foundation
Address	Tokyo 1-1-5 Sendagi, Bunkyo-ku, Tokyo
Tel	03-5802-8202
Email	officetokutei@nms.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	jRCTs031180037
Org. issuing International ID_1	jRCT
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 06 Month 16 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	74
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2017 Year 06 Month 15 Day
Date of IRB	2017 Year 10 Month 02 Day
Anticipated trial start date	2017 Year 10 Month 01 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Transfer to jRCT

Management information
Registered date	2017 Year 06 Month 16 Day
Last modified on	2020 Year 05 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031837