UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation on alterations of skin-infiltrating T cell populations and peripheral blood biomarkers upon administration of Cosentyx (secukinumab) in patients with plaque psoriasis
Title of the study (Brief title)	Investigation on alterations of skin-infiltrating T cell populations and peripheral blood biomarkers upon administration of Cosentyx (secukinumab) in patients with plaque psoriasis
Region	Japan

Condition
Condition	Psoriasis vulgaris
Classification by specialty	Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We will evaluate the changes of skin-infiltrating T cell populations before and after secukinumab therapy, and monitor useful peripheral blood biomarkers during treatment with secukinumab.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Evaluation of changes in skin-infiltrating Th17, Th22, Th1 and Th2 cells before and at week 24 after the initial administration of secukinumab (10-time injections).
Key secondary outcomes	Evaluation of changes in peripheral blood Th17, Th22, Th1 and Th2 cells and in serum levels of IL-22, VEGF-A, and other cytokines, before and at week 24 after the initial administration of secukinumab (10-time injections). Evaluation of changes in skin-infiltrating Th17, Th22, Th1 and Th2 cells, in peripheral blood Th17, Th22, Th1 and Th2 cells, and in serum levels of IL-22, VEGF-A, and other cytokines, before and at week 4 after the initial administration of secukinumab (5 injections).

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	An open, one-therapeutic arm, single group-structured, non-randomized study is conducted. Patients with plaque psoriasis are treated with secukinumab 300 mg daily, once a week from baseline to week 4 and then every 4 weeks thereafter. Secukinumab will be obtained from market. The treatment will be performed on the basis of the usual health insurance system in Japan.Before the therapy, 4-mm punch biopsy specimens will be taken from both lesional psoriasis skin and non-lesional normal-appearing skin (internal control). At week 4 and week 24 after initiation of the therapy, 4-mm punch biopsy specimens will be again taken from the same plaque of psoriasis. In addition, peripheral blood samples (10 ml with heparin for lymphocytes and 5 ml for sera) will be collected before and at week 4 and week 24 after initiation of the therapy.
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	20 years-old <=
Age-upper limit	70 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Male or female aged 20-70 years. 2. Moderate and severe psoriasis vulgaris 3. More than 6 months since the diagnosis of psoriasis vulgaris 4. Subject's desire for initiation of secukinumab treatment 5. Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
Key exclusion criteria	1. Administration of adalimumab, infliximab and etanercept within 3 months before initiation of secukinumab.2. Administration of ustekinumab, alefacept, briakinumab and efalizumab within 6 months before initiation of secukinumab.3. Administration of cyclosporine A, methotrexate, corticosteroid, cyclophosphamide, retinoid and fumaric acid ester, and treatment with PUVA therapy within 4 weeks before initiation of secukinumab.4. Phototherapy with UVA and UVB, and topical treatment with reagents possibly affecting psoriatic lesions and symptoms, including corticosteroid, vitamin D3 analogue, tacrolimus, pimecrolimus, retinoid, salicylate petrolatum, salicylate, lactate, tar, uric acid, and hydroxy acid (fruit acid), within 2 weeks before initiation of secukinumab. 5.Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.6. Pregnancy.
Target sample size	10

Research contact person
Name of lead principal investigator	Yoshiki Tokura
Organization	Hamamatsu University School of Medicine
Division name	Department of Dermatology
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu 431-3192, Japan
TEL	053-435-2303
Email	tokura@hama-med.ac.jp

Public contact
Name of contact person	Toshiharu Fujiyama
Organization	Hamamatsu University School of Medicine
Division name	Department of Dermatology
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu 431-3192, Japan
TEL	053-435-2303
Homepage URL
Email	fujiyama@hama-med.ac.jp

Sponsor
Institute	Department of Dermatology, Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization	Novartis
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Shizuoka General Hospital, Shizuoka Shimada Municipal Hospital
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	浜松医科大学医学部附属病院（静岡県）、市立島田市民病院（静岡県）、静岡県立総合病院（静岡県）

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 11 Day
Anticipated trial start date	2016 Year 08 Month 01 Day
Last follow-up date	2018 Year 05 Month 26 Day
Date of closure to data entry	2018 Year 05 Month 26 Day
Date trial data considered complete	2018 Year 08 Month 31 Day
Date analysis concluded	2018 Year 08 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 08 Month 01 Day
Last modified on	2018 Year 08 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026640