UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023424 |
|---|---|
| Receipt number | R000026640 |
| Scientific Title | Investigation on alterations of skin-infiltrating T cell populations and peripheral blood biomarkers upon administration of Cosentyx (secukinumab) in patients with plaque psoriasis |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2018/08/09 09:32:50 |
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Basic information
Public title
Investigation on alterations of skin-infiltrating T cell populations and peripheral blood biomarkers upon administration of Cosentyx (secukinumab) in patients with plaque psoriasis
Acronym
Investigation on alterations of skin-infiltrating T cell populations and peripheral blood biomarkers upon administration of Cosentyx (secukinumab) in patients with plaque psoriasis
Scientific Title
Investigation on alterations of skin-infiltrating T cell populations and peripheral blood biomarkers upon administration of Cosentyx (secukinumab) in patients with plaque psoriasis
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Yoshiki Tokura |
Organization
Hamamatsu University School of Medicine
Division name
Department of Dermatology
Zip code
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu 431-3192, Japan
TEL
053-435-2303
tokura@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiharu Fujiyama |
Organization
Hamamatsu University School of Medicine
Division name
Department of Dermatology
Zip code
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu 431-3192, Japan
TEL
053-435-2303
Homepage URL
fujiyama@hama-med.ac.jp
Sponsor or person
Institute
Department of Dermatology, Hamamatsu University School of Medicine
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
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
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 11 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026640
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