UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057732 |
|---|---|
| Receipt number | R000065933 |
| Scientific Title | A prospective, observational study of quality of life and treatment satisfaction in adult patients with moderate to severe psoriasis treated with bimekizumab in a real-world setting in Japan |
| Date of disclosure of the study information | 2025/05/01 |
| Last modified on | 2026/07/02 13:22:15 |
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Basic information
Public title
A prospective, observational study of quality of life and treatment satisfaction in adult patients with moderate to severe psoriasis treated with bimekizumab in a real-world setting in Japan
Acronym
SAKURA
Scientific Title
A prospective, observational study of quality of life and treatment satisfaction in adult patients with moderate to severe psoriasis treated with bimekizumab in a real-world setting in Japan
Scientific Title:Acronym
SAKURA
Region
| Japan |
Condition
Condition
Plaque psoriasis, generalized pustular psoriasis, and erythrodermic psoriasis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the quality of life (QoL) and treatment satisfaction in adult patients with moderate-to-severe plaque psoriasis, generalized pustular psoriasis, or erythrodermic psoriasis newly treated with bimekizumab (BKZ) in a real-world setting in Japan and to examine the real-world outcomes of BKZ for treatment history and patient characteristics. In addition, to examine the association of QoL improvement and treatment satisfaction with skin clearance, patient needs, and treatment outcomes.
Basic objectives2
Others
Basic objectives -Others
Evaluation of QoL
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Early and sustained Dermatology Life Quality Index (DLQI) 0/1 response at 16 and 48 weeks
Early DLQI 0/1 response rate is defined as the rate of achieving DLQI 0/1 at 16 weeks in a group of patients with baseline DLQI >=2.
Sustained DLQI 0/1 response rate is defined as the rate of achieving DLQI 0/1 at 16 and 48 weeks in a group of patients with baseline DLQI >=2.
Key secondary outcomes
Other primary outcomes
1. Changes in DLQI score categories (0-1, 2-5, 6-10, 11-20 and 21-30) from baseline at 4, 16, and 48 weeks
2. Changes in minimum clinical important difference (MCID) response of DLQI from baseline at 4, 16, and 48 weeks
MCID response is defined as achieving a 4-point or greater reduction in the DLQI total score in a group of patients with baseline DLQI >=4.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 confirmed diagnosis of plaque psoriasis, generalized pustular psoriasis, or erythrodermic psoriasis
2. Be 18 years or older at the time of informed consent
3. Be newly initiating BKZ (without prior use of BKZ) according to the local package insert for plaque psoriasis, generalized pustular psoriasis, or erythrodermic psoriasis (patients who are not initiated on BKZ for the purpose of this study, but who are initiated on BKZ under routine medical care when treatment is deemed appropriate)
4. Patients who have necessary language skills to read and understand and have the willingness to complete the PRO questionnaires
5. Patients who provide a signed and dated informed consent to participate in this study
Key exclusion criteria
1. Patients for whom BKZ is contraindicated (i.e., patients with serious infections, active tuberculosis, or a history of hypersensitivity to the components of BKZ).
2. The Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) >=3.
3. Patients participating in an interventional study including clinical trials.
4. Patients deemed unsuitable for participating in the study by the investigator
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Akimichi |
| Middle name | |
| Last name | Morita |
Organization
Nagoya City University Hospital
Division name
Department of Dermatology
Zip code
4678602
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya city, Aichi, Japan
TEL
052-853-8261
hihuka@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Saori |
| Middle name | |
| Last name | Kasuya |
Organization
Nagoya City University Hospital
Division name
Department of Dermatology
Zip code
4678602
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya city, Aichi, Japan
TEL
052-853-8261
Homepage URL
hihuka@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Hospital
Institute
Department
Personal name
Akimichi Morita
Funding Source
Organization
UCB Japan Co. Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya City University Medical Research Institutional Review Board
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya city, Aichi, Japan
Tel
052-853-8348
irb_jimu@med.nagoya-cu.ac.jp
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
旭川医科 大学病院（北海道）、JR札幌病院（北海道）、豊水総合メディカルクリニック（北海道）、秋田大学医学部附属病院（秋田県）、東北大学病院（宮城県）、東北労災病院（宮城県）、福島県立医科大学附属病院（福島県）、筑波大学附属病院（茨城県）、自治医科大学附属病院（栃木県）、群馬大学医学部附属病院（群馬県）、順天堂大学医学部附属順天堂医院（東京都）、聖路加国際病院（東京都）、帝京大学医学部（東京都）、東京医科大学病院（東京都）、東京慈恵会医科大学附属病院（東京都）、日本大学医学部附属板橋病院（東京都）、東海大学医学部付属病院（神奈川県）、横浜市立大学附属病院（神奈川県）、富山大学附属病院（富山県）、信州大学医学部附属病院（長野県）、浜松医科大学医学部附属病院（静岡県）、中京病院（愛知県）、名古屋市立大学医学部附属西部医療センター（愛知県）、名古屋市立大学病院（愛知県）、藤田医科大学病院（愛知県）、京都府立医科大学附属病院（京都府）、大阪急性期・総合医療センター（大阪府）、大阪公立大学医学部附属病院（大阪府）、大阪大学医学部附属病院（大阪府）、関西医科大学附属病院（大阪府）、近畿大学医学部（大阪府）、日本生命病院（大阪府）、兵庫県立はりま姫路総合医療センター（兵庫県）、岡山大学病院（岡山県）、武岡皮膚科クリニック（香川県）、北九州市立八幡病院（福岡県） 、九州大学病院（福岡県）、久留米大学病院（福岡県）、産業医科大学病院（福岡県）、福岡大学病院（福岡県）、大分大学医学部附属病院（大分県）、今村総合病院（鹿児島県）、琉球大学病院（沖縄県）
Asahikawa Medical University Hospital (Hokkaido), JR Sapporo Hospital (Hokkaido), Hosui General Medical Clinic (Hokkaido), Akita University Hospital (Akita), Tohoku University Hospital (Miyagi), Tohoku Rosai Hospital (Miyagi), Fukushima Medical University Hospital (Fukushima), University of Tsukuba Hospital (Ibaraki), Jichi Medical University Hospital (Tochigi), Gunma University Hospital (Gunma), Juntendo University Hospital (Tokyo), St. Luke's International Hospital (Tokyo), Teikyo University School of Medicine (Tokyo), Tokyo Medical University Hospital (Tokyo), The Jikei University Hospital (Tokyo), Nihon University Itabashi Hospital (Tokyo), Tokai University Hospital (Kanagawa), Yokohama City University Hospital (Kanagawa), Toyama University Hospital (Toyama), Shinshu University Hospital (Nagano), Hamamatsu University Hospital (Shizuoka), Chukyo Hospital (Aichi), Nagoya City University West Medical Center (Aichi), Nagoya City University Hospital (Aichi), Fujita Health University Hospital (Aichi), University Hospital, Kyoto Prefectural University of Medicine (Kyoto), Osaka General Medical Center (Osaka), Osaka Metropolitan University Hospital (Osaka), the University of Osaka Hospital (Osaka) , Kansai Medical University Hospital (Osaka), Kindai University Faculty of Medicine (Osaka) , Nippon Life Hospital (Osaka), Hyogo Prefectural Harima-Himeji General Medical Center (Hyogo), Okayama University Hospital (Okayama), Takeoka Hifuka Clinic (Kagawa), Kitakyushu City Yahata Hospital (Fukuoka), Kyushu University Hospital (Fukuoka), Kurume University Hospital (Fukuoka), Hospital of the University of Occupational and Environmental Health, Japan (Fukuoka), Fukuoka University Hospital (Fukuoka), Oita University Hospital (Oita), Imamura General Hospital (Kagoshima), University of the Ryukyus Hospital (Okinawa)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 15 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 30 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design:
multicenter, prospective, non-interventional, primary data collection, single cohort study
Method of recruitment:
Patients who visit a participating site during the enrollment period (from the date of approval by the chief of research entity to December 31, 2026), who meet the inclusion criteria, who do not meet the exclusion criteria, and who are deemed appropriate for treatment with BKZ by investigators will be explained the treatment with BKZ, and consent for the treatment will be obtained from them. Then, patients will be informed about the study, and written consent for participation in the study will be obtained.
Observational items:
Background information (e.g., sex, month and year of birth, family history of psoriasis, comorbidities, medical history, diagnosed name of psoriasis, date of the diagnosis)
Psoriasis treatment history (e.g., prior use of biologics, categories of the most recent biologics, history of non-biologic psoriasis treatment)
Physician's global assessment of psoriasis severity (e.g., areas of residual skin rash and its severity)
PRO questionnaires [DLQI, Treatment Satisfaction Questionnaire for Medication version 9 (TSQM-9), Patient Benefit Index 2.0 (PBI 2.0), Patient's global assessment]
BKZ administration status (e.g., date of administration, formulation administered)
Other psoriasis treatments (e.g., use of phototherapy and topical medications)
Others (e.g., adverse event, other safety control information, adverse device effects)
Management information
Registered date
| 2025 | Year | 04 | Month | 28 | Day |
Last modified on
| 2026 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065933
