UMIN-ICDS Clinical Trial

Public title

Registry of Psoriasis Health Outcomes: A Longitudinal Real-world Collaboration (RePhlect) - A real-world, prospective, observational study of the comparative effectiveness of deucravacitinib in adults with plaque psoriasis in Japan

Acronym

RePhlect Japan

Scientific Title

Registry of Psoriasis Health Outcomes: A Longitudinal Real-world Collaboration (RePhlect) - A real-world, prospective, observational study of the comparative effectiveness of deucravacitinib in adults with plaque psoriasis in Japan

Scientific Title:Acronym

RePhlect Japan

Region

Japan

Condition

Plaque psoriasis

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To assess the real-world effectiveness and safety of deucravacitinib (DEUC) and comparative effectiveness against apremilast (APR) for the treatment of plaque psoriasis over a 5-year period among Japanese adult patients treated in real-world clinical practice.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

To evaluate the real-world effectiveness of DEUC in terms of:
1. Skin clearance
a. Change in Body Surface Area (BSA) from baseline to follow-up
b. Physician's Global Assessment (PGA) 0/1 response at follow-up
c. Absolute Psoriasis Area and Severity Index (PASI) <=2 response at follow-up

2. Health-related quality of life (HRQoL)
- Dermatology Life Quality Index (DLQI) 0/1 response at follow-up

3. Drug survival of DEUC
- Time from therapy initiation until discontinuation

Key secondary outcomes

Secondary outcomes
1. To compare the effectiveness of DEUC and APR regarding:
a. Skin clearance
i) Change in BSA from baseline to follow-up
ii) PGA 0/1 response at follow-up
iii) Absolute PASI <=2 response at follow-up
b. HRQoL
- DLQI 0/1 response at follow-up
c. Drug survival
- Time from therapy initiation until discontinuation

2. To describe patients initiating DEUC or APR regarding demographics, disease characteristics, and medical history

3. Additional DEUC effectiveness measures regarding:
a. PGA change
b. DLQI <=5; change in DLQI
c. PASI 75 response, PASI 90 response, absolute PASI score <=3, 5
d. National Psoriasis Foundation (NPF) Acceptable BSA: BSA <=3% or BSA75 and Target response (BSA <=1%)
e. Severity score in the hard-to-treat areas (scalp, nail, palmoplantar)
i). Scalp specific PGA (ss-PGA) 0/1
ii). PGA-Fingernail (PGA-F) 0/1
iii). Palmoplantar PGA (pp-PGA) 0/1

4. Additional comparative effectiveness of DEUC and APR measures regarding:
a. PGA change
b. DLQI <=5; change in DLQI
c. PASI 75 response, PASI 90 response, absolute PASI score <=3, 5
d. NPF Acceptable BSA: BSA <=3% or BSA75 and Target response (BSA <=1%)
e. Severity score in the hard-to-treat areas (scalp, nail, palmoplantar)
i). ss-PGA 0/1
ii). PGA-F 0/1
iii). pp-PGA 0/1

Exploratory outcomes
1. To describe the development of psoriatic arthritis in patients taking DEUC and APR
2. To describe the frequency of adverse events (AEs) and serious AEs for DEUC
3. To describe treatment changes (e.g., switching, subsequent treatment, discontinuation, resumption, and reasons for discontinuation/switching) in DEUC and APR
4. To compare change in 100-point Visual Analog Scale in DEUC and APR
a. Itch
b. Skin pain
5. To compare change in PGA x BSA in DEUC and APR
6. To evaluate treatment satisfaction in DEUC using TSQM-9
7. To evaluate the gastro-intestinal intolerance during the initiation phase of DEUC and APR using questions

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

To be eligible for this study, patients will be required to meet all of the following criteria at the time of consent:
- Be aged 18 years old or older
- Physician-reported diagnosis of plaque psoriasis
- Be newly initiating DEUC or APR according to the label
- Patients who have signed informed consent

Key exclusion criteria

Patients who meet any of the following criteria will be excluded from the study:
- Patients currently participating in or planning to participate in an interventional clinical trial
- Patients enrolled in DEUC Post Marketing Surveillance (PMS; ClinicalTrial.gov ID: NCT05633264)
- Previous treatment experience with the treatment of interest (e.g. patients who have history of APR will not be eligible to be enrolled in APR arm of the study and similar for DEUC)

Target sample size

600

Name of lead principal investigator

1st name	Shinichi
Middle name
Last name	Imafuku

Organization

Fukuoka University

Division name

Faculty of Medicine, Department of Dermatology

Zip code

814-0180

Address

7-45-1 Nanakuma, Jonan-ku, Fukuoka city, Fukuoka

TEL

092-801-1011

Email

dermatologist@mac.com

Name of contact person

1st name	Yuki
Middle name
Last name	Murabayashi

Organization

Mebix, Inc.

Division name

Research Promotion Headquarters

Zip code

107-0052

Address

Akasaka Intercity, 1-11-44 Akasaka, Minato-ku, Tokyo

TEL

03-4362-4500

Homepage URL

Email

REPHLECT_CRA@mebix.co.jp

Institute

Bristol-Myers Squibb K.K.

Institute

Department

Personal name

Katsuyoshi Habiro

Organization

Bristol-Myers Squibb K.K.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

The United States

Co-sponsor

Name of secondary funder(s)

Organization

Non-Profit Organization MINS Institutional Review Board

Address

5-20-9-401 Mita, Minato-ku, Tokyo

Tel

03-6416-1868

Email

npo-mins@j-irb.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

福岡大学病院（福岡県）、自治医科大学附属病院（栃木県）、名古屋市立大学病院（愛知県）、帝京大学医学部附属病院（東京都）、医療法人桜仁会いがらし皮膚科東五反田（東京都）、神戸大学医学部附属病院（兵庫県）、国立大学法人群馬大学医学部附属病院（群馬県）、東京慈恵会医科大学附属病院（東京都）、猿渡ひふ科クリニック（鹿児島県）、東海大学医学部付属病院（神奈川県）、浜松医科大学医学部附属病院（静岡県）、東京医科大学病院（東京都）、東北大学病院（宮城県）、産業医科大学病院（福岡県）、岡山大学病院（岡山県）、徳島大学病院（徳島県）、岐阜大学医学部附属病院（岐阜県）、愛知医科大学病院（愛知県）、北九州市立八幡病院（福岡県）、公立大学法人横浜市立大学附属病院（神奈川県）、兵庫医科大学病院（兵庫県）、熊本大学病院（熊本県）、学校法人藤田学園藤田医科大学病院（愛知県）、医療法人社団仁優会武岡皮膚科クリニック（香川県）、地方独立行政法人大阪府立病院機構大阪急性期・総合医療センター（大阪府）、医療法人社団廣仁会札幌皮膚科クリニック（北海道）、医療法人社団廣仁会豊水総合メディカルクリニック（北海道）、国立大学法人東京医科歯科大学病院（東京都）、社会福祉法人聖母会聖母病院（東京都）、北海道大学病院（北海道）、東京慈恵会医科大学附属第三病院（東京都）、公益財団法人慈愛会今村総合病院（鹿児島県）、医療法人社団高木皮膚科診療所分院（北海道）、ＮＴＴ東日本関東病院（東京都）、国立大学法人三重大学医学部附属病院（三重県）、独立行政法人地域医療機能推進機構東京山手メディカルセンター（東京都）、近畿大学病院（大阪府）、久留米大学病院（福岡県）、鳥取大学医学部附属病院（鳥取県）、京都府立医科大学附属病院（京都府）、独立行政法人地域医療機能推進機構中京病院（愛知県）、日野皮フ科医院（福岡県）、埼玉医科大学病院（埼玉県）、掛川市・袋井市病院企業団立中東遠総合医療センター（静岡県）

Date of disclosure of the study information

2023

Year

11

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2023

Year

09

Month

28

Day

Date of IRB

2023

Year

11

Month

16

Day

Anticipated trial start date

2024

Year

01

Month

22

Day

Last follow-up date

2029

Year

12

Month

31

Day

Date of closure to data entry

2030

Year

03

Month

31

Day

Date trial data considered complete

2030

Year

06

Month

30

Day

Date analysis concluded

2030

Year

12

Month

31

Day

Other related information

This is a prospective, observational real-world study of Japanese adults with a physician-reported diagnosis of plaque psoriasis who start to be treated with DEUC or APR. Study participants who meet the study eligibility criteria will be enrolled from Japanese Dermatological Association (JDA)-certified hospitals and clinics that are allowed to prescribe molecular targeted agents for patients with psoriasis in Japan. The target number of participants is 600 participants, including 400 in the DEUC arm and 200 in the APR arm.
In this study, the study participants will be observed for up to 60 months or until the end of the study, whichever comes earlier (observation period).
The study participants will be followed at 1, 3 and 6 months after the start of observation (initiation of DEUC or APR), and then every 6 months until discontinuation of DEUC or APR during the observation period. If study participants discontinue DEUC earlier than the end of the observation period, they will be followed for up to 6 months after discontinuation, but no longer than the observation period. If study participants receiving APR as the first treatment discontinue APR earlier than the end of the observation period, they will not be followed after discontinuation of APR. If study participants restart DEUC within 6 months after discontinuation of DEUC, they will be followed at the restart of DEUC, and 3 and 6 months for up to 6 months after restart of DEUC, but no longer than the observation period.
This study will collect prescription data on DEUC or APR, disease assessments within routine clinial practice (e.g., BSA, PGA, PASI, DLQI), and adverse events (DEUC only). Moreover, assessments using questionnaires (VAS [itching, skin pain], GI intolerane, TSQM-9) will be conducted.

Registered date

2023

Year

11

Month

30

Day

Last modified on

2023

Year

11

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060110