ShibaMatsuo Building 4F, 2-9-1, Shibakoen, Minato-ku, Tokyo
+81-3-6435-3833
crt-info@ebc-m.com
Recruiting
Sept. 25, 2024
Feb. 14, 2025
100
Interventional
non-randomized controlled trial
open(masking not used)
uncontrolled control
parallel assignment
treatment purpose
1)Psoriasis vulgaris patients over 18 years old
2)Patients with psoriasis vulgaris less than 2 years or more than 5 years after onset
3)Patients who have given a written explanation of the study and obtained written consent to participate in the study.
4)Patients who fulfill any of the following (1)~(3)
(1)Patients who do not respond adequately to existing systemic therapies, including phototherapy, and whose skin rash covers more than 10% of their body surface area
(2)Patients with severely impaired quality of life: DLQI > 10
(3)Patients with refractory skin rashes:
Patients with skin rash on difficult-to-treat areas (scalp, palms, soles, genitalia, etc.) and PASI 5 or higher
1)Patients who have been treated with multiple biologics(However, only one type of experience in the use of biological products is acceptable for registration.)
2)Patients who have been previously treated with the investigational drug deucravacitinib and were unable to continue treatment for safety or other reasons
3)Patients with serious infections and active tuberculosis
4)Patients with a history of hypersensitivity to any component of the drugs under study
5)Patients who have participated or are participating in a clinical trial within the past 6 months
6)Patients deemed ineligible by the physician in charge
18age old over
No limit
Both
Psoriasis vulgaris
1)Start of treatment (0 week) -24 weeks observation date
The study drug (deucravacitinib) will be administered orally at a dose of 6 mg once daily for 24 weeks.
2)After 24 weeks observation date
(1) At the 24 weeks observation date, study subjects who achieve PASI >= 90 or PASI score =<1:discontinue study medication and move to remission maintenance follow-up.
(2)At the 24-week follow-up, subjects with a PASI < 90 (75 =< PASI < 90) will receive an additional dose of the study drug, 6 mg orally once daily for 12 weeks. The study drug will then be evaluated at the 36-week follow-up visit.
-Study subjects who achieve PASI >= 90 or PASI score =<1 at the 36-week follow-up date: Discontinue study drug and move to remission maintenance follow-up.
-Study subjects who fail to achieve either PASI >=90 or PASI score =<1 at the 36-week observation date: Use of the study drug and the study will be discontinued and appropriate treatment will be provided as usual.
(3)At the 24-week observation date, study subjects with PASI<75:
Use of the drug under study and the study will be discontinued and appropriate treatment will be provided as part of normal medical care.
psoriasis
C17.800.859.675
D002986
Percentage achieving PASI >= 90 or PASI score <=1 at 24 weeks of treatment
Patients with psoriasis less than 2 years after onset (Group A) vs. patients with psoriasis more than 5 years after onset (Group B)
The following items will be compared for all patients and for patients who have had psoriasis for less than 2 years (Group A) and for patients who have had psoriasis for more than 5 years (Group B).
1)Duration of remission (time to relapse*) and maintenance rate after discontinuation of the study drug
*Criteria for relapse:
PASI score worsens to 50% of the PASI score value at enrollment after achieving PASI90
2)PASI >=90 or PASI score =<1 after achieving
-Maintenance period and maintenance rate for PASI>=90
-Maintenance period and maintenance rate for PASI>=75
-Maintenance period and maintenance rate of PASI score=<1
3Trends, percent change, and change over time for each of the following index scores
PASI, BSA, PGA, sPGA, ScPGA, NAPSI, DLQI
4)Changes in concomitant medications
Dosage of topical steroids
5)exploratory study items
-Various chemokines and cytokines in serum
-Skin biopsy
Comparison of skin rash and rashless areas (before starting treatment)
Change over time in skin rash location and correlation with severity score of each psoriasis
Correlation between remission maintenance rate and duration
Association with the development of complications
Bristol Myers Squibb Co., Ltd
Not applicable
Nagoya City University Clinical Research Review Board
