Psoriasis vulgaris psoriasis
Conditions
Interventions
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) A
Sponsors
Morita Akimichi
Miyachi Yoshiki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 ==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 | — |
Contacts
Public ContactMotohiro Honda
EBC&M LLC
Outcome results
None listed