Investigation of the usefulness of deucravacitinib in early onset psoriasis

Recruiting

• Conditions: Psoriasis vulgaris

• Registration Number: jRCTs041240089

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-25
• Study Start: 2025-02-14
• Last Update Posted: 2025-05-02

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1)Psoriasis vulgaris patients over 18 years old 2)Patients with psoriasis vulgaris less than 2 years or more than 10 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

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

Study & Design

• Study Type: Interventional
• Study Design: parallel assignment

Primary Outcome Measures

Name	Time	Method
Percentage achieving PASI >= 90 or PASI score <=1	24 weeks of treatment	Patients with psoriasis less than 2 years after onset (Group A) vs. patients with psoriasis more than 10 years after onset (Group B)

Secondary Outcome Measures

Name	Time	Method
Duration of remission and maintenance rate		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
Trends and changes in index scores		Trends, percent change, and change over time for each of the following index scores: PASI, BSA, PGA, sPGA, ScPGA, NAPSI, DLQI
PASI >=90 or PASI score =<1 maintenance		-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
Changes in concomitant medications		Dosage of topical steroids
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