Investigation of the usefulness of duklavacitinib in early onset psoriasis

JRCT ID: jRCTs041240089

Registered date:25/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Psoriasis vulgaris
• Date of first enrollment: 25/09/2024
• Target sample size: 100
• Study type: Interventional

Intervention(s)

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.

Outcome(s)

Primary Outcome

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 10 years after onset (Group B)

Secondary Outcome

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 10 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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Morita Akimichi
• Secondary Sponsor: Miyachi Yoshiki
• Source(s) of Monetary Support: Bristol Myers Squibb Co., Ltd