A Study of the Comparative Effectiveness of Deucravacitinib in Adults With Plaque Psoriasis in Japan (RePhlect)

Recruiting

• Conditions: Plaque Psoriasis
• Interventions: Drug: Apremilast; Drug: Deucravacitinib

• Registration Number: NCT06382987
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

This is a prospective, observational, real-world study of adult participants in Japan with physician-reported diagnosis of plaque psoriasis treated with deucravacitinib or apremilast.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-22
• Status Verified: 2024-04
• Study First Submitted: 2024-04-22
• Study First Submitted QC: 2024-04-22
• Last Update Submitted: 2024-04-22
• Study First Posted: 2024-04-25
• Last Update Posted: 2024-04-25
• Primary Completion: 2029-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Japanese adult participants aged 18 years old or older
• Physician-reported diagnosis of plaque psoriasis
• Newly initiating deucravacitinib or apremilast according to the label
• Participants who have signed informed consent

Exclusion Criteria

• Participants currently participating in or planning to participate in an interventional clinical trial
• Patients enrolled in deucravacitinib post-marketing surveillance study (ClinicalTrial.gov ID: NCT05633264)
• Previous treatment experience with the treatment of interest (e.g. patients who have history of apremilast will not be eligible to be enrolled in apremilast arm of the study and similar for deucravacitinib)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants that have initiated apremilast treatment	Apremilast	-
Participants that have initiated deucravacitinib treatment	Deucravacitinib	-

Primary Outcome Measures

Name	Time	Method
Change in percent Body Surface Area (BSA) involved affected by plaque psoriasis from baseline to follow up in participants treated with deucravacitinib.	1 month, 3 months, 6 months and every 6 months up to 5 years
Number of participants who achieved Physician's Global Assessment (PGA) of 0/1 from baseline to follow-up	1 month, 3 months, 6 months and every 6 months up to 5 years
Number of participants who achieved Absolute Psoriasis Area and Severity Index (aPASI) of ≤2 from baseline to follow-up	1 month, 3 months, 6 months and every 6 months up to 5 years
Number of participants who achieved Dermatology Life Quality Index (DLQI) of 0 /1 from baseline to follow-up	1 month, 3 months, 6 months and every 6 months up to 5 years
Participant duration of treatment (time difference between date of treatment initiation to date of discontinuation)	1 month, 3 months, 6 months and every 6 months up to 5 years

Secondary Outcome Measures

Name	Time	Method
Number of participants who achieve a National Psoriasis Foundation (NPF) Acceptable Body Surface Area response from baseline to follow-up	1 month, 3 months, 6 months and every 6 months up to 5 years
Change in percent Body Surface Area (BSA) involved affected by plaque psoriasis from baseline to follow up in participants treated with deucravacitinib or apremilast	1 month, 3 months, 6 months and every 6 months up to 5 years
Number of participants who achieved Dermatology Life Quality Index (DLQI) of 0/1 from baseline to follow-up	1 month, 3 months, 6 months and every 6 months up to 5 years
Participant duration of treatment (time difference between date of treatment initiation to date of discontinuation) from baseline to follow-up	1 month, 3 months, 6 months and every 6 months up to 5 years
Number of participants treated with deucravacitinib with a change in Physician's Global Assessment (PGA) from baseline to follow-up	1 month, 3 months, 6 months and every 6 months up to 5 years
Number of participants achieving a Dermatology Life Quality Index (DLQI) score of ≤5 from baseline to follow-up	1 month, 3 months, 6 months and every 6 months up to 5 years
Number of participants who achieve an absolute Palmoplantar Physician's Global Assessment (pp-PGA) of 0/1 from baseline to follow-up	1 month, 3 months, 6 months and every 6 months up to 5 years
Number of participants treated with deucravacitinib with a change in Dermatology Life Quality Index (DLQI) from baseline to follow-up	1 month, 3 months, 6 months and every 6 months up to 5 years
Number of participants who achieve an absolute Psoriasis Area Severity Index (aPASI) score ≤5 from baseline to follow-up	1 month, 3 months, 6 months and every 6 months up to 5 years
Number of participants who achieve a Psoriasis Area Severity Index (PASI) response of 75 from baseline to follow-up	1 month, 3 months, 6 months and every 6 months up to 5 years
Number of participants who achieve a Psoriasis Area Severity Index (PASI) response of 90 from baseline to follow-up	1 month, 3 months, 6 months and every 6 months up to 5 years
Number of participants who achieve an absolute Psoriasis Area Severity Index (aPASI) score ≤3 from baseline to follow-up	1 month, 3 months, 6 months and every 6 months up to 5 years
Number of participants who achieve an absolute scalp-specific Physician's Global Assessment (ss-PGA) of 0/1 from baseline to follow-up	1 month, 3 months, 6 months and every 6 months up to 5 years
Number of participants who achieve an absolute Physician's Global Assessment-Fingernail (PGA-F) of 0/1 from baseline to follow-up	1 month, 3 months, 6 months and every 6 months up to 5 years

Trial Locations

Locations (2)

Mebix. Inc.; 🇯🇵 Minato-ku, Tokyo, Japan

Fukuoka University Hospital; 🇯🇵 Fukuoka, Japan