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

Plaque Psoriasis Clinical Trial

— RePhlect  

Official title:

Registry of Psoriasis Health Outcomes: A Longitudinal Real-world Collaboration (RePhlect) - A Real-World, Prospective, Observational Study of the Comparative Effectiveness of Deucravacitinib in Adults With Plaque Psoriasis in Japan

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06382987
• Other study ID #: IM011-1124
• Status: Recruiting
• Start date: January 22, 2024
• Est. completion date: December 31, 2029

Study information

• Verified date: April 2024
• Source: Bristol-Myers Squibb
• Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com
• Phone: 855-907-3286
• Email: Clinical.Trials[@]bms.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• Deucravacitinib
According to the product label
• Apremilast
According to the product label

Locations

Country	Name	City	State
Japan	Fukuoka University Hospital	Fukuoka
Japan	Mebix. Inc.	Minato-ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls