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

NCT06382987 | Recruiting FDA Drug

• 1 other identifier: IM011-1124
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 2

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.

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (14)

• 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 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

Study Arms (2)

Participants that have initiated deucravacitinib treatment

Drug: Deucravacitinib

Participants that have initiated apremilast treatment

Drug: Apremilast

Interventions

Deucravacitinib DRUG

According to the product label

Participants that have initiated deucravacitinib treatment

Apremilast DRUG

According to the product label

Participants that have initiated apremilast treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include Japanese adults with a physician-reported diagnosis of plaque psoriasis who start treated with either deucravacitinib or apremilast. Study participants will be enrolled from Japanese Dermatological Association (JDA)-certified hospitals and clinics that are allowed to prescribe molecular targeted agents for patients with psoriasis.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (2)

Mebix. Inc.

Minato-ku, Tokyo, 1070052, Japan

RECRUITING

Fukuoka University Hospital

Fukuoka, Japan

RECRUITING

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Interventions

deucravacitinib; apremilast

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Study Connect Contact Center www.BMSStudyConnect.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: April 25, 2024
• Study Start: January 22, 2024
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 25, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (2)