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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Drug: Deucravacitinib; Drug: Apremilast

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: BMS Study Connect Contact Center www.BMSStudyConnect.com; Phone Number: 855-907-3286; Email: Clinical.Trials@bms.com
• Study Contact Backup: Name: First line of the email MUST contain NCT # and Site #.

Study Locations

• Japan
  • Fukuoka, Japan
    • Recruiting
    • Fukuoka University Hospital
  • Tokyo
    • Minato-ku, Tokyo, Japan, 1070052
      • Recruiting
      • Mebix. Inc.
      • Contact: Minoru Tonogai, Site 0001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants that have initiated deucravacitinib treatment	Drug: Deucravacitinib; According to the product label
Participants that have initiated apremilast treatment	Drug: Apremilast; According to the product label

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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
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 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 ≤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 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 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
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
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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2024
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: April 22, 2024
• First Submitted That Met QC Criteria: April 22, 2024
• First Posted (Actual): April 25, 2024

Study Record Updates

• Last Update Posted (Actual): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Dermatologic Agents; Protein Kinase Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 4 Inhibitors; Apremilast; Deucravacitinib
• Other Study ID Numbers: IM011-1124

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No