A Real-world Study to Evaluate the Effectiveness of Deucravacitinib in Adults With Plaque Psoriasis in France (RePhlect)

Recruiting

• Conditions: Psoriasis
• Interventions: Drug: Deucravacitinib

• Registration Number: NCT06701513
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to assess the real-world effectiveness of deucravacitinib treatment in adults diagnosed with moderate-to-severe plaque psoriasis

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-20
• Study First Submitted QC: 2024-11-20
• Study First Posted: 2024-11-22
• Study Start: 2025-01-29
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-11
• Primary Completion: 2028-04-30
• Study Completion: 2028-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

• ≥18 years of age
• Physician-reported diagnosis of moderate to severe plaque psoriasis
• Be newly initiating deucravacitinib
• Do not object to participate

Exclusion Criteria

• Currently participating in or planning to participate in an interventional clinical trial
• Previous treatment experience with deucravacitinib, including patients who received deucravacitinib as part of a blinded, randomized trial

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants that have initiated deucravacitinib treatment	Deucravacitinib	-

Primary Outcome Measures

Name	Time	Method
Physician's Global Assessment (PGA) 0/1 response	Baseline and at months 4, 12, 18 (optional), and 24
Dermatology Life Quality Index (DLQI) 0/1 response	Baseline and at months 4, 12, 18 (optional), and 24
Time from date of treatment initiation to date of discontinuation	Up to 24 months

Secondary Outcome Measures

Name	Time	Method
Change in percentage involved Body Surface Area (BSA) from start of deucravacitinib treatment	Baseline and at months 4, 12, 18 (optional), and 24
Change in patient reported symptom burden as assed by the 100-point Visual Analog Scale (VAS) - Itch	Baseline and months 1, 4, 12, 18 (optional) and 24
Change in patient reported symptom burden as assed by the 100-point Visual Analog Scale (VAS) - Skin pain	Baseline and months 1, 4, 12, 18 (optional) and 24
Change in patient reported symptom burden as assed by the 100-point Visual Analog Scale (VAS)] - Fatigue	Baseline and months 1, 4, 12, 18 (optional) and 24
Physician's Global Assessment (PGA) score change from start of deucravacitinib treatment to follow-up	Baseline and at months 4, 12, 18 (optional), and 24
Dermatology Life Quality Index (DLQI) score of ≤5	Baseline and at months 1, 4, 12 18 (optional) and 24
Body Surface Area (BSA) of ≤ 3%	Baseline and at months 4, 12, 18 (optional), and 24
Body Surface Area (BSA) of ≤ 1%	Baseline and at months 4, 12, 18 (optional), and 24
Reasons for deucravacitinib treatment discontinuation	Up to 24 months

Trial Locations

Locations (39)

Local Institution - 060; 🇫🇷 Amiens cedex 1, France

Cabinet Médical Elisabeth Lion; 🇫🇷 Angers, France

Local Institution - 045; 🇫🇷 Argenteuil, France

CH ARRAS; 🇫🇷 Arras, France

Local Institution - 041; 🇫🇷 Bordeaux, France

Local Institution - 048; 🇫🇷 Bordeaux, France

Local Institution - 077; 🇫🇷 Dijon, France

Local Institution - 011; 🇫🇷 La Tronche, France

Local Institution - 074; 🇫🇷 Le Puy En Velay, France

Local Institution - 039; 🇫🇷 Lens Cedex, France

Local Institution - 004; 🇫🇷 Marcq En Baroeul, France

Local Institution - 036; 🇫🇷 Montpellier, France

Local Institution - 012; 🇫🇷 Nice, France

Local Institution - 062; 🇫🇷 Nimes, France

Local Institution - 008; 🇫🇷 Niort, France

Local Institution - 070; 🇫🇷 Niort, France

Local Institution - 073; 🇫🇷 Paris, France

Local Institution - 078; 🇫🇷 Perigueux, France

Local Institution - 046; 🇫🇷 Roubaix, France

Local Institution - 047; 🇫🇷 Roubaix, France

Local Institution - 051; 🇫🇷 Saint-mandé, France

Local Institution - 072; 🇫🇷 Saint-maur-des-fosses, France

Hia Sainte Anne; 🇫🇷 Toulon, France

Local Institution - 054; 🇫🇷 Toulon, France

Local Institution - 021; 🇫🇷 Toulouse cedex 9, France

Local Institution - 037; 🇫🇷 Toulouse cedex 9, France

Local Institution - 005; 🇫🇷 Toulouse, France

Local Institution - 061; 🇫🇷 Vandœuvre-lès-nancy, France

Local Institution - 064; 🇫🇷 Vandœuvre-lès-nancy, France

Local Institution - 003; 🇫🇷 Villeurbanne, France

Local Institution - 006; 🇫🇷 Villeurbanne, France

Cabinet Medical; 🇨🇭 La chaux de fonds, Switzerland

Local Institution - 007; 🇨🇭 La chaux de fonds, Switzerland

Local Institution - 025; 🇨🇭 La chaux de fonds, Switzerland

Local Institution - 029; 🇨🇭 La chaux de fonds, Switzerland

Local Institution - 038; 🇨🇭 La chaux de fonds, Switzerland

Local Institution - 044; 🇨🇭 La chaux de fonds, Switzerland

Centre Hospitalier William Morey - Hématologie; 🇫🇷 Chalon sur Saone, France

CHU Dijon; 🇫🇷 Dijon, France