Menu
Recruiting NCT06701513

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

— Observational Psoriasis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Deucravacitinib.
Who it may be relevant to
Registry conditions: Psoriasis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France, Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Registry of Psoriasis Health Outcomes: A Longitudinal Real-world Collaboration (RePhlect) - A Real-world, Prospective, Observational Study of the Effectiveness of Deucravacitinib in Adults With Moderate-to-Severe Plaque Psoriasis in France

Overview

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

Interventions

  • Drug Deucravacitinib
    As prescribed by treating clinician

Primary outcome measures

  • Physician's Global Assessment (PGA) 0/1 response [Time frame: Baseline and at months 4, 12, 18 (optional), and 24]
  • Dermatology Life Quality Index (DLQI) 0/1 response [Time frame: Baseline and at months 4, 12, 18 (optional), and 24]
  • Time from date of treatment initiation to date of discontinuation [Time frame: Up to 24 months]
Secondary outcome measures (9)
  • Change in percentage involved Body Surface Area (BSA) from start of deucravacitinib treatment [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Baseline and at months 4, 12, 18 (optional), and 24]
  • Dermatology Life Quality Index (DLQI) score of ≤5 [Time frame: Baseline and at months 1, 4, 12 18 (optional) and 24]
  • Body Surface Area (BSA) of ≤ 3% [Time frame: Baseline and at months 4, 12, 18 (optional), and 24]
  • Body Surface Area (BSA) of ≤ 1% [Time frame: Baseline and at months 4, 12, 18 (optional), and 24]
  • Reasons for deucravacitinib treatment discontinuation [Time frame: Up to 24 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

France · 39 centers
  • Chu Amiens Picardie - Site Sud — Amiens
  • Cabinet Médical Elisabeth Lion — Angers
  • Ch Victor Dupouy — Argenteuil
  • Local Institution - 089 — Argenteuil
  • CH ARRAS — Arras
  • Cabinet Dermatologie — Bordeaux
  • Cabinet Dermatologie — Bordeaux
  • Centre Hospitalier William Morey - Hématologie — Chalon-sur-Saône
  • … and 31 more centers
Switzerland · 9 centers
  • Cabinet Medical — La Chaux-de-Fonds
  • Cabinet Medical — La Chaux-de-Fonds
  • Cabinet Medical — La Chaux-de-Fonds
  • Cabinet Medical — La Chaux-de-Fonds
  • Cabinet Medical — La Chaux-de-Fonds
  • Cabinet Medical — La Chaux-de-Fonds
  • Cabinet Medical — La Chaux-de-Fonds
  • Local Institution - 056 — La Chaux-de-Fonds
  • … and 1 more center

Identifiers

NCT: NCT06701513 · IM011-1127

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗