A Study to Evaluate Deucravacitinib in Participants With Moderate-to-Severe Plaque Psoriasis in Germany (DELPHIN)
- Registration Number
- NCT06104644
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this observational study is to describe the effectiveness of deucravacitinib treatment and quality of life in adults with moderate-to-severe plaque psoriasis in routine clinical practice in Germany over a 5-year period
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 550
Inclusion Criteria
- Patients with a physician-reported diagnosis of moderate-to-severe plaque psoriasis initiating deucravacitinib according to approved label in the European Union
- The decision upon treatment with deucravacitinib must have been made before enrollment and independently of this non-interventional observational study
- Patient is at least 18 years of age at the time of treatment decision
- Patient provided written informed consent to participate in the study
Exclusion Criteria
- Any contraindications according to the approved deucravacitinib Summary of Product Characteristics
- Prior treatment with deucravacitinib
- Simultaneous participation in an interventional clinical trial for moderate-to-severe psoriasis
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Moderate-to-severe plaque psoriasis Deucravacitinib -
- Primary Outcome Measures
Name Time Method Proportion of patients achieving an absolute Psoriasis Area Severity Index (aPASI) score ≤ 3 at Week 24 or nearest visit Approximately 24 weeks after treatment initiation (data to be collected at visit nearest to this timepoint)
- Secondary Outcome Measures
Name Time Method Effectiveness of deucravacitinib treatment measured by the number of participants who achieve Psoriasis Area Severity Index (PASI) 75/90/100 5 years Effectiveness of deucravacitinib treatment in sensitive body areas measured by Physician's Global Assessment (PGA) for the genital area 5 years Effectiveness of deucravacitinib treatment in sensitive body areas measured by Physician's Global Assessment (PGA) for the intertriginous areas 5 years Including but not limited to axilla, popliteal fossa, inguinal, genital, submammary, anal region
Effectiveness of deucravacitinib treatment in sensitive body areas measured by palmoplantar psoriasis Physician's Global Assessment (pp-PGA) for the palmoplantar area 5 years Effectiveness of deucravacitinib treatment in sensitive body areas measured by target Nail Psoriasis Severity Index (NAPSI) for the nails 5 years Effectiveness of deucravacitinib treatment in sensitive body areas measured by scalp-specific Physician's Global Assessment (ss-PGA) for the scalp 5 years Treatment modalities and patient's satisfaction with deucravacitinib therapy measured by the Treatment Satisfaction Questionnaire for Medication (TSQM)-9 5 years Treatment modalities and patient's satisfaction with deucravacitinib therapy measured by the persistence of deucravacitinib therapy 5 years Time from therapy initiation until discontinuation visualized using Kaplan-Meier methods
Patient-reported outcomes measured by the Dermatology Life Quality Index (DLQI) 5 years Effectiveness of deucravacitinib treatment measured by the number of participants who achieve an absolute Psoriasis Area Severity Index (aPASI) score ≤ 3 and ≤ 6 5 years Effectiveness of deucravacitinib treatment measured by the number of participants who achieved static Physician's Global Assessment (sPGA) 0/1 and change in sPGA over time 5 years Effectiveness of deucravacitinib treatment measured by body surface area (BSA) affected by psoriasis and changes in BSA from baseline and over time 5 years Treatment modalities and patient's satisfaction with deucravacitinib therapy measured by reasons for therapy discontinuation 5 years Discontinuation of deucravacitinib defined as a treatment interruption of \>90 days with or without resumption of deucravacitinib treatment, with or without start of a follow-up therapy
Patient-reported outcomes measured by the Patient Benefit Index standard version (PBI-S) 5 years Patient-reported outcomes evaluating pruritus measured by the Itch Numeric Rating Scale (NRS) 5 years
Trial Locations
- Locations (2)
Dermatologische Spezial- und Schwerpunktpraxis Selters
🇩🇪Selters, Rhineland-Palatinate, Germany
Company for Medical Study & Service Selters
🇩🇪Selters, Germany