Clinical trial NCT06104644: A Study to Evaluate Deucravacitinib in Participants With Moderate-to-Severe Plaque Psoriasis in Germany
Official title: Deucravacitinib in Routine Clinical Practice: A 5-year, Multicenter, Prospective, Non-Interventional Cohort Study to Evaluate Effectiveness and Quality of Life in Patients With Moderate-to-Severe Plaque Psoriasis in Germany (DELPHIN)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Plaque Psoriasis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-10-27
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with moderate-to-severe plaque psoriasis in Germany

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


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients achieving an absolute Psoriasis Area Severity Index (aPASI) score ≤ 3 at Week 24 or nearest visit
timeFrame: Approximately 24 weeks after treatment initiation (data to be collected at visit nearest to this timepoint)
Secondary outcomes:
measure: Effectiveness of deucravacitinib treatment measured by the number of participants who achieve an absolute Psoriasis Area Severity Index (aPASI) score ≤ 3 and ≤ 6
timeFrame: 5 years
measure: Effectiveness of deucravacitinib treatment measured by the number of participants who achieve Psoriasis Area Severity Index (PASI) 75/90/100
timeFrame: 5 years
measure: 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
timeFrame: 5 years
measure: Effectiveness of deucravacitinib treatment measured by body surface area (BSA) affected by psoriasis and changes in BSA from baseline and over time
timeFrame: 5 years
measure: Effectiveness of deucravacitinib treatment in sensitive body areas measured by Physician's Global Assessment (PGA) for the genital area
timeFrame: 5 years
measure: Effectiveness of deucravacitinib treatment in sensitive body areas measured by Physician's Global Assessment (PGA) for the intertriginous areas
timeFrame: 5 years
measure: Effectiveness of deucravacitinib treatment in sensitive body areas measured by palmoplantar psoriasis Physician's Global Assessment (pp-PGA) for the palmoplantar area
timeFrame: 5 years
measure: Effectiveness of deucravacitinib treatment in sensitive body areas measured by target Nail Psoriasis Severity Index (NAPSI) for the nails
timeFrame: 5 years
measure: Effectiveness of deucravacitinib treatment in sensitive body areas measured by scalp-specific Physician's Global Assessment (ss-PGA) for the scalp
timeFrame: 5 years
measure: Treatment modalities and patient's satisfaction with deucravacitinib therapy measured by the Treatment Satisfaction Questionnaire for Medication (TSQM)-9
timeFrame: 5 years
measure: Treatment modalities and patient's satisfaction with deucravacitinib therapy measured by the persistence of deucravacitinib therapy
timeFrame: 5 years
measure: Treatment modalities and patient's satisfaction with deucravacitinib therapy measured by reasons for therapy discontinuation
timeFrame: 5 years
measure: Patient-reported outcomes measured by the Dermatology Life Quality Index (DLQI)
timeFrame: 5 years
measure: Patient-reported outcomes evaluating pruritus measured by the Itch Numeric Rating Scale (NRS)
timeFrame: 5 years
measure: Patient-reported outcomes measured by the Patient Benefit Index standard version (PBI-S)
timeFrame: 5 years
Other outcomes:
Locations:
city: Selters
country: Germany
facility: Dermatologische Spezial- und Schwerpunktpraxis Selters
state: Rhineland-Palatinate
city: Selters
country: Germany
facility: Local Institution - 0001
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: