A Study to Evaluate Deucravacitinib in Participants With Moderate-to-Severe Plaque Psoriasis in Germany (DELPHIN)

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)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Drug: Deucravacitinib

• Study Type: Observational
• Enrollment (Estimated): 550

Contacts and Locations

Study Locations

• Germany
  • Selters, Germany, 56242
    • Local Institution - 0001
  • Rhineland-Palatinate
    • Selters, Rhineland-Palatinate, Germany
      • Dermatologische Spezial- und Schwerpunktpraxis Selters

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Adults with moderate-to-severe plaque psoriasis in Germany

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Moderate-to-severe plaque psoriasis	Drug: Deucravacitinib; Non-interventional observational study of patients receiving treatment with commercially available deucravacitinib 6 mg once daily according to the Summary of Product Characteristics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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 achieve Psoriasis Area Severity Index (PASI) 75/90/100		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
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	Including but not limited to axilla, popliteal fossa, inguinal, genital, submammary, anal region	5 years
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	Time from therapy initiation until discontinuation visualized using Kaplan-Meier methods	5 years
Treatment modalities and patient's satisfaction with deucravacitinib therapy measured by reasons for therapy discontinuation	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	5 years
Patient-reported outcomes measured by the Dermatology Life Quality Index (DLQI)		5 years
Patient-reported outcomes evaluating pruritus measured by the Itch Numeric Rating Scale (NRS)		5 years
Patient-reported outcomes measured by the Patient Benefit Index standard version (PBI-S)		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): April 13, 2023
• Primary Completion (Actual): August 18, 2025
• Study Completion (Estimated): May 31, 2030

Study Registration Dates

• First Submitted: October 6, 2023
• First Submitted That Met QC Criteria: October 23, 2023
• First Posted (Actual): October 27, 2023

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: November 27, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Psoriasis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Dermatologic Agents; Protein Kinase Inhibitors; deucravacitinib
• Other Study ID Numbers: IM011-250

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