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NCT Number: NCT06104644

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Plaque Psoriasis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dermatologische Spezial- und Schwerpunktpraxis Selters, Selters, Rhineland-Palatinate, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Deucravacitinib

Drug

Non-interventional observational study of patients receiving treatment with commercially available deucravacitinib 6 mg once daily according to the Summary of Product Characteristics

Primary outcomes

  1. Proportion of patients achieving an absolute Psoriasis Area Severity Index (aPASI) score ≤ 3 at Week 24 or nearest visit

    Time frame: Approximately 24 weeks after treatment initiation (data to be collected at visit nearest to this timepoint)

Secondary outcomes

  1. Effectiveness of deucravacitinib treatment measured by the number of participants who achieve an absolute Psoriasis Area Severity Index (aPASI) score ≤ 3 and ≤ 6

    Time frame: 5 years

  2. Effectiveness of deucravacitinib treatment measured by the number of participants who achieve Psoriasis Area Severity Index (PASI) 75/90/100

    Time frame: 5 years

  3. 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

    Time frame: 5 years

  4. Effectiveness of deucravacitinib treatment measured by body surface area (BSA) affected by psoriasis and changes in BSA from baseline and over time

    Time frame: 5 years

  5. Effectiveness of deucravacitinib treatment in sensitive body areas measured by Physician's Global Assessment (PGA) for the genital area

    Time frame: 5 years

  6. Effectiveness of deucravacitinib treatment in sensitive body areas measured by Physician's Global Assessment (PGA) for the intertriginous areas

    Time frame: 5 years

    Including but not limited to axilla, popliteal fossa, inguinal, genital, submammary, anal region

  7. Effectiveness of deucravacitinib treatment in sensitive body areas measured by palmoplantar psoriasis Physician's Global Assessment (pp-PGA) for the palmoplantar area

    Time frame: 5 years

  8. Effectiveness of deucravacitinib treatment in sensitive body areas measured by target Nail Psoriasis Severity Index (NAPSI) for the nails

    Time frame: 5 years

  9. Effectiveness of deucravacitinib treatment in sensitive body areas measured by scalp-specific Physician's Global Assessment (ss-PGA) for the scalp

    Time frame: 5 years

  10. Treatment modalities and patient's satisfaction with deucravacitinib therapy measured by the Treatment Satisfaction Questionnaire for Medication (TSQM)-9

    Time frame: 5 years

  11. Treatment modalities and patient's satisfaction with deucravacitinib therapy measured by the persistence of deucravacitinib therapy

    Time frame: 5 years

    Time from therapy initiation until discontinuation visualized using Kaplan-Meier methods

  12. Treatment modalities and patient's satisfaction with deucravacitinib therapy measured by reasons for therapy discontinuation

    Time frame: 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

  13. Patient-reported outcomes measured by the Dermatology Life Quality Index (DLQI)

    Time frame: 5 years

  14. Patient-reported outcomes evaluating pruritus measured by the Itch Numeric Rating Scale (NRS)

    Time frame: 5 years

  15. Patient-reported outcomes measured by the Patient Benefit Index standard version (PBI-S)

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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)

Acronym: DELPHIN

Important dates

Study start
2023
Primary completion
2025
Study completion
2030
First posted
Oct 27, 2023
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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