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

Plaque Psoriasis Clinical Trial

— DELPHIN  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06104644
• Other study ID #: IM011-250
• Status: Recruiting
• Start date: April 13, 2023
• Est. completion date: April 30, 2030

Study information

• Verified date: April 2024
• Source: Bristol-Myers Squibb
• Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com
• Phone: 855-907-3286
• Email: Clinical.Trials[@]bms.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: April 30, 2030
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

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

Locations

Country	Name	City	State
Germany	Company for Medical Study & Service Selters	Selters
Germany	Dermatologische Spezial- und Schwerpunktpraxis Selters	Selters	Rhineland-Palatinate

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Effectiveness of deucravacitinib treatment measured by the number of participants who achieve Psoriasis Area Severity Index (PASI) 75/90/100		5 years
Secondary	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
Secondary	Effectiveness of deucravacitinib treatment measured by body surface area (BSA) affected by psoriasis and changes in BSA from baseline and over time		5 years
Secondary	Effectiveness of deucravacitinib treatment in sensitive body areas measured by Physician's Global Assessment (PGA) for the genital area		5 years
Secondary	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
Secondary	Effectiveness of deucravacitinib treatment in sensitive body areas measured by palmoplantar psoriasis Physician's Global Assessment (pp-PGA) for the palmoplantar area		5 years
Secondary	Effectiveness of deucravacitinib treatment in sensitive body areas measured by target Nail Psoriasis Severity Index (NAPSI) for the nails		5 years
Secondary	Effectiveness of deucravacitinib treatment in sensitive body areas measured by scalp-specific Physician's Global Assessment (ss-PGA) for the scalp		5 years
Secondary	Treatment modalities and patient's satisfaction with deucravacitinib therapy measured by the Treatment Satisfaction Questionnaire for Medication (TSQM)-9		5 years
Secondary	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
Secondary	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
Secondary	Patient-reported outcomes measured by the Dermatology Life Quality Index (DLQI)		5 years
Secondary	Patient-reported outcomes evaluating pruritus measured by the Itch Numeric Rating Scale (NRS)		5 years
Secondary	Patient-reported outcomes measured by the Patient Benefit Index standard version (PBI-S)		5 years

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls