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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06104644
Other study ID # IM011-250
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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