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

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Study population

Groups and cohorts

• Moderate-to-severe plaque psoriasis

  Drug: Deucravacitinib

Interventions

• DrugDeucravacitinib

  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

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

   Time frame: 5 years

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 from therapy initiation until discontinuation visualized using Kaplan-Meier methods

    Time frame: 5 years

12. 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

    Time frame: 5 years

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

Related links

• BMS Clinical Trial Information ↗
• FDA Safety Alerts and Recalls ↗

Individual participant data

Plan to share: No