L40.0
Conditions
Interventions
Group 1: deucravacitinib
Sponsors
Uniklinikum Dresden, Klinik und Poliklinik für Dermatologie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male or female adult patients with the confirmed diagnosis of moderate to severe psoriasis vulgaris for at least 6 months. 2. Start of therapy with deucravacitinib according to the marketing authorisation after verbal and written infor-mation and consent of the patient. 3. Coexistence of an atopic diathesis with an Erlanger Atopy Score (EAS) of at least 10 points. 4. Signed and dated informed consent has been obtained prior to any protocol-related procedures. 5. Patient able to provide written informed consent. 6. Patient willing and able to comply with clinic visits and study related procedures.
Exclusion criteria
Exclusion criteria: 1. Diagnosis of a concurrent skin disease other than PV or AD, e.g. B. Tinea manuum, chronic spontaneous urticaria. 2. Presence of skin comorbidities that could affect the study assessment. 3. Treatment with a non-biological or biological drug containing any of the following active ingredients: Janus kinase inhibitors, immunosuppressants/immunomodulators, including but not limited to methotrexate, azathioprine, dapsone, apremilast, leflunomide, mycophenolate mofetil, retinoids, cyclosporine , sulphasalasine, hydroxychloroquine sulfate, TNF-alpha inhibitors inhibitors, IL-17 inhibitors, or IL-(12)/23 inhibitors within 1 month before screening or five drug pharmacokinetic half-lives (whichever is longer) before screening. 4. The subject is currently participating in another investigational drug or drug study(s). 5. Women who are pregnant, breastfeeding or planning to become pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of daily application of 6 mg deucravacitinib in the treatment of adult subjects with Psoriasis vulgaris and atopy. • Achievement of PASI 75 and sPGA at week 16 • sPGA 0/1 (clear/almost clear) with = 2-point-improvement from baseline at week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| • Mean change of pruritus on the NRS [Time Frame: Baseline; Week 4, 16, 24] • Determination of eczema scores (Mean change of EASI, IGA, oSCORAD) ) [Time Frame: Baseline; Week 4, 16, 24] • Mean chance of quality of life (DLQI) [Time Frame: Baseline; Week 4, 16, 24] | — |
Countries
Germany
Contacts
Public ContactKatharina Blümlein
Universitätsklinikum Dresden, Klinik und Poliklinik für Dermatologie
Outcome results
None listed