Immunological and functional characteristics of T memory-like cells in psoriasis under treatment with deucravacitinib.

Prior treatment

• Participation in any other clinical trial or treatment with investigational medicinal products (IMPs) or previous therapies with known or potential overlapping toxicities with the IMP and its relevant metabolites, within a period equivalent to five times the half-life of the IMP or its relevant metabolites (whichever is longer) prior to screening.
• Patients with prior exposure to systemic treatments targeting IL-23 or IL-12.
• Patients receiving biologics (IL-17) within 3 months of first administration of Sotyktu® at V1 (baseline).
• Patients receiving biologics (TNF-α) within 1 months of first administration of Sotyktu® at V1 (baseline).
• Patients receiving any systemic immunosuppressants (eg, MTX, azathioprine, cyclosporine, 6-thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, and tacrolimus) or anakinra within 4 weeks of the first administration of Sotyktu® at V1 (baseline).
• Patients receiving phototherapy or any systemic medications/treatments that could affect psoriasis or PGA evaluation (including, but not limited to, oral or injectable corticosteroids, retinoids, 1,25dihydroxy vitamin D3 and analogues, psoralens, sulfasalazine, hydroxyurea, or fumaric acid derivatives) within 4 weeks of the first administration of Sotyktu® after V1 (baseline).Patients receiving topical medications/treatments that could affect psoriasis or PGA evaluation (including, but not limited to, corticosteroids, anthralin, calcipotriene, topical vitamin D derivatives, retinoids, tazarotene, methoxsalen, trimethylpsoralens, pimecrolimus, apremilast and tacrolimus) within 1 week of the first administration of Sotyktu® at V1 (baseline).
• Patients with prior exposure to deucravacitinib or other JAK-inhibitor.
• Patients with prior exposure to more than one biologic.

Other illness

• History of allergy to any component of Sotyktu ®
• Subjects deprived of freedrom i.e., detainment or commitment to psychiatric ward, prison or state institution by law court or legal authority
• Permanent severe diseases, especially those affecting the immune system other than psoriasis, such as: a. Systemic lupus erythematodes, b. autoimmune blistering diseases (AIBD), c. myasthenia gravis, d. multiple sclerosis, e. seropositive rheumatoid arthritis, f. Crohn´s disease, g. ulcerative colitis
• Contraindications to Deucravacitinib: a. Known hypersensitivity to Deucravacitinib or any of its excipients, b. Active tuberculosis, untreated latent tuberculosis, or serious chronic infections, c. Active or chronic hepatitis B or C, or HIV infection, d. Severe hepatic impairment, e. Severe renal impairment (glomerular filtration rate <30 mL/min), f. History of malignancies, including lymphoproliferative disorders, except successfully treated non-metastatic basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix, g. Use of live vaccines within 4 weeks prior to baseline or planned during the trial.
• History of lymphoproliferative disorders.

Lab values

• Leukopenia a. absolute WBC count < 3000/mm3 b. Lymphopenia (ALC < 500/mm3) c. Neutropenia (ANC < 1000/mm3) d. Thrombocytopenia (platelet count < 100,000/mm3)

Other

• Female subjects of childbearing potential who are not using a highly effective method of contraception as recommended by the “CTCG Recommendations related to contraception and pregnancy testing in clinical trials, Version 1.2."
• Subjects who are unwilling or unable to comply with the pregnancy testing requirements during the study period
• Pustular Psoriasis
• Patients who are considered potentially unreliable or may not consistently attend scheduled study visits.
• Inability or unwillingness to undergo repeated venepuncture (e.g., because of poor tolerability or lack of access to veins).
• Pregnant or breastfeeding women

• Patients must be planned to be initiated on Sotyktu® in routine clinical care
• Patients with psoriasis less than 5 years since onset
• Subjects must be willing to participate in the study
• able to understand the patient information
• and sign the informed consent form
• all sexes
• Age ≥18 years
• The patient has moderate to severe psoriasis as defined by the German S3 guideline, characterized by: a. Body-surface area (BSA) of 10% or more and Dermatological Life Quality Index (DLQI) score of 10 or higher, OR b. Psoriasis Area and Severity Index (PASI) score of 10 or higher and Dermatological Life Quality Index (DLQI) score of 10 or higher, OR c. Meeting any of the following upgrade criteria according to the German S3 guidelines for systemic treatment: i. Severe disease in visual areas, ii. Severe disease of the scalp, iii. Genital psoriasis, iv. Palmoplantar psoriasis, v. Onycholysis or onychodystrophy of at least 2 fingernails, vi. Experience pruritus and associated itching, vii. Therapy-resistant plaques.