Molecular effects of deucravacitinib on plaque psoriasis and hard-to-treat psoriasis sites.

Trial details

Who runs it

Charite Universitaetsmedizin Berlin KöR

Trial code

EU 2023-508948-22-00

Record updated

2025. február 10.

Original description

Assess the immunological response based on the gene expression signature in classic and hard to-treat plaques comparing baseline with 16 weeks of treatmentRead full original descriptionShow less

A Mono-Center, Prospective Biomarker Study to investigate the differences in the inflammatory gene expression signature, the distribution of immune cells, psoriasis-driving factors and signaling molecules between classic and hard-to-treat psoriasis plaques and the effects of TYK2 blockade with deucravacitinib – MED-PSO

Assess the immunological response based on the gene expression signature in classic and hard to-treat plaques comparing baseline with 16 weeks of treatment

Inclusion: Patient has been prescribed the drug Sotyktu in routine clinical practice; Prescription is independent of the study; Subjects is willing to participate in the study and sign the informed consent form (ICF); Men or women, ≥18 years old; 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; Patient has a disease history of 6 months or longer; In addition to plaque psoriasis, disease manifestation is present at at least one hard-to-treat area body site (scalp, palmoplantar (non-pustular) or inverse) with a minimum total plaque size of 2x2cm. Multiple smaller lesions may add up to that size. Biopsies of the hands are preferred over biopsies taken from feet.

Exclusion: 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 receiving biologics (IL-17) within 3 months of first visit of study; Patients receiving biologics (TNF-alpha) within 3 months of first visit of study; Patients receiving any systemic immunosuppressants or anakinra within 4 weeks of the first visit of the study • Example immunosuppressants: MTX, azathioprine, cyclosporine, 6-thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea and tacrolimus; Patients receiving phototherapy or any systemic medications/treatments that could affect psoriasis or PGA evaluation within 4 weeks of the first visit of the study • Including, but not limited to, oral or injectable corticosteroids, retinoids, 1,25dihydroxy vitamin D3 and analogues, psoralens, sulfasalazine, hydroxyurea, or fumaric acid derivatives; 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, and tacrolimus. within 2 weeks of the first visit of the study; Patients has prior exposure to deucravacitinib or other JAK-inhibitors; Patients has prior exposure to more than one biologic; Patients has prior exposure to systemic treatments targeting IL-23 or IL-12; Patient is deprived of freedom, detained or commited to psychiatric ward, prison or state institution by court or legal authority; Patient has allergies to local anesthetics; Patient has permanent severe diseases, especially those affecting the immune system other than psoriasis • (Example: Systemic lupus erythematodes, autoimmune blistering diseases (AIBD), myasthenia gravis, multiple sclerosis, seropositive rheumatoid arthritis, Crohn´s disease, 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; History of allergy to any component of deucravacitinib; Patient has at least one parameter of blood works outside of defined range at screening • Absolute white blood cell count <3000/mm3 • Absolute lymphocyte count <500/mm3 • Absolute neutrophil count <1000/mm3 • Platelet count <100,000/mm3 • Hemoglobin <9 g/dL • Renal impairment based on an estimated glomerular filtration rate <45 mL/min • Alanine and/or aspartate aminotransferase >3 × upper limit of normal (ULN); Pateint has a dependence on the sponsor; Pregnant or breastfeeding women; 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; Patient has pustular psoriasis or other forms of psoriasis • Exception: plaques, palmoplantar, inverse and scalp; Patients is considered potentially unreliable or may not consistently attend scheduled study visits.

EU CTIS 2023-508948-22-00