A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety deucravacitinib in patients with chronic hand eczema (investigator-sponsored research)

INTERVENTION: Product Name: Matching placebo to IMP,Product Code: N/A,Pharmaceutical Form: N/A,Other descriptive name: N/A,Strength: N/A,Pharmaceutical form of the placebo: N/A,Product Name: SOTYKTU 6 mg film‐coated tablets,Product Code: PRD10314809,Pharmaceutical Form: FILM‐COATED TABLET,Other descriptive name: ,Strength: Deucravacitinib 6mg CONDITION: Chronic Hand Eczema Therapeutic area: Diseases [C] ‐ Skin and Connective Tissue Diseases [C17] PRIMARY OUTCOME: Main Objective:To evaluate the efficacy of daily application of 6 mg BID deucravacitinib compared with a placebo in the treatment of adult subjects with chronic hand eczema. Primary end point(s):Therapeutic efficacy of deucravacitinib defined as the percentage of patients achieving a clinical response (Investigator Global Assessment 0 or 1) with = 2‐point improvement in IGA for patients with chronic hand eczema at week 16 Secondary Objective:To evaluate the health‐related quality of life and safety of daily application of 6 mg BID deucravacitinib compared with a placebo in the treatment of adult subjects with chronic hand eczema. SECONDARY OUTCOME: Secondary end point(s):Change in histology, in expression of skin barrier proteins, expression of cytokines, in extent of immune cells in skin biopsies, and the transcriptome from baseline to week 16 Secondary end point(s):Change in skin physiology from baseline to week 16 Secondary end point(s):Evaluation of safety in terms of number of AE and lab parameters Secondary end point(s):Hand eczema severity inde X(HECSI) [Time Frame: Baseline; Week 4, 8, 16] Secondary end point(s):Participant self‐assessment (PSA) [Time Frame: Baseline, week 2, 4, 6, 8, 12 and 16] Secondary end point(s):Quality of Life in Hand Eczema Questionnaire (QOLHEQ) [Time Frame: Baseline; Week 4, 8, 16] INCLUSION CRITERIA: Patients must have signed and dated an IRB/IEC‐approved written informed consent form in accordance with regulatory and institutional guidelines before the performance of any protocol‐related procedures,Patients with diagnosis of chronic hand eczema (persisted > 3 months or returned twice or more within the past 12 months),Patients with moderate to severe disease and Investigator Global Assessment (IGA) score = 3 (scale of 0 to 4) at screening and baseline visit.,Patients with failed topical therapy for 6 weeks will be included and patients should be eligible for a systemic therapy,Male or female patients aged 18 to 65 years old,Patients with BMI (body mass index) of ca. 18‐35 kg/m2,Patients able to provide written informed consent,Patient willing and able to comply with clinic visits and study related procedures