DEUCRALIP

INTERVENTION: Product Name: DEUCRAVACITINIB,Product Code: SUB214583,Pharmaceutical Form: FILM‐COATED TABLET,Other descriptive name: ,Strength: 6mg,Current Sponsor code: BMS‐986165,Product Name: Product name: Placebo to match deucravacitinib 6mg Name of manufacturer: Bristol‐Myers Squibb (BMS) Ingredients: Lactose monohydrate, microcrystalline cellulose, magnesium stearate, and Opadry II coating Pharmaceutical form: Film‐coated tablet, Age‐appropriate oral solid dosage form,Product Code: N/A,Pharmaceutical Form: N/A,Other descriptive name: N/A,Strength: N/A,Pharmaceutical form of the placebo: N/A CONDITION: Lichen planus ; MedDRA version: 20.0Level: PTClassification code: 10024429Term: Lichen planusSystem Organ Class: 100000004858 ; MedDRA version: 20.1Level: PTClassification code: 10030983Term: Oral lichen planusSystem Organ Class: 100000004856 MedDRA version: 20.0Level: PTClassification code: 10024429Term: Lichen planusSystem Organ Class: 100000004858 MedDRA version: 20.1Level: PTClassification code: 10030983Term: Oral lichen planusSystem Organ Class: 100000004856 Therapeutic area: Diseases [C] ‐ Skin and Connective Tissue Diseases [C17] PRIMARY OUTCOME: Main Objective:Evaluation of the efficacy of deucravacitinib on objective clinical symptoms/ disease activity in lichen planus patients Primary end point(s):Change in the objective clinical symptoms (measured with the Lichen Planus Activity and Damage Index(LiPADI) Activity Score, from baseline (V1, day 1) to EOS (V4, day 112) Secondary Objective:To assess whether the administration of deucravacitinib in lichen planus patients is associated with reduced inflammatory parameters (from blood and skin samples) => mRNA‐based gene expression analysis of IFN genes (CXCL10, CXCL9, CCL5, MxA, BLyS, TRAIL etc.),To assess whether the administration of deucravacitinib in lichen planus patients is associated with improvement of quality of life (Dermatological Quality of Live Index = DLQI, validated score),To assess whether the administration of deucravacitinib in lichen planus patients is associated with improvement of itching via the Numeric rating scale (NRS) for average itch during the past 24 hours,To assess whether the administration of deucravacitinib in lichen planus patients is associated with improvement/reduction of the amount of steroids used INCLUSION CRITERIA: Subjects male or female, aged =18 years,The subject has given written informed consent to participate in the trial,Subjects with histologically proven and symptomatic lichen planus,Ability to follow study instructions and willingness to attend and complete all required visits,LiPADI Acivity Score = 6 or = 3 in patients with mucosal involvement only SECONDARY OUTCOME: Secondary end point(s):Change in IFN gene expression profile (CXCL10, CXCL9, CCL5, MxA, BLyS, TRAIL etc.) in peripheral blood and skin (BOS/V1 vs EOS/V4 vs OLE‐V3) in both arms Secondary end point(s):Change in the amount of steroids used from baseline (V1) to EOS (V4) between placebo and treatment arm Secondary end point(s):Change in the LiPADI Activity Score from baseline (V1) to V3, V4/OLE‐V1, SC‐1, SC‐2, OLE‐V2, SC‐3 and OLE‐V3 in both arms Secondary end point(s):Change of DLQI from baseline (V1) to EOS (V4) between placebo and treatment arm Secondary end point(s):Change of DLQI from baseline (V1) to V3, V4/OLE‐V1, SC‐1, SC‐2, OLE‐V2, SC‐3, OLE‐V3 in both arms Secondary end point(s):Change of Itch NRS from baseline (V1) to EOS (V4) between placebo and treatment arm Secondary end point(s):Change of Itch NRS from baseline (V1) to V3, V4/OLE‐V1, SC‐1, SC‐2, OLE‐V2, SC‐3, OLE‐V3 in both arms Secondary end point(s):Differences in IFN gene expression profile (CXCL10, CXCL9, CCL5, MxA, BLyS, TRAIL etc.) in peripheral blood and skin (BOS/V1, EOS/V4, OLE‐V3) between placebo and treatment arm