Proof of concept study (multicenter, phase II) on the efficacy of the selective TYK2 inhibitor Deucravacitinib in Lichen planus patients (DEUCRALIP)

Conditions

Lichen planus

Brief summary

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)

Detailed description

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, Differences in IFN gene expression profile (CXCL10, CXCL9, CCL5, MxA, BLyS, TRAIL etc.) in peripheral blood and skin or (only in case of solely oral involvement) in lesional oral mucosa (BOS/V1, EOS/V4, OLE-V3) between placebo and treatment arm, Change in IFN gene expression profile (CXCL10, CXCL9, CCL5, MxA, BLyS, TRAIL etc.) in peripheral blood and skin or (only in case of solely oral involvement) in lesional oral mucosa (BOS/V1 vs EOS/V4 vs OLE-V3) in both arms, Change of DLQI from baseline (V1) to EOS (V4) between placebo and treatment arm, Change of DLQI from baseline (V1) to V3, V4/OLE-V1, SC-1, SC-2, OLE-V2, SC-3, OLE-V3 in both arms, Change of Itch NRS from baseline (V1) to EOS (V4) between placebo and treatment arm, 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, Change in the amount of steroids used from baseline (V1) to EOS (V4) between placebo and treatment arm

Related papers

No related papers found yet.

Interventions

DRUGProduct name: Placebo to match deucravacitinib 6mg Name of manufacturer: Bristol-Myers Squibb (BMS) Ingredients: Lactose monohydrate

DRUGmicrocrystalline cellulose

DRUGmagnesium stearate

DRUGand Opadry II coating Pharmaceutical form: Film-coated tablet

DRUGAge-appropriate oral solid dosage form

DRUGDEUCRAVACITINIB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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, Differences in IFN gene expression profile (CXCL10, CXCL9, CCL5, MxA, BLyS, TRAIL etc.) in peripheral blood and skin or (only in case of solely oral involvement) in lesional oral mucosa (BOS/V1, EOS/V4, OLE-V3) between placebo and treatment arm, Change in IFN gene expression profile (CXCL10, CXCL9, CCL5, MxA, BLyS, TRAIL etc.) in peripheral blood and skin or (only in case of solely oral involvement) in lesional oral mucosa (BOS/V1 vs EOS/V4 vs OLE-V3) in both arms, Change of DLQI from baseline (V1) to EOS (V4) between placebo and treatment arm, Change of DLQI from baseline (V1) to V3, V4/OLE-V1, SC-1, SC-2, OLE-V2, SC-3, OLE-V3 in both arms, Change of Itch NRS from baseline (V1) to EOS (V4) between placebo and treatment arm, 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, Change in the amount of steroids used	—

Measure

Time frame

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, Differences in IFN gene expression profile (CXCL10, CXCL9, CCL5, MxA, BLyS, TRAIL etc.) in peripheral blood and skin or (only in case of solely oral involvement) in lesional oral mucosa (BOS/V1, EOS/V4, OLE-V3) between placebo and treatment arm, Change in IFN gene expression profile (CXCL10, CXCL9, CCL5, MxA, BLyS, TRAIL etc.) in peripheral blood and skin or (only in case of solely oral involvement) in lesional oral mucosa (BOS/V1 vs EOS/V4 vs OLE-V3) in both arms, Change of DLQI from baseline (V1) to EOS (V4) between placebo and treatment arm, Change of DLQI from baseline (V1) to V3, V4/OLE-V1, SC-1, SC-2, OLE-V2, SC-3, OLE-V3 in both arms, Change of Itch NRS from baseline (V1) to EOS (V4) between placebo and treatment arm, 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, Change in the amount of steroids used

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Countries

Germany

Outcome results

None listed