UPADACITINIB for Erosive mucosal lichen planus | Lichen planopilaris

Inclusion criteria

• {"criterion_text":"- Written informed consent must be obtained before any assessment is performed\n- Female and male patients ≥ 18 years and < 65 years old at Baseline Visit\n- Subjects must have biopsy-confirmed forms of mucosal lichen planus (MLP) or active lichen planopilaris (LPP) eligible for systemic therapy based on the following criteria: ·\tRated IGA of ≥ 3 (moderate or severe) AND ·\tInadequate response to topical corticosteroids of high - ultrahigh potency in the opinion of the investigator\n- A negative serum pregnancy test for all female subjects considered to be of childbearing potential at the Screening Visit and a negative urine pregnancy test at baseline prior to the first dose of study drug."}

Exclusion criteria

• {"criterion_text":"- Clinical history suspicious for lichenoid drug eruption\n- Clinical picture or history suspicious of paraneoplastic mucosal lichen planus\n- Mucosal lichen planus of the oral cavity or gastrointestinal involvement requiring the patient to use parenteral nutrition or feeding tube\n- Clinical picture of burnt-out cicatricial alopecia (alopecia of Brocq)\n- Patients diagnosed with frontal fibrosing alopecia (FFA) without active patches of LPP\n- Hepatitis C antibody positive at screening unless viral load is 0\n- Subjects with active TB or latent TB without history of appropriate prophylaxis"}

Primary endpoints

• {"endpoint_text":"- Achievement of IGA response (absolute IGA score ≤2) at Week 16","definition_or_measurement_approach":"Investigator Global Assessment (IGA) response defined as an absolute IGA score ≤2 measured at Week 16."}

Secondary endpoints

• {"endpoint_text":"- Achievement of 2 points improvement in the IGA at Week 32\n- Achievement of DLQI 0/1 score at Week 16 and Week 32\n- PGIS at Week 16 and Week 32\n- PGIC at Week 16 and Week 32\n- Adverse events, laboratory values, vital signs from baseline to end of study visit analysis\n- Absolute and relative change in REU, OLPSSM and NRS score at Week 16 and Week 32\n- Absolute and relative change in LPPAI and SCALPDEX Questionnaire score at Week 16 and Week 32","definition_or_measurement_approach":"Secondary endpoints measured at specified timepoints (Week 16 and Week 32) including IGA change, Dermatology Life Quality Index (DLQI 0/1), Patient Global Impression of Severity (PGIS), Patient Global Impression of Change (PGIC), safety assessments (AEs, labs, vitals), and validated score changes (REU, OLPSSM, NRS, LPPAI, SCALPDEX)."}

France

Earliest CTIS Part Ii Submission Date

10-02-2026

Latest Decision Or Authorization Date

10-04-2026

Processing Time Days

59

Number Of Sites

5

Number Of Participants

56

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Nice

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France