Upadacitinib in Adult Patients With Erosive Mucosal Lichen Planus and Lichen Planopilaris: a Prospective Multicenter Randomized Placebo-controlled Study.

Starting soon · Phase 2 · Has a placebo group

Conditions studied: Lichen Penis Planus

In brief

Lichen planus (LP) is a common immune-mediated skin disease with a prevalence of 1-2% in the general population. It can present with a broad spectrum of clinical manifestations affecting primarily the skin (cutaneous LP \[CLP\]), the mucosae (mucosal LP \[MLP\]), hair follicles (lichen planopilaris \[LPP\]), or nails (nail lichen planus (NLP). The often treatment-refractory nature of the disease, the pronounced itch of CLP lesions, the pain of erosive MLP lesions, and the visible impact of NLP or LPP induced hair loss are well reflected by the poor quality of life (QoL) of patients with LP. There is no treatment for LP approved by the Food and Drug Administration (FDA) or European Medicines Agency (EMA). The pathogenesis of LP is now better understood. LP lesions are infiltrated with T cells, including CD8+ and CD4+ populations. CD8+ T cells, mainly located around the basal layer of the epidermis, can trigger apoptosis of epidermal keratinocytes. Recent data underline the role of the Th1 response in LP suggesting that oral inhibitors of Janus Kinase 1 (JAK1) could be of interest. This is supported by isolated cases and open series of successful treatment of CLP, erosive MLP and LPP by several topical and oral JAK inhibitors (JAKi), including upadacitinib. However, the results are variable depending on patient characteristics, type of JAKi and doses used. Upadacitinib is a selective JAK1 inhibitor and provides a good safety profile. We hypothesize that it could be an effective option for LPP and erosive MLP, the most severe and disabling forms of LP. This is a multicenter, randomized, double-blind, placebo-controlled, parallel- group trial assessing the efficacy and safety of upadacitinib 30 mg in patients with biopsy-proven LPP or erosive MLP.

Key facts

Study ID: NCT07492251
Run by: Centre Hospitalier Universitaire de Nice
People needed: 56
Starts: 2026-06-01
Expected to finish: 2028-08-01
Last updated by the study team: 2026-03-25

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Written informed consent must be obtained before any assessment is performed
Female and male patients ≥ 18 years and < 65 years old at Baseline Visit
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:
Rated IGA of ≥ 3 (moderate or severe) AND
Inadequate response to topical corticosteroids of high - ultrahigh potency in the opinion of the investigator
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.

You may not qualify if…

Clinical history suspicious for lichenoid drug eruption
Clinical picture or history suspicious of paraneoplastic mucosal lichen planus
Mucosal lichen planus of the oral cavity or gastrointestinal involvement requiring the patient to use parenteral nutrition or feeding tube
Clinical picture of burnt-out cicatricial alopecia (alopecia of Brocq)
Patients diagnosed with frontal fibrosing alopecia (FFA) without active patches of LPP
History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months prior to Baseline.
Meeting any of the following conditions at Baseline:
Three or more prior episodes of herpes zoster, or one or more episodes of disseminated herpes zoster;
One or more prior episodes of disseminated herpes simplex (including eczema herpeticum);
Human immunodeficiency virus (HIV) infection, defined as confirmed positive anti-HIV antibody (HIV Ab) test or a positive HIV Ab/Ag test
Active tuberculosis (TB) or meet TB exclusionary parameters;
Active infection(s) requiring treatment with intravenous anti-infectives within 30 days, or oral/intramuscular anti-infectives within 14 days prior to the Baseline Visit;
Chronic recurring infection and/or active viral infection that, based on the investigator's clinical assessment, makes the subject an unsuitable candidate for the study;
Hepatitis B virus (HBV) and hepatitis C virus (HCV) screening values that meet the following criteria at the most recent testing prior to the first dose of study treatment:
HBV: hepatitis B surface antigen (HBs Ag) positive (+) test or detectable HBV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) qualitative test for subjects who are hepatitis B core antibody (HBc Ab) positive (+);
HCV: detectable HCV ribonucleic acid (RNA) in any subject with anti-HCV antibody (HCV Ab).
At Baseline any of the following medical diseases or disorders:
Recent (within past 6 months) cerebrovascular accident, myocardial infarction, coronary stenting, aorto-coronary bypass surgery, or venous thromboembolism;
History of an organ transplant which requires continued immunosuppression;
History of an allergic reaction or significant sensitivity to constituents of the study drug and/or other products in the same class;
History of gastrointestinal (GI) perforation (other than due to appendicitis or mechanical injury), diverticulitis, or significantly increased risk for GI perforation per investigator judgment;
Conditions that could interfere with drug absorption including but not limited to short bowel syndrome or gastric bypass surgery (including sleeve gastrectomy); subjects with a history of gastric banding/segmentation are not excluded;
History of malignancy except for successfully treated non-melanoma skin cancer (NMSC) or localized carcinoma in situ of the cervix;
Females of child-bearing potential who meet the following criteria for pregnancy testing:
Subjects with a positive serum pregnancy test at the Screening Visit or a positive urine pregnancy test at Baseline prior to the first dose of study treatment (local practices may require serum pregnancy testing at Baseline).

Where it is running

CHU de Nice — Nice, Alpes Maritimes, France
APHP — Paris, France
Centre privé de Dermatologie — Reims, France
CHU de Rouen — Rouen, France
CHU de Tours — Tours, France

Full record on ClinicalTrials.gov

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