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

NCT07492251 | Not Yet Recruiting Phase 2

• 1 other identifier: 25-PP-10
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Lichen Penis Planus

Outcome Measures

Primary Outcomes (1)

• Efficacity of treatement

  To assess the clinical efficacy of upadacitinib 30 mg QD in subjects with erosive MLP and in subjects with LPP when compared to placebo after 16 weeks of treatment.It's the number of patients who will have had an IGA score (Investigator Global Assessment) of \<2 after 16 weeks of treatment

  At 16 weeks

Secondary Outcomes (1)

• Tolerance of Upadacitinib

  At 32 weeks

Study Arms (2)

Drug

EXPERIMENTAL

28 patients for each condition (56 total) to upadacitinib 30mg QD for 16 weeks.

Drug: Upadacitinib

Placebo

PLACEBO COMPARATOR

28 patients to placebo n30mg QD for 16 weeks.

Drug: Placebo

Interventions

Upadacitinib DRUG

28 Patients will received to upadacitinib 30mg QD for 16 weeks. Participants will continue in the open-label study phase, where they will receive upadacitinib 30mg QD for a further 16 weeks.

Drug

Placebo DRUG

28 patients will received 30mg QD placebo for 16 weeks. Participants will continue in the open-label study phase, where they will receive upadacitinib 30mg QD for a further 16 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 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).

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (5)

CHU de Nice

Nice, Alpes Maritimes, 06200, France

Location

APHP

Paris, France

Location

Centre privé de Dermatologie

Reims, France

Location

CHU de Rouen

Rouen, France

Location

CHU de Tours

Tours, France

Location

MeSH Terms

Interventions

upadacitinib

Study Officials

• Thierry Passeron, PhD

  CHU de Nice, Hôpital Archet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thierry Passeron, PhD

CONTACT

+33492034924; passeron.t@chu-nice.fr

Ruxanda Moschoi

CONTACT

moschoi.r@chu-nice.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 25, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

FR (5)