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

NCT07492251 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2026-03-25

No results posted yet for this study

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

Interventions

DRUG

Upadacitinib

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

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.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nice

    lead OTHER

Principal Investigators

  • Thierry Passeron, PhD · CHU de Nice, Hôpital Archet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2028-02-01
Completion
2028-08-01

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07492251 on ClinicalTrials.gov