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

Conditions

• Lichen Penis Planus

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

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.
• 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.

Study Details

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 Dates

Start date

Jun 1, 2026

Status verified

Mar 2026

Primary completion

Feb 1, 2028

Completion

Aug 1, 2028

Study Design

Enrollment

56 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Drug
  28 patients for each condition (56 total) to upadacitinib 30mg QD for 16 weeks.
• Placebo Comparator: Placebo
  28 patients to placebo n30mg QD for 16 weeks.

Primary Outcome Measure

Efficacity of treatement [ Time Frame: At 16 weeks ]

Central Contacts

• Thierry Passeron, PhD
  +33492034924
  [email protected]
• Ruxanda Moschoi
  [email protected]