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.
Written informed consent must be obtained before any assessment is performed
Female and male patients ≥ 18 years and < 65 years old at Baseline Visit
Rated IGA of ≥ 3 (moderate or severe) AND
Inadequate response to topical corticosteroids of high - ultrahigh potency in the opinion of the investigator
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)
Parallel
Upadacitinib
Drug28 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
Drug28 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.
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
Tolerance of Upadacitinib
To describe the safety profile of upadacitinib at 30 mg QD throughout the duration of the study. It's the numbers of indesirable current.
Click on the lead sponsor to view all of their trials.
