The Efficacy and Safety of Deucravacitinib to that of Methotrexate, in Patients with Vulvar Lichen Planus who have Failed Topical Therapy with Potent Corticosteroids: A Randomized Controlled Trial

Exclusion Criteria15

• Those with a lichen sclerosus / lichen planus overlap.
• Patients receiving other systemic immune-modulating therapy within the previous 4 weeks.
• Has cancer or history of cancer (solid organ, hematologic including myelodysplastic syndrome or melanoma in situ) or lymphoproliferative disease within the previous 5 years (other than resected cutaneous basal cell or squamous cell carcinoma, or carcinoma of cervix in situ that has been treated with no evidence of recurrence).
• Premalignant cervical or vulvar disease.
• Live vaccine administration within the last 4 weeks.
• The concomitant use of strong CYP3A4 enzyme inducers.
• Inadequate birth control (if pre-menopausal), pregnancy, planning pregnancy during the study period and/or breast-feeding.
• A past medical history of depression and/or suicidal ideation. If these are reported on screening questions, then the subject will undergo a Patient Health Questionnaire 8 items (PHQ-8) excluding those when the total score is >=15.
• Patients with severe renal/liver impairment or concurrent medications that would interact with the trial medications.
• Patients with active tuberculosis (TB), including any symptoms or signs, or imaging showing active TB, or latent TB determined by a positive IFN-gamma release assay and including current treatment for latent TB.
• Patients with other serious infections, defined by evidence of active infection or febrile illness within 7 days prior to day 1; a history of serious bacterial, fungal, or viral infection requiring hospitalization and/or intravenous antimicrobial intervention within 60 days prior to Day 1; any ongoing evidence of chronic, bacterial infection (e.g. chronic pyelonephritis, chronic osteomyelitis, chronic bronchiectasis); a history of prosthetic joint infection where the prosthesis was not removed; Active herpes simplex virus or herpes zoster infection at Day 1; positive test for hepatitis B virus (positive HBsAg, HBcAb); Evidence of, or test positive for, hepatitis C virus (HCV) at Screening (anti-HCVAb), positive for human immunodeficiency virus by antibody testing (HIV-1 and -2 Ab).
• Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant’s immune status (e.g. history of opportunistic infections [e.g. Pneumocystis jirovecii pneumonia, histoplasmosis, or coccidioidomycosis], history of splenectomy, primary immunodeficiency).
• Severe SARS-CoV-2 infection (e.g. worsened shortness of breath and pneumonia) within 4 weeks prior to Screening. Additionally, in the case of prior SARS-CoV-2 infection, symptoms must have completely resolved and based on Investigator assessment in consultation with the clinical trial physician, there are no sequelae that would place the participant at a higher risk of receiving investigational intervention.
• Any history of hypersensitivity to the active substance(s) or to any of the excipients of deucravacitinib or methotrexate.
• Participation in another trial that could affect the current study.