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

Phase 2

• Conditions: Vulvar Lichen Planus; Skin - Dermatological conditions

• Registration Number: ACTRN12623000682640
• Lead Sponsor: Dr Rebecca Bronwyn Saunderson

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-06-26
• Last Update Posted: 10 July 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 116

Inclusion Criteria

Female
-18 years or older
-Histopathologically confirmed vulvar lichen planus (VLP), or fulfils diagnostic criteria developed by Wu et al. (2020) or Simpson et al. (2013)
-Moderate to severe VLP, determined by GELP score >=5, of which erythema and pain have to score >=1

Exclusion Criteria

-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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified