severe oral lichen planus (LP) with variable phenotype (erosive, ulcerating, hyperplastic/leucoplastic, and combined forms) MedDRA version: 20.1 Level: PT Classification code 10030983 Term: Oral lichen planus System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Trade Name: Tremfya
Product Name: Guselkumab
Pharmaceutical Form: Solution for infusion in pre-filled syringe
Sponsors
Philipps University Marburg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent form 2. Capability and willingness to comply with study procedures 3. Adult patients = 18 years 4. Moderate to severe Oral LP with variable phenotype (erosive, ulcerating, hyperplastic/leukoplakic, and combined forms and other side manifestations like skin manifestations) 5. Oral involvement = 3 month 6. Escudier-Score = 10 7. Histology characteristic for LP 8. Refractory to topical therapy with high-potency glucocorticoids (group I, II, III as per WHO definition) 9. For women of child-bearing potential: a negative result in a pregnancy test AND agreement to practice a highly effective method of contraception during the entire period from informed consent up to 90 days after the last administration of the IMP. 10. For non-sterilised males who are sexually active with a female partner of child-bearing potential: Agreement to practice highly effective methods of contraception during the entire period from first study intervention up to 90 days after the last administration of the IMP Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: 1. 1. Subjects with either a chronic infection, a prior history of recurrent infection, or a clinically important active infection (e.g. active tuberculosis) should not be administered Guselkumab. 2. History of latent tuberculosis 3. Patients with clinical relevant illnesses (e.g. severe renal, heart and/ or liver insufficiency, malignancies) and clinical relevant changes in lab parameter (e.g. WBC, absolute neutrophile count, hemoglobin, AST/ALT, bilirubin) 4. History of any malignancy or obligatory precancerous condition of any organ system other than cervical carcinoma of Stage 1B or less, or non-invasive basal cell carcinoma of the skin in the last 5 years before IMP administration 5. Patients tested positive for hepatitis B virus (HBV) infection, hepatitis C virus (HCV) or human immunodeficiency viruses (HIV) 6. Systemic/topical glucocorticoids of high - ultrahigh potency (group I, II, III as per WHO definition) within 4 weeks days prior to treatment* 7. Severe hypersensitivity, intolerance or allergy against Guselkumab, to human immunoglobulin (Ig) proteins, mAbs, or antibody fragments 8. Live or inactive vaccine within the 28 days before first study treatment, or a planned vaccination during the study. NOTE: SARS-CoV2 and influenza vaccinations may be performed at the earliest 28 days before or after the last IMP treatment 9. Breastfeeding 10. Concomitant therapy with immunosuppressive drugs, biologics or phototherapy 11. Patients with an increased risk of respiratory infections (e.g. patients with chronic obstructive pulmonary disease)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy of Guselkumab treatment on mucosal T-cell infiltration 12 weeks after study entry in patients with oral lichen planus (LP) with different phenotypes (erosive, ulcerative, hyperplastic / leukoplastic and combined forms) ;Secondary Objective: Pharmacodynamics, Association between the mechanistical responders/ improvement and the clinical improvement, Quality of Life, Safety, immunological read outs ;Primary end point(s): The primary endpoint is the proportion of patients who experience a 50% reduction in the relative number (of total CD3+ T cells) of IL-17+ CD4+ and IL-17+ CD8+ T cells in mucosal biopsies at week 12 compared to week 0 (pre-treatment). For the sake of simplicity, these patients will be called “responders” in the statistical section. The responder rates will be compared between the two groups (waiting list and verum) ;Timepoint(s) of evaluation of this end point: week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Pharmcodynamics 2)Association between the mechanistical responders/ improvement and the clinical improvement 3)Quality of Life 4)Safety Immunolgical read-outs ;Timepoint(s) of evaluation of this end point: 1. Pharmacodynamics of Guselkumab in patients with oral LP (Week 0 vs. 12 and 24) 2. Association between the mechanistical responders/ improvement and the clinical improvement (comparison week 12 and 24) 3. Quality of Life (Patient reported Outcomes) in patients with oral LP treated with Guselkumab (Weeks 0, 4, 12, 20, 24) 4. Safety (throughout study) | — |
Countries
Germany
Contacts
Public ContactNelli Ens-Jäger
Koordinierungszentrum für Klinische Studien (KKS) Marburg
Outcome results
None listed