Guselkumab In Patients With Oral Lichen Planus - An open label, parallel, randomized, multi- center, phase II trial

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 45

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-sterilized 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.

Exclusion Criteria

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, hemoglobin, AST and 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) within4 weeks days prior to treatment*
7. Known hypersensitivity, intolerance or allergy against Guselkumab, to human immunoglobulin (Ig) proteins, mAbs, or antibody fragments
8. Live vaccine within the 12 weeks before first IMP application, 12 weeks after the last IMP application or a planned vaccination during the study. NOTE: for inactivated vaccine, as for SARS-CoV2 and Influenza vaccination, there is no timely limit
9. pregnancy
10. Breastfeeding
11. Concomitant therapy with immunosuppressive drugs, biologics or phototherapy
12. Patients with an increased risk of respiratory infections (e.g. patients with chronic obstructive pulmonary disease)
13. Participation in any other interventional clinical trial within the three months before first study treatment.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective is to evaluate the 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 Outcome Measures

Name	Time	Method
Pharmacodynamics, Association between the mechanistical responders/ improvement and the clinical improvement, Quality of Life, Safety, immunological read outs