Patients with the chronic inflammatory skin disease Lichen planus will be treated with the JAK inhibitor upadacitinib. MedDRA version: 20.1 Level: PT Classification code 10030983 Term: Oral lichen planus System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Product Name: Upadacitinib
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Upadacitinib
Other descriptive name: RINVOQ
Concentration unit: mg milligram(s)
Concentration type: equal
Sponsors
Charité - Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with diagnosis of acute or chronic (>3 months) Lichen planus and with a clinical presentation and histopathology consistent (performed within 6 months prior to screening) with Lichen planus. 2. Patients with moderate to severe disease and Investigator Global Assessment (IGA) score = 3 (scale of 0 to 4) at screening and baseline visit. 3. Patient with involvement of the oral cavity (with at least one target lesion of oral lichen planus). 4. Male or female patient aged 18 to 65 years old. 5. Patients with body weight = 40 kg and = 120 kg. 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 22 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Presence of skin comorbidities that may interfere with the study assessments. 2. Evidence of acute contact dermatitis at screening. 3. Evidence of other Lichen planus variants including but not limited to hypertrophic, atrophic, follicular (including lichen planopilaris), and bullous cutaneous forms. Evidence of asymptomatic reticulate or hypertrophic oral Lichen planus. 4. History of allergy to any component of the study medication. 5. Women of childbearing potential who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 12 weeks after the last dose. 6. Pregnant or breastfeeding women or planning to become pregnant or breastfeed during the patient’s participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Therapeutic efficacy defined as the percentage of patients achieving a clinical response (IGA 0 or 1) in mucosal disease at week 12.;Timepoint(s) of evaluation of this end point: 12 weeks;Main Objective: To evaluate the efficacy of upadacitinib (Rinvoq®) therapy in patients with Lichen planus.;Secondary Objective: To evaluate the immunological response and safety of upadacitinib (Rinvoq®) therapy in patients with Lichen planus. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Improvement of the Participant self-assessment (PSA) from baseline. Improvement of the Physician Assessment of Surface Area of Disease (PSAD) from baseline. Improvement of the pain on Visual Analogue Scale (VAS) from baseline. The Improvement of pruritus (itching) on Visual Analogue Scale (VAS) from baseline. The Improvement of immunological effects of upadacitinib from baseline. Improvement of DLQI from baseline. ;Timepoint(s) of evaluation of this end point: PSA: week 2, 4, 6, 8, and 12 PSAD: week 4, 8, and 12 Pain VAS: week 4, 8, and 12 Itch VAS: week 4, 8, and 12 Immunological effects: week 12 DLQI: week 4, 8, and 12 | — |
Countries
Germany
Contacts
Public ContactAllergy Center Charité
Charité - Universitätsmedizin Berlin
Outcome results
None listed