The AP-GELP Study: A Clinical Trial on the Effects of Apremilast in Female Genital Erosive Lichen Planus
Lichen Planus of Vulva, Female Genital Disease
About this trial
This is an interventional treatment trial for Lichen Planus of Vulva focused on measuring apremilast, genital erosive lichen planus
Eligibility Criteria
Inclusion Criteria:
- Moderate to severe GELP at inclusion with the diagnosis based on characteristic clinical and/or histological features. Minimum GELP score 5/30 in vagina and/or vulva (scored separately), of which erythema and pain ≥1 are mandatory
- Informed consent from the patient to the protocol and clinical procedures.
Exclusion Criteria:
- Patients receiving other systemic immune modulating therapy
- Concomitant use of strong CYP3A4 enzyme inducers
- Inadequate birth control, pregnancy and/or breast-feeding
- Depression and suicidal ideation
- Patients with severe renal impairment
- Patients with active tuberculosis, serious infections or cancer
- Unexplained and clinically significant weight loss in underweight patients
- Hypersensitivity to the active substance(s) or to any of the excipients
- Hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption
- Participating in another trial that might affect the current study or there should be minimum 90 days between participation in another intervention trial
Sites / Locations
- Oslo University Hospital HF
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Apremilast
Placebo + Apremilast
Week 0-24: 21 patients will receive apremilast oral tablets with initial standard titration of dose day 1-6 followed by standard dose of 30 mg apremilast b.i.d. Initial titration: Day 1: 10 mg in morning. Day 2: 10 mg in morning and 10 mg in evening. Day 3: 10 mg in morning and 20 mg in evening. Day 4: 20 mg in morning and 20 mg in evening. Day 5: 20 mg in morning and 30 mg in evening. Day 6 and thereafter: 30 mg twice daily.
Week 0-24: 21 patients will receive matching placebo oral tablets, with initial titration.