The AP-GELP Study: A Clinical Trial on the Effects of Apremilast in Female Genital Erosive Lichen Planus

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

Genital erosive lichen planus (GELP) is a chronic inflammatory disease causing painful genital sores and scarring in women. Treatment options are limited and often unsatisfactory. This trial will study the effects of treatment with apremilast and quality of life and sexual function in women with GELP.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oslo University Hospital
• Collaborators: Amgen; Celgene Corporation
• Treatments: Apremilast; Thalidomide

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