NCT05875714

Apremilast for Erythema Multiforme

Apremilast for the Treatment of Refractory Erythema Multiforme

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Robert Micheletti · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

This study is recruiting patients with chronic, treatment resistant erythema multiforme (EM), which is a disease that can affect the skin and mucous membranes (mucocutaneous). EM often impacts quality of life with pain, anorexia, hospitalization, and related long-term issues. While there are medications used to treat EM, no single therapeutic agent has been consistently effective for long-term management of disease. Apremilast (trade name: Otezla) is approved to treat Bechet's Disease, a different but similar mucocutaneous disease. In this study, eligible patients will receive apremilast for 6 months of treatment so we can evaluate if there is a difference in pain and the number of EM flares compared to prior to treatment with apremilast.

Conditions

• Erythema Multiforme

Interventions

Type	Name	Description
DRUG	Apremilast	Apremilast (Otezla), oral medication Day 1: 10 mg in the morning. Day 2: 10 mg in the morning and 10 mg in the evening. Day 3: 10 mg in the morning and 20 mg in the evening. Day 4: 20 mg in the morning and 20 mg in the evening. Day 5: 20 mg in the morning and 30 mg in the evening Day 6: 30 mg twice daily Maintenance dosing: 30 mg twice daily

Timeline

• Start date: 2022-01-13
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2023-05-25
• Last updated: 2025-09-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study