NCT07172659

Efficacy and Safety Study of Dovramilast in People With Leprosy Type 2 Reaction

A 12-week, Open-label, Randomized, Standard of Care Controlled, Dose-ranging Safety and Efficacy Study of Dovramilast in People With Moderate to Severe Acute or Recurrent Leprosy Type 2 Reaction

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Medicines Development for Global Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Dovramilast has not been approved for leprosy type 2 reaction (erythema nodosum leprosum, ENL) or any other disease anywhere in the world. In this study, an experimental drug called dovramilast is being tested to see how it compares to current treatments for leprosy type 2 reaction. Specifically, this study aims to assess the efficacy of 100mg or 150 mg dovramilast compared with standard treatments (also known as standard of care). This study also aims to assess the safety of two strengths in adults with leprosy type 2 reaction.

Conditions

• Erythema Nodosum Leprosum

Interventions

Type	Name	Description
DRUG	Dovramilast	Dovramilast
DRUG	Prednisolone	Standard of care
DRUG	Thalidomide	Standard of care (US only)

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-01-01
• Completion: 2027-12-01
• First posted: 2025-09-15
• Last updated: 2025-12-23

Locations

6 sites across 5 countries: United States, Benin, Côte d’Ivoire, Indonesia, Philippines

Regulatory

• FDA-regulated drug study