drugset / Trial / NCT07172659
Efficacy and Safety Study of Dovramilast in People With Leprosy Type 2 Reaction
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2026-05-25
- Primary completion
- 2027-01
- Completion
- 2027-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dovramilast | Small molecule | 100 mg | — |
| Subject | Dovramilast | Small molecule | 150 mg | — |
| Comparator | Prednisolone | Other / unclassified | — | — |
| Comparator | Thalidomide | Other / unclassified | — | — |