Medicines Development for Global Health
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.
Inclusion Criteria: 1. Aged 18 years of age or older. 2. Provision of written informed consent. 3. Laboratory confirmed previous or current Mycobacterium leprae or Mycobacterium lepromatosis infection. 4. Leprosy type 2 reaction meeting the following criteria: * Either: i. Acute (first episode and no treatment initiated) or ii. Recurrent (at least one further episode occurring 28 days or more after withdrawal of leprosy type 2 reaction treatment). * Presence of at least 10 leprosy type 2 reaction tender papular and/or nodular skin lesions (not including scars). * An ENLIST sco…
Dovramilast
Standard of care
Standard of care (US only)