Divo

Researchers are studying dovramilast, an experimental drug not yet approved for leprosy type 2 reaction erythema nodosum leprosum, ENL, to compare its effects with current standard treatments. The study focuses on adults with moderate to severe acute or recurrent leprosy type 2 reaction to evaluate the safety and efficacy of two doses of dovramilast, 100 mg and 150 mg. This Phase 2 trial aims to understand how well these doses improve skin lesions and assess any adverse effects. Participants will be randomly assigned to receive either 100 mg or 150 mg of dovramilast or standard care, which includes prednisolone or thalidomide in US sites only. The treatment period lasts 12 weeks, during which the responses to these interventions are monitored. The study is open-label, meaning both researchers and participants know which treatment is given. The trial includes a dose-ranging design to evaluate different strengths of dovramilast. During the 12-week trial, participants will undergo assessments including skin lesion evaluations, fever resolution, and neuropathy changes. Researchers will use the ENLIST severity scale and monitor the need for rescue medications. Safety is closely monitored by tracking adverse events. Additional follow-up up to 48 weeks will assess recurrences and drug exposure. Participants will be regularly evaluated with laboratory tests and photographic assessments to measure outcomes and ensure adherence.