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

Recruiting Phase 2 Interventional Study
Erythema Nodosum Leprosum
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
45 (estimated)
Sponsor
Medicines Development for Global Health · Other
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About This Trial
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 treatment…
Trial Locations
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Eligibility Criteria
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 ep…
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