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

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Minor Secondary endpoints: details revised at 2 of 16 entries
    • Site details revised at 2 of 6 sites
    • Eligibility criteria expanded, about 1 word
  2. Notable Start date: May 25, 2026 to Sep 15, 2026
    • Site details revised at 1 of 6 sites
    • Eligibility criteria expanded, about 5 words
    v4
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jan 2026 to May 25, 2026
    • Study sites revised (6)
    v3
  4. Notable Start date: Oct 2025 to Jan 2026
    • Primary completion date: Dec 2026 to Jan 2027
    • Study completion date: Oct 2027 to Dec 2027
    v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07172659
Lead Sponsor Medicines Development for Global Health
Conditions
(from sponsor)
Erythema Nodosum Leprosum
Enrollment 45 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov