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

NCT07172659 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-12-23

No results posted yet for this study

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.

Conditions

  • Erythema Nodosum Leprosum

Interventions

DRUG

Dovramilast

Dovramilast

DRUG

Prednisolone

Standard of care

DRUG

Thalidomide

Standard of care (US only)

Sponsors & Collaborators

  • Medicines Development for Global Health

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2027-01-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States
  • Benin
  • Côte d’Ivoire
  • Indonesia
  • Philippines

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07172659 on ClinicalTrials.gov