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

Conditions

• Erythema Nodosum Leprosum

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Dovramilast — DRUG
  Dovramilast
• Prednisolone — DRUG
  Standard of care
• Thalidomide — DRUG
  Standard of care (US only)

Study Details

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.

Key Dates

Start date

May 25, 2026

Status verified

May 2026

Primary completion

Jan 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

45 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Dovramilast 100 mg
• Experimental: Dovramilast 150 mg
• Active Comparator: Standard of care
  Prednisolone (or thalidomide US sites only)

Primary Outcome Measure

The proportion of dovramilast (100 mg or 150 mg) recipients achieving a 75% improvement in leprosy type 2 reaction skin lesions at week 12 [ Time Frame: 12 weeks ]

Locations (1)

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