Ignite Creation Date:
2025-12-24 @ 2:51 PM
Ignite Modification Date:
2025-12-24 @ 2:51 PM
Study NCT ID:
NCT07172659
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-23
First Post:
2025-08-07
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Study of Dovramilast in People With Leprosy Type 2 Reaction
Sponsor:
Medicines Development for Global Health
Organization:
Study Overview
Official Title:
A 12-week, Open-label, Randomized, Standard of Care Controlled, Dose-ranging Safety and Efficacy Study of Dovramilast in People With Moderate to Severe Acute or Recurrent Leprosy Type 2 Reaction
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: