Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2025-12-29 @ 12:11 AM
Study NCT ID:
NCT06997159
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-30
First Post:
2025-05-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial to Investigate Efficacy, Safety and Pharmacokinetics (PK) of Two LXE408 Oral Regimens and Oral Miltefosine as Active Control in Participants Aged ≥ 18 Years Old With Localized Cutaneous Leishmaniasis in the Region of the Americas (AMR).
Sponsor:
Drugs for Neglected Diseases
Organization:
Study Overview
Official Title:
A Randomized, Multicentre, Observer-blind Phase II Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of Two LXE408 Regimens and Miltefosine as an Active Control in Patients With Localized Cutaneous Leishmaniasis in the Region of the Americas (AMR).
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this clinical trial is to measure efficacy, safety and pharmacokinetics (PK) of two LXE408 oral regimens and oral miltefosine tablets as active control in localized cutaneous leishmaniasis in the region of the Americas (AMR), and assess its suitability for use in monotherapy for the treatment of patients with cutaneous leishmaniasis (CL).
Detailed Description:
Participants who met all inclusion criteria and none of the exclusion criteria will be randomized to the study will be allocated to one of three arms in a 2:2:1 ratio.
* Arm 1: LXE408 BID for 14 days followed by placebo BID for 14 days
* Arm 2: LXE408 BID for 28 days
* Arm 3: Miltefosine 50 mg PO TID for 28 days orally
Each arm will consist of a screening period of up to 15 days, a 28-day treatment period, and a follow-up period from Day 29 to Day 180. During the treatment period, all participants will return to the sites at Days 1, 8, 15, 22 and 29 (+/- 2 days). During the follow-up period they will return for the Day 63 (+/- 7 days), Day 90 (+/- 7 days) and Day 180 (+/- 14 days) visits. If at D90 participants present a re-epithelization of the ulcer(s) more or equal to 75% but less than 100%, they will be asked to return at D105 for a late responder assessment.
* Arm 1: LXE408 BID for 14 days followed by placebo BID for 14 days
* Arm 2: LXE408 BID for 28 days
* Arm 3: Miltefosine 50 mg PO TID for 28 days orally
Each arm will consist of a screening period of up to 15 days, a 28-day treatment period, and a follow-up period from Day 29 to Day 180. During the treatment period, all participants will return to the sites at Days 1, 8, 15, 22 and 29 (+/- 2 days). During the follow-up period they will return for the Day 63 (+/- 7 days), Day 90 (+/- 7 days) and Day 180 (+/- 14 days) visits. If at D90 participants present a re-epithelization of the ulcer(s) more or equal to 75% but less than 100%, they will be asked to return at D105 for a late responder assessment.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CLXE408C12201R | OTHER | Novartis | View |