Ignite Creation Date:
2024-05-06 @ 10:51 AM
Last Modification Date:
2024-10-26 @ 12:36 PM
Study NCT ID:
NCT03368664
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-09-21
First Post:
2017-11-02
Brief Title:
A Study to Evaluate Efficacy Safety and Tolerability of Alemtuzumab in Pediatric Patients With RRMS With Disease Activity on Prior DMT
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
A Multi-center Open-label Single-arm Before and After Switch Study to Evaluate the Efficacy Safety and Tolerability of Alemtuzumab in Paediatric Patients With Relapsing Remitting Multiple Sclerosis RRMS With Disease Activity on Prior Disease Modifying Therapy DMT
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-09
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:
LemKids
Brief Summary:
Primary Objective
To evaluate the efficacy safety and tolerability of alemtuzumab intravenously IV in pediatric participants from 10 to less than 18 years of age with Relapsing Remitting Multiple Sclerosis RRMS who have disease activity on prior DMT
Secondary Objective
To assess the pharmacokinetics PK pharmacodynamics PD anti-drug antibody ADA formation and potential effects of alemtuzumab on other multiple sclerosis MS disease characteristics such as cognition and quality of life QoL
To evaluate the efficacy safety and tolerability of alemtuzumab intravenously IV in pediatric participants from 10 to less than 18 years of age with Relapsing Remitting Multiple Sclerosis RRMS who have disease activity on prior DMT
Secondary Objective
To assess the pharmacokinetics PK pharmacodynamics PD anti-drug antibody ADA formation and potential effects of alemtuzumab on other multiple sclerosis MS disease characteristics such as cognition and quality of life QoL
Detailed Description:
The duration of study per participant will be approximately 5 years and 5 months
Study Oversight
Has Oversight DMC:
None
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?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1180-6352 | OTHER | UTN | None |
| 2016-003100-30 | EUDRACT_NUMBER | None | None |