Ignite Creation Date:
2024-07-17 @ 10:55 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06463587
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-06-11
Brief Title:
Efficacy and Safety of a New Formulation of Oral Cladribine Compared With Placebo in Participants With Generalized Myasthenia Gravis MyClad
Sponsor:
Merck Healthcare KGaA Darmstadt Germany an affiliate of Merck KGaA Darmstadt Germany
Organization:
Merck Healthcare KGaA Darmstadt Germany an affiliate of Merck KGaA Darmstadt Germany
Study Overview
Official Title:
A Phase 3 Randomized Double-Blind Placebo-Controlled 3-Arm 3-Period Study to Assess the Efficacy and Safety of a New Formulation of Oral Cladribine Compared With Placebo in Participants With Generalized Myasthenia GravisMyClad
Status:
RECRUITING
Status Verified Date:
2024-09
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:
The purpose of this clinical study is to determine the efficacy and safety of a new oral cladribine formulation in participants with Generalized Myasthenia Gravis gMG in comparison to placebo It will also investigate the sustained efficacy the need for retreatment and the long-term safety of oral cladribine in gMG An additional component is included to characterize the Pharmacokinetics PK of the new cladribine formulation in gMG participants This study is divided into 3 periods the double-blind placebo control DBPC pivotal period and 2 extensions the blinded extension BE and the retreatment RT period
Detailed Description:
None
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-507746-83-00 | OTHER | None | None |