Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-25 @ 1:27 PM
Study NCT ID:
NCT06282159
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-07
First Post:
2023-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 2 Study to Evaluate DNTH103 in Adults With Generalized Myasthenia Gravis (MAGIC)
Sponsor:
Dianthus Therapeutics
Organization:
Study Overview
Official Title:
A Phase 2, Randomized, Blinded, Placebo-Controlled, Study to Evaluate Safety, Tolerability, Pharmacometrics, and Efficacy of DNTH103 in Adults With Generalized Myasthenia Gravis (MAGIC)
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-10
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:
MAGIC
Brief Summary:
The purpose of this Phase 2 study is to evaluate the safety, tolerability, pharmacometrics, and efficacy of DNTH103 in participants with generalized myasthenia gravis (gMG).
Detailed Description:
The study includes the following periods:
* Screening (up to 10 weeks)
* Randomized, blinded, controlled treatment (RCT) period (13 weeks)
* Open-label extension (OLE) period (optional) for eligible participants (52 weeks)
* Safety follow-up (40 weeks)
* Screening (up to 10 weeks)
* Randomized, blinded, controlled treatment (RCT) period (13 weeks)
* Open-label extension (OLE) period (optional) for eligible participants (52 weeks)
* Safety follow-up (40 weeks)
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2024-512865-15-00 | CTIS | None | View |