Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06524687
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-23
Brief Title:
A Study of Imvotamab in Active Refractory Idiopathic Inflammatory Myopathies
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1b Open-Label Study to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of Imvotamab in Adult Participants With Active Refractory Moderate-Severe Idiopathic Inflammatory Myopathies
Status:
RECRUITING
Status Verified Date:
2024-07
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 study is to determine the safety and tolerability of imvotamab in patients with Moderate-Severe Idiopathic Inflammatory Myopathies who have failed prior therapies
Participants will be given imvotamab through a vein ie intravenously
Participants will be given imvotamab through a vein ie intravenously
Detailed Description:
This is a Phase 1b open-label study to determine the safety tolerability pharmacokinetics PK and pharmacodynamics PD of imvotamab in adult participants with active refractory moderate-severe Idiopathic Inflammatory Myopathies Approximately 5-10 participants will be assigned
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None