Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06371417
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-04-04
Brief Title:
Phase 1b Trial of RAY121 in Immunological Diseases RAINBOW Trial
Sponsor:
Chugai Pharmaceutical
Organization:
Chugai Pharmaceutical
Study Overview
Official Title:
Phase 1b Open-label Basket Trial of RAY121 to Inhibit Classical Complement Pathway in Immunological Diseases RAINBOW Trial
Status:
RECRUITING
Status Verified Date:
2024-07
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:
This Phase 1b basket trial will investigate the safety tolerability pharmacokinetics pharmacodynamics immunogenicity and preliminary efficacy of RAY121 a inhibitor of classical complement pathway after multiple dose administration in patients with immunological diseases such as antiphospholipid syndrome APS bullous pemphigoid BP Behçets Syndrome BS dermatomyositis DM immune-mediated necrotizing myopathy IMNM and immune thrombocytopenia ITP
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