Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06210945
Status:
SUSPENDED
Last Update Posted:
2024-01-18
First Post:
2023-08-22
Brief Title:
Study to Evaluate the Safety Tolerability and Activity of CM-101 in Patients With Systemic Sclerosis
Sponsor:
ChemomAb Ltd
Organization:
ChemomAb Ltd
Study Overview
Official Title:
A Phase 2 Multicenter Randomized Double-Blind Proof of Biology Study to Evaluate the Safety Tolerability and Activity of CM-101 in Patients With Systemic Sclerosis
Status:
SUSPENDED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
pending financial resources
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ABATE
Brief Summary:
This study is designed to assess the safety and tolerability of the anti-human CCL24 monoclonal antibody CM-101 in adult patients with systemic sclerosis SSc Approximately 45 patients at approximately 40 sites will be randomized in a 21 ratio to receive either 10 mgkg CM-101 or placebo
Detailed Description:
This study will consist of a screening period double-blind treatment period open-label treatment period and safety follow-up Approximately 45 patients will be randomized in a 21 ratio to receive either 10 mgkg CM-101 or placebo The study drug or placebo will be administered as a 60-minute intravenous IV infusion once every 3 weeks for a treatment coverage of 24 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?:
None