Ignite Creation Date:
2024-05-06 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 2:21 PM
Study NCT ID:
NCT05183646
Status:
RECRUITING
Last Update Posted:
2023-10-26
First Post:
2021-11-29
Brief Title:
A Study of the Efficacy and Safety of DMX-200 in Patients With FSGS Who Are Receiving an ARB
Sponsor:
Dimerix Bioscience Pty Ltd
Organization:
Dimerix Bioscience Pty Ltd
Study Overview
Official Title:
A Pivotal Phase 3 Multicenter Randomized Double-blind Placebo-controlled Study of the Efficacy and Safety of DMX-200 in Patients With Focal Segmental Glomerulosclerosis FSGS Who Are Receiving an Angiotensin II Receptor Blocker ARB
Status:
RECRUITING
Status Verified Date:
2023-10
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:
ACTION3
Brief Summary:
DMX-200 repagermanium is a C-C chemokine receptor type 2 CCR2 inhibitor that when administered concurrently with an ARB is designed to inhibit recruitment of monocytes implicated in the inflammatory chemokine environment of chronic disease The purpose of this pivotal randomized double-blind study is to investigate the efficacy and safety of DMX-200 120 mg twice daily BID compared with placebo over a treatment period of 104 weeks in adult patients with FSGS who are being treated with an ARB Given the rarity of the disease and the similarities between adults and pediatric patients with FSGS Dimerix will also investigate the efficacy and safety of DMX 200 in adolescents aged 12 to 17 years The double-blind period will be followed by an open-label extension OLE which aims to assess the long-term efficacy and safety of DMX 200 for up to 2 additional years
Detailed Description:
This is a pivotal Phase 3 multicenter randomized double-blind placebo-controlled study of the efficacy and safety of DMX-200 in patients with FSGS The duration of the double-blind period per patient is estimated to be maximum of 122 weeks a Screening and Qualification period of between 6 and 14 weeks including a 4 week period to complete the assessments required for Screening Titration if required up to 4 weeks and 6-weeks of Stabilization a 104-week Treatment period and up to a 4-week off-treatment Follow-up period The treatment duration of the OLE period per patient is estimated to be a minimum of 104 weeks 2 years with a 4-week off-treatment Follow-up period The total study duration double-blind period and OLE combined is currently estimated to be a minimum of 230 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?:
False
Is an FDA AA801 Violation?:
None