Ignite Creation Date:
2024-07-17 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06499285
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-07-05
Brief Title:
The Efficacy and Safety of Elritercept in Adult Participants With Very Low Low or Intermediate Risk Myelodysplastic Syndromes MDS With Anemia RENEW
Sponsor:
Keros Therapeutics Inc
Organization:
Keros Therapeutics Inc
Study Overview
Official Title:
A Phase 3 Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elritercept KER-050 for the Treatment of Transfusion-Dependent Anemia in Adult Participants With Very Low- Low- or Intermediate-Risk Myelodysplastic Syndromes MDS RENEW
Status:
NOT_YET_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:
KER-050-D301 is a Phase 3 double-blind randomized placebo-controlled study to evaluate the efficacy and safety of KER-050 versus placebo in adult participants with transfusion-dependent anemia with very low low or intermediate risk MDS or more recently defined as myelodysplastic neoplasms with or without ring sideroblasts The study is divided into the Screening Period Treatment Period Safety Follow-Up Period and Long-term Follow-up Period
Detailed Description:
This is a Phase 3 double-blind randomized placebo-controlled study of KER-050 where participants will be randomized and enter the Primary Phase of the Double-blind Treatment Period Participants will be randomly assigned in a 21 ratio to receive either KER-050 or placebo subcutaneously SC every 4 weeks Q4W Participants will be stratified according to their RS status RS-positive versus non-RS and baseline transfusion burden LTB versus HTB during the Screening Period The Primary Phase of the Double-blind Treatment Period will last up to 24 weeks Study visits will occur approximately every 2 weeks during the first 24 weeks and approximately every 4 weeks thereafter For participants to remain on double-blind treatment they must meet the criteria outlined in the MDS disease assessment criteria every 24 weeks Based on the outcome of the Week 24 MDS disease assessment participants will either continue in the Extension Phase of the Double-blind Treatment Period or will be discontinued from treatment and proceed to End of Treatment and then into the Safety Follow-up Period
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