Ignite Creation Date:
2024-05-06 @ 7:20 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05975905
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2023-07-13
Brief Title:
A Study to Investigate the Safety and Efficacy of KER-012 in Combination With Background Therapy in Adult Participants With Pulmonary Arterial Hypertension PAH TROPOS Study
Sponsor:
Keros Therapeutics Inc
Organization:
Keros Therapeutics Inc
Study Overview
Official Title:
A Randomized Phase 2 Double-blind Placebo-controlled Study to Investigate the Safety and Efficacy of KER-012 in Combination With Background Therapy in Adult Participants With Pulmonary Arterial Hypertension TROPOS Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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:
Study KER-012-A201 is Phase 2 double-blind randomized placebo-controlled study to determine the efficacy and safety of KER-012 compared to Placebo in adults with PAH WHO Group 1 PH on stable background PAH therapy The study is divided into the Screening Period Treatment Period Extension Period and Follow-Up Period
Detailed Description:
This is a randomized phase 2 double-blind placebo-controlled study of KER-012 in combination with background therapy in participants with PAH of World Health Organization WHO Group 1 functional class II-III Participants will be randomly assigned in a 2223 ratio to receive KER-012 Dose A KER-012 Dose B KER-012 Dose C or placebo by subcutaneous injection SC every 4 weeks for a period of 24 weeks in the placebo-controlled treatment period of the study while on background therapy Evaluations will include changes in pulmonary vascular resistance PVR 6-minute walk distance 6MWD and safety parameters Participants who have not discontinued early from the placebo-controlled treatment period and have had their post-treatment period PVR assessment will be able to continue into the 72-week extension period in which KER-012 treated participants will continue to receive their same assigned dose level from the treatment period every 4 weeks and placebo treated participants will receive KER-012 Dose B every 4 weeks while on background therapy For more information please check httpstropospahstudycom
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