Ignite Creation Date:
2024-05-06 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 12:44 PM
Study NCT ID:
NCT03496207
Status:
COMPLETED
Last Update Posted:
2023-04-19
First Post:
2018-03-29
Brief Title:
A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension PAH
Sponsor:
Acceleron Pharma Inc a wholly-owned subsidiary of Merck Co Inc Rahway NJ USA
Organization:
Acceleron Pharma Inc a wholly-owned subsidiary of Merck Co Inc Rahway NJ USA
Study Overview
Official Title:
A Phase 2 Double-Blind Placebo-Controlled Randomized Study to Compare the Efficacy and Safety of Sotatercept ACE-011 Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension PAH
Status:
COMPLETED
Status Verified Date:
2023-03
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:
PULSAR
Brief Summary:
Study A011-09 is designed to assesses the efficacy and safety of sotatercept ACE-011 relative to placebo in adults with pulmonary arterial hypertension PAH Eligible participants will receive study treatment for 24 weeks during the placebo-controlled treatment period and then will be eligible to enroll into a 30-month extension period during which all participants will receive sotatercept All treated patients will also undergo a follow-up period after last study drug treatment
Detailed Description:
This is a Phase 2 double-blind randomized placebo-controlled parallel-group study of sotatercept plus standard of care SOC versus placebo plus SOC in participants with PAH of World Health Organization WHO Group 1 functional class II-III Participants will be randomly assigned in a 334 ratio to receive placebo sotatercept 03 mgkg or sotatercept 07 mgkg by subcutaneous SC injection every 21 days for a period of 24 weeks in the placebo-controlled treatment period of the study while on SOC therapy Evaluations will include changes in pulmonary vascular resistance PVR 6-minute walk distance 6MWD quality of life questionnaires echocardiographic parameters and safety 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 30-month extension period in which sotatercept-treated participants will receive their latest dose level of sotatercept SC every 21 days and placebo-treated participants will be re-randomized 11 to receive sotatercept 03 mgkg SC or sotatercept 07 mgkg SC every 21 days while on SOC therapy
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2017-004738-27 | EUDRACT_NUMBER | None | None |