Ignite Creation Date:
2024-05-06 @ 12:21 PM
Last Modification Date:
2024-10-26 @ 12:57 PM
Study NCT ID:
NCT03738150
Status:
COMPLETED
Last Update Posted:
2023-02-10
First Post:
2018-11-02
Brief Title:
A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension
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 2a Single-Arm Open-Label Multicenter Exploratory Study to Assess the Effects of Sotatercept ACE-011 for the Treatment of Pulmonary Arterial Hypertension
Status:
COMPLETED
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:
SPECTRA
Brief Summary:
This study evaluates the effect of sotatercept ACE-011 in adults with pulmonary arterial hypertension PAH Each eligible participant will receive standard of care SOC plus sotatercept ACE-011 for a 24-week treatment period followed by an 18-month extension period and an 8-week follow-up period
Detailed Description:
This is a Phase 2a single-arm open-label multicenter exploratory study to determine the effects of sotatercept plus SOC in adults with WHO functional class III PAH
All eligible participants will receive SOC plus sotatercept at a starting dose level of 03 mgkg by subcutaneous SC injection for Cycle 1 and escalating to 07 mgkg at Cycle 2 for the remainder of the treatment period Participants will be required to attend clinic visits once every three weeks for the 24-week treatment period and once every three weeks for the 18-month extension period to perform one or more protocol specified evaluations Evaluations include hemodynamic measures collected during right heart catheterization RHC with invasive cardiopulmonary exercise test iCPET and cardiac magnetic resonance imaging MR 6-minute walk distance 6MWD pharmacokinetic parameters pharmacodynamic parameters anti-drug antibody testing and adverse events
All eligible participants will receive SOC plus sotatercept at a starting dose level of 03 mgkg by subcutaneous SC injection for Cycle 1 and escalating to 07 mgkg at Cycle 2 for the remainder of the treatment period Participants will be required to attend clinic visits once every three weeks for the 24-week treatment period and once every three weeks for the 18-month extension period to perform one or more protocol specified evaluations Evaluations include hemodynamic measures collected during right heart catheterization RHC with invasive cardiopulmonary exercise test iCPET and cardiac magnetic resonance imaging MR 6-minute walk distance 6MWD pharmacokinetic parameters pharmacodynamic parameters anti-drug antibody testing and adverse events
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 |
|---|---|---|---|
| 7962-002 | OTHER | Merck | None |