Pulmonary Arterial HypertensionPhase 2SPECTRANCT03738150
A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension
A Phase 2 study testing Sotatercept and SOC in people with Pulmonary Arterial Hypertension, run by Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Sotatercept and SOC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 4 sitesUnited States
- Study dates
- 19 Apr 2019to 22 Mar 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Documented findings on RHC at any time prior to Screening consistent with a diagnosis of World Health Organization (WHO) pulmonary hypertension Group 1: PAH of any of the following subtypes:
- Idiopathic PAH
- Heritable PAH
- Drug- or toxin-induced PAH
- PAH associated with connective tissue disease
Show all 16Show fewer
- PAH associated with simple, congenital systemic-to-pulmonary shunts at least 1 year following shunt repair
- Symptomatic pulmonary hypertension classified as WHO functional class III
- Screening RHC documenting a minimum PVR of ≥ 4 Wood units
- Pulmonary function tests within 6 months prior to Screening as follows:
- Total lung capacity > 70% predicted; or if between 60% to 70% predicted, or not possible to be determined, confirmatory high-resolution computed tomography (CT) indicating no more than mild interstitial lung disease per investigator interpretation or
- Forced expiratory volume (first second) (FEV1)/forced vital capacity (FVC) > 70% predicted
- For subjects with a history of lobectomy or pneumonectomy, and for whom there are no population-based normalization methods, assessment based on residual lung volume will be permitted to assess eligibility.
- Ventilation-perfusion (VQ) scan (or, if unavailable, a negative CT pulmonary angiogram [CTPA] or pulmonary angiography result), any time prior to Screening or conducted during Screening Period with normal or low probability result
- 6MWD ≥ 100 and ≤ 550 meters repeated twice during Screening Period and both values within 15% of each other, calculated from the highest value
- Combination PAH therapy at stable (per investigator) dose levels for at least 90 days prior to Cycle 1 Day 1 (C1D1)
Who cannot join
- Participants will be excluded from the study if they meet any of the following criteria:
- Started or stopped receiving any general supportive therapy for pulmonary hypertension (e.g., diuretics, oxygen, anticoagulants, digoxin) within 60 days prior to C1D1 (Cycle 1 Day 1)
- Received intravenous inotropes (e.g., dobutamine, dopamine, norepinephrine, vasopressin) within 30 days prior to C1D1
- History of atrial septostomy within 180 days prior to Screening
- History of more than mild obstructive sleep apnea that is untreated
- History of portal hypertension or chronic liver disease, defined as mild to severe hepatic impairment (Child-Pugh Classes A to C)
Show all 18Show fewer
- History of human immunodeficiency virus infection-associated PAH
- Prior exposure to sotatercept (ACE-011) or luspatercept (ACE-536)
- Uncontrolled systemic hypertension as evidenced by sitting systolic BP > 160 mm Hg or sitting diastolic BP > 100 mm Hg during Screening after a period of rest
- Systolic BP < 90 mm Hg during Screening or at baseline
- History of known pericardial constriction
- Electrocardiogram (ECG) with QTcF > 480 msec during Screening or C1D1
- History of personal or family history of long QTc syndrome or sudden cardiac death
- History of restrictive or constrictive cardiomyopathy
- Left ventricular ejection fraction < 45% on echocardiogram performed within 6 months of Screening OR pulmonary capillary wedge pressure (PCWP) > 15 mm Hg on RHC during baseline evaluation
- Any current symptomatic coronary disease (myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery, or cardiac anginal chest pain in the past 6 months prior to Screening)
- Acutely decompensated heart failure within 30 days prior to C1D1, as per investigator assessment
- Significant (≥ 2+ regurgitation) mitral regurgitation or aortic regurgitation valvular disease
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Mayo Clinic
Rochester, Minnesota, 55905
The University of Arizona
Tucson, Arizona, 85724
About this study
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
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.
Read the 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 0.3 mg/kg by subcutaneous (SC) injection for Cycle 1 and escalating to 0.7 mg/kg 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.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Sotatercept, SOC
- Keywords
- PAH
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SotaterceptBiological
Also called ACE-011
Sotatercept injection
SOCOther
SOC therapy refers to combination therapy consisting of drugs from two or more of the following drug classes: an endothelin-receptor antagonist (ERA), a phosphodiesterase 5 (PDE5) inhibitor, a soluble guanylate cyclase stimulator, and/or a prostacyclin analogue or receptor agonist.
| Study group | Role | What they receive |
|---|---|---|
| Sotatercept | Experimental | Each participant will receive SOC plus sotatercept at a dose of 0.3 mg/kg SC for Cycle 1. (Each cycle will be 21 days.) From Cycle 2 through Cycle 9, the dose will be escalated to 0.7 mg/kg SC. Dosing will be every three weeks during the 24-week treatment period and 18-month extension period. Receives: Biological: Sotatercept; Other: SOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Peak Oxygen Uptake (VO2 Max) at 24 Weeks
Each participant's VO2 max was measured by an invasive cardiopulmonary exercise test (iCPET) at baseline and at 24 weeks.
Measured: Baseline and 24 weeks
Secondary outcomes (25)
Change From Baseline in Right Ventricular Stroke Volume (RV SV) at 24 Weeks
Each participant's RV SV was measured by cardiac MRI at baseline and at 24 weeks.
Measured: Baseline and 24 weeks
Change From Baseline in Right Ventricular End-Systolic Volume (RV ESV) at 24 Weeks
Each participant's RV ESV was measured by cardiac MR imaging at baseline and at 24 weeks.
Measured: Baseline and 24 weeks
Change From Baseline in Right Ventricular End-Diastolic Volume (RV EDV) at 24 Weeks
Each participant's RV EDV was measured by cardiac MR imaging at baseline and at 24 weeks.
Measured: Baseline and 24 weeks
Percent Change From Baseline in Right Ventricular Ejection Fraction (RV EF) at 24 Weeks
Each participant's RV EF was measured by cardiac MR imaging at baseline and at 24 weeks.
Measured: Baseline and 24 Weeks
Change From Baseline in Right Ventricular Stroke Volume Index (RV SVI) at 24 Weeks
Each participant's RV SVI was measured by cardiac MR imaging at baseline and at 24 weeks.
Measured: Baseline and 24 weeks
Change From Baseline in Right Ventricular (RV) Mass at 24 Weeks
Each participant's RV mass was measured by cardiac MR imaging at baseline and at 24 weeks.
Measured: Baseline and 24 weeks
Change From Baseline in Ventilatory Efficiency (VE/VCO2 Slope) at 24 Weeks
VE/VCO2 slope refers to the slope of the regression line of Minute Ventilation (VE) in liters/minute in the Y-axis and corresponding carbon dioxide production per minute (VCO2) in liters/minute in the X-axis plotted with multiple measurements taken during exercise. Each participant's VE/VCO2 slope at peak exercise was measured by an iCPET at baseline and at 24 weeks.
Measured: Baseline and 24 weeks
Change From Baseline in Cardiac Index at 24 Weeks
Each participant's cardiac index at peak exercise was measured by iCPET at baseline and at 24 weeks.
Measured: Baseline and 24 weeks
Change From Baseline in Mean Pulmonary Arterial Pressure at 24 Weeks
Each participant's pulmonary arterial pressure at peak exercise was measured by iCPET at baseline and at 24 weeks.
Measured: Baseline and 24 weeks
Change From Baseline in Arteriovenous O2 Content Difference (Ca-vO2) at 24 Weeks
Each participant's Ca-vO2 at peak exercise was measured by iCPET at baseline and at 24 weeks.
Measured: Baseline and 24 weeks
Change From Baseline in Pulmonary Vascular Resistance (PVR) at 24 Weeks
Each participant's PVR, at resting supine, was measured by right heart catheterization (RHC) at baseline and at 24 weeks.
Measured: Baseline and 24 weeks
Change From Baseline in 6-Minute Walk Distance (6MWD) at 24 Weeks
6MWD is measured by an exercise test known as 6MWT that assesses aerobic capacity and endurance. It measures the distance covered over a time of 6 minutes and is used as an outcome measure by which to compare changes in performance capacity. Each participant's 6MWD was measured at baseline and at 24 weeks. An increase in the distance walked during the 6MWT indicates improvement in basic mobility.
Measured: Baseline and 24 weeks
Change From Baseline in Concentration of Amino-Terminal Brain Natriuretic Propeptide (NT-proBNP) at 24 Weeks
Each participant's laboratory biomarkers N-terminal prohormone brain-type natriuretic peptide (NT-proBNP) or brain-type natriuretic peptide (BNP) were measured at baseline and at 24 weeks.
Measured: Baseline and 24 Weeks
Change From Baseline in WHO (World Health Organization) Functional Class at 24 Weeks
The World Health Organization (WHO) functional class describes how severe a person's pulmonary hypertension symptoms are. There are four different classes - I is the mildest and IV the most severe form of pulmonary hypertension.
Measured: Baseline and 24 Weeks
Number of Participants With One or More Adverse Events (AEs)
An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Measured: Up to 24 weeks
Number of Participants Who Experienced One or More Events Indicative of Clinical Worsening of Pulmonary Arterial Hypertension (PAH)
Events that indicate clinical worsening of PAH include death, need for and/or worsening-related listing for lung and/or heart transplant, need to initiate an approved PAH SOC rescue therapy, PAH-specific hospitalization, or functional deterioration (worsened WHO Functional Class AND 15% decrease in 6MWD).
Measured: Up to 102 weeks
Observed Trough Concentration (Ctrough) of Sotatercept at Cycle 9
Ctrough is the plasma concentration of a drug prior to administration.
Measured: Day 1 of Cycle 9 (Each cycle was 21 days.)
Maximum Plasma Concentration (Cmax) of Sotatercept at Cycle 9
Cmax is a measure of the maximum amount of drug in the plasma after the dose is given. PopPK modeling approach was used to build a population PK model that captures the totality of the observed data from Cycles 1 to 9. The Cmax parameter is derived from this preliminary popPK modeling.
Measured: Day 1 of each 21-day cycle: Cycles 1-9
Minimum Plasma Concentration (Cmin) of Sotatercept at Cycle 9
Cmin is a measure of the minimum amount of drug in the plasma after the dose is given. PopPK modeling approach was used to build a population PK model that captures the totality of the observed data from Cycles 1 to 9. The Cmin parameter is derived from this preliminary popPK modeling.
Measured: Day 1 of each 21-day cycle: Cycles 1-9
Average Concentration (Cavg) of Sotatercept at Cycle 9
Cavg is calculated by area under the plasma concentration versus dosing interval time curve at steady-state divided by the dosing interval. PopPK modeling approach was used to build a population PK model that captures the totality of the observed data from Cycles 1 to 9. The Cavg parameter is derived from this preliminary popPK modeling.
Measured: Day 1 of each 21-day cycle: Cycles 1-9
Area Under the Concentration-Time Curve From 0 to T (AUC0-T) of Sotatercept at Cycle 9
AUC0-T (area under the plasma concentration versus time curve from time zero after a dose is given to a period of one 21-day cycle) is a measure of the mean concentration levels of a drug in the plasma at steady state. PopPK modeling approach was used to build a population PK model that captures the totality of the observed data from Cycles 1 to 9. The AUC0-T parameter is derived from this preliminary popPK modeling.
Measured: Day 1 of each 21-day cycle: Cycles 1-9
Apparent Terminal Half-life (t1/2 ) of Sotatercept at Cycle 9
t1/2 is the elimination half-life of study drug: the time it takes for half of the study drug in the blood plasma to dissipate. PopPK modeling approach was used to build a population PK model that captures the totality of the observed data from Cycles 1 to 9. The t1/2 parameter is derived from this preliminary popPK modeling.
Measured: Day 1 of each 21-day cycle: Cycles 1-9
Apparent Serum Clearance (CL) of Sotatercept at Cycle 9
Apparent serum CL is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. PopPK modeling approach was used to build a population PK model that captures the totality of the observed data from Cycles 1 to 9. The apparent serum CL parameter is derived from this preliminary popPK modeling.
Measured: Day 1 of each 21-day cycle: Cycles 1-9
Apparent Volume of Distribution (Vz/F) of Sotatercept at Cycle 9
Vz/F is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. PopPK modeling approach was used to build a population PK model that captures the totality of the observed data from Cycles 1 to 9. The Vz/F parameter is derived from this preliminary popPK modeling.
Measured: Day 1 of each 21-day cycle: Cycles 1-9
Absorption Rate Constant (Ka) of Sotatercept at Cycle 9
Ka is the proportionality constant that relates the rate of drug absorbed into the body. Ka is a value used to describe the rate at which a drug enters into the system. It is expressed in units of time. PopPK modeling approach was used to build a population PK model that captures the totality of the observed data from Cycles 1 to 9. The Ka parameter is derived from this preliminary popPK modeling.
Measured: Day 1 of each 21-day cycle: Cycles 1-9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start19 Apr 2019
- Primary completion21 Dec 2021
- Study completion22 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLCJonathan Lu, MD, Study director, Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03738150
- Sponsor's protocol ID
- A011-10
- Other IDs
- 7962-002
- Acronym
- SPECTRA
- Status last verified
- Jul 2024
- First submitted
- 2 Nov 2018
- Last updated
- 27 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Waxman AB, Systrom DM, Manimaran S, de Oliveira Pena J, Lu J, Rischard FP. SPECTRA Phase 2b Study: Impact of Sotatercept on Exercise Tolerance and Right Ventricular Function in Pulmonary Arterial Hypertension. Circ Heart Fail. 2024 May;17(5):e011227. doi: 10.1161/CIRCHEARTFAILURE.123.011227. Epub 2024 Apr 4.
PubMed 38572639
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03738150
- Acronym / sponsor ID
- SPECTRA / A011-10
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- PAH
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USAIndustry (pharma, biotech, devices)
- Study start
- 19 Apr 2019 (actual)
- Primary completion
- 21 Dec 2021 (actual)
- Study completion
- 22 Mar 2022 (actual)
- First posted
- 13 Nov 2018 (actual)
- Results
- Posted 10 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 0.3 mg/kg by subcutaneous (SC) injection for Cycle 1 and escalating to 0.7 mg/kg 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sotatercept | Experimental | Biological: Sotatercept, Other: SOCEach participant will receive SOC plus sotatercept at a dose of 0.3 mg/kg SC for Cycle 1. (Each cycle will be 21 days.) From Cycle 2 through Cycle 9, the dose will be escalated to 0.7 mg/kg SC. Dosing will be every three weeks during the 24-week treatment period and 18-month extension period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age ≥ 18 years
- Documented findings on RHC at any time prior to Screening consistent with a diagnosis of World Health Organization (WHO) pulmonary hypertension Group 1: PAH of any of the following subtypes:
- Symptomatic pulmonary hypertension classified as WHO functional class III
- Screening RHC documenting a minimum PVR of ≥ 4 Wood units
- Pulmonary function tests within 6 months prior to Screening as follows:
Key exclusion criteria (18 listed)
- Started or stopped receiving any general supportive therapy for pulmonary hypertension (e.g., diuretics, oxygen, anticoagulants, digoxin) within 60 days prior to C1D1 (Cycle 1 Day 1)
- Received intravenous inotropes (e.g., dobutamine, dopamine, norepinephrine, vasopressin) within 30 days prior to C1D1
- History of atrial septostomy within 180 days prior to Screening
- History of more than mild obstructive sleep apnea that is untreated
- History of portal hypertension or chronic liver disease, defined as mild to severe hepatic impairment (Child-Pugh Classes A to C)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SotaterceptAlso: ACE-011Sotatercept injection | Biological | Sotatercept |
| SOCSOC therapy refers to combination therapy consisting of drugs from two or more of the following drug classes: an endothelin-receptor antagonist (ERA), a phosphodiesterase 5 (PDE5) inhibitor, a soluble guanylate cyclase stimulator, and/or a prostacyclin analogue or receptor agonist. | Other | Sotatercept |
Primary outcome
Change From Baseline in Peak Oxygen Uptake (VO2 Max) at 24 Weeks
Time frame: Baseline and 24 weeks
Each participant's VO2 max was measured by an invasive cardiopulmonary exercise test (iCPET) at baseline and at 24 weeks.
25 secondary outcomes
Change From Baseline in Right Ventricular Stroke Volume (RV SV) at 24 Weeks
Time frame: Baseline and 24 weeks
Change From Baseline in Right Ventricular End-Systolic Volume (RV ESV) at 24 Weeks
Time frame: Baseline and 24 weeks
Change From Baseline in Right Ventricular End-Diastolic Volume (RV EDV) at 24 Weeks
Time frame: Baseline and 24 weeks
Percent Change From Baseline in Right Ventricular Ejection Fraction (RV EF) at 24 Weeks
Time frame: Baseline and 24 Weeks
Change From Baseline in Right Ventricular Stroke Volume Index (RV SVI) at 24 Weeks
Time frame: Baseline and 24 weeks
Change From Baseline in Right Ventricular (RV) Mass at 24 Weeks
Time frame: Baseline and 24 weeks
Change From Baseline in Ventilatory Efficiency (VE/VCO2 Slope) at 24 Weeks
Time frame: Baseline and 24 weeks
Change From Baseline in Cardiac Index at 24 Weeks
Time frame: Baseline and 24 weeks
Change From Baseline in Mean Pulmonary Arterial Pressure at 24 Weeks
Time frame: Baseline and 24 weeks
Change From Baseline in Arteriovenous O2 Content Difference (Ca-vO2) at 24 Weeks
Time frame: Baseline and 24 weeks
Change From Baseline in Pulmonary Vascular Resistance (PVR) at 24 Weeks
Time frame: Baseline and 24 weeks
Change From Baseline in 6-Minute Walk Distance (6MWD) at 24 Weeks
Time frame: Baseline and 24 weeks
Change From Baseline in Concentration of Amino-Terminal Brain Natriuretic Propeptide (NT-proBNP) at 24 Weeks
Time frame: Baseline and 24 Weeks
Change From Baseline in WHO (World Health Organization) Functional Class at 24 Weeks
Time frame: Baseline and 24 Weeks
Number of Participants With One or More Adverse Events (AEs)
Time frame: Up to 24 weeks
Number of Participants Who Experienced One or More Events Indicative of Clinical Worsening of Pulmonary Arterial Hypertension (PAH)
Time frame: Up to 102 weeks
Observed Trough Concentration (Ctrough) of Sotatercept at Cycle 9
Time frame: Day 1 of Cycle 9 (Each cycle was 21 days.)
Maximum Plasma Concentration (Cmax) of Sotatercept at Cycle 9
Time frame: Day 1 of each 21-day cycle: Cycles 1-9
Minimum Plasma Concentration (Cmin) of Sotatercept at Cycle 9
Time frame: Day 1 of each 21-day cycle: Cycles 1-9
Average Concentration (Cavg) of Sotatercept at Cycle 9
Time frame: Day 1 of each 21-day cycle: Cycles 1-9
Area Under the Concentration-Time Curve From 0 to T (AUC0-T) of Sotatercept at Cycle 9
Time frame: Day 1 of each 21-day cycle: Cycles 1-9
Apparent Terminal Half-life (t1/2 ) of Sotatercept at Cycle 9
Time frame: Day 1 of each 21-day cycle: Cycles 1-9
Apparent Serum Clearance (CL) of Sotatercept at Cycle 9
Time frame: Day 1 of each 21-day cycle: Cycles 1-9
Apparent Volume of Distribution (Vz/F) of Sotatercept at Cycle 9
Time frame: Day 1 of each 21-day cycle: Cycles 1-9
Absorption Rate Constant (Ka) of Sotatercept at Cycle 9
Time frame: Day 1 of each 21-day cycle: Cycles 1-9
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 38572639Waxman AB, Systrom DM, Manimaran S, de Oliveira Pena J, Lu J, Rischard FP. SPECTRA Phase 2b Study: Impact of Sotatercept on Exercise Tolerance and Right Ventricular Function in Pulmonary Arterial Hypertension. Circ Heart Fail. 2024 May;17(5):e011227. doi: 10.1161/CIRCHEARTFAILURE.123.011227. Epub 2024 Apr 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
Jonathan Lu, MD study director
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sotatercept and SOC in people with Pulmonary Arterial Hypertension, run by Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Peak Oxygen Uptake (VO2 Max) at 24 Weeks (time frame: Baseline and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03738150, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.