Trial · NCT03496207
A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (PAH)
NCT03496207, Phase 2, Completed, Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA; results first posted 2023-04-19
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (PAH). Trials, record NCT03496207. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03496207
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (PAH)
- NCT number
- NCT03496207
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 106 participants, actual
- Lead sponsor
- Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Placebo, Sotatercept, SOC
- First posted
- 2018-04-12
- Last updated
- 2023-04-19
- Other registries' IDs
- eudract:2017-004738-27
- Results first posted
- 2023-04-19
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Base Study: Change From Baseline in Pulmonary Vascular Resistance (PVR) at 24 Weeks | Baseline and 24 weeks | Each participant's PVR, at resting supine, was measured by right heart catheterization at baseline and at 24 weeks. |
| Primary | Extension Period: Change From Baseline in PVR (Delayed-Start Analysis) | Baseline and timepoint at which third right heart catheterization was performed, which occurred between Month 18 and Month 24 | Each participant's PVR, at resting supine, was measured by right heart catheterization at baseline and the timepoint at which the third right heart catheterization was performed, which occurred between Month 18 and Month 24. |
| Primary | Extension Period: Change From Baseline in PVR (Placebo-Crossed Analysis) | Baseline and the timepoint at which the third right heart catheterization was performed, which occurred between Month 18 and Month 24. | Each participant's PVR, at resting supine, was measured by right heart catheterization at baseline and the timepoint at which the third right heart catheterization was performed, which occurred between Month 18 and Month 24. |
| Primary | Extension Period: Number of Participants Who Experienced One or More Adverse Events (AEs) | Up to approximately 32 months | 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. |
| Primary | Extension Period: Number of Participants Who Discontinued Study Treatment Due to an AE | Up to 30 months | 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. |
| Secondary | Base Study: Change From Baseline in 6-Minute Walk Distance (6MWD) at 24 Weeks | Baseline and 24 weeks | 6MWD is measured by an exercise test known as 6-Minute Walk Test (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. |
| Secondary | Base Study: Change From Baseline in Concentration of Amino-Terminal Brain Natriuretic Propeptide (NT-proBNP) at 24 Weeks | Baseline and 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. |
| Secondary | Base Study: Change From Baseline in Tricuspid Annular Plane Systolic Excursion (TAPSE) at 24 Weeks | Baseline and 24 weeks | Each participant's TAPSE, which is commonly used to evaluate tricuspid valve annulus movement as an indicator of right heart function, was measured by echocardiography at baseline and 24 weeks. |
| Secondary | Base Study: Change From Baseline in Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) Score at Cycle 9 | Baseline and Day 1 of Cycle 9, up to 24 weeks (Each cycle was 21 days.) | The CAMPHOR is participant-reported questionnaire that contains 65 items in total, 25 relating to symptoms, 25 relating to quality of life (QoL), and 15 relating to activities. Symptom items are scored from 0-25, with a higher score indicating worse symptoms. QoL items are also scored from 0-25, with a higher score indicating a worse QoL and greater functional limitation. Activity items are scored from 0-30, with a higher score indicating poorer functioning. The combined score is obtained by summing up the symptoms score, QoL score and activity score. The lowest combined score possible is 0, while the highest combined score possible is 80. Each participant's CAMPHOR score was recorded at baseline and on Day 1 of Cycle 9. |
| Secondary | Base Study: Change From Baseline in 36-Item Short Form Health Survey (SF-36) Score | Baseline and Day 1 of Cycle 9, up to 24 weeks (Each cycle was 21 days.) | The SF-36 questionnaire is a participant-reported survey of a participant's health. The survey evaluates 8 aspects of functional health and well-being that relate to either physical health or mental health. The physical component summary is based primarily on physical functioning, bodily pain, and general health. The mental component summary encompasses vitality, social functioning, and emotional and mental health. Total scores for the physical component range from 0-100, with 100 representing the highest level of physical functioning. The total scores for the mental component also range from 0-100, with 100 representing the highest level of mental functioning. Each participant's SF-36 was recorded at baseline and on Day 1 of Cycle 9. Each cycle was 21 days. |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Base Study: Change From Baseline in Pulmonary Vascular Resistance (PVR) at 24 Weeks | Baseline and 24 weeks | All randomized participants administered their assigned treatment who received at least 6 of the same doses during Base Study, had baseline and post-Base Study PVR assessment and End of Treatment (EOT) assessment. Note: Data from participants whose dose was down-titrated were analyzed according to dose received at least 6 times rather than dose originally assigned. Per protocol, only participants who consistently received in 0.3 mg/kg or 0.7 mg/kg of sotatercept were planned to be analyzed. | dynes*sec/cm^5 | MEAN |
| PRIMARY | Extension Period: Change From Baseline in PVR (Delayed-Start Analysis) | Baseline and timepoint at which third right heart catheterization was performed, which occurred between Month 18 and Month 24 | All randomized participants who received their assigned treatment, transitioned to the extension period, and had data for the respective timepoints | dynes*sec/cm^5 | MEAN |
| PRIMARY | Extension Period: Change From Baseline in PVR (Placebo-Crossed Analysis) | Baseline and the timepoint at which the third right heart catheterization was performed, which occurred between Month 18 and Month 24. | All randomized participants who received their assigned treatment, transitioned to the extension period, and had data for the respective timepoints | dynes*sec/cm^5 | MEAN |
| PRIMARY | Extension Period: Number of Participants Who Experienced One or More Adverse Events (AEs) | Up to approximately 32 months | All randomized participants who transitioned to the extension period and received at least 1 dose of study treatment | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Extension Period: Number of Participants Who Discontinued Study Treatment Due to an AE | Up to 30 months | All randomized participants who transitioned to the extension period and received at least 1 dose of study treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Base Study: Change From Baseline in 6-Minute Walk Distance (6MWD) at 24 Weeks | Baseline and 24 weeks | All randomized participants administered their assigned treatment who received at least 6 of the same doses during Base Study, had baseline and post-Base Study PVR assessment and EOT assessment. Note: Data from participants whose dose was down-titrated were analyzed according to dose received at least 6 times rather than dose originally assigned. Per protocol, only participants who consistently received in 0.3 mg/kg or 0.7 mg/kg of sotatercept were planned to be analyzed. | meters | LEAST_SQUARES_MEAN |
| SECONDARY | Base Study: Change From Baseline in Concentration of Amino-Terminal Brain Natriuretic Propeptide (NT-proBNP) at 24 Weeks | Baseline and 24 Weeks | All randomized participants administered their assigned treatment who received ≥6 of the same doses during Base Study, had baseline and post-Base Study PVR assessment and EOT assessment, and had data for the outcome measure. Note: Data from participants whose dose was down-titrated were analyzed according to dose received ≥6 times rather than dose originally assigned. Per protocol, only participants who consistently received in 0.3 mg/kg or 0.7 mg/kg of sotatercept were planned to be analyzed. | pg/mL | MEAN |
| SECONDARY | Base Study: Change From Baseline in Tricuspid Annular Plane Systolic Excursion (TAPSE) at 24 Weeks | Baseline and 24 weeks | All randomized participants administered their assigned treatment who received ≥6 of the same doses during Base Study, had baseline and post-Base Study PVR assessment and EOT assessment, and had data for the outcome measure. Note: Data from participants whose dose was down-titrated were analyzed according to dose received ≥6 times rather than dose originally assigned. Per protocol, only participants who consistently received in 0.3 mg/kg or 0.7 mg/kg of sotatercept were planned to be analyzed. | cm | MEAN |
| SECONDARY | Base Study: Change From Baseline in Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) Score at Cycle 9 | Baseline and Day 1 of Cycle 9, up to 24 weeks (Each cycle was 21 days.) | All randomized participants administered their assigned treatment who received ≥6 of the same doses during Base Study, had baseline and post-Base Study PVR assessment and EOT assessment, and had data for the outcome measure. Note: Data from participants whose dose was down-titrated were analyzed according to dose received ≥6 times rather than dose originally assigned. Per protocol, only participants who consistently received in 0.3 mg/kg or 0.7 mg/kg of sotatercept were planned to be analyzed. | Score on a scale | MEAN |
| SECONDARY | Base Study: Change From Baseline in 36-Item Short Form Health Survey (SF-36) Score | Baseline and Day 1 of Cycle 9, up to 24 weeks (Each cycle was 21 days.) | All randomized participants administered their assigned treatment who received ≥6 of the same doses during Base Study, had baseline and post-Base Study PVR assessment and EOT assessment, and had data for the outcome measure. Note: Data from participants whose dose was down-titrated were analyzed according to dose received ≥6 times rather than dose originally assigned. Per protocol, only participants who consistently received in 0.3 mg/kg or 0.7 mg/kg of sotatercept were planned to be analyzed. | Score on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group73
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Base Study: Change From Baseline in Pulmonary Vascular Resistance (PVR) at 24 Weeks | Placebo | Base Study: Change from Baseline in PVR at 24 Weeks | -27.6 | Standard Deviation 251.08 | dynes*sec/cm^5 |
| Base Study: Change From Baseline in Pulmonary Vascular Resistance (PVR) at 24 Weeks | Sotatercept 0.3 mg/kg | Base Study: Change from Baseline in PVR at 24 Weeks | -168.4 | Standard Deviation 262.93 | dynes*sec/cm^5 |
| Base Study: Change From Baseline in Pulmonary Vascular Resistance (PVR) at 24 Weeks | Sotatercept 0.7 mg/kg | Base Study: Change from Baseline in PVR at 24 Weeks | -258.9 | Standard Deviation 169.42 | dynes*sec/cm^5 |
| Base Study: Change From Baseline in Pulmonary Vascular Resistance (PVR) at 24 Weeks | Placebo | Baseline | 802.0 | Standard Deviation 331.05 | dynes*sec/cm^5 |
| Base Study: Change From Baseline in Pulmonary Vascular Resistance (PVR) at 24 Weeks | Sotatercept 0.3 mg/kg | Baseline | 772.0 | Standard Deviation 285.62 | dynes*sec/cm^5 |
| Base Study: Change From Baseline in Pulmonary Vascular Resistance (PVR) at 24 Weeks | Sotatercept 0.7 mg/kg | Baseline | 715.5 | Standard Deviation 267.11 | dynes*sec/cm^5 |
| Extension Period: Change From Baseline in PVR (Delayed-Start Analysis) | Placebo-Crossed Treatment Group | Extension Period: Change from Baseline in PVR (Delayed-Start Analysis) | -246.9 | Standard Deviation 300.01 | dynes*sec/cm^5 |
| Extension Period: Change From Baseline in PVR (Delayed-Start Analysis) | Continued Sotatercept Treatment Group | Extension Period: Change from Baseline in PVR (Delayed-Start Analysis) | -212.6 | Standard Deviation 254.24 | dynes*sec/cm^5 |
| Extension Period: Change From Baseline in PVR (Delayed-Start Analysis) | Placebo-Crossed Treatment Group | Baseline | 802.0 | Standard Deviation 331.05 | dynes*sec/cm^5 |
| Extension Period: Change From Baseline in PVR (Delayed-Start Analysis) | Continued Sotatercept Treatment Group | Baseline | 783.7 | Standard Deviation 371.59 | dynes*sec/cm^5 |
1 to 10 of 73Source ClinicalTrials.gov
See all 73 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Base Study | STARTED | Extension Period: Placebo→Sotatercept 0.3 mg/kg | 0 | |
| Base Study | STARTED | Extension Period: Placebo→Sotatercept 0.7 mg/kg | 0 | |
| Base Study | STARTED | Placebo | 32 | |
| Base Study | STARTED | Sotatercept 0.3 mg/kg | 32 | |
| Base Study | STARTED | Sotatercept 0.7 mg/kg | 42 | |
| Base Study | COMPLETED | Extension Period: Placebo→Sotatercept 0.3 mg/kg | 0 | |
| Base Study | COMPLETED | Extension Period: Placebo→Sotatercept 0.7 mg/kg | 0 | |
| Base Study | COMPLETED | Placebo | 30 | |
| Base Study | COMPLETED | Sotatercept 0.3 mg/kg | 31 | |
| Base Study | COMPLETED | Sotatercept 0.7 mg/kg | 36 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events2,023
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Base Study: Placebo | 2 | 32 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | Base Study: Sotatercept 0.3 mg/kg | 1 | 32 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Base Study: Sotatercept 0.7 mg/kg | 2 | 42 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Extension Period: Placebo→Sotatercept 0.3 mg/kg | 0 | 15 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Extension Period: Placebo→Sotatercept 0.7 mg/kg | 2 | 15 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Extension Period: Sotatercept 0.3 mg/kg | 8 | 31 | 13 |
| other | Anaemia | Blood and lymphatic system disorders | Extension Period: Sotatercept 0.7 mg/kg | 1 | 36 | 2 |
| other | Blood loss anaemia | Blood and lymphatic system disorders | Base Study: Placebo | 0 | 32 | 0 |
| other | Blood loss anaemia | Blood and lymphatic system disorders | Base Study: Sotatercept 0.3 mg/kg | 0 | 32 | 0 |
| other | Blood loss anaemia | Blood and lymphatic system disorders | Base Study: Sotatercept 0.7 mg/kg | 0 | 42 | 0 |
1 to 10 of 2,023Source ClinicalTrials.gov
See all 2,023 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Base Study: Placebo | 0 | 32 |
| Total, all-cause mortality | Base Study: Sotatercept 0.3 mg/kg | 0 | 32 |
| Total, all-cause mortality | Base Study: Sotatercept 0.7 mg/kg | 1 | 42 |
| Total, all-cause mortality | Extension Period: Placebo→Sotatercept 0.3 mg/kg | 1 | 15 |
| Total, all-cause mortality | Extension Period: Placebo→Sotatercept 0.7 mg/kg | 0 | 15 |
| Total, all-cause mortality | Extension Period: Sotatercept 0.3 mg/kg | 1 | 32 |
| Total, all-cause mortality | Extension Period: Sotatercept 0.7 mg/kg | 2 | 42 |
| Total, other adverse events | Base Study: Placebo | 25 | 32 |
| Total, other adverse events | Base Study: Sotatercept 0.3 mg/kg | 29 | 32 |
| Total, other adverse events | Base Study: Sotatercept 0.7 mg/kg | 33 | 42 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
Continued Sotatercept Treatment Group vs Placebo-Crossed Treatment Group: Extension Period: Number of Participants Who Experienced an Improvement From Baseline in WHO Functional Class (Delayed-Start Analysis) |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03496207
GET https://conductscience.org/api/trials/v1/NCT03496207/registered?page=2