Trial · NCT04576988
A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (MK-7962-003/A011-11)(STELLAR)
NCT04576988, Phase 3, Completed, Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA; results first posted 2023-08-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (MK-7962-003/A011-11)(STELLAR). Trials, record NCT04576988. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04576988
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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 (MK-7962-003/A011-11)(STELLAR)
- NCT number
- NCT04576988
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 324 participants, actual
- Lead sponsor
- Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Sotatercept, Placebo, Background PAH Therapy
- First posted
- 2020-10-06
- Last updated
- 2024-09-19
- Other registries' IDs
- eudract:2020-004142-11
- Results first posted
- 2023-08-23
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in 6-Minute Walk Distance (6MWD) at Week 24 | Baseline and Week 24 | The 6MWD was the distance walked in 6 minutes as a measure of functional capacity. This was assessed using the 6-minute walk test (6MWT). Per protocol, change from baseline in 6MWD at Week 24 was reported for DBPC period. |
| Primary | Number of Participants Who Experienced an Adverse Event (AE) | Up to approximately 24 weeks | An AE was any untoward medical occurrence in a study participant administered a study drug, which did not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug whether or not it was considered related to the study drug. Per protocol, the number of participants who reported an AE were reported for DBPC period. |
| Primary | Number of Participants Who Discontinued Study Treatment Due to an AE | Up to approximately 24 weeks | An AE was any untoward medical occurrence in a study participant administered a study drug, which did not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug whether or not it was considered related to the study drug. Per protocol, the number of participants who discontinued study treatment due to an AE were reported for DBPC period. |
| Secondary | Change From Baseline in the Percentage of Participants Achieving Multicomponent Improvement at Week 24 | Baseline and Week 24 | Multicomponent Improvement was defined as consisting of all of the following: (a) Improvement in 6MWD (increase ≥30 meters) (b) Improvement in N-terminal pro b-type natriuretic peptide (NT-proBNP; decrease in NT-proBNP ≥30%) or maintenance/achievement of NT-proBNP level \<300 ng/L (c) Improvement in World Health Organization (WHO) Functional Class (FC) or maintenance of WHO FC II. Per protocol, change from baseline in the percentage of participants achieving multicomponent improvement at Week 24 was reported for DBPC period. |
| Secondary | Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 24 | Baseline and Week 24 | PVR is a hemodynamic variable of pulmonary circulation and was measured by right heart catheterization (RHC). Per protocol, the change from baseline in PVR at Week 24 was reported for DBPC period. |
| Secondary | Change From Baseline in NT-proBNP Levels at Week 24 | Baseline and Week 24 | NT-proBNP is a circulating biomarker that reflects myocardial stretch. Per protocol, the change from baseline in NT-proBNP level at Week 24 was reported for DBPC period. |
| Secondary | Change From Baseline in the Percentage of Participants Who Improve in WHO FC at Week 24 | Baseline and Week 24 | The severity of participant's pulmonary arterial hypertension (PAH) symptoms will be graded using the WHO FC system. WHO functional classification for PAH ranges from Class I (no limitation in physical activity, no dyspnea with normal activity), Class II (slight limitation of physical activity), Class III (marked limitation of physical activity) and Class IV (cannot perform a physical activity without any symptoms, dyspnea at rest). Participants who improve in WHO FC were classified into "Improved", "No change" and "Worsened". Improvement = reduction in FC, worsened = increase in FC and no change = no change in FC. Per protocol, change from baseline in the percentage of participants who improve in WHO FC at Week 24 were reported for DBPC period. |
| Secondary | Time to Death or the First Occurrence of Clinical Worsening Event | Up to approximately 18 months | Clinical Worsening events are defined as any of the following: worsening-related listing for lung and/or heart transplant; need to initiate rescue therapy with an approved background PAH therapy or the need to increase the dose of infusion prostacyclin by 10% or more; need for atrial septostomy; hospitalization for worsening of PAH (≥ 24 hours); or deterioration of PAH defined by both of the following events occurring at any time: worsened WHO FC and decrease in 6MWD by ≥15% confirmed by 2 tests at least 4 hours apart, but no more than 1 week. Per protocol, time to death or the first occurrence of clinical worsening event was reported. |
| Secondary | Change From Baseline in Percentage of Participants Who Maintain or Achieve a Low Risk Score Using the Simplified French Risk Score Calculator at Week 24 | Baseline and Week 24 | The simplified French risk scoring system was based on the 2015 European Society of Cardiology (ESC)/European Respiratory Society (ERS) guidelines for the diagnosis and treatment of pulmonary hypertension (PH). In this study, the noninvasive parameters were used to determine the score. 'Low risk' was defined as attaining or maintaining all 3 low-risk criteria: WHO FC I or II, 6MWD \> 440 m, and NT-proBNP \<300 ng/L. Per protocol, change from baseline in percentage of participants who maintained or achieved a low risk score using the simplified French risk score calculator at Week 24 was reported for DBPC period. |
| Secondary | Change From Baseline in the Physical Impacts Domain Score of Pulmonary Arterial Hypertension - Symptoms and Impact (PAH-SYMPACT®) at Week 24 | Baseline and Week 24 | The PAH SYMPACT is a 23-item questionnaire to measure pulmonary arterial hypertension (PAH)-related symptoms and impact of PAH on daily life. The physical impact domain consists of walking slowly on a flat surface, walking quickly on a flat surface, walking uphill, carrying things, doing light indoor household chores, washing, or dressing oneself, and needing help from others. Participants were asked to recall and report on each item experienced in past 7 days. Score for each item ranges from 0 (not difficult at all) to 4 (extremely difficult). A domain score was calculated by summing the individual responses for each item and dividing by the number of impact items (range: 0=no physical impact to 4=severe physical impact). A higher score indicated more severe physical impact. Per protocol, change from baseline in the physical impacts domain score at Week 24 was reported for DBPC period. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in 6-Minute Walk Distance (6MWD) at Week 24 | Baseline and Week 24 | All randomized participants who received at least one dose of study treatment and had a baseline value of 6MWD. | meters | MEDIAN |
| PRIMARY | Number of Participants Who Experienced an Adverse Event (AE) | Up to approximately 24 weeks | All randomized participants who received at least one dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Discontinued Study Treatment Due to an AE | Up to approximately 24 weeks | All randomized participants who received at least one dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in the Percentage of Participants Achieving Multicomponent Improvement at Week 24 | Baseline and Week 24 | All randomized participants who received at least one dose of study treatment and who had a baseline measurement for the multicomponent improvement. | Percent change | NUMBER |
| SECONDARY | Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 24 | Baseline and Week 24 | All randomized participants who received at least one dose of study treatment and who had a baseline measurement for the PVR. | dynes*sec/cm^5 | MEDIAN |
| SECONDARY | Change From Baseline in NT-proBNP Levels at Week 24 | Baseline and Week 24 | All randomized participants who received at least one dose of study treatment and who had a baseline measurement for the NT-proBNP levels. | pg/mL | MEDIAN |
| SECONDARY | Change From Baseline in the Percentage of Participants Who Improve in WHO FC at Week 24 | Baseline and Week 24 | All randomized participants who received at least one dose of study treatment and who had a baseline measurement for the WHO FC. | Percent change | NUMBER |
| SECONDARY | Time to Death or the First Occurrence of Clinical Worsening Event | Up to approximately 18 months | All randomized participants who received at least one dose of study treatment and who died or experienced a first clinical worsening event. | Weeks | MEDIAN |
| SECONDARY | Change From Baseline in Percentage of Participants Who Maintain or Achieve a Low Risk Score Using the Simplified French Risk Score Calculator at Week 24 | Baseline and Week 24 | All randomized participants who received at least one dose of study treatment and who had a baseline measurement for the low risk score. | Percent Change | NUMBER |
| SECONDARY | Change From Baseline in the Physical Impacts Domain Score of Pulmonary Arterial Hypertension - Symptoms and Impact (PAH-SYMPACT®) at Week 24 | Baseline and Week 24 | All randomized participants who received at least one dose of study treatment and who had a baseline physical impact domain score. | Score on a scale | MEDIAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in 6-Minute Walk Distance (6MWD) at Week 24 | Sotatercept Plus Background PAH Therapy (DBPC Period) | 34.4 | Full Range 32.5 to 35.5 | meters | |
| Change From Baseline in 6-Minute Walk Distance (6MWD) at Week 24 | Placebo Plus Background PAH Therapy (DBPC Period) | 1.0 | Full Range -1.0 to 5.0 | meters | |
| Number of Participants Who Experienced an Adverse Event (AE) | Sotatercept Plus Background PAH Therapy (DBPC Period) | 138 | Participants | ||
| Number of Participants Who Experienced an Adverse Event (AE) | Placebo Plus Background PAH Therapy (DBPC Period) | 140 | Participants | ||
| Number of Participants Who Discontinued Study Treatment Due to an AE | Sotatercept Plus Background PAH Therapy (DBPC Period) | 3 | Participants | ||
| Number of Participants Who Discontinued Study Treatment Due to an AE | Placebo Plus Background PAH Therapy (DBPC Period) | 10 | Participants | ||
| Change From Baseline in the Percentage of Participants Achieving Multicomponent Improvement at Week 24 | Sotatercept Plus Background PAH Therapy (DBPC Period) | 38.9 | Percent change | ||
| Change From Baseline in the Percentage of Participants Achieving Multicomponent Improvement at Week 24 | Placebo Plus Background PAH Therapy (DBPC Period) | 10.1 | Percent change | ||
| Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 24 | Sotatercept Plus Background PAH Therapy (DBPC Period) | -165.1 | Full Range -184.0 to -152.0 | dynes*sec/cm^5 | |
| Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 24 | Placebo Plus Background PAH Therapy (DBPC Period) | 32.8 | Full Range 24.0 to 40.0 | dynes*sec/cm^5 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double Blind Placebo Controlled (DBPC) | STARTED | Sotatercept Plus Background PAH Therapy | 163 | |
| Double Blind Placebo Controlled (DBPC) | STARTED | Placebo Plus Background PAH Therapy | 160 | |
| Double Blind Placebo Controlled (DBPC) | Treated | Sotatercept Plus Background PAH Therapy | 163 | |
| Double Blind Placebo Controlled (DBPC) | Treated | Placebo Plus Background PAH Therapy | 160 | |
| Double Blind Placebo Controlled (DBPC) | COMPLETED | Sotatercept Plus Background PAH Therapy | 159 | |
| Double Blind Placebo Controlled (DBPC) | COMPLETED | Placebo Plus Background PAH Therapy | 148 | |
| Double Blind Placebo Controlled (DBPC) | NOT COMPLETED | Sotatercept Plus Background PAH Therapy | 4 | |
| Double Blind Placebo Controlled (DBPC) | NOT COMPLETED | Placebo Plus Background PAH Therapy | 12 | |
| Long Term Double Blind (LTDB) | STARTED | Sotatercept Plus Background PAH Therapy | 159 | |
| Long Term Double Blind (LTDB) | STARTED | Placebo Plus Background PAH Therapy | 142 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events484
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 | Thrombocytopenia | Blood and lymphatic system disorders | Sotatercept Plus Background PAH Therapy (DBPC Period) | 8 | 163 | 9 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo Plus Background PAH Therapy (DBPC Period) | 3 | 160 | 3 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Sotatercept Plus Background PAH Therapy (LTDB Period) | 8 | 158 | 9 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo Plus Background PAH Therapy (LTDB Period) | 0 | 142 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Sotatercept Plus Background PAH Therapy (DBPC Period) | 20 | 163 | 21 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo Plus Background PAH Therapy (DBPC Period) | 12 | 160 | 13 |
| other | Diarrhoea | Gastrointestinal disorders | Sotatercept Plus Background PAH Therapy (LTDB Period) | 6 | 158 | 7 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo Plus Background PAH Therapy (LTDB Period) | 3 | 142 | 4 |
| other | Nausea | Gastrointestinal disorders | Sotatercept Plus Background PAH Therapy (DBPC Period) | 17 | 163 | 25 |
| other | Nausea | Gastrointestinal disorders | Placebo Plus Background PAH Therapy (DBPC Period) | 17 | 160 | 26 |
1 to 10 of 484Source ClinicalTrials.gov
See all 484 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sotatercept Plus Background PAH Therapy (DBPC Period) | 0 | 163 |
| Total, all-cause mortality | Placebo Plus Background PAH Therapy (DBPC Period) | 6 | 160 |
| Total, all-cause mortality | Sotatercept Plus Background PAH Therapy (LTDB Period) | 2 | 159 |
| Total, all-cause mortality | Placebo Plus Background PAH Therapy (LTDB Period) | 1 | 142 |
| Total, other adverse events | Sotatercept Plus Background PAH Therapy (DBPC Period) | 111 | 163 |
| Total, other adverse events | Placebo Plus Background PAH Therapy (DBPC Period) | 88 | 160 |
| Total, other adverse events | Sotatercept Plus Background PAH Therapy (LTDB Period) | 82 | 158 |
| Total, other adverse events | Placebo Plus Background PAH Therapy (LTDB Period) | 50 | 142 |
| Total, serious adverse events | Sotatercept Plus Background PAH Therapy (DBPC Period) | 23 | 163 |
| Total, serious adverse events | Placebo Plus Background PAH Therapy (DBPC Period) | 36 | 160 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers5
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Sotatercept Plus Background PAH Therapy (DBPC Period) vs Placebo Plus Background PAH Therapy (DBPC Period): Number of Participants Who Discontinued Study Treatment Due to an AE | Trial comparisons |
| Sotatercept Plus Background PAH Therapy (DBPC Period) vs Placebo Plus Background PAH Therapy (DBPC Period): Number of Participants Who Experienced an Adverse Event (AE) | 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.
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Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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