A Phase 2 interventional study of Sotatercept in Anemia, Myelodysplastic Syndromes and Chronic Myelomonocytic Leukemia, sponsored by Merck Sharp & Dohme LLC. Completed at 20 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-24.
Sponsored by Merck Sharp & Dohme LLC · Phase 2, Interventional, and Treatment
The primary objective of this study is to determine a safe, tolerable and effective dose of sotatercept that results in the greatest frequency of improvement of anemia in patients diagnosed with low- or intermediate-1 risk myelodysplastic syndromes (MDS) or non-proliferative chronic myelomonocytic leukemia (CMML).
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 74 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Sotatercept 0.1 mg/kg
Drug: Sotatercept
Sotatercept 0.3 mg/kg
Drug: Sotatercept
Sotatercept 0.5 mg/kg
Drug: Sotatercept
Sotatercept 1.0 mg/kg
Drug: Sotatercept
Sotatercept 1.5 mg/kg
Drug: Sotatercept
Sotatercept 2.0 mg/kg
Drug: Sotatercept
Sotatercept is supplied as a lyophilized powder that is reconstituted using Water for Injection (WFI) and administered as a subcutaneous injection (SC) injection by the study staff at the clinical site.
Also known as: ACE-011, ActRIIA-IgG1Fc
Percentage of Participants With Erythroid Hematological Improvement (HI-E) Starting Before the Completion of Five Cycles of Treatment (Responder Rate)
The responder rate includes non-transfusion dependent efficacy (NTDE) participants and transfusion dependent efficacy (TDE) participants. For non-transfusion dependence efficacy (NTDE) participants who required \< 4 units of RBCs in the 8 weeks prior to start of therapy, HI-E was defined as an increase of \>=1.5 g/dL hemoglobin sustained for 56 days over a period of \>=8 weeks. For transfusion dependence efficacy (TDE) participants who required \>=4 units of RBCs in the 8 weeks prior to start of therapy, HI-E was defined as a decrease of \>= 4 units of RBCs transfused sustained for 56 days over a period of 8 weeks.
Time frame: Day 2 to Day 142
Time to Erythroid Hematological Improvement (HI-E) Response
Time to first response = start date of first response (HI-E) - first dose date + 1 day. For NTDE participants (who required \< 4 units of RBCs in the 8 weeks prior to start of therapy), HI-E was defined as an increase of \>=1.5 g/dL hemoglobin sustained for 56 days over a period of \>=8 weeks. For TDE participants (who required \>=4 units of RBCs in the 8 weeks prior to start of therapy), HI-E was defined as a decrease of \>= 4 units of RBCs transfused sustained for 56 days over a period of 8 weeks.
Time frame: Day 1 to Day 87
Duration of Erythroid Hematological Improvement (HI-E)
The duration of HI-E response for participants who responded was (the last date of the consecutive hemoglobin \[Hgb\] measurements of the first \>=56 day interval) - (the first date of the consecutive Hgb measurements of the first \>=56 day interval) + 1 day.
Time frame: Day 1 to 183.7 weeks
Time to Progression to Acute Myeloid Leukemia (AML) for Participants Who Had Progression
Progression to AML used criteria by the International Working Group (IWG) Response Criteria in Myelodysplasia (Cheson, 2006). Progression is considered if any of the following are met: - \>=50% increase in blasts - \>=50% decrement from maximum remission/response levels in granulocytes or platelets - Reduction in Hgb concentration by \>=2 g/dL - Transfusion dependence This outcome was defined as a Kaplan-Meier estimate however few participants progressed so a Kaplan-Meier analysis could not be performed. Disclosed are time to progression values only for participants who did progress to AML.
Time frame: Day 1 to 183.7 weeks
Time to Progression to Events of Higher Risk Myelodysplastic Syndromes (MDS) Using the International Prognostic Scoring System (IPSS) For Participants Who Had Progression
Progression to events of higher risk MDS used criteria from the International Prognostic Scoring System for MDS (IPSS) which assigns a prognostic score (0=good and increasing in risk by half-grades with the top score outlined below) for three prognostic variables: - Marrow blasts (score 0-2.0) - Karyotype (score 0-1.0) - Cytopenias: neutrophil, platelets, and Hg counts (score 0-0.5) The three individual scores are summed resulting in a full range of 0- 3.5 and placed into risk categories 0 = low risk 0.5-1.0 = intermediate-1 risk 1.5-2.0 = intermediate-2 risk \>=2.5 = high risk This outcome was defined as a Kaplan-Meier estimate however few participants progressed so a Kaplan-Meier analysis could not be performed. Data reported represent event times (weeks) for participants who did progress to higher risk MDS categories.
Time frame: Day 1 to 257.3 weeks
Kaplan-Meier Estimates for Progression-free Survival
Participants who had disease progression were considered to have events. Participants who died without acute myeloid leukemia (AML) were also considered to have events with the event date as the date of death. Those who did not have disease progression and who were lost to follow-up were censored at the last known disease progression assessment date. Participants without disease progression at the last follow-up contact were censored at the date of the last follow-up contact date. Disease Progression to AML used criteria by the International Working Group (IWG) Response Criteria in Myelodysplasia (Cheson, 2006). Progression is considered if any of the following are met: - \>=50% increase in blasts - \>=50% decrement from maximum remission/response levels in granulocytes or platelets - Reduction in hemoglobin (Hgb) concentration by \>=2 g/dL - Transfusion dependence
Time frame: Day 1 to 257.3 weeks
Kaplan-Meier Estimates for Overall Survival (OS)
OS was defined as the time between start of treatment and the death/censored date. Participants who died (regardless of the cause of death) were considered to have an event. Participants who were alive at the end of the study, and participants who were lost to follow-up, were censored at the last date when subjects were known to be alive.
Time frame: Day 1 to 257.3 weeks
Pharmacokinetic Parameters of Sotatercept: Serum Concentration at Various Study Timepoints
Maximum observed serum concentration, obtained directly from the observed concentration versus time data.
Time frame: Cycle 1 Day 8 and !5 up to Cycle 2 Day 1
Participants With Treatment-Emergent Adverse Events (TEAE)
An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 42 days after the last dose. The severity of AEs was graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.0 and the scale: Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death. Relation to study drug was determined by the investigator. A treatment-related TEAE is defined as TEAE which was considered to be related to the study drug and reported as 'Suspected' on the CRF. AEs with a missing relationship were treated as 'treatment-related' in data summaries.
Time frame: Day 1 up to 59.2 months
Dose Limiting Toxicities (DLTs)
The following were DLTs if the investigator suspected they were treatment related: 1. Increase to \>= 140 mmHg systolic blood pressure 2. Increase to \>=90 mmHg diastolic blood pressure 3. Increase to \>=140 systolic and increase \> 20 mmHg compared to baseline systolic 4. Increase to \>=90 mmHg diastolic and increase \> 20 mmHg compared to baseline diastolic 5. Introduction of new anti-hypertension medication during treatment 6. Increase in dose of baseline anti-hypertension medication during treatment 7. \>= Grade 2 (moderate severity or worse) hypertension as an adverse event
Time frame: Day 1 to 59.2 months
Number of Participants Who Achieved Red Blood Cell (RBC)-Transfusion Independence During the Erythroid Hematological Improvement (HI-E) Interval
Number of participants who achieved RBC-independence was defined as participants who required no RBC-transfusions during a 56-day interval of erythroid hematological improvement (HI-E). NTDE = non-transfusion dependence efficacy participants who required \< 4 units of RBCs in the 8 weeks prior to start of therapy TDE = transfusion dependence efficacy participants who required \>=4 units of RBCs in the 8 weeks prior to start of therapy
Time frame: Day 2 to Day 142
Participants were stratified by concentration of serum erythropoietin (EPO) (\<500 versus ≥500 IU/L), by number of transfusions within 56 days of study enrollment (\<4 versus ≥4 units of red blood cells) and assigned randomly to 0.1 mg/kg and 0.3 mg/kg arms.
| Milestone | Sotatercept 0.1 mg/kg | Sotatercept 0.3 mg/kg | Sotatercept 0.5 mg/kg | Sotatercept 1.0 mg/kg | Sotatercept 2.0 mg/kg |
|---|---|---|---|---|---|
| Started | 7 | 6 | 21 | 35 | 5 |
| Completed | 0 | 0 | 0 | 0 | 0 |
| Not completed | 7 | 6 | 21 | 35 | 5 |
| Withdrew: Disease relapse | 0 | 0 | 2 | 1 | 0 |
| Withdrew: Adverse event | 0 | 2 | 2 | 3 | 2 |
| Withdrew: Withdrawal by subject | 0 | 0 | 3 | 1 | 1 |
| Withdrew: Lack of therapeutic effect | 7 | 4 | 13 | 20 | 1 |
| Withdrew: Progressive disease | 0 | 0 | 0 | 1 | 0 |
| Withdrew: Other | 0 | 0 | 1 | 9 | 1 |
The responder rate includes non-transfusion dependent efficacy (NTDE) participants and transfusion dependent efficacy (TDE) participants. For non-transfusion dependence efficacy (NTDE) participants who required \< 4 units of RBCs in the 8 weeks prior to start of therapy, HI-E was defined as an increase of \>=1.5 g/dL hemoglobin sustained for 56 days over a period of \>=8 weeks. For transfusion dependence efficacy (TDE) participants who required \>=4 units of RBCs in the 8 weeks prior to start of therapy, HI-E was defined as a decrease of \>= 4 units of RBCs transfused sustained for 56 days over a period of 8 weeks.
| percentage of participants | Sotatercept 0.1 mg/kg | Sotatercept 0.3 mg/kg | Sotatercept 0.5 mg/kg | Sotatercept 1.0 mg/kg | Sotatercept 2.0 mg/kg |
|---|---|---|---|---|---|
| All participants | 0 | 66.7 | 42.9 | 60.0 | 40.0 |
| NTDE subpopulation | — | — | 33.3 | 62.5 | 100 |
| TDE subpopulation | 0 | 66.7 | 44.4 | 59.3 | 25.0 |
Time to first response = start date of first response (HI-E) - first dose date + 1 day. For NTDE participants (who required \< 4 units of RBCs in the 8 weeks prior to start of therapy), HI-E was defined as an increase of \>=1.5 g/dL hemoglobin sustained for 56 days over a period of \>=8 weeks. For TDE participants (who required \>=4 units of RBCs in the 8 weeks prior to start of therapy), HI-E was defined as a decrease of \>= 4 units of RBCs transfused sustained for 56 days over a period of 8 weeks.
| days | Sotatercept 0.1 mg/kg | Sotatercept 0.3 mg/kg | Sotatercept 0.5 mg/kg | Sotatercept 1.0 mg/kg | Sotatercept 2.0 mg/kg |
|---|---|---|---|---|---|
| All participants | — | 24.0 (2 to 44) | 1.0 (1 to 2) | 1.0 (1 to 86) | 48 (9 to 87) |
| NTDE subpopulation | — | — | 1.0 (1 to 1) | 1.0 (1 to 52) | 9.0 (9 to 9) |
| TDE subpopulation | — | 24.0 (2 to 44) | 1.5 (1 to 2) | 1.5 (1 to 86) | 87 (87 to 87) |
The duration of HI-E response for participants who responded was (the last date of the consecutive hemoglobin \[Hgb\] measurements of the first \>=56 day interval) - (the first date of the consecutive Hgb measurements of the first \>=56 day interval) + 1 day.
| days | Sotatercept 0.1 mg/kg | Sotatercept 0.3 mg/kg | Sotatercept 0.5 mg/kg | Sotatercept 1.0 mg/kg | Sotatercept 2.0 mg/kg |
|---|---|---|---|---|---|
| All participants | — | 62.5 (62 to 69) | 104.0 (56 to 1794) | 133.0 (58 to 1554) | 96.0 (58 to 134) |
| NTDE subpopulation | — | — | 79.0 (79 to 79) | 1043.0 (69 to 1554) | 134.0 (134 to 134) |
| TDE subpopulation | — | 62.5 (62 to 69) | 105.5 (56 to 1794) | 96.5 (58 to 1033) | 58.0 (58 to 58) |
Progression to AML used criteria by the International Working Group (IWG) Response Criteria in Myelodysplasia (Cheson, 2006). Progression is considered if any of the following are met: - \>=50% increase in blasts - \>=50% decrement from maximum remission/response levels in granulocytes or platelets - Reduction in Hgb concentration by \>=2 g/dL - Transfusion dependence This outcome was defined as a Kaplan-Meier estimate however few participants progressed so a Kaplan-Meier analysis could not be performed. Disclosed are time to progression values only for participants who did progress to AML.
| weeks | Sotatercept 0.1 mg/kg | Sotatercept 0.3 mg/kg | Sotatercept 0.5 mg/kg | Sotatercept 1.0 mg/kg | Sotatercept 2.0 mg/kg |
|---|---|---|---|---|---|
| Time to Progression to Acute Myeloid Leukemia (AML) for Participants Who Had Progression | — | — | 45.6 | 78.0 | — |
Progression to events of higher risk MDS used criteria from the International Prognostic Scoring System for MDS (IPSS) which assigns a prognostic score (0=good and increasing in risk by half-grades with the top score outlined below) for three prognostic variables: - Marrow blasts (score 0-2.0) - Karyotype (score 0-1.0) - Cytopenias: neutrophil, platelets, and Hg counts (score 0-0.5) The three individual scores are summed resulting in a full range of 0- 3.5 and placed into risk categories 0 = low risk 0.5-1.0 = intermediate-1 risk 1.5-2.0 = intermediate-2 risk \>=2.5 = high risk This outcome was defined as a Kaplan-Meier estimate however few participants progressed so a Kaplan-Meier analysis could not be performed. Data reported represent event times (weeks) for participants who did progress to higher risk MDS categories.
| weeks | Sotatercept 0.1 mg/kg | Sotatercept 0.3 mg/kg | Sotatercept 0.5 mg/kg | Sotatercept 1.0 mg/kg | Sotatercept 2.0 mg/kg |
|---|---|---|---|---|---|
| Time to Progression to Events of Higher Risk Myelodysplastic Syndromes (MDS) Using the International Prognostic Scoring System (IPSS) For Participants Who Had Progression | 15.1 | — | 24.7 | 67.4 | — |
Participants who had disease progression were considered to have events. Participants who died without acute myeloid leukemia (AML) were also considered to have events with the event date as the date of death. Those who did not have disease progression and who were lost to follow-up were censored at the last known disease progression assessment date. Participants without disease progression at the last follow-up contact were censored at the date of the last follow-up contact date. Disease Progression to AML used criteria by the International Working Group (IWG) Response Criteria in Myelodysplasia (Cheson, 2006). Progression is considered if any of the following are met: - \>=50% increase in blasts - \>=50% decrement from maximum remission/response levels in granulocytes or platelets - Reduction in hemoglobin (Hgb) concentration by \>=2 g/dL - Transfusion dependence
| weeks | Sotatercept 0.1 mg/kg | Sotatercept 0.3 mg/kg | Sotatercept 0.5 mg/kg | Sotatercept 1.0 mg/kg | Sotatercept 2.0 mg/kg |
|---|---|---|---|---|---|
| Kaplan-Meier Estimates for Progression-free Survival | 82.7 (15.1 to 82.7) | NA (91.1 to NA) | NA (58.6 to NA) | NA (NA to NA) | NA (79.9 to NA) |
OS was defined as the time between start of treatment and the death/censored date. Participants who died (regardless of the cause of death) were considered to have an event. Participants who were alive at the end of the study, and participants who were lost to follow-up, were censored at the last date when subjects were known to be alive.
| weeks | Sotatercept 0.1 mg/kg | Sotatercept 0.3 mg/kg | Sotatercept 0.5 mg/kg | Sotatercept 1.0 mg/kg | Sotatercept 2.0 mg/kg |
|---|---|---|---|---|---|
| Kaplan-Meier Estimates for Overall Survival (OS) | 82.7 (NA to NA) | NA (91.00 to NA) | NA (58.6 to NA) | NA (NA to NA) | NA (79.1 to NA) |
Maximum observed serum concentration, obtained directly from the observed concentration versus time data.
| ng/mL | Sotatercept 0.1 mg/kg | Sotatercept 0.3 mg/kg | Sotatercept 0.5 mg/kg | Sotatercept 1.0 mg/kg | Sotatercept 2.0 mg/kg |
|---|---|---|---|---|---|
| Cycle 1 Day 8 | 288.06 ± 70.94 | 1426.00 ± 27.76 | 2237.46 ± 40.77 | 6525.37 ± 28.31 | 12886.14 ± 30.47 |
| Cycle 1 Day 15 | 240.31 ± 75.32 | 1207.68 ± 16.14 | 1869.52 ± 36.97 | 5149.74 ± 36.04 | 8303.73 ± 43.57 |
| Cycle 2 Day 1 | 252.20 ± 28.43 | 957.58 ± 18.63 | 1323.91 ± 44.40 | 3467.58 ± 57.06 | 5329.63 ± 38.27 |
An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 42 days after the last dose. The severity of AEs was graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.0 and the scale: Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death. Relation to study drug was determined by the investigator. A treatment-related TEAE is defined as TEAE which was considered to be related to the study drug and reported as 'Suspected' on the CRF. AEs with a missing relationship were treated as 'treatment-related' in data summaries.
| Participants | Sotatercept 0.1 mg/kg | Sotatercept 0.3 mg/kg | Sotatercept 0.5 mg/kg | Sotatercept 1.0 mg/kg | Sotatercept 2.0 mg/kg |
|---|---|---|---|---|---|
| >= 1 Treatment-emergent adverse event (TEAE) | 6 | 4 | 20 | 34 | 5 |
| >=1 Treatment-related TEAE | 2 | 3 | 7 | 18 | 4 |
| >=1 Serious TEAE | 1 | 2 | 6 | 10 | 2 |
| >=1 Serious TEAE related to treatment | 0 | 0 | 0 | 0 | 1 |
| >=1 TEAE severity 3 or 4 | 1 | 2 | 9 | 13 | 2 |
| >=1 TEAE severity grade 3/4 related to treatment | 0 | 0 | 1 | 0 | 1 |
| >=1 TEAE leading to death | 0 | 1 | 0 | 0 | 0 |
| >=1 TEAE leading to dose reduction | 0 | 0 | 0 | 0 | 0 |
| >=1 TEAE leading to dose interruption | 0 | 1 | 2 | 9 | 1 |
| >=1 TEAE leading to dose interruption + reduction | 0 | 0 | 0 | 1 | 0 |
| >= 1 TEAE leading to drug discontinuation | 0 | 2 | 2 | 3 | 2 |
The following were DLTs if the investigator suspected they were treatment related: 1. Increase to \>= 140 mmHg systolic blood pressure 2. Increase to \>=90 mmHg diastolic blood pressure 3. Increase to \>=140 systolic and increase \> 20 mmHg compared to baseline systolic 4. Increase to \>=90 mmHg diastolic and increase \> 20 mmHg compared to baseline diastolic 5. Introduction of new anti-hypertension medication during treatment 6. Increase in dose of baseline anti-hypertension medication during treatment 7. \>= Grade 2 (moderate severity or worse) hypertension as an adverse event
| Participants | Sotatercept 0.1 mg/kg | Sotatercept 0.3 mg/kg | Sotatercept 0.5 mg/kg | Sotatercept 1.0 mg/kg | Sotatercept 2.0 mg/kg |
|---|---|---|---|---|---|
| 1. Increase to >= 140 mmHg systolic | 1 | 1 | 8 | 19 | 2 |
| 2. Increase to >=90 mmHg diastolic | 0 | 0 | 2 | 2 | 1 |
| 3. =140 systolic and increase > 20 mmHg base | 0 | 1 | 5 | 10 | 2 |
| 4. >=90 mmHg diastolic and increase > 20 mmHg base | 0 | 0 | 2 | 2 | 1 |
| 5. Introduction of new anti-hypertension med | 0 | 0 | 4 | 3 | 1 |
| 6. Incre in dose of baseline anti-hypertension med | 0 | 0 | 0 | 0 | 0 |
| 7.>= Grade 2 hypertension TEAE | 0 | 1 | 2 | 4 | 1 |
Number of participants who achieved RBC-independence was defined as participants who required no RBC-transfusions during a 56-day interval of erythroid hematological improvement (HI-E). NTDE = non-transfusion dependence efficacy participants who required \< 4 units of RBCs in the 8 weeks prior to start of therapy TDE = transfusion dependence efficacy participants who required \>=4 units of RBCs in the 8 weeks prior to start of therapy
| Participants | Sotatercept 0.1 mg/kg | Sotatercept 0.3 mg/kg | Sotatercept 0.5 mg/kg | Sotatercept 1.0 mg/kg | Sotatercept 2.0 mg/kg |
|---|---|---|---|---|---|
| All participants | 0 | 1 | 3 | 15 | 1 |
| NTDE subpopulation | — | — | 1 | 6 | 1 |
| TDE subpopulation | 0 | 1 | 2 | 9 | 0 |
Collected over Day 1 up to 60.7 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sotatercept 0.1 mg/kg | 1/7 (14.3%) | 1/7 (14.3%) | 6/7 (85.7%) |
| Sotatercept 0.3 mg/kg | 1/6 (16.7%) | 2/6 (33.3%) | 4/6 (66.7%) |
| Sotatercept 0.5 mg/kg | 6/21 (28.6%) | 6/21 (28.6%) | 18/21 (85.7%) |
| Sotatercept 1.0 mg/kg | 6/35 (17.1%) | 10/35 (28.6%) | 32/35 (91.4%) |
| Sotatercept 2.0 mg/kg | 1/5 (20%) | 2/5 (40%) | 5/5 (100%) |
| Event | Sotatercept 0.1 mg/kg | Sotatercept 0.3 mg/kg | Sotatercept 0.5 mg/kg | Sotatercept 1.0 mg/kg | Sotatercept 2.0 mg/kg |
|---|---|---|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 0/7 | 0/6 | 1/21 | 0/35 | 1/5 |
| Transfusion reactionInjury, poisoning and procedural complications | 0/7 | 0/6 | 0/21 | 0/35 | 1/5 |
| Blood pressure increasedInvestigations | 0/7 | 0/6 | 0/21 | 0/35 | 1/5 |
| PneumoniaInfections and infestations | 0/7 | 1/6 | 1/21 | 0/35 | 0/5 |
| Subdural haematomaInjury, poisoning and procedural complications | 0/7 | 1/6 | 0/21 | 0/35 | 0/5 |
| Aortic stenosisVascular disorders | 0/7 | 1/6 | 0/21 | 0/35 | 0/5 |
| BronchitisInfections and infestations | 1/7 | 0/6 | 0/21 | 0/35 | 0/5 |
| InfluenzaInfections and infestations | 1/7 | 0/6 | 0/21 | 0/35 | 0/5 |
| Hip fractureInjury, poisoning and procedural complications | 0/7 | 0/6 | 2/21 | 0/35 | 0/5 |
| ColitisGastrointestinal disorders | 0/7 | 0/6 | 0/21 | 3/35 | 0/5 |
| Event | Sotatercept 0.1 mg/kg | Sotatercept 0.3 mg/kg | Sotatercept 0.5 mg/kg | Sotatercept 1.0 mg/kg | Sotatercept 2.0 mg/kg |
|---|---|---|---|---|---|
| HeadacheNervous system disorders | 3/7 | 1/6 | 4/21 | 5/35 | 1/5 |
| DiarrhoeaGastrointestinal disorders | 0/7 | 2/6 | 7/21 | 9/35 | 2/5 |
| NauseaGastrointestinal disorders | 0/7 | 1/6 | 4/21 | 8/35 | 2/5 |
| Urinary tract infectionInfections and infestations | 1/7 | 0/6 | 0/21 | 4/35 | 2/5 |
| DizzinessNervous system disorders | 1/7 | 2/6 | 1/21 | 6/35 | 2/5 |
| Oedema peripheralGeneral disorders | 2/7 | 2/6 | 6/21 | 11/35 | 0/5 |
| FallInjury, poisoning and procedural complications | 0/7 | 2/6 | 1/21 | 1/35 | 0/5 |
| FatigueGeneral disorders | 0/7 | 1/6 | 6/21 | 11/35 | 1/5 |
| ConstipationGastrointestinal disorders | 0/7 | 1/6 | 6/21 | 3/35 | 0/5 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 0/7 | 1/6 | 6/21 | 2/35 | 1/5 |
All randomized participants
| Age, Continuous(years) | Sotatercept 0.1 mg/kg | Sotatercept 0.3 mg/kg | Sotatercept 0.5 mg/kg | Sotatercept 1.0 mg/kg | Sotatercept 2.0 mg/kg | Total |
|---|---|---|---|---|---|---|
| Mean | 67 ± 8.3 | 75 ± 6.9 | 69 ± 8.0 | 71 ± 8.2 | 69 ± 13.0 | 70 ± 8.4 |
| Age, Customized(Participants) | Sotatercept 0.1 mg/kg | Sotatercept 0.3 mg/kg | Sotatercept 0.5 mg/kg | Sotatercept 1.0 mg/kg | Sotatercept 2.0 mg/kg | Total |
|---|---|---|---|---|---|---|
| <65 years | 3 | 0 | 7 | 6 | 1 | 17 |
| >=65 - <75 years | 2 | 3 | 8 | 17 | 2 | 32 |
| >=75 years | 2 | 3 | 6 | 12 | 2 | 25 |
| Sex: Female, Male(Participants) | Sotatercept 0.1 mg/kg | Sotatercept 0.3 mg/kg | Sotatercept 0.5 mg/kg | Sotatercept 1.0 mg/kg | Sotatercept 2.0 mg/kg | Total |
|---|---|---|---|---|---|---|
| Female | 3 | 0 | 4 | 17 | 4 | 28 |
| Male | 4 | 6 | 17 | 18 | 1 | 46 |
| Ethnicity (NIH/OMB)(Participants) | Sotatercept 0.1 mg/kg | Sotatercept 0.3 mg/kg | Sotatercept 0.5 mg/kg | Sotatercept 1.0 mg/kg | Sotatercept 2.0 mg/kg | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 2 | 0 | 0 | 2 |
| Not Hispanic or Latino | 7 | 6 | 13 | 19 | 4 | 49 |
| Unknown or Not Reported | 0 | 0 | 6 | 16 | 1 | 23 |
| Race (NIH/OMB)(Participants) | Sotatercept 0.1 mg/kg | Sotatercept 0.3 mg/kg | Sotatercept 0.5 mg/kg | Sotatercept 1.0 mg/kg | Sotatercept 2.0 mg/kg | Total |
|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 1 | 0 | 1 |
| White | 7 | 6 | 14 | 18 | 3 | 48 |
| More than one race | NA | NA | NA | NA | NA | NA |
| Unknown or Not Reported | 0 | 0 | 7 | 16 | 1 | 24 |
| Region of Enrollment(Participants) | Sotatercept 0.1 mg/kg | Sotatercept 0.3 mg/kg | Sotatercept 0.5 mg/kg | Sotatercept 1.0 mg/kg | Sotatercept 2.0 mg/kg | Total |
|---|---|---|---|---|---|---|
| United States | 7 | 6 | 15 | 18 | 4 | 50 |
| France | 0 | 0 | 6 | 17 | 1 | 24 |
| Height(meters) | Sotatercept 0.1 mg/kg | Sotatercept 0.3 mg/kg | Sotatercept 0.5 mg/kg | Sotatercept 1.0 mg/kg | Sotatercept 2.0 mg/kg | Total |
|---|---|---|---|---|---|---|
| Mean | 1.70 ± 0.110 | 1.75 ± 0.054 | 1.70 ± 0.093 | 1.68 ± 0.089 | 1.56 ± 0.043 | 1.68 ± 0.095 |
| Weight(kg) | Sotatercept 0.1 mg/kg | Sotatercept 0.3 mg/kg | Sotatercept 0.5 mg/kg | Sotatercept 1.0 mg/kg | Sotatercept 2.0 mg/kg | Total |
|---|---|---|---|---|---|---|
| Mean | 85.3 ± 21.79 | 79.5 ± 13.90 | 77.9 ± 13.97 | 73.5 ± 15.55 | 56.4 ± 7.25 | 75.2 ± 16.14 |
6 further baseline measures are reported on the registry.
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