Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is the first study in hemodialysis subjects with anemia to evaluate the pharmacokinetics, safety, efficacy, tolerability, and pharmacodynamics of sotatercept (ACE-011)
Part 1:
Approximately 8 subjects will be randomized to receive either a single 0.1 mg/kg subcutaneous dose of sotatercept or matching placebo in a 3:1 ratio
Part 2:
Approximately 8 subjects will be randomized to each of the 3 sequential dose groups (0.3mg/kg or 0.5mg/kg or 0.7 mg/kg) with a 3:1 ratio of sotatercept or placebo (6 subjects in the sotatercept arm and 2 in the placebo arm). A total of 24-36 subjects may be randomized in the 3 dose groups.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.1mg/kg Sotatercept | Experimental | Approximately 8 subjects will be randomized to receive either a single 0.1 mg/kg subcutaneous dose of sotatercept or matching placebo in a 3:1 ratio |
|
| 0.3mg/kg Sotatercept | Experimental | Dose Group 1: 0.3 mg/kg sotatercept subcutaneous every 28 days |
|
| 0.5mg/kg Sotatercept | Experimental | Dose Group 2: 0.5 mg/kg sotatercept subcutaneous every 28 days |
|
| 0.7mg/kg Sotatercept | Experimental | Dose Group 3: 0.7 mg/kg sotatercept subcutaneous every 28 days |
|
| Placebo | Placebo Comparator | The Placebo to Sotatercept ratio is 1:3 meaning for every 1 patient that receives Placebo, 3 patients will receive Sotatercept. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sotatercept | Biological | Part 1: Sotatercept single dose 0.1mg/kg subcutaneous Part 2: Sotatercept starting dose groups of 0.3mg/kg, 0.5mg/kg or 0.7 mg/kg in a sequential design, dosed subcutaneously every 28 days for up to 8 doses |
| Measure | Description | Time Frame |
|---|---|---|
| Observed Maximum Concentration (Cmax) | Cmax is a pharmacokinetic parameter defined as the observed maximum concentration of the study drug in the serum and/or blood. Cmax will be estimated from the sotatercept concentration versus time data using noncompartmental method. | From first dose up to Day 28 |
| Time to Maximum Concentration (Tmax) | Time to observed maximum concentration (Tmax) is defined as the amount of time in days for a drug to reach the maximum concentration after administration. | From first dose up to Day 28 |
| Area Under Curve (AUC)-28 Days | AUC-28 days is defined as area under the concentration-time curve over the first 28-day dosing interval | From first dose up to Day 28 |
| AUCinf: Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity | Area under the concentration-time curve from time zero extrapolated to infinity. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint. | From first dose up to Day 28 |
| Apparent Total Clearance (CL/F) | Apparent Total Clearance (CL/F) is defined as the volume of plasma from which the study drug is completely removed per unit of time. It is equal to the drug dose divided by the area-under-the-curve. | From first dose up to Day 28 |
| Apparent Volume of Distribution Based on Terminal Phase (Vz/F) | Apparent volume of distribution based on terminal phase (Vz/F) is defined as the apparent volume in which the current amount of drug in the body must be dispersed in order to give the current plasma concentration. Apparent volume of distribution is important for determining the dose required to produce a desired plasma concentration of the drug. |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) | An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. | From first dose up to 115 days post last dose |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| William T Smith, MD | Celgene Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North American Research Institute | Azusa | California | 91702-3439 | United States | ||
| West Glendale Dialysis |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Part 1-Placebo | Participants received a single subcutaneous dose of placebo prior to dialysis on Day 1 via an IVRS. |
| FG001 | Part 1-ACE-011 0.1 mg/kg | Participants received a single subcutaneous dose of sotatercept (0.1 mg/kg) prior to dialysis on Day 1 via an IVRS |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Biological | Placebo |
|
| From first dose up to Day 28 |
| Terminal Half-Life (t1/2,z) | Terminal plasma half-life (t1/2,z) is the time taken for concentration of the study drug to decrease from its maximum concentration (Cmax) to half of Cmax in the blood plasma. | Days 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 15, 22, 29, 43, 57, 85 and 113 |
| Number of Participants With Hemoglobin > 12g/dL | Number of participants with hemoglobin > 12g/dL including Hb values obtained after first study drug dose and before any rescue. | Pre-dose; Dose 1-Days 1, 8, 15, 22, 29; Doses 2, 3, 4, 5, 6, 7-Days 1, 15, 29; Follow-up Phase Days 225, 253, 281, and 309 |
| Proportion of Participants With Rise in Hemoglobin > 2 g/dL During 4 Week Period | Proportion of participants with rise in hemoglobin (Hb) > 2 g/dL during a 4-week period including Hb values obtained after first study drug dose and before any rescue. | Pre-dose; Dose 1-Days 1, 8, 15, 22, 29; Doses 2, 3, 4, 5, 6, 7-Days 1, 15, 29; Follow-up Phase Days 225, 253, 281, and 309 |
| Blood Pressure Changes From Baseline | Blood pressure was generally recorded on the day of dialysis and represent pre-dialysis values. Baseline is defined as blood pressure measurements recorded on Day 1 of the first dose administered. | From pre-dose up to the final visit 112 days after last dose (up to 225 days) |
| Changes in Follicle Stimulating Hormone (FSH) | The change in follicle stimulating measured at pre-specified timepoints throughout the treatment period. | Day 1 (baseline), Day 15, Day 29, and Day 113 |
| Number of Participants With Hemoglobin > 10g/dL | Number of participants with hemoglobin > 10g/dL including Hb values obtained after first study drug dose and before any rescue. Baseline is defined as hemoglobin measurements recorded on Day 1 of the first dose administered. | Pre-dose; Dose 1-Days 1, 8, 15, 22, 29; Doses 2, 3, 4, 5, 6, 7-Days 1, 15, 29; Follow-up Phase Days 225, 253, 281, and 309 |
| Number of Participants With Change From Baseline Hemoglobin ≥ 1g/dL | Number of participants with a change from in hemoglobin values ≥ 1g/dL including Hb values obtained after first study drug dose and before any rescue. Baseline is defined as hemoglobin measurements recorded on Day 1 of the first dose administered. | Pre-dose; Dose 1-Days 1, 8, 15, 22, 29; Doses 2, 3, 4, 5, 6, 7-Days 1, 15, 29; Follow-up Phase Days 225, 253, 281, and 309 |
| Number of Participants With Hemoglobin > 10g/dL and Change From Baseline Hemoglobin ≥ 1g/dL | Number of participants with Hemoglobin > 10g/dL and a change from in hemoglobin values ≥ 1g/dL including Hb values obtained after first study drug dose and before any rescue. Baseline is defined as hemoglobin measurements recorded on Day 1 of the first dose administered. | Pre-dose; Dose 1-Days 1, 8, 15, 22, 29; Doses 2, 3, 4, 5, 6, 7-Days 1, 15, 29; Follow-up Phase Days 225, 253, 281, and 309 |
| Length of Time to Rescue Therapy | The length of time in days that participants who were rescued received treatment. When applicable, participants were rescued for anemia. During the rescue, participants discontinued sotatercept and were unblinded to the study treatment. Participants who were rescued continued in the treatment phase of 200 days and a follow-up phase of 112 days after the treatment phase. Rescue is defined as the need for a blood transfusion or Erythropoiesis-stimulating agent (ESA) therapy. | From first dose up to blood transfusion or ESA therapy, up to approximately 209 days |
| Change From Baseline in Hemoglobin Values | Dose Cycle 1 is defined as the first 28 days of treatment for Dose Groups 0.3 mg/kg, 0.5 mg/kg, and 0.7 mg/kg and the first 14 days of treatment for Dose Group 0.7/0.4 mg/kg. End of the Treatment Period is defined as the day before the follow-up phase started. Baseline is defined as hemoglobin measurements recorded on Day 1 of the first dose administered. | From first dose up to Day 225 |
| Glendale |
| California |
| 91205 |
| United States |
| California Institute of Renal Research | La Mesa | California | 91942 | United States |
| Academic Medical Center | Los Angeles | California | 90022 | United States |
| Academic Medical Research Institute | Los Angeles | California | 90022 | United States |
| Nephrology Specialist Medical Group | Orange | California | 92868 | United States |
| Pines Clinical Research Inc. | Pembroke Pines | Florida | 33028 | United States |
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
| Fresenius Medical Care North America MI | Kalamazoo | Michigan | 49007 | United States |
| DaVita Clinical Research | Minneapolis | Minnesota | 55404 | United States |
| Nephrology and Hypertension Associates, LTD | Tupelo | Mississippi | 38801 | United States |
| St. Louis University Medical Center | St Louis | Missouri | 63110 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Kidney Specialists of Southen Nevada | Las Vegas | Nevada | 89106 | United States |
| Brookview Hill Research Associates, LLC | Winston-Salem | North Carolina | 27103 | United States |
| MetroHealth Medical Systems | Cleveland | Ohio | 44109 | United States |
| Northeast Clinical Research Center | Bethlehem | Pennsylvania | 18017 | United States |
| Nephrology Associates, PC | Nashville | Tennessee | 37205 | United States |
| Corva Kidney Center Webster | Houston | Texas | 77003 | United States |
| Beechnut Dialysis Center | Houston | Texas | 77036 | United States |
| Miracle Medical Clinic | Houston | Texas | 77055 | United States |
| Gessner Dialysis Center | Houston | Texas | 77074 | United States |
| Tyler Nephrology Associates, PC | Tyler | Texas | 75702 | United States |
| University of Virginia at University Ave. | Charlottesville | Virginia | 22908 | United States |
| FG002 | Part 2- Placebo | Participants received a single subcutaneous dose of placebo |
| FG003 | Part 2-0.3 mg/kg | Participants received a single subcutaneous dose of 0.3 mg/kg sotatercept every 28 days for up to 8 doses |
| FG004 | Part 2-0.5 mg/kg | Participants received a single subcutaneous dose of 0.5 mg/kg sotatercept every 28 days for up to 8 doses |
| FG005 | Part 2-0.7 mg/kg | Participants received a single subcutaneous dose of 0.7 mg/kg sotatercept every 28 days for up to 8 doses |
| FG006 | Part 2-0.7/0.4 mg/kg | Participants received a subcutaneous dose of 0.7 mg/kg sotatercept loading followed by a subcutaneous dose of 0.4 mg/kg sotatercept every 14 days for up to 15 doses |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Part 1-Placebo | Participants received a single subcutaneous dose of placebo prior to dialysis on Day 1 via an IVRS. |
| BG001 | Part 1-ACE-011 0.1 mg/kg | Participants received a single subcutaneous dose of sotatercept (0.1 mg/kg) prior to dialysis on Day 1 via an IVRS |
| BG002 | Part 2- Placebo | Participants received a single subcutaneous dose of placebo |
| BG003 | Part 2-0.3 mg/kg | Participants received a single subcutaneous dose of 0.3 mg/kg sotatercept every 28 days for up to 8 doses |
| BG004 | Part 2-0.5 mg/kg | Participants received a single subcutaneous dose of 0.5 mg/kg sotatercept every 28 days for up to 8 doses |
| BG005 | Part 2-0.7 mg/kg | Participants received a single subcutaneous dose of 0.7 mg/kg sotatercept every 28 days for up to 8 doses |
| BG006 | Part 2-0.7/0.4 mg/kg | Participants received a subcutaneous dose of 0.7 mg/kg sotatercept loading followed by a subcutaneous dose of 0.4 mg/kg sotatercept every 14 days for up to 15 doses |
| BG007 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Observed Maximum Concentration (Cmax) | Cmax is a pharmacokinetic parameter defined as the observed maximum concentration of the study drug in the serum and/or blood. Cmax will be estimated from the sotatercept concentration versus time data using noncompartmental method. | Participants with evaluable pharmacokinetic data. Pharmacokinetic data was not recorded for participants who received placebo because no study drug was administered. | Posted | Mean | Standard Deviation | ug/mL | From first dose up to Day 28 |
|
|
| |||||||||||||||||||||||||||||||||||||||||||
| Primary | Time to Maximum Concentration (Tmax) | Time to observed maximum concentration (Tmax) is defined as the amount of time in days for a drug to reach the maximum concentration after administration. | Participants with evaluable pharmacokinetic data. Pharmacokinetic data was not recorded for participants who received placebo because no study drug was administered. | Posted | Median | Full Range | Days | From first dose up to Day 28 |
| |||||||||||||||||||||||||||||||||||||||||||||
| Primary | Area Under Curve (AUC)-28 Days | AUC-28 days is defined as area under the concentration-time curve over the first 28-day dosing interval | Participants with evaluable pharmacokinetic data. Pharmacokinetic data was not recorded for participants who received placebo because no study drug was administered. | Posted | Mean | Standard Deviation | ug·day/mL | From first dose up to Day 28 |
| |||||||||||||||||||||||||||||||||||||||||||||
| Primary | AUCinf: Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity | Area under the concentration-time curve from time zero extrapolated to infinity. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint. | Pre-specified in the protocol to be collected in Part 1 pharmacokinetic evaluable participants only. Pharmacokinetic data was not recorded for participants who received placebo because no study drug was administered. | Posted | Mean | Standard Deviation | ug·day/mL | From first dose up to Day 28 |
| |||||||||||||||||||||||||||||||||||||||||||||
| Primary | Apparent Total Clearance (CL/F) | Apparent Total Clearance (CL/F) is defined as the volume of plasma from which the study drug is completely removed per unit of time. It is equal to the drug dose divided by the area-under-the-curve. | Participants with evaluable pharmacokinetic data. Pharmacokinetic data was not recorded for participants who received placebo because no study drug was administered. | Posted | Mean | Standard Deviation | L/day | From first dose up to Day 28 |
| |||||||||||||||||||||||||||||||||||||||||||||
| Primary | Apparent Volume of Distribution Based on Terminal Phase (Vz/F) | Apparent volume of distribution based on terminal phase (Vz/F) is defined as the apparent volume in which the current amount of drug in the body must be dispersed in order to give the current plasma concentration. Apparent volume of distribution is important for determining the dose required to produce a desired plasma concentration of the drug. | Pre-specified in the protocol to be collected in Part 1 pharmacokinetic evaluable participants only. Pharmacokinetic data was not recorded for participants who received placebo because no study drug was administered. | Posted | Mean | Standard Deviation | mL/kg | From first dose up to Day 28 |
| |||||||||||||||||||||||||||||||||||||||||||||
| Primary | Terminal Half-Life (t1/2,z) | Terminal plasma half-life (t1/2,z) is the time taken for concentration of the study drug to decrease from its maximum concentration (Cmax) to half of Cmax in the blood plasma. | Participants with evaluable pharmacokinetic data. Pharmacokinetic data was not recorded for participants who received placebo because no study drug was administered. | Posted | Mean | Standard Deviation | Day | Days 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 15, 22, 29, 43, 57, 85 and 113 |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) | An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. | All randomized participants | Posted | Count of Participants | Participants | From first dose up to 115 days post last dose |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Hemoglobin > 12g/dL | Number of participants with hemoglobin > 12g/dL including Hb values obtained after first study drug dose and before any rescue. | All randomized participants | Posted | Count of Participants | Participants | Pre-dose; Dose 1-Days 1, 8, 15, 22, 29; Doses 2, 3, 4, 5, 6, 7-Days 1, 15, 29; Follow-up Phase Days 225, 253, 281, and 309 |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Participants With Rise in Hemoglobin > 2 g/dL During 4 Week Period | Proportion of participants with rise in hemoglobin (Hb) > 2 g/dL during a 4-week period including Hb values obtained after first study drug dose and before any rescue. | All randomized participants | Posted | Count of Participants | Participants | Pre-dose; Dose 1-Days 1, 8, 15, 22, 29; Doses 2, 3, 4, 5, 6, 7-Days 1, 15, 29; Follow-up Phase Days 225, 253, 281, and 309 |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Blood Pressure Changes From Baseline | Blood pressure was generally recorded on the day of dialysis and represent pre-dialysis values. Baseline is defined as blood pressure measurements recorded on Day 1 of the first dose administered. | Safety population- all randomized participant who received at least 1 dose of sotatercept and had evaluable safety data | Posted | Mean | Standard Deviation | mmHg | From pre-dose up to the final visit 112 days after last dose (up to 225 days) |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Changes in Follicle Stimulating Hormone (FSH) | The change in follicle stimulating measured at pre-specified timepoints throughout the treatment period. | All randomized participants in Part 1 | Posted | Mean | Standard Deviation | IU/L | Day 1 (baseline), Day 15, Day 29, and Day 113 |
|
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Hemoglobin > 10g/dL | Number of participants with hemoglobin > 10g/dL including Hb values obtained after first study drug dose and before any rescue. Baseline is defined as hemoglobin measurements recorded on Day 1 of the first dose administered. | All randomized participants in Part 2 | Posted | Count of Participants | Participants | Pre-dose; Dose 1-Days 1, 8, 15, 22, 29; Doses 2, 3, 4, 5, 6, 7-Days 1, 15, 29; Follow-up Phase Days 225, 253, 281, and 309 |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Change From Baseline Hemoglobin ≥ 1g/dL | Number of participants with a change from in hemoglobin values ≥ 1g/dL including Hb values obtained after first study drug dose and before any rescue. Baseline is defined as hemoglobin measurements recorded on Day 1 of the first dose administered. | All randomized participants in Part 2 | Posted | Count of Participants | Participants | Pre-dose; Dose 1-Days 1, 8, 15, 22, 29; Doses 2, 3, 4, 5, 6, 7-Days 1, 15, 29; Follow-up Phase Days 225, 253, 281, and 309 |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Hemoglobin > 10g/dL and Change From Baseline Hemoglobin ≥ 1g/dL | Number of participants with Hemoglobin > 10g/dL and a change from in hemoglobin values ≥ 1g/dL including Hb values obtained after first study drug dose and before any rescue. Baseline is defined as hemoglobin measurements recorded on Day 1 of the first dose administered. | All randomized participants in Part 2 | Posted | Count of Participants | Participants | Pre-dose; Dose 1-Days 1, 8, 15, 22, 29; Doses 2, 3, 4, 5, 6, 7-Days 1, 15, 29; Follow-up Phase Days 225, 253, 281, and 309 |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Length of Time to Rescue Therapy | The length of time in days that participants who were rescued received treatment. When applicable, participants were rescued for anemia. During the rescue, participants discontinued sotatercept and were unblinded to the study treatment. Participants who were rescued continued in the treatment phase of 200 days and a follow-up phase of 112 days after the treatment phase. Rescue is defined as the need for a blood transfusion or Erythropoiesis-stimulating agent (ESA) therapy. | Participants in Part 2 who received rescue therapy | Posted | Mean | Standard Deviation | Days | From first dose up to blood transfusion or ESA therapy, up to approximately 209 days |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Hemoglobin Values | Dose Cycle 1 is defined as the first 28 days of treatment for Dose Groups 0.3 mg/kg, 0.5 mg/kg, and 0.7 mg/kg and the first 14 days of treatment for Dose Group 0.7/0.4 mg/kg. End of the Treatment Period is defined as the day before the follow-up phase started. Baseline is defined as hemoglobin measurements recorded on Day 1 of the first dose administered. | All randomized participants in Part 2 | Posted | Mean | Standard Deviation | g/L | From first dose up to Day 225 |
|
Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part 1 - Placebo | Participants received a single subcutaneous dose of placebo prior to dialysis on Day 1 via an IVRS. | 0 | 1 | 0 | 1 | 1 | 1 |
| EG001 | Part 1 - ACE-011 0.1 mg/kg | Participants received a single subcutaneous dose of sotatercept (0.1 mg/kg) prior to dialysis on Day 1 via an IVRS | 1 | 6 | 2 | 6 | 6 | 6 |
| EG002 | Part 2 - Placebo | Participants received a single subcutaneous dose of placebo | 2 | 11 | 3 | 11 | 6 | 11 |
| EG003 | Part 2 - 0.3 mg/kg | Participants received a single subcutaneous dose of 0.3 mg/kg sotatercept every 28 days for up to 8 doses | 0 | 9 | 4 | 9 | 8 | 9 |
| EG004 | Part 2 - 0.5 mg/kg | Participants received a single subcutaneous dose of 0.5 mg/kg sotatercept every 28 days for up to 8 doses | 0 | 8 | 0 | 8 | 6 | 8 |
| EG005 | Part 2 - 0.7 mg/kg | Participants received a single subcutaneous dose of 0.7 mg/kg sotatercept every 28 days for up to 8 doses | 0 | 9 | 5 | 9 | 8 | 9 |
| EG006 | Part 2 - 0.7/0.4 mg/kg | Participants received a subcutaneous dose of 0.7 mg/kg sotatercept loading followed by a subcutaneous dose of 0.4 mg/kg sotatercept every 14 days for up to 15 doses | 0 | 6 | 1 | 6 | 4 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | 14.0 | Systematic Assessment |
| |
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | 14.0 | Systematic Assessment |
| |
| ANGINA PECTORIS | Cardiac disorders | 14.0 | Systematic Assessment |
| |
| ANGINA UNSTABLE | Cardiac disorders | 14.0 | Systematic Assessment |
| |
| ARTERIOSCLEROSIS CORONARY ARTERY | Cardiac disorders | 14.0 | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | 14.0 | Systematic Assessment |
| |
| CARDIOMYOPATHY | Cardiac disorders | 14.0 | Systematic Assessment |
| |
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | 14.0 | Systematic Assessment |
| |
| ILEUS | Gastrointestinal disorders | 14.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | 14.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | 14.0 | Systematic Assessment |
| |
| GAIT DISTURBANCE | General disorders | 14.0 | Systematic Assessment |
| |
| NON-CARDIAC CHEST PAIN | General disorders | 14.0 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | 14.0 | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | 14.0 | Systematic Assessment |
| |
| OESOPHAGEAL CANDIDIASIS | Infections and infestations | 14.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | 14.0 | Systematic Assessment |
| |
| PNEUMONIA BACTERIAL | Infections and infestations | 14.0 | Systematic Assessment |
| |
| TRACHEOBRONCHITIS | Infections and infestations | 14.0 | Systematic Assessment |
| |
| ARTERIOVENOUS FISTULA SITE HAEMORRHAGE | Injury, poisoning and procedural complications | 14.0 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | 14.0 | Systematic Assessment |
| |
| HEART RATE IRREGULAR | Investigations | 14.0 | Systematic Assessment |
| |
| TYPE 2 DIABETES MELLITUS | Metabolism and nutrition disorders | 14.0 | Systematic Assessment |
| |
| BLADDER CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 14.0 | Systematic Assessment |
| |
| TUMOUR THROMBOSIS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 14.0 | Systematic Assessment |
| |
| SUBARACHNOID HAEMORRHAGE | Nervous system disorders | 14.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | 14.0 | Systematic Assessment |
| |
| AORTIC ANEURYSM | Vascular disorders | 14.0 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | 14.0 | Systematic Assessment |
| |
| HYPERTENSIVE CRISIS | Vascular disorders | 14.0 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | 14.0 | Systematic Assessment |
| |
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | 14.0 | Systematic Assessment |
| |
| FLUID OVERLOAD | Metabolism and nutrition disorders | 14.0 | Systematic Assessment |
| |
| RENAL FAILURE CHRONIC | Renal and urinary disorders | 14.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| LYMPHADENOPATHY | Blood and lymphatic system disorders | 14.0 | Systematic Assessment |
| |
| ANGINA UNSTABLE | Cardiac disorders | 14.0 | Systematic Assessment |
| |
| CORONARY ARTERY DISEASE | Cardiac disorders | 14.0 | Systematic Assessment |
| |
| RETINAL DETACHMENT | Eye disorders | 14.0 | Systematic Assessment |
| |
| VITREOUS HAEMORRHAGE | Eye disorders | 14.0 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | 14.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | 14.0 | Systematic Assessment |
| |
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | 14.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | 14.0 | Systematic Assessment |
| |
| OESOPHAGITIS | Gastrointestinal disorders | 14.0 | Systematic Assessment |
| |
| RECTAL HAEMORRHAGE | Gastrointestinal disorders | 14.0 | Systematic Assessment |
| |
| TOOTHACHE | Gastrointestinal disorders | 14.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | 14.0 | Systematic Assessment |
| |
| ASTHENIA | General disorders | 14.0 | Systematic Assessment |
| |
| FATIGUE | General disorders | 14.0 | Systematic Assessment |
| |
| MEDICAL DEVICE COMPLICATION | General disorders | 14.0 | Systematic Assessment |
| |
| OEDEMA | General disorders | 14.0 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | 14.0 | Systematic Assessment |
| |
| PAIN | General disorders | 14.0 | Systematic Assessment |
| |
| ACARODERMATITIS | Infections and infestations | 14.0 | Systematic Assessment |
| |
| ARTERIOVENOUS FISTULA SITE INFECTION | Infections and infestations | 14.0 | Systematic Assessment |
| |
| BACTERAEMIA | Infections and infestations | 14.0 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | 14.0 | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | 14.0 | Systematic Assessment |
| |
| CORNEAL INFECTION | Infections and infestations | 14.0 | Systematic Assessment |
| |
| FOLLICULITIS | Infections and infestations | 14.0 | Systematic Assessment |
| |
| GASTROENTERITIS VIRAL | Infections and infestations | 14.0 | Systematic Assessment |
| |
| OTITIS MEDIA | Infections and infestations | 14.0 | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | 14.0 | Systematic Assessment |
| |
| STAPHYLOCOCCAL BACTERAEMIA | Infections and infestations | 14.0 | Systematic Assessment |
| |
| TOOTH INFECTION | Infections and infestations | 14.0 | Systematic Assessment |
| |
| TRACHEOBRONCHITIS | Infections and infestations | 14.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | 14.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | 14.0 | Systematic Assessment |
| |
| VIRAL INFECTION | Infections and infestations | 14.0 | Systematic Assessment |
| |
| ARTERIOVENOUS FISTULA SITE COMPLICATION | Injury, poisoning and procedural complications | 14.0 | Systematic Assessment |
| |
| ARTERIOVENOUS FISTULA SITE HAEMORRHAGE | Injury, poisoning and procedural complications | 14.0 | Systematic Assessment |
| |
| ARTERIOVENOUS FISTULA THROMBOSIS | Injury, poisoning and procedural complications | 14.0 | Systematic Assessment |
| |
| ARTERIOVENOUS GRAFT SITE HAEMORRHAGE | Injury, poisoning and procedural complications | 14.0 | Systematic Assessment |
| |
| CONTUSION | Injury, poisoning and procedural complications | 14.0 | Systematic Assessment |
| |
| EXCORIATION | Injury, poisoning and procedural complications | 14.0 | Systematic Assessment |
| |
| EYE PENETRATION | Injury, poisoning and procedural complications | 14.0 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | 14.0 | Systematic Assessment |
| |
| JOINT DISLOCATION | Injury, poisoning and procedural complications | 14.0 | Systematic Assessment |
| |
| JOINT INJURY | Injury, poisoning and procedural complications | 14.0 | Systematic Assessment |
| |
| MENISCUS LESION | Injury, poisoning and procedural complications | 14.0 | Systematic Assessment |
| |
| MUSCLE STRAIN | Injury, poisoning and procedural complications | 14.0 | Systematic Assessment |
| |
| POST PROCEDURAL HAEMORRHAGE | Injury, poisoning and procedural complications | 14.0 | Systematic Assessment |
| |
| SKELETAL INJURY | Injury, poisoning and procedural complications | 14.0 | Systematic Assessment |
| |
| SUTURE RELATED COMPLICATION | Injury, poisoning and procedural complications | 14.0 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | 14.0 | Systematic Assessment |
| |
| BLOOD GLUCOSE INCREASED | Investigations | 14.0 | Systematic Assessment |
| |
| BLOOD PHOSPHORUS DECREASED | Investigations | 14.0 | Systematic Assessment |
| |
| BLOOD PHOSPHORUS INCREASED | Investigations | 14.0 | Systematic Assessment |
| |
| C-REACTIVE PROTEIN INCREASED | Investigations | 14.0 | Systematic Assessment |
| |
| EOSINOPHIL COUNT INCREASED | Investigations | 14.0 | Systematic Assessment |
| |
| HEART RATE INCREASED | Investigations | 14.0 | Systematic Assessment |
| |
| HEPATIC ENZYME INCREASED | Investigations | 14.0 | Systematic Assessment |
| |
| INTERNATIONAL NORMALISED RATIO INCREASED | Investigations | 14.0 | Systematic Assessment |
| |
| VITAMIN D DECREASED | Investigations | 14.0 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | 14.0 | Systematic Assessment |
| |
| HYPERKALAEMIA | Metabolism and nutrition disorders | 14.0 | Systematic Assessment |
| |
| HYPOCALCAEMIA | Metabolism and nutrition disorders | 14.0 | Systematic Assessment |
| |
| HYPOGLYCAEMIA | Metabolism and nutrition disorders | 14.0 | Systematic Assessment |
| |
| IRON DEFICIENCY | Metabolism and nutrition disorders | 14.0 | Systematic Assessment |
| |
| TYPE 2 DIABETES MELLITUS | Metabolism and nutrition disorders | 14.0 | Systematic Assessment |
| |
| VITAMIN D DEFICIENCY | Metabolism and nutrition disorders | 14.0 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | 14.0 | Systematic Assessment |
| |
| ARTHRITIS | Musculoskeletal and connective tissue disorders | 14.0 | Systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | 14.0 | Systematic Assessment |
| |
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | 14.0 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | 14.0 | Systematic Assessment |
| |
| SPINAL COLUMN STENOSIS | Musculoskeletal and connective tissue disorders | 14.0 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | 14.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | 14.0 | Systematic Assessment |
| |
| PRESYNCOPE | Nervous system disorders | 14.0 | Systematic Assessment |
| |
| SCIATICA | Nervous system disorders | 14.0 | Systematic Assessment |
| |
| AGITATION | Psychiatric disorders | 14.0 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | 14.0 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | 14.0 | Systematic Assessment |
| |
| CHROMATURIA | Renal and urinary disorders | 14.0 | Systematic Assessment |
| |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | 14.0 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | 14.0 | Systematic Assessment |
| |
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | 14.0 | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | 14.0 | Systematic Assessment |
| |
| RESPIRATORY TRACT CONGESTION | Respiratory, thoracic and mediastinal disorders | 14.0 | Systematic Assessment |
| |
| THROAT IRRITATION | Respiratory, thoracic and mediastinal disorders | 14.0 | Systematic Assessment |
| |
| ALOPECIA | Skin and subcutaneous tissue disorders | 14.0 | Systematic Assessment |
| |
| DRY GANGRENE | Skin and subcutaneous tissue disorders | 14.0 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | 14.0 | Systematic Assessment |
| |
| URTICARIA | Skin and subcutaneous tissue disorders | 14.0 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | 14.0 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | 14.0 | Systematic Assessment |
| |
| PERIPHERAL VASCULAR DISORDER | Vascular disorders | 14.0 | Systematic Assessment |
| |
| STEAL SYNDROME | Vascular disorders | 14.0 | Systematic Assessment |
| |
| ANAEMIA | Blood and lymphatic system disorders | 14.0 | Systematic Assessment |
| |
| ORBITAL OEDEMA | Eye disorders | 14.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | 14.0 | Systematic Assessment |
| |
| DRY MOUTH | Gastrointestinal disorders | 14.0 | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | 14.0 | Systematic Assessment |
| |
| CHILLS | General disorders | 14.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | 14.0 | Systematic Assessment |
| |
| ARTERIOVENOUS FISTULA SITE HAEMATOMA | Injury, poisoning and procedural complications | 14.0 | Systematic Assessment |
| |
| HYPERPHOSPHATAEMIA | Metabolism and nutrition disorders | 14.0 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | 14.0 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please email | Clinical.Trails@bms.com |
| ID | Term |
|---|---|
| D000740 | Anemia |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C542017 | ACE-011 |
Not provided
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG004 | Part 2-0.5 mg/kg | Participants received a single subcutaneous dose of 0.5 mg/kg sotatercept every 28 days for up to 8 doses |
| OG005 | Part 2-0.7 mg/kg | Participants received a single subcutaneous dose of 0.7 mg/kg sotatercept every 28 days for up to 8 doses |
| OG006 | Part 2-0.7/0.4 mg/kg | Participants received a subcutaneous dose of 0.7 mg/kg sotatercept loading followed by a subcutaneous dose of 0.4 mg/kg sotatercept every 14 days for up to 15 doses |
|
|
| OG004 | Part 2-0.5 mg/kg | Participants received a single subcutaneous dose of 0.5 mg/kg sotatercept every 28 days for up to 8 doses |
| OG005 | Part 2-0.7 mg/kg | Participants received a single subcutaneous dose of 0.7 mg/kg sotatercept every 28 days for up to 8 doses |
| OG006 | Part 2-0.7/0.4 mg/kg | Participants received a subcutaneous dose of 0.7 mg/kg sotatercept loading followed by a subcutaneous dose of 0.4 mg/kg sotatercept every 14 days for up to 15 doses |
|
|
Participants received a single subcutaneous dose of 0.3 mg/kg sotatercept every 28 days for up to 8 doses
| OG004 | Part 2-0.5 mg/kg | Participants received a single subcutaneous dose of 0.5 mg/kg sotatercept every 28 days for up to 8 doses |
| OG005 | Part 2-0.7 mg/kg | Participants received a single subcutaneous dose of 0.7 mg/kg sotatercept every 28 days for up to 8 doses |
| OG006 | Part 2-0.7/0.4 mg/kg | Participants received a subcutaneous dose of 0.7 mg/kg sotatercept loading followed by a subcutaneous dose of 0.4 mg/kg sotatercept every 14 days for up to 15 doses |
|
|
| OG004 | Part 2-0.5 mg/kg | Participants received a single subcutaneous dose of 0.5 mg/kg sotatercept every 28 days for up to 8 doses |
| OG005 | Part 2-0.7 mg/kg | Participants received a single subcutaneous dose of 0.7 mg/kg sotatercept every 28 days for up to 8 doses |
| OG006 | Part 2-0.7/0.4 mg/kg | Participants received a subcutaneous dose of 0.7 mg/kg sotatercept loading followed by a subcutaneous dose of 0.4 mg/kg sotatercept every 14 days for up to 15 doses |
|
|
| Part 2-0.3 mg/kg |
Participants received a single subcutaneous dose of 0.3 mg/kg sotatercept every 28 days for up to 8 doses |
| OG004 | Part 2-0.5 mg/kg | Participants received a single subcutaneous dose of 0.5 mg/kg sotatercept every 28 days for up to 8 doses |
| OG005 | Part 2-0.7 mg/kg | Participants received a single subcutaneous dose of 0.7 mg/kg sotatercept every 28 days for up to 8 doses |
| OG006 | Part 2-0.7/0.4 mg/kg | Participants received a subcutaneous dose of 0.7 mg/kg sotatercept loading followed by a subcutaneous dose of 0.4 mg/kg sotatercept every 14 days for up to 15 doses |
|
|
| OG004 | Part 2-0.5 mg/kg | Participants received a single subcutaneous dose of 0.5 mg/kg sotatercept every 28 days for up to 8 doses |
| OG005 | Part 2-0.7 mg/kg | Participants received a single subcutaneous dose of 0.7 mg/kg sotatercept every 28 days for up to 8 doses |
| OG006 | Part 2-0.7/0.4 mg/kg | Participants received a subcutaneous dose of 0.7 mg/kg sotatercept loading followed by a subcutaneous dose of 0.4 mg/kg sotatercept every 14 days for up to 15 doses |
|
|
| OG004 | Part 2-0.5 mg/kg | Participants received a single subcutaneous dose of 0.5 mg/kg sotatercept every 28 days for up to 8 doses |
| OG005 | Part 2-0.7 mg/kg | Participants received a single subcutaneous dose of 0.7 mg/kg sotatercept every 28 days for up to 8 doses |
| OG006 | Part 2-0.7/0.4 mg/kg | Participants received a subcutaneous dose of 0.7 mg/kg sotatercept loading followed by a subcutaneous dose of 0.4 mg/kg sotatercept every 14 days for up to 15 doses |
|
|
| OG004 | Part 2-0.5 mg/kg | Participants received a single subcutaneous dose of 0.5 mg/kg sotatercept every 28 days for up to 8 doses |
| OG005 | Part 2-0.7 mg/kg | Participants received a single subcutaneous dose of 0.7 mg/kg sotatercept every 28 days for up to 8 doses |
| OG006 | Part 2-0.7/0.4 mg/kg | Participants received a subcutaneous dose of 0.7 mg/kg sotatercept loading followed by a subcutaneous dose of 0.4 mg/kg sotatercept every 14 days for up to 15 doses |
|
|
| OG004 | Part 2-0.5 mg/kg | Participants received a single subcutaneous dose of 0.5 mg/kg sotatercept every 28 days for up to 8 doses |
| OG005 | Part 2-0.7 mg/kg | Participants received a single subcutaneous dose of 0.7 mg/kg sotatercept every 28 days for up to 8 doses |
| OG006 | Part 2-0.7/0.4 mg/kg | Participants received a subcutaneous dose of 0.7 mg/kg sotatercept loading followed by a subcutaneous dose of 0.4 mg/kg sotatercept every 14 days for up to 15 doses |
|
|
| OG004 | Part 2-0.5 mg/kg | Participants received a single subcutaneous dose of 0.5 mg/kg sotatercept every 28 days for up to 8 doses |
| OG005 | Part 2-0.7 mg/kg | Participants received a single subcutaneous dose of 0.7 mg/kg sotatercept every 28 days for up to 8 doses |
| OG006 | Part 2-0.7/0.4 mg/kg | Participants received a subcutaneous dose of 0.7 mg/kg sotatercept loading followed by a subcutaneous dose of 0.4 mg/kg sotatercept every 14 days for up to 15 doses |
|
|
|
| OG004 | Part 2-0.7/0.4 mg/kg | Participants received a subcutaneous dose of 0.7 mg/kg sotatercept loading followed by a subcutaneous dose of 0.4 mg/kg sotatercept every 14 days for up to 15 doses |
|
|
| OG004 | Part 2-0.7/0.4 mg/kg | Participants received a subcutaneous dose of 0.7 mg/kg sotatercept loading followed by a subcutaneous dose of 0.4 mg/kg sotatercept every 14 days for up to 15 doses |
|
|
Participants received a single subcutaneous dose of 0.7 mg/kg sotatercept every 28 days for up to 8 doses
| OG004 | Part 2-0.7/0.4 mg/kg | Participants received a subcutaneous dose of 0.7 mg/kg sotatercept loading followed by a subcutaneous dose of 0.4 mg/kg sotatercept every 14 days for up to 15 doses |
|
|
| Part 2-0.7 mg/kg |
Participants received a single subcutaneous dose of 0.7 mg/kg sotatercept every 28 days for up to 8 doses |
| OG004 | Part 2-0.7/0.4 mg/kg | Participants received a subcutaneous dose of 0.7 mg/kg sotatercept loading followed by a subcutaneous dose of 0.4 mg/kg sotatercept every 14 days for up to 15 doses |
|
|
| OG004 | Part 2-0.7/0.4 mg/kg | Participants received a subcutaneous dose of 0.7 mg/kg sotatercept loading followed by a subcutaneous dose of 0.4 mg/kg sotatercept every 14 days for up to 15 doses |
|
|
|
|
|
|
|