Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as hActRIIA-IgG1, Sotatercept
ACE-011 · 1 trial · 1 indication
A treatment emergent adverse event (TEAE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causality assessment. A TEAE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. Any worsening (i.e., any clinical significant adverse change in frequency and/or intensity) of a preexisting condition, which was temporally associated with the use of the sponsor's medicinal (investigational) product, was also a TEAE. The number of participants with at least one TEAE are reported.
A treatment emergent adverse event (TEAE) related to study drug was defined as any untoward medical occurrence in a participant administered a pharmaceutical product, that was determined to be related to the study drug. A TEAE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product. Any worsening (i.e., any clinical significant adverse change in frequency and/or intensity) of a preexisting condition, which was temporally associated with the use of the sponsor's medicinal (investigational) product, was also a TEAE. The number of participants with at least one TEAE are reported. Treatment emergent adverse events were assessed by the investigator as possibly, probably, or definitely related to the study drug.
A Serious Adverse Event (SAE) was defined as any untoward medical occurrence that at any dose (including overdose) that was fatal, was life threatening, required or prolonged inpatient hospitalization, resulted in permanent or significant disability/incapacity, or was a congenital anomaly/birth defect. The number of participants with at least one serious adverse event are reported.
Summary of the change from baseline in hemoglobin (g/dL) by the pre-specified timepoints. Baseline was defined as the last measurement prior to dosing. Data were summarized for all treated participants who had at least 1 postdosing measurement.
The number of participants with at least one clinically significant postbaseline electrocardiogram abnormality. The abnormalities included left ventricular hypertrophy, atrial fibrillation, sinus bradycardia, sinus tachycardia, and myocardial ischemia. Data is reported as the cumulative number of participants with abnormalities over the scheduled collection timepoints.
The number of participants who experienced hypertension or an increase in blood pressure from baseline up to Day 92. Abnormal blood pressure was defined as: * Systolic blood pressure ≤ 90 or ≥ 180 mmHg * Systolic blood pressure change (increase or decrease) ≥ 20 mmHg * Diastolic blood pressure ≤ 60 or ≥ 100 mmHg * Diastolic blood pressure change (increase or decrease) ≥ 15 mmHg
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Subcutaneous injection on days 1, 29, 57 and 85. |
| ACE-011 0.1 mg/kg | EXPERIMENTAL | Subcutaneous injection of ACE-011 0.1 mg/kg every 28 days totaling four doses (days 1, 29, 57 and 85). |
| ACE-011 0.3 mg/kg | EXPERIMENTAL | Subcutaneous injection of ACE-011 0.3 mg/kg every 28 days totaling four doses (days 1, 29, 57 and 85). |
| ACE-011 0.5 mg/kg | EXPERIMENTAL | Subcutaneous injection of ACE-011 0.5 mg/kg every 28 days totaling four doses (days 1, 29, 57 and 85). |
| Name | Type | Description |
|---|---|---|
| ACE-011 | BIOLOGICAL | ACE-011 given by the subcutaneous route of administration monthly for 4 doses. |
| Placebo | BIOLOGICAL | Placebo given by the subcutaneous route of administration monthly for 4 doses. |
Key Inclusion Criteria: * Patient at least 18 years of age with stage II or III multiple myeloma * One or more lytic bone lesions * If currently receiving bisphosphonate therapy, have been on a stable dose for ≥ 2 months before dosing day 1 or must not have received bisphosphonates within 2 months ...
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ACE-011 is an investigational monoclonal antibody being studied for the treatment of Multiple Myeloma, specifically in patients with osteolytic lesions of the disease. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
ACE-011 is a monoclonal antibody, but its specific molecular target has not been disclosed in the available information. The drug is being investigated for its potential role in treating bone lesions associated with Multiple Myeloma.
ACE-011 is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical trials to evaluate the drug's safety and efficacy.
ACE-011 is in Phase 2 clinical development. It has completed one Phase 2 trial, and no active trials are currently listed. The drug remains investigational and has not received FDA approval.
ACE-011 has been studied in a completed Phase 2 trial with the identifier NCT00747123, titled 'A Safety, Tolerability and Efficacy Study of ACE-011 in Patients With Osteolytic Lesions of Multiple Myeloma.' The trial enrolled 30 participants in Russia and was randomized, double-blind, and placebo-controlled.