Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Sotatercept · 15 trials · 9 indications
PVR was the resistance against blood flow from the pulmonary artery to the left atrium. PVR was measured in dyn\*sec/cm\^5 by right heart catheterization (RHC). RHC was performed during the screening period (baseline) and Week 24. Per protocol, the change in PVR from baseline at Week 24 was reported for the primary treatment period.
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Per protocol, the number of participants who experienced an AE were reported for the primary treatment period.
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Per protocol, the number of participants who discontinued study treatment due to AEs were reported for the primary treatment period.
Morbidity or mortality events were defined as all-cause death, lung transplantation, or PAH worsening-related hospitalization of ≥24 hours. All events were adjudicated by a blinded, independent committee of clinical experts. Only adjudication-confirmed lung transplantation and PAH worsening-related hospitalization of ≥24 hours were included in the primary analysis. All deaths that are a first event for a participant were included regardless of adjudication. The time from randomization to the first confirmed morbidity or mortality event, calculated using the non-parametric Kaplan-Meier method, is presented.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.
ADAs will be detected in serum. The number of participants with detectable ADAs will be reported.
Blood samples will be collected to determine the concentration of platelets and hemoglobin.
Blood samples will be collected to determine the concentration of creatinine, total bilirubin, and ALT.
Change from baseline in body weight will be reported.
Change from baseline in systolic and diastolic blood pressure will be reported.
Change from baseline in ECG (12-lead) for the determination of Fridericia's corrected QT interval (QTcF) will be reported.
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.
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.
An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Hematological parameters will be investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. The concentration of hemoglobin will be presented.
Hematological parameters will be investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. The hematocrit will be presented.
Hematological parameters will be investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. The RBC count will be presented.
Hematological parameters will be investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. The reticulocyte count will be presented.
Hematological parameters will be investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. The platelet count will be presented.
BP will be assessed while the participant was seated after a period of rest in a quiet setting with no distractions (eg, television and cell phones).
Neutralizing antibody analysis will be performed on blood samples for participants who are confirmed as antidrug antibody-positive. The number of participants with detectable neutralizing antibodies at any time during the study will be presented.
Serum samples collected predose will be used to determine serum trough concentration (Ctrough) of sotatercept.
The change from baseline in PVRI will be presented.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study intervention due to an AE will be reported.
Steady-state Cavg of sotatercept will be reported.
An AE is a health problem that happens or worsens during a study. Number of participants who discontinue study treatment will be reported.
Blood samples will be collected at multiple time points to estimate the AUCss of Sotatercept.
Blood samples will be collected at Predose Day 1, Day 7, Day 14, and Predose Day 21 to estimate the AUC0-3 weeks of Sotatercept.
An AE is any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants with 1 or more AEs will be assessed.
An AE is any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. The percentage of participants who discontinued the study drug due to an AE regardless of study completion status will be assessed.
ADA to Sotatercept will be assessed.
PVR, a hemodynamic variable of pulmonary circulation, is measured by right heart catheterization (RHC).
Each participant's VO2 max was measured by an invasive cardiopulmonary exercise test (iCPET) at baseline and at 24 weeks.
Each participant's PVR, at resting supine, was measured by right heart catheterization at baseline and at 24 weeks.
Each participant's PVR, at resting supine, was measured by right heart catheterization at baseline and the timepoint at which the third right heart catheterization was performed, which occurred between Month 18 and Month 24.
Each participant's PVR, at resting supine, was measured by right heart catheterization at baseline and the timepoint at which the third right heart catheterization was performed, which occurred between Month 18 and Month 24.
An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
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.
Blood samples will be collected to determine the AUC0-inf of sotatercept in plasma.
Blood samples will be collected to determine the AUC0-last of sotatercept in plasma.
Blood samples will be collected to determine the Cmax of sotatercept in plasma.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study due to an AE will be reported.
Blood samples will be collected to determine the Cmax of sotatercept.
Blood samples will be collected to determine the Tmax of sotatercept.
Blood samples will be collected to determine the AUC0-last of MK-7962.
Blood samples will be collected to determine the AUC0-inf of MK-7962.
Blood samples will be collected to determine the AUC0-28 days of MK-7962.
Blood samples will be collected to determine the t1/2 of MK-7962.
Blood samples will be collected to determine the CL/F of MK-7962.
Blood samples will be collected to determine the Vz/F of MK-7962.
| Arm | Type | Description |
|---|---|---|
| Sotatercept | EXPERIMENTAL | Participants on background PAH therapy will receive sotatercept subcutaneous (SC) injections at a starting dose of 0.3 mg/kg with a target dose of 0.7 mg/kg every 3 weeks up to 24 weeks. Thereafter, participants may choose to receive the sotatercept treatment at same dose and schedule in the extension treatment period from Week 24 until up to 6 months after sotatercept becomes locally commercially available and reimbursed in Japan. |
| Placebo | PLACEBO_COMPARATOR | Participants on background PAH therapy will be administered placebo by SC injection every 21 days |
| Sotatercept plus background PAH therapy | EXPERIMENTAL | Sotatercept at a starting dose of 0.3 mg/kg with a target dose of 0.7 mg/kg administered subcutaneously (SC) every 21 days plus background PAH therapy |
| Placebo plus background PAH therapy | PLACEBO_COMPARATOR | Placebo administered (SC) every 21 days plus background PAH therapy |
| Weight-banded sotatercept dosing | EXPERIMENTAL | Participants will receive sotatercept via subcutaneous (SC) injection every 3 weeks at an initial dose of up to 45 mg and then at a maintenance dose of up to 90 mg using a weight-banded method and will continue treatment for up to 24 months. All eligible participants will receive weight-banded dosing at the dosing level (initial or maintenance) at which they finished MK-7962-024 (LIGHTRAY). Participants will continue to take their background PAH therapy during the study. |
| Sotatercept 0.3 mg/kg | EXPERIMENTAL | Participants receive sotatercept 0.3 mg/kg subcutaneous (SC) injection every 3 weeks (Q3W) for up to approximately 10 years or until discontinuation. |
| Sotatercept 0.7 mg/kg | EXPERIMENTAL | Participants receive sotatercept 0.7 mg/kg SC injection Q3W for up to approximately 10 years or until discontinuation. |
| Weight-based sotatercept dosing | EXPERIMENTAL | Participants will receive sotatercept via subcutaneous (SC) injection every 3 weeks at an initial dose of 0.3 mg/kg and then at a maintenance dose of 0.7 mg/kg using a weight-based method during a 24-week treatment period. Participants will continue to take their background PAH therapy during the study. |
| Children ≥1 to <18 years old | EXPERIMENTAL | Participants will receive a subcutaneous (SC) injection every 3 weeks (Q3W) of 0.3 mg/kg. Dosage may be adjusted based on protocol-specific guidelines. |
| Sotatercept 0.3 mg/kg, escalating to 0.7 mg.kg | EXPERIMENTAL | Sotatercept SC at a starting dose level of 0.3 mg/kg for 3 dosing visits (Q3W), then escalating to 0.7 mg/kg SC on the fourth dosing visit and Q3W for the remainder of the 24-week treatment Period. |
| Sotatercept 0.1 mg/kg | EXPERIMENTAL | Sotatercept 0.1 mg/kg |
| Sotatercept 0.5 mg/kg | EXPERIMENTAL | Sotatercept 0.5 mg/kg |
| Sotatercept 1.0 mg/kg | EXPERIMENTAL | Sotatercept 1.0 mg/kg |
| Sotatercept 1.5 mg/kg | EXPERIMENTAL | Sotatercept 1.5 mg/kg |
| Sotatercept 2.0 mg/kg | EXPERIMENTAL | Sotatercept 2.0 mg/kg |
| High Dose Subcutaneous Injection | ACTIVE_COMPARATOR | Participants will receive a single subcutaneous high dose of sotatercept administered via syringe. |
| High Dose Subcutaneous Autoinjector | EXPERIMENTAL | Participants will receive a single subcutaneous high dose of sotatercept administered via autoinjector. |
| Low Dose Subcutaneous Autoinjector | EXPERIMENTAL | Participants will receive a single subcutaneous low dose of sotatercept administered via autoinjector. |
| Sotatercept Dose Level 1 | EXPERIMENTAL | Participants received a single dose of sotatercept at dose level 1. |
| Sotatercept Dose Level 2 | EXPERIMENTAL | Participants received a single dose of sotatercept at dose level 2. |
| Name | Type | Description |
|---|---|---|
| Sotatercept | BIOLOGICAL | SC injection at a starting dose of 0.3 mg/kg with a target dose of 0.7 mg/kg every 21 days plus background PAH therapy. |
| Placebo | OTHER | Placebo-matched SC injection |
| Background PAH Therapy | DRUG | Background PAH therapy may consist of the following drug classes: an endothelin-receptor antagonist (ERA), a phosphodiesterase 5 (PDE5) inhibitor, a soluble guanylate cyclase stimulator, and/or a prostacyclin analogue or receptor agonist. |
| Sotatercept 0.3 mg/kg | DRUG | Administered by subcutaneous injection. Sotatercept (ACE-011) is a recombinant fusion protein consisting of the extracellular domain of the human activin receptor type IIA linked to the Fc piece of human IgG1. |
| Sotatercept 0.3 mg/kg escalating to 0.7 mg/kg | DRUG | Administered by subcutaneous injection. Sotatercept (ACE-011) is a recombinant fusion protein consisting of the extracellular domain of the human activin receptor type IIA linked to the Fc piece of human IgG1. |
| SOC | OTHER | SOC therapy refers to combination therapy consisting of drugs from two or more of the following drug classes: an endothelin-receptor antagonist (ERA), a phosphodiesterase 5 (PDE5) inhibitor, a soluble guanylate cyclase stimulator, and/or a prostacyclin analogue or receptor agonist. |
| Sotatercept Autoinjector | BIOLOGICAL | Subcutaneous Auto Injection |
Inclusion Criteria: * Documented diagnostic right heart catheterization (RHC) at any time prior to screening confirming the diagnosis of World Health Organization (WHO) pulmonary arterial hypertension (PAH) Group 1 in any of the following subtypes: * Idiopathic PAH * Heritable PAH * Drug/tox...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| United Therapeutics Corporation | UTHR | 5 | PHASE3 | Ralinepag |
| Merck & Co., Inc. | MRK | 6 | PHASE3 | Riociguat |
| Insmed Incorporated | INSM | 4 | PHASE3 | Treprostinil Palmitil |
| Johnson & Johnson | JNJ | 4 | PHASE3 | Selexipag |
| Liquidia Corporation | LQDA | 4 | PHASE3 | L606 |
| Tenax Therapeutics, Inc. | TENX | 3 | PHASE3 | TNX-103 |
| Inhibikase Therapeutics, Inc. | IKT | 1 | PHASE3 | IKT-001 |
| Gossamer Bio, Inc. | GOSS | 2 | PHASE3 | Seralutinib |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE2 | REGN13335 |
| Pfizer Inc. | PFE | 1 | PHASE2 | PF-07868489 |
| Tectonic Therapeutic Inc | TECX | 1 | PHASE2 | TX000045- Dose A, TX000045- Dose B |
| Abbott Laboratories | ABT | 1 | N/A | Undisclosed |
Sotatercept is an investigational drug being studied for the treatment of Pulmonary Arterial Hypertension (PAH), a condition of high blood pressure in the lungs. It is developed by Merck & Company, Inc. and is currently in Phase 2 clinical trials. Sotatercept is not yet approved by the FDA.
Sotatercept is being developed by Merck & Company, Inc., which is publicly traded under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Pulmonary Arterial Hypertension.
Sotatercept is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied in multiple clinical trials for the treatment of Pulmonary Arterial Hypertension.
Sotatercept has been studied in several clinical trials, including NCT03496207, NCT03738150, NCT06664801, and NCT06925750. These trials are Phase 2 studies focused on Pulmonary Arterial Hypertension, with some completed and others active but not recruiting. The trials have enrolled patients from multiple countries.
Sotatercept is not FDA approved. It is an investigational drug currently in Phase 2 clinical trials for Pulmonary Arterial Hypertension. The drug is being developed by Merck & Company, Inc. and has not yet received regulatory approval for any indication.