What side effects are associated with this type of intervention?

Common treatments for Pulmonary Arterial Hypertension (PAH) include endothelin receptor antagonists (ERAs), phosphodiesterase-5 inhibitors (PDE5Is), and prostacyclin analogs. ERAs can cause liver enzyme elevations, peripheral edema, and nasal congestion. PDE5Is are associated with headaches, flushing, dyspepsia, and visual disturbances. Prostacyclin analogs often lead to side effects such as jaw pain, nausea, diarrhea, and flushing. Sotatercept, a newer treatment under investigation, has shown promise in improving hemodynamics and function in PAH patients, but its long-term safety and tolerability are still being studied.

What prior FDA approvals exist?

The FDA has approved several treatments for Pulmonary Arterial Hypertension (PAH), including endothelin receptor antagonists (e.g., bosentan, ambrisentan), phosphodiesterase-5 inhibitors (e.g., sildenafil, tadalafil), and prostacyclin analogs (e.g., epoprostenol, treprostinil). These treatments target different pathways involved in PAH pathogenesis. Similar to sotatercept, which targets the TGF-β superfamily, other advanced therapies include riociguat, a soluble guanylate cyclase stimulator, and selexipag, an oral prostacyclin receptor agonist. These therapies aim to improve hemodynamics and functional capacity in PAH patients.

What other types of research exist?

Promising novel alternatives to Sotatercept for PAH treatment in 2024 include: 1) Fasudil, a Rho-kinase inhibitor, which has shown acute vasodilator effects and long-term benefits in PAH patients. 2) Getagozumab, a monoclonal antibody targeting endothelin receptor A, which has demonstrated significant reductions in pulmonary arterial pressure in preclinical models. 3) Toceranib and Sorafenib, which have shown efficacy in reversing PAH and cardiopulmonary remodeling in animal studies.

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Sotatercept for Pulmonary Arterial Hypertension (SOTERIA Trial)

Phase 3

Recruiting

Research Sponsored by Acceleron Pharma Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male participants must agree to use a condom, defined as a male latex condom or non latex condom NOT made out of natural (animal) membrane (e.g., polyurethane), during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions, and for at least 16 weeks (112 days) following investigational product discontinuation, even if he has undergone a successful vasectomy

Be older than 18 years old

Must not have

Presence of an ongoing serious adverse event (SAE) that occurred during a PAH sotatercept clinical study that is assessed to be possibly or probably related to sotatercept

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 116 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing sotatercept, a medication for high blood pressure in the lungs, in adults with PAH who have completed earlier studies. It aims to see if the medication is safe and effective over a long period. Sotatercept helps lung blood vessels function better, reducing lung pressure. Sotatercept has shown promising results in earlier studies for reducing lung pressure and improving exercise tolerance in patients with pulmonary arterial hypertension (PAH).

Who is the study for?

This trial is for adults with Pulmonary Arterial Hypertension who've completed previous sotatercept studies without early discontinuation. Participants must agree to contraception and not donate blood or sperm. They can't join if they missed more than 4 doses between studies, have ongoing serious side effects from prior sotatercept trials, or are pregnant/breastfeeding.

What is being tested?

The study tests the long-term safety and effectiveness of a drug called Sotatercept in patients with PAH when added to their current treatment regimen. It's an open-label follow-up to earlier phases where Sotatercept showed promise in improving heart and lung function.

What are the potential side effects?

While specific side effects aren't listed here, participants will be monitored for any adverse reactions given that it's a study focusing on the long-term safety and tolerability of Sotatercept as part of PAH therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I agree to use specified condoms during the study and for 16 weeks after, even if I've had a vasectomy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am experiencing a serious side effect from a PAH drug study possibly due to sotatercept.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 116 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 116 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 116 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change From Baseline in Blood Pressure

Change From Baseline in Body Weight

Change From Baseline in Electrocardiogram (ECG)

+6 more

Secondary study objectives

Change From Baseline in 6-Minute Walk Distance (6MWD)

Change From Baseline in Borg Dyspnea Scale Category Ratio 10 (Borg CR 10) Score

Change From Baseline in N-Terminal Pro-Hormone B-type Natriuretic Peptide (NT-proBNP) Levels

+4 more

Side effects data

From 2022 Phase 3 trial • 324 Patients • NCT04576988

20%

Headache

15%

COVID-19

12%

Diarrhoea

12%

Epistaxis

10%

Telangiectasia

10%

Nausea

10%

Fatigue

10%

Dizziness

Injection site pain

Rash

Hypokalaemia

Flushing

Oedema peripheral

Thrombocytopenia

Nasopharyngitis

Urinary tract infection

Dyspnoea

Iron deficiency

Fall

Bronchitis

Pulmonary arterial hypertension

Inguinal hernia

Atrial flutter

Supraventricular tachycardia

Abdominal pain

Pancreatitis

Cellulitis

Pneumonia

Pneumonia influenzal

Respiratory tract infection

Sepsis

Upper respiratory tract infection

Osteoporotic fracture

Acute kidney injury

Haemoptysis

Pulmonary artery aneurysm

Upper gastrointestinal haemorrhage

Joint injury

Sjogren's syndrome

Cerebral haematoma

Device malfunction

Nephritis

Sarcoidosis

Gastroenteritis viral

100%

80%

60%

40%

20%

Study treatment Arm

Placebo Plus Background PAH Therapy (LTDB Period)

Placebo Plus Background PAH Therapy (DBPC Period)

Sotatercept Plus Background PAH Therapy (DBPC Period)

Sotatercept Plus Background PAH Therapy (LTDB Period)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Sotatercept TreatmentExperimental Treatment1 Intervention

Participants rolling over from a blinded parent study will begin sotatercept at a dose of 0.3 mg/kg SC for Visit 1. Dose will escalate to 0.7 mg/kg SC at Visit 2 through remainder of the study. Participants rolling over from an unblinded parent study will continue sotatercept at their current dose and if at dose \< 0.7 mg/kg SC can titrate up to 0.7 mg/kg SC for the remainder of the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sotatercept

2019

Completed Phase 3

~690

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Pulmonary Arterial Hypertension (PAH) include endothelin receptor antagonists (ERAs) that block endothelin-1, a potent vasoconstrictor; phosphodiesterase-5 inhibitors (PDE5Is) that enhance nitric oxide signaling to promote vasodilation; prostacyclin analogs that mimic prostacyclin to dilate blood vessels and inhibit platelet aggregation; and soluble guanylate cyclase stimulators that increase cyclic GMP to relax pulmonary arteries. Sotatercept, a ligand trap for activins and growth differentiation factors in the TGF-β superfamily, targets vascular remodeling and inflammation. These treatments are vital for PAH patients as they address the underlying mechanisms of the disease, improving hemodynamics, exercise capacity, and quality of life.

Direct Extracellular NAMPT Involvement in Pulmonary Hypertension and Vascular Remodeling. Transcriptional Regulation by SOX and HIF-2α.Therapeutic Monoclonal Antibody Antagonizing Endothelin Receptor A for Pulmonary Arterial Hypertension.Double-blind, placebo-controlled clinical trial with a rho-kinase inhibitor in pulmonary arterial hypertension.